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CDC Seeks Public Input on Tough Vaccine Decisions
At the next meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), the group will need to decide whether to recommend routine meningococcal conjugate vaccine (MCV) use in infants. Because other federal committees recently suggested that the CDC engage the public before such decisions, the agency developed a new information-gathering process involving consumers. This took the form of focus group meetings designed to be open and to elicit input from those who might hold differing opinions about vaccines.
Over the summer, four pilot group meetings were held in Concord N.H., Chicago, Seattle, and Denver. There were about 100 attendees in Chicago and Seattle, and about half that number each in New Hampshire and Denver. Participants included provaccine groups such as the Meningitis Angels, who passionately support routine meningococcal immunization for young infants, representatives of the antivaccine group, who call themselves the National Vaccine Information Center, as well as more or less "neutral" individuals recruited through local health departments. They were asked a series of hypothetical questions about their opinions on use of new/future vaccines and the extent that they’d be willing to support and pay for such vaccines. The answers would likely apply to MCV.
Insights from these focus groups will likely play a role in ACIP’s October discussions of routine infant immunization against meningococcal disease. The decision is complicated because of three potentially competing vaccine formulations that are not currently interchangeable and with potentially different schedules:
• Sanofi-Pasteur’s MenACWY-D (Menactra) is currently licensed starting at 9 months of age in select high-risk groups, but could be expanded to all infants.
• Novartis’ MenACWY-CRM (Menveo) was recently approved for children ages 2 years and above, but is before the U.S. Food and Drug Administration (FDA) for licensure at 2, 4, and 6 months of age.
• A not yet licensed GlaxoSmithKline’s HibMenCY (MenHibRix) is a combination vaccine containing Haemophilus influenzae type b and meningococcal type A and C antigens. GSK is seeking licensure for use down to 2 months of age.
In June, ACIP recommended Sanofi-Pasteur’s quadrivalent MenACWY-D for specific high-risk children aged 9-23 months, such as travelers to meningococcal disease-endemic areas, infants with complement deficiencies, those in outbreak situations, and HIV-infected infants with other indications for vaccination. The committee postponed voting on whether 9- to 23-month-olds with functional or anatomic asplenia, including sickle cell disease, should receive this vaccine. This was due to data that pneumococcal geometric mean titers were reduced when MenACWY-D was given at the same time as pneumococcal conjugate vaccine (PCV-7). The clinical impact of such lower titers (that are still in the protective range) are unclear, but pneumococcus is a higher threat than meningococcus for these groups.
So what is the rationale for waiting until 9 months of age to begin MCV? For one, it avoids the need for a potential extra injection at 2, 4, and 6 months, and there are only two, not four doses. Also, none of the candidate MCVs contains meningococcal serotype B, the most common serotype affecting children less than 3 years of age. Several manufacturers are working on a B serogroup vaccine, which is years away from release. Lastly, the absolute number of annually prevented deaths (about five per year) would be relatively small among those less than 9 months of age.
What is the rationale for giving MCV at 2 months of age? Because children aged less than 3 years have the highest attack rate for invasive meningococcal disease (about 50% serogroup B and 50% of the other serogroups combined), it also makes sense to start MCV as early as possible to maximize reduction of nonserogroup-B invasive meningococcal disease. And if one used the GSK combo DTaP-Hep B- IPV vaccine plus Hib MenCY, there would not be additional injections at 2, 4, and 6 months.
So if the licensures for use in 2-month-olds come through soon as is expected, ACIP will need to address routine infant MCV immunization. Consider the complexity. It’s unlikely that Sanofi’s MenACWY-D will be licensed for this age soon, so it remains a candidate only for routine first dosing at 9 months of age. It would become almost obsolete if ACIP recommends routine 2, 4, and 6 month MCV dosing. However, a 2, 4, and 6 month recommendation raises added questions. Should the GSK HibMenCY be preferred over the Novartis MenACWY-CRM (which does not contain Hib) if both are FDA approved for 2-month-olds? And what impact would use of HibMenCY have on the use of Sanofi’s combo DTaP-Hib-IPV vaccine? You wouldn’t use HibMenCY with DTaP-Hib-IPV, because that would be a double dose of Hib vaccine.
So which approach would you use in your practice? It is something to consider. If ACIP recommends both for initial dosing at 2 months, vaccine buying groups may be making decisions for clinicians based on price and package deals. Regardless, it will further complicate the vaccine schedule. And if it is complicated for us, parents are going to be even less likely to understand if their child is "up to date."
The CDC organized the focus groups to help inform those decisions. One question was "Which type of disease do you think should be given priority when it comes to developing new vaccines?" Choices were those diseases that affect many people but aren’t severe; those that are relatively rare but if contracted can cause severe disability or death; or equal priority for both. The attendees had varied opinions, but 26% in Concord and 59% in Seattle chose the rare/severe option, while 34% in Chicago to 48% in Concord chose "equal priority for both."
They also asked, "How many children need to get a severe illness in a typical year in the United States to make it a good idea that children be vaccinated?" Options were 1 in 100, 1 in 1,000, 1 in 10,000, 1 in 100,000, or 1 in 1 million. While each option was picked by at least some participants, the 1 in 100 option was a frequent choice, ranging from 23% in Denver to 57% in Chicago.
When asked what they believed ACIP should recommend for MCV, most – ranging from 53% in Seattle to 86% in Chicago – chose "add the meningococcal vaccine to the schedule for infants/children, and recommend all children be vaccinated." The other choices were less popular. The "no ACIP or CDC recommendation, but add to the Vaccines for Children program" was chosen by 8%-31%, and "no ACIP/CDC recommendation and do not add to the VFC program" was chosen by 7%-21%.
And as for what they would be willing to pay out of pocket, the largest subset in Chicago (44%) and Concord (53%) agreed to pay the highest priced option for those cities (more than $150), while in Denver and Seattle, 31% and 34%, respectively, actually appeared willing to pay more than $500.
Of course, these are very small samples of likely biased data from subsets of the public having high interest in vaccines (positive or negative attitudes). Still, I think it’s a very interesting new direction the CDC has taken to elicit this kind of information when planning to discuss difficult vaccine policy decisions. At the very least, it improves transparency, which should hopefully help us when talking with our patients about new vaccine recommendations and the complicated schedules, whatever they may be.
Dr. Christopher J. Harrison is a professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. Dr. Harrison receives grant funding from GlaxoSmithKline for research trials of MMR.
At the next meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), the group will need to decide whether to recommend routine meningococcal conjugate vaccine (MCV) use in infants. Because other federal committees recently suggested that the CDC engage the public before such decisions, the agency developed a new information-gathering process involving consumers. This took the form of focus group meetings designed to be open and to elicit input from those who might hold differing opinions about vaccines.
Over the summer, four pilot group meetings were held in Concord N.H., Chicago, Seattle, and Denver. There were about 100 attendees in Chicago and Seattle, and about half that number each in New Hampshire and Denver. Participants included provaccine groups such as the Meningitis Angels, who passionately support routine meningococcal immunization for young infants, representatives of the antivaccine group, who call themselves the National Vaccine Information Center, as well as more or less "neutral" individuals recruited through local health departments. They were asked a series of hypothetical questions about their opinions on use of new/future vaccines and the extent that they’d be willing to support and pay for such vaccines. The answers would likely apply to MCV.
Insights from these focus groups will likely play a role in ACIP’s October discussions of routine infant immunization against meningococcal disease. The decision is complicated because of three potentially competing vaccine formulations that are not currently interchangeable and with potentially different schedules:
• Sanofi-Pasteur’s MenACWY-D (Menactra) is currently licensed starting at 9 months of age in select high-risk groups, but could be expanded to all infants.
• Novartis’ MenACWY-CRM (Menveo) was recently approved for children ages 2 years and above, but is before the U.S. Food and Drug Administration (FDA) for licensure at 2, 4, and 6 months of age.
• A not yet licensed GlaxoSmithKline’s HibMenCY (MenHibRix) is a combination vaccine containing Haemophilus influenzae type b and meningococcal type A and C antigens. GSK is seeking licensure for use down to 2 months of age.
In June, ACIP recommended Sanofi-Pasteur’s quadrivalent MenACWY-D for specific high-risk children aged 9-23 months, such as travelers to meningococcal disease-endemic areas, infants with complement deficiencies, those in outbreak situations, and HIV-infected infants with other indications for vaccination. The committee postponed voting on whether 9- to 23-month-olds with functional or anatomic asplenia, including sickle cell disease, should receive this vaccine. This was due to data that pneumococcal geometric mean titers were reduced when MenACWY-D was given at the same time as pneumococcal conjugate vaccine (PCV-7). The clinical impact of such lower titers (that are still in the protective range) are unclear, but pneumococcus is a higher threat than meningococcus for these groups.
So what is the rationale for waiting until 9 months of age to begin MCV? For one, it avoids the need for a potential extra injection at 2, 4, and 6 months, and there are only two, not four doses. Also, none of the candidate MCVs contains meningococcal serotype B, the most common serotype affecting children less than 3 years of age. Several manufacturers are working on a B serogroup vaccine, which is years away from release. Lastly, the absolute number of annually prevented deaths (about five per year) would be relatively small among those less than 9 months of age.
What is the rationale for giving MCV at 2 months of age? Because children aged less than 3 years have the highest attack rate for invasive meningococcal disease (about 50% serogroup B and 50% of the other serogroups combined), it also makes sense to start MCV as early as possible to maximize reduction of nonserogroup-B invasive meningococcal disease. And if one used the GSK combo DTaP-Hep B- IPV vaccine plus Hib MenCY, there would not be additional injections at 2, 4, and 6 months.
So if the licensures for use in 2-month-olds come through soon as is expected, ACIP will need to address routine infant MCV immunization. Consider the complexity. It’s unlikely that Sanofi’s MenACWY-D will be licensed for this age soon, so it remains a candidate only for routine first dosing at 9 months of age. It would become almost obsolete if ACIP recommends routine 2, 4, and 6 month MCV dosing. However, a 2, 4, and 6 month recommendation raises added questions. Should the GSK HibMenCY be preferred over the Novartis MenACWY-CRM (which does not contain Hib) if both are FDA approved for 2-month-olds? And what impact would use of HibMenCY have on the use of Sanofi’s combo DTaP-Hib-IPV vaccine? You wouldn’t use HibMenCY with DTaP-Hib-IPV, because that would be a double dose of Hib vaccine.
So which approach would you use in your practice? It is something to consider. If ACIP recommends both for initial dosing at 2 months, vaccine buying groups may be making decisions for clinicians based on price and package deals. Regardless, it will further complicate the vaccine schedule. And if it is complicated for us, parents are going to be even less likely to understand if their child is "up to date."
The CDC organized the focus groups to help inform those decisions. One question was "Which type of disease do you think should be given priority when it comes to developing new vaccines?" Choices were those diseases that affect many people but aren’t severe; those that are relatively rare but if contracted can cause severe disability or death; or equal priority for both. The attendees had varied opinions, but 26% in Concord and 59% in Seattle chose the rare/severe option, while 34% in Chicago to 48% in Concord chose "equal priority for both."
They also asked, "How many children need to get a severe illness in a typical year in the United States to make it a good idea that children be vaccinated?" Options were 1 in 100, 1 in 1,000, 1 in 10,000, 1 in 100,000, or 1 in 1 million. While each option was picked by at least some participants, the 1 in 100 option was a frequent choice, ranging from 23% in Denver to 57% in Chicago.
When asked what they believed ACIP should recommend for MCV, most – ranging from 53% in Seattle to 86% in Chicago – chose "add the meningococcal vaccine to the schedule for infants/children, and recommend all children be vaccinated." The other choices were less popular. The "no ACIP or CDC recommendation, but add to the Vaccines for Children program" was chosen by 8%-31%, and "no ACIP/CDC recommendation and do not add to the VFC program" was chosen by 7%-21%.
And as for what they would be willing to pay out of pocket, the largest subset in Chicago (44%) and Concord (53%) agreed to pay the highest priced option for those cities (more than $150), while in Denver and Seattle, 31% and 34%, respectively, actually appeared willing to pay more than $500.
Of course, these are very small samples of likely biased data from subsets of the public having high interest in vaccines (positive or negative attitudes). Still, I think it’s a very interesting new direction the CDC has taken to elicit this kind of information when planning to discuss difficult vaccine policy decisions. At the very least, it improves transparency, which should hopefully help us when talking with our patients about new vaccine recommendations and the complicated schedules, whatever they may be.
Dr. Christopher J. Harrison is a professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. Dr. Harrison receives grant funding from GlaxoSmithKline for research trials of MMR.
At the next meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), the group will need to decide whether to recommend routine meningococcal conjugate vaccine (MCV) use in infants. Because other federal committees recently suggested that the CDC engage the public before such decisions, the agency developed a new information-gathering process involving consumers. This took the form of focus group meetings designed to be open and to elicit input from those who might hold differing opinions about vaccines.
Over the summer, four pilot group meetings were held in Concord N.H., Chicago, Seattle, and Denver. There were about 100 attendees in Chicago and Seattle, and about half that number each in New Hampshire and Denver. Participants included provaccine groups such as the Meningitis Angels, who passionately support routine meningococcal immunization for young infants, representatives of the antivaccine group, who call themselves the National Vaccine Information Center, as well as more or less "neutral" individuals recruited through local health departments. They were asked a series of hypothetical questions about their opinions on use of new/future vaccines and the extent that they’d be willing to support and pay for such vaccines. The answers would likely apply to MCV.
Insights from these focus groups will likely play a role in ACIP’s October discussions of routine infant immunization against meningococcal disease. The decision is complicated because of three potentially competing vaccine formulations that are not currently interchangeable and with potentially different schedules:
• Sanofi-Pasteur’s MenACWY-D (Menactra) is currently licensed starting at 9 months of age in select high-risk groups, but could be expanded to all infants.
• Novartis’ MenACWY-CRM (Menveo) was recently approved for children ages 2 years and above, but is before the U.S. Food and Drug Administration (FDA) for licensure at 2, 4, and 6 months of age.
• A not yet licensed GlaxoSmithKline’s HibMenCY (MenHibRix) is a combination vaccine containing Haemophilus influenzae type b and meningococcal type A and C antigens. GSK is seeking licensure for use down to 2 months of age.
In June, ACIP recommended Sanofi-Pasteur’s quadrivalent MenACWY-D for specific high-risk children aged 9-23 months, such as travelers to meningococcal disease-endemic areas, infants with complement deficiencies, those in outbreak situations, and HIV-infected infants with other indications for vaccination. The committee postponed voting on whether 9- to 23-month-olds with functional or anatomic asplenia, including sickle cell disease, should receive this vaccine. This was due to data that pneumococcal geometric mean titers were reduced when MenACWY-D was given at the same time as pneumococcal conjugate vaccine (PCV-7). The clinical impact of such lower titers (that are still in the protective range) are unclear, but pneumococcus is a higher threat than meningococcus for these groups.
So what is the rationale for waiting until 9 months of age to begin MCV? For one, it avoids the need for a potential extra injection at 2, 4, and 6 months, and there are only two, not four doses. Also, none of the candidate MCVs contains meningococcal serotype B, the most common serotype affecting children less than 3 years of age. Several manufacturers are working on a B serogroup vaccine, which is years away from release. Lastly, the absolute number of annually prevented deaths (about five per year) would be relatively small among those less than 9 months of age.
What is the rationale for giving MCV at 2 months of age? Because children aged less than 3 years have the highest attack rate for invasive meningococcal disease (about 50% serogroup B and 50% of the other serogroups combined), it also makes sense to start MCV as early as possible to maximize reduction of nonserogroup-B invasive meningococcal disease. And if one used the GSK combo DTaP-Hep B- IPV vaccine plus Hib MenCY, there would not be additional injections at 2, 4, and 6 months.
So if the licensures for use in 2-month-olds come through soon as is expected, ACIP will need to address routine infant MCV immunization. Consider the complexity. It’s unlikely that Sanofi’s MenACWY-D will be licensed for this age soon, so it remains a candidate only for routine first dosing at 9 months of age. It would become almost obsolete if ACIP recommends routine 2, 4, and 6 month MCV dosing. However, a 2, 4, and 6 month recommendation raises added questions. Should the GSK HibMenCY be preferred over the Novartis MenACWY-CRM (which does not contain Hib) if both are FDA approved for 2-month-olds? And what impact would use of HibMenCY have on the use of Sanofi’s combo DTaP-Hib-IPV vaccine? You wouldn’t use HibMenCY with DTaP-Hib-IPV, because that would be a double dose of Hib vaccine.
So which approach would you use in your practice? It is something to consider. If ACIP recommends both for initial dosing at 2 months, vaccine buying groups may be making decisions for clinicians based on price and package deals. Regardless, it will further complicate the vaccine schedule. And if it is complicated for us, parents are going to be even less likely to understand if their child is "up to date."
The CDC organized the focus groups to help inform those decisions. One question was "Which type of disease do you think should be given priority when it comes to developing new vaccines?" Choices were those diseases that affect many people but aren’t severe; those that are relatively rare but if contracted can cause severe disability or death; or equal priority for both. The attendees had varied opinions, but 26% in Concord and 59% in Seattle chose the rare/severe option, while 34% in Chicago to 48% in Concord chose "equal priority for both."
They also asked, "How many children need to get a severe illness in a typical year in the United States to make it a good idea that children be vaccinated?" Options were 1 in 100, 1 in 1,000, 1 in 10,000, 1 in 100,000, or 1 in 1 million. While each option was picked by at least some participants, the 1 in 100 option was a frequent choice, ranging from 23% in Denver to 57% in Chicago.
When asked what they believed ACIP should recommend for MCV, most – ranging from 53% in Seattle to 86% in Chicago – chose "add the meningococcal vaccine to the schedule for infants/children, and recommend all children be vaccinated." The other choices were less popular. The "no ACIP or CDC recommendation, but add to the Vaccines for Children program" was chosen by 8%-31%, and "no ACIP/CDC recommendation and do not add to the VFC program" was chosen by 7%-21%.
And as for what they would be willing to pay out of pocket, the largest subset in Chicago (44%) and Concord (53%) agreed to pay the highest priced option for those cities (more than $150), while in Denver and Seattle, 31% and 34%, respectively, actually appeared willing to pay more than $500.
Of course, these are very small samples of likely biased data from subsets of the public having high interest in vaccines (positive or negative attitudes). Still, I think it’s a very interesting new direction the CDC has taken to elicit this kind of information when planning to discuss difficult vaccine policy decisions. At the very least, it improves transparency, which should hopefully help us when talking with our patients about new vaccine recommendations and the complicated schedules, whatever they may be.
Dr. Christopher J. Harrison is a professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. Dr. Harrison receives grant funding from GlaxoSmithKline for research trials of MMR.
Watch for Foodborne Illness
The recent Escherichia coli outbreak in Germany reminds us yet again about the threat of foodborne illness and the need for awareness about the clinical manifestations, the treatment, and the public health implications. On June 14, a 2-year-old boy became the first child and the 37th person to die in Germany's ongoing E. coli outbreak. Here in the United States, the Centers for Disease Control and Prevention estimates 48 million people – 1 in every 6 Americans – become ill, 128,000 are hospitalized, and 3,000 die of foodborne illness annually. About half of all foodborne illness occurs in children, who are particularly vulnerable because of their immature immune systems, lower body weight, and reduced stomach acid production.
Norovirus has become the most common recognized foodborne pathogen, causing about 5 million illnesses a year, followed by nontyphoidal Salmonella, with just over 1 million annual cases, and Clostridium perfringens, at just under 1 million, according to the CDC. Norovirus illness is usually mild, but it did cause an estimated 149 annual deaths. Nontyphoidal Salmonella is the most common serious cause of foodborne illness with an estimated 378 annual deaths, followed by Toxoplasma gondii (327 deaths) and Listeria monocytogenes (255 deaths).
The following foodborne illnesses are frequent causes of morbidity in children. Information on the possible foodborne sources and the effects of infection are from a report compiled by the Pew Health Group in collaboration with the Center for Foodborne Illness Research and Prevention.
▸ Salmonella. These infections occur in approximately 75 children/100,000 under age 4 years, according to the CDC. It is commonly associated with foods of animal origin, including beef, poultry, milk, and eggs, or cross-contamination from these with other foods. Typical symptoms include diarrhea, fever, and abdominal cramps. More serious short-term manifestations can include colitis, meningitis, septicemia, and death. Treatment involves rehydration as needed.
In general, antibiotic therapy is not warranted, but in immunocompromised hosts and children younger than age 6 months, antimicrobial therapy may be beneficial. In such settings, ceftriaxone is effective when susceptible, specifically in high-risk populations.
▸ Shigella. This infection occurs in about 28/100,000 children under age 4 years and 26/100,000 for those aged 4-11 years, according to the CDC. It is often associated with vegetables harvested in fields contaminated with sewage; flies that breed in infected feces and contaminate the food; and drinking, swimming, or playing in contaminated water. Short-term effects include high fever, diarrhea that is often bloody, stomach cramps, and seizures in children less than age 2 years. Reactive or chronic arthritis can be a postinfectious sequelae.
Treatment includes rehydration as necessary, and antibiotics for severe disease or dysentery, particularly in those with underlying immunosuppression. Ceftriaxone and ciprofloxacin are effective, although the latter is not licensed for use in young children. Resistance to amoxicillin and trimethoprim-sulfamethoxazole (TMP-SMZ) is common. Treatment of mild cases may be indicated to shorten the duration of excretion.
▸ Campylobacter. This infection affects 29/100,000 children under age 4 years, similar in incidence to Shigella. Foodborne sources included raw or undercooked poultry or foods cross-contaminated by poultry, unpasteurized milk, and contaminated water. Symptoms include diarrhea (sometimes bloody), cramping, abdominal pain, urinary tract infection, fever, and meningitis. Campylobacter is also associated with Guillain-Barré syndrome or reactive/chronic arthritis. Again, treatment involves rehydration as necessary. Macrolides (azithromycin or erythromycin) can shorten duration of illness and prevent relapse.
▸ E. coli or other shiga toxin–producing strains. This foodborne infection has been in the headlines lately, and affects about 4/100,000 children between 4 and 11 years of age. Typical food sources include ground beef and other meats, green leafy vegetables, unpasteurized juices or raw milk, or soft cheeses made from raw milk. Symptoms include severe stomach cramps, diarrhea (often bloody), and vomiting. Hemolytic-uremic syndrome occurs in about 15% of children with E. coli 0157:H7 infection. This can result in long-term kidney damage as well as death.
In general, antibiotics have not been shown to benefit patients. Early reports of increased risk of hemolytic-uremic syndrome with antibiotic treatment have not been confirmed. As with the others, rehydration and supportive therapy are the mainstays of treatment.
▸ Listeria. This infection occurs in about 0.76/100,000 children under age 4 years, according to the CDC. About one-third of all cases involve pregnant women. Common food sources include uncooked meats, particularly cold cuts and hot dogs, as well as smoked seafood, raw milk, soft cheeses made from raw milk, and vegetables grown in contaminated soil or fertilizer. Symptoms include fever, muscle aches, nausea, and diarrhea. Headaches, stiff neck, confusion, loss of balance, and seizures can result if infection spreads to the nervous system.
For invasive disease, ampicillin plus an aminoglycoside is recommended. For penicillin-allergic patients, TMP-SMZ or high-dose vancomycin can be used. Cephalosporins are generally inactive. In the majority of patients with febrile gastroenteritis, the illness is self-limited (typical duration, 2 days or less) and therefore, generally no antibiotic treatment is necessary.
In pregnant women, listerial febrile gastroenteritis can lead to fetal death, premature birth, or infected newborns. Oral ampicillin or TMP-SMZ can be given for several days in immunocompromised or pregnant patients with listerial febrile gastroenteritis, particularly if they are still symptomatic once the culture result is known.
The recent Escherichia coli outbreak in Germany reminds us yet again about the threat of foodborne illness and the need for awareness about the clinical manifestations, the treatment, and the public health implications. On June 14, a 2-year-old boy became the first child and the 37th person to die in Germany's ongoing E. coli outbreak. Here in the United States, the Centers for Disease Control and Prevention estimates 48 million people – 1 in every 6 Americans – become ill, 128,000 are hospitalized, and 3,000 die of foodborne illness annually. About half of all foodborne illness occurs in children, who are particularly vulnerable because of their immature immune systems, lower body weight, and reduced stomach acid production.
Norovirus has become the most common recognized foodborne pathogen, causing about 5 million illnesses a year, followed by nontyphoidal Salmonella, with just over 1 million annual cases, and Clostridium perfringens, at just under 1 million, according to the CDC. Norovirus illness is usually mild, but it did cause an estimated 149 annual deaths. Nontyphoidal Salmonella is the most common serious cause of foodborne illness with an estimated 378 annual deaths, followed by Toxoplasma gondii (327 deaths) and Listeria monocytogenes (255 deaths).
The following foodborne illnesses are frequent causes of morbidity in children. Information on the possible foodborne sources and the effects of infection are from a report compiled by the Pew Health Group in collaboration with the Center for Foodborne Illness Research and Prevention.
▸ Salmonella. These infections occur in approximately 75 children/100,000 under age 4 years, according to the CDC. It is commonly associated with foods of animal origin, including beef, poultry, milk, and eggs, or cross-contamination from these with other foods. Typical symptoms include diarrhea, fever, and abdominal cramps. More serious short-term manifestations can include colitis, meningitis, septicemia, and death. Treatment involves rehydration as needed.
In general, antibiotic therapy is not warranted, but in immunocompromised hosts and children younger than age 6 months, antimicrobial therapy may be beneficial. In such settings, ceftriaxone is effective when susceptible, specifically in high-risk populations.
▸ Shigella. This infection occurs in about 28/100,000 children under age 4 years and 26/100,000 for those aged 4-11 years, according to the CDC. It is often associated with vegetables harvested in fields contaminated with sewage; flies that breed in infected feces and contaminate the food; and drinking, swimming, or playing in contaminated water. Short-term effects include high fever, diarrhea that is often bloody, stomach cramps, and seizures in children less than age 2 years. Reactive or chronic arthritis can be a postinfectious sequelae.
Treatment includes rehydration as necessary, and antibiotics for severe disease or dysentery, particularly in those with underlying immunosuppression. Ceftriaxone and ciprofloxacin are effective, although the latter is not licensed for use in young children. Resistance to amoxicillin and trimethoprim-sulfamethoxazole (TMP-SMZ) is common. Treatment of mild cases may be indicated to shorten the duration of excretion.
▸ Campylobacter. This infection affects 29/100,000 children under age 4 years, similar in incidence to Shigella. Foodborne sources included raw or undercooked poultry or foods cross-contaminated by poultry, unpasteurized milk, and contaminated water. Symptoms include diarrhea (sometimes bloody), cramping, abdominal pain, urinary tract infection, fever, and meningitis. Campylobacter is also associated with Guillain-Barré syndrome or reactive/chronic arthritis. Again, treatment involves rehydration as necessary. Macrolides (azithromycin or erythromycin) can shorten duration of illness and prevent relapse.
▸ E. coli or other shiga toxin–producing strains. This foodborne infection has been in the headlines lately, and affects about 4/100,000 children between 4 and 11 years of age. Typical food sources include ground beef and other meats, green leafy vegetables, unpasteurized juices or raw milk, or soft cheeses made from raw milk. Symptoms include severe stomach cramps, diarrhea (often bloody), and vomiting. Hemolytic-uremic syndrome occurs in about 15% of children with E. coli 0157:H7 infection. This can result in long-term kidney damage as well as death.
In general, antibiotics have not been shown to benefit patients. Early reports of increased risk of hemolytic-uremic syndrome with antibiotic treatment have not been confirmed. As with the others, rehydration and supportive therapy are the mainstays of treatment.
▸ Listeria. This infection occurs in about 0.76/100,000 children under age 4 years, according to the CDC. About one-third of all cases involve pregnant women. Common food sources include uncooked meats, particularly cold cuts and hot dogs, as well as smoked seafood, raw milk, soft cheeses made from raw milk, and vegetables grown in contaminated soil or fertilizer. Symptoms include fever, muscle aches, nausea, and diarrhea. Headaches, stiff neck, confusion, loss of balance, and seizures can result if infection spreads to the nervous system.
For invasive disease, ampicillin plus an aminoglycoside is recommended. For penicillin-allergic patients, TMP-SMZ or high-dose vancomycin can be used. Cephalosporins are generally inactive. In the majority of patients with febrile gastroenteritis, the illness is self-limited (typical duration, 2 days or less) and therefore, generally no antibiotic treatment is necessary.
In pregnant women, listerial febrile gastroenteritis can lead to fetal death, premature birth, or infected newborns. Oral ampicillin or TMP-SMZ can be given for several days in immunocompromised or pregnant patients with listerial febrile gastroenteritis, particularly if they are still symptomatic once the culture result is known.
The recent Escherichia coli outbreak in Germany reminds us yet again about the threat of foodborne illness and the need for awareness about the clinical manifestations, the treatment, and the public health implications. On June 14, a 2-year-old boy became the first child and the 37th person to die in Germany's ongoing E. coli outbreak. Here in the United States, the Centers for Disease Control and Prevention estimates 48 million people – 1 in every 6 Americans – become ill, 128,000 are hospitalized, and 3,000 die of foodborne illness annually. About half of all foodborne illness occurs in children, who are particularly vulnerable because of their immature immune systems, lower body weight, and reduced stomach acid production.
Norovirus has become the most common recognized foodborne pathogen, causing about 5 million illnesses a year, followed by nontyphoidal Salmonella, with just over 1 million annual cases, and Clostridium perfringens, at just under 1 million, according to the CDC. Norovirus illness is usually mild, but it did cause an estimated 149 annual deaths. Nontyphoidal Salmonella is the most common serious cause of foodborne illness with an estimated 378 annual deaths, followed by Toxoplasma gondii (327 deaths) and Listeria monocytogenes (255 deaths).
The following foodborne illnesses are frequent causes of morbidity in children. Information on the possible foodborne sources and the effects of infection are from a report compiled by the Pew Health Group in collaboration with the Center for Foodborne Illness Research and Prevention.
▸ Salmonella. These infections occur in approximately 75 children/100,000 under age 4 years, according to the CDC. It is commonly associated with foods of animal origin, including beef, poultry, milk, and eggs, or cross-contamination from these with other foods. Typical symptoms include diarrhea, fever, and abdominal cramps. More serious short-term manifestations can include colitis, meningitis, septicemia, and death. Treatment involves rehydration as needed.
In general, antibiotic therapy is not warranted, but in immunocompromised hosts and children younger than age 6 months, antimicrobial therapy may be beneficial. In such settings, ceftriaxone is effective when susceptible, specifically in high-risk populations.
▸ Shigella. This infection occurs in about 28/100,000 children under age 4 years and 26/100,000 for those aged 4-11 years, according to the CDC. It is often associated with vegetables harvested in fields contaminated with sewage; flies that breed in infected feces and contaminate the food; and drinking, swimming, or playing in contaminated water. Short-term effects include high fever, diarrhea that is often bloody, stomach cramps, and seizures in children less than age 2 years. Reactive or chronic arthritis can be a postinfectious sequelae.
Treatment includes rehydration as necessary, and antibiotics for severe disease or dysentery, particularly in those with underlying immunosuppression. Ceftriaxone and ciprofloxacin are effective, although the latter is not licensed for use in young children. Resistance to amoxicillin and trimethoprim-sulfamethoxazole (TMP-SMZ) is common. Treatment of mild cases may be indicated to shorten the duration of excretion.
▸ Campylobacter. This infection affects 29/100,000 children under age 4 years, similar in incidence to Shigella. Foodborne sources included raw or undercooked poultry or foods cross-contaminated by poultry, unpasteurized milk, and contaminated water. Symptoms include diarrhea (sometimes bloody), cramping, abdominal pain, urinary tract infection, fever, and meningitis. Campylobacter is also associated with Guillain-Barré syndrome or reactive/chronic arthritis. Again, treatment involves rehydration as necessary. Macrolides (azithromycin or erythromycin) can shorten duration of illness and prevent relapse.
▸ E. coli or other shiga toxin–producing strains. This foodborne infection has been in the headlines lately, and affects about 4/100,000 children between 4 and 11 years of age. Typical food sources include ground beef and other meats, green leafy vegetables, unpasteurized juices or raw milk, or soft cheeses made from raw milk. Symptoms include severe stomach cramps, diarrhea (often bloody), and vomiting. Hemolytic-uremic syndrome occurs in about 15% of children with E. coli 0157:H7 infection. This can result in long-term kidney damage as well as death.
In general, antibiotics have not been shown to benefit patients. Early reports of increased risk of hemolytic-uremic syndrome with antibiotic treatment have not been confirmed. As with the others, rehydration and supportive therapy are the mainstays of treatment.
▸ Listeria. This infection occurs in about 0.76/100,000 children under age 4 years, according to the CDC. About one-third of all cases involve pregnant women. Common food sources include uncooked meats, particularly cold cuts and hot dogs, as well as smoked seafood, raw milk, soft cheeses made from raw milk, and vegetables grown in contaminated soil or fertilizer. Symptoms include fever, muscle aches, nausea, and diarrhea. Headaches, stiff neck, confusion, loss of balance, and seizures can result if infection spreads to the nervous system.
For invasive disease, ampicillin plus an aminoglycoside is recommended. For penicillin-allergic patients, TMP-SMZ or high-dose vancomycin can be used. Cephalosporins are generally inactive. In the majority of patients with febrile gastroenteritis, the illness is self-limited (typical duration, 2 days or less) and therefore, generally no antibiotic treatment is necessary.
In pregnant women, listerial febrile gastroenteritis can lead to fetal death, premature birth, or infected newborns. Oral ampicillin or TMP-SMZ can be given for several days in immunocompromised or pregnant patients with listerial febrile gastroenteritis, particularly if they are still symptomatic once the culture result is known.
Unreliable Herd Immunity Leads to More Measles
The Centers for Disease Control and Prevention's summary of the alarming 118 U.S. cases of measles in 2011 reports that nearly all were caused by scattered inadvertent measles introduction from measles-endemic countries. This importation resulted from U.S. residents returning or immigrants coming from endemic countries. A dozen or so imported cases of measles are not unexpected or new. Every year, cases of imported measles occur.
So why is there an increase in the number of transmitted cases in the United States? Increased vulnerability to ongoing transmission is now possible because herd immunity has become unreliable.
Herd immunity in the past was often discussed in the context of protecting the less than 5% of the community who are too young (less than 12 months old) to receive MMR vaccine or who have true contraindications to vaccine. For measles, reliable herd immunity requires approximately 90% of the community to be immune to measles. To achieve this, we need 95% of the community immunized because approximately 5% of immunized children fail to become immune from a single immunization.
This became clear during the 1990s measles outbreaks and led to a recommendation for two doses, the second dose at 4–6 years of age. That controlled measles outbreaks until the past 2 years, when measles has been increasingly reported. Partly, this is due to the increase in the number of countries with endemic measles, including developed countries, most notably France, as reported in MMWR (2011:60;666-8). So the number of imported cases likely increased. But if herd immunity is strong, secondary cases should not be frequent.
What is new, and has directly led to many cases, is an increase in the number of geographic clusters of unvaccinated children due to parents delaying or refusing measles vaccine. In those areas, secondary cases are occurring at a rate not seen in decades. It's not that the overall national measles immunization rate is that much lower. The overall rate of one dose of MMR vaccine is near 90%, and two-dose coverage is around 80%.
The problem is that the extra geographically clustered 5% who choose to delay or avoid MMR vaccine permit transmission from imported cases mostly among unvaccinated children. In those areas, herd immunity is broken. Just this relatively small shift in local immunization density breaks down herd immunity to measles.
Why is it so? Measles is one of the three most contagious infections, being transmitted via airborne particles. Further, during the first 3 days of measles the presentation is a nonspecific febrile upper respiratory tract infection. So persons with measles often do not restrict their activity and may expose many people via normal activities or even in the reception rooms at medical facilities.
It is not until the third day or perhaps the fourth day of contagion and fever that the classic symptoms of cough, coryza, and nonpurulent conjunctivitis (the 3 C's) begin to appear, along with the beginnings of a maculopapular rash starting on the head. Because most clinicians under 60 years of age have little if any experience with measles, measles may go initially undiagnosed. This leads to additional exposures.
So imported measles added to focal weak spots in herd immunity to measles is the mechanism for increasing measles cases in the United States. Now children whose parents choose to avoid measles vaccine because the disease “is gone” or because of unfounded fears of adverse effects are no longer safe from disease. Note that 105 of the 118 (89%) cases were unvaccinated. And parents who would wish to vaccinate their children but cannot because of age or true contraindication also can no longer rely on herd immunity to protect their children.
This is a call to action. First, we should continue to be strong advocates for on-time MMR vaccination. We are unlikely to convince adamant antivaccine parents, but perhaps we can sway those who are merely conflicted by the false and discredited information promulgated by antivaccine groups.
Second, each of us needs to be aware of whether measles has occurred in our practice area, or in areas where our patients are planning to travel. If there is an expectation of possible exposure, consider administering the second MMR dose anytime more than 1 month after the first dose. And if the child is 9–12 months of age, consider giving a first dose prior to the usual 12 months of age. This will not be a valid dose per current Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics recommendations, but it may save the child from an illness with risks for both immediate and long-term severe pulmonary or neurological complications.
Third, don't miss the disease if it shows up in your patient. Be hypervigilant for the three C's plus high fever, and classic morbilliform rash.
Measles is in the air and until herd immunity is restored, expect cases in every major city in the United States. Hopefully, we as pediatric clinicians, in partnership with our local health departments, can make a difference and minimize these outbreaks.
The Centers for Disease Control and Prevention's summary of the alarming 118 U.S. cases of measles in 2011 reports that nearly all were caused by scattered inadvertent measles introduction from measles-endemic countries. This importation resulted from U.S. residents returning or immigrants coming from endemic countries. A dozen or so imported cases of measles are not unexpected or new. Every year, cases of imported measles occur.
So why is there an increase in the number of transmitted cases in the United States? Increased vulnerability to ongoing transmission is now possible because herd immunity has become unreliable.
Herd immunity in the past was often discussed in the context of protecting the less than 5% of the community who are too young (less than 12 months old) to receive MMR vaccine or who have true contraindications to vaccine. For measles, reliable herd immunity requires approximately 90% of the community to be immune to measles. To achieve this, we need 95% of the community immunized because approximately 5% of immunized children fail to become immune from a single immunization.
This became clear during the 1990s measles outbreaks and led to a recommendation for two doses, the second dose at 4–6 years of age. That controlled measles outbreaks until the past 2 years, when measles has been increasingly reported. Partly, this is due to the increase in the number of countries with endemic measles, including developed countries, most notably France, as reported in MMWR (2011:60;666-8). So the number of imported cases likely increased. But if herd immunity is strong, secondary cases should not be frequent.
What is new, and has directly led to many cases, is an increase in the number of geographic clusters of unvaccinated children due to parents delaying or refusing measles vaccine. In those areas, secondary cases are occurring at a rate not seen in decades. It's not that the overall national measles immunization rate is that much lower. The overall rate of one dose of MMR vaccine is near 90%, and two-dose coverage is around 80%.
The problem is that the extra geographically clustered 5% who choose to delay or avoid MMR vaccine permit transmission from imported cases mostly among unvaccinated children. In those areas, herd immunity is broken. Just this relatively small shift in local immunization density breaks down herd immunity to measles.
Why is it so? Measles is one of the three most contagious infections, being transmitted via airborne particles. Further, during the first 3 days of measles the presentation is a nonspecific febrile upper respiratory tract infection. So persons with measles often do not restrict their activity and may expose many people via normal activities or even in the reception rooms at medical facilities.
It is not until the third day or perhaps the fourth day of contagion and fever that the classic symptoms of cough, coryza, and nonpurulent conjunctivitis (the 3 C's) begin to appear, along with the beginnings of a maculopapular rash starting on the head. Because most clinicians under 60 years of age have little if any experience with measles, measles may go initially undiagnosed. This leads to additional exposures.
So imported measles added to focal weak spots in herd immunity to measles is the mechanism for increasing measles cases in the United States. Now children whose parents choose to avoid measles vaccine because the disease “is gone” or because of unfounded fears of adverse effects are no longer safe from disease. Note that 105 of the 118 (89%) cases were unvaccinated. And parents who would wish to vaccinate their children but cannot because of age or true contraindication also can no longer rely on herd immunity to protect their children.
This is a call to action. First, we should continue to be strong advocates for on-time MMR vaccination. We are unlikely to convince adamant antivaccine parents, but perhaps we can sway those who are merely conflicted by the false and discredited information promulgated by antivaccine groups.
Second, each of us needs to be aware of whether measles has occurred in our practice area, or in areas where our patients are planning to travel. If there is an expectation of possible exposure, consider administering the second MMR dose anytime more than 1 month after the first dose. And if the child is 9–12 months of age, consider giving a first dose prior to the usual 12 months of age. This will not be a valid dose per current Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics recommendations, but it may save the child from an illness with risks for both immediate and long-term severe pulmonary or neurological complications.
Third, don't miss the disease if it shows up in your patient. Be hypervigilant for the three C's plus high fever, and classic morbilliform rash.
Measles is in the air and until herd immunity is restored, expect cases in every major city in the United States. Hopefully, we as pediatric clinicians, in partnership with our local health departments, can make a difference and minimize these outbreaks.
The Centers for Disease Control and Prevention's summary of the alarming 118 U.S. cases of measles in 2011 reports that nearly all were caused by scattered inadvertent measles introduction from measles-endemic countries. This importation resulted from U.S. residents returning or immigrants coming from endemic countries. A dozen or so imported cases of measles are not unexpected or new. Every year, cases of imported measles occur.
So why is there an increase in the number of transmitted cases in the United States? Increased vulnerability to ongoing transmission is now possible because herd immunity has become unreliable.
Herd immunity in the past was often discussed in the context of protecting the less than 5% of the community who are too young (less than 12 months old) to receive MMR vaccine or who have true contraindications to vaccine. For measles, reliable herd immunity requires approximately 90% of the community to be immune to measles. To achieve this, we need 95% of the community immunized because approximately 5% of immunized children fail to become immune from a single immunization.
This became clear during the 1990s measles outbreaks and led to a recommendation for two doses, the second dose at 4–6 years of age. That controlled measles outbreaks until the past 2 years, when measles has been increasingly reported. Partly, this is due to the increase in the number of countries with endemic measles, including developed countries, most notably France, as reported in MMWR (2011:60;666-8). So the number of imported cases likely increased. But if herd immunity is strong, secondary cases should not be frequent.
What is new, and has directly led to many cases, is an increase in the number of geographic clusters of unvaccinated children due to parents delaying or refusing measles vaccine. In those areas, secondary cases are occurring at a rate not seen in decades. It's not that the overall national measles immunization rate is that much lower. The overall rate of one dose of MMR vaccine is near 90%, and two-dose coverage is around 80%.
The problem is that the extra geographically clustered 5% who choose to delay or avoid MMR vaccine permit transmission from imported cases mostly among unvaccinated children. In those areas, herd immunity is broken. Just this relatively small shift in local immunization density breaks down herd immunity to measles.
Why is it so? Measles is one of the three most contagious infections, being transmitted via airborne particles. Further, during the first 3 days of measles the presentation is a nonspecific febrile upper respiratory tract infection. So persons with measles often do not restrict their activity and may expose many people via normal activities or even in the reception rooms at medical facilities.
It is not until the third day or perhaps the fourth day of contagion and fever that the classic symptoms of cough, coryza, and nonpurulent conjunctivitis (the 3 C's) begin to appear, along with the beginnings of a maculopapular rash starting on the head. Because most clinicians under 60 years of age have little if any experience with measles, measles may go initially undiagnosed. This leads to additional exposures.
So imported measles added to focal weak spots in herd immunity to measles is the mechanism for increasing measles cases in the United States. Now children whose parents choose to avoid measles vaccine because the disease “is gone” or because of unfounded fears of adverse effects are no longer safe from disease. Note that 105 of the 118 (89%) cases were unvaccinated. And parents who would wish to vaccinate their children but cannot because of age or true contraindication also can no longer rely on herd immunity to protect their children.
This is a call to action. First, we should continue to be strong advocates for on-time MMR vaccination. We are unlikely to convince adamant antivaccine parents, but perhaps we can sway those who are merely conflicted by the false and discredited information promulgated by antivaccine groups.
Second, each of us needs to be aware of whether measles has occurred in our practice area, or in areas where our patients are planning to travel. If there is an expectation of possible exposure, consider administering the second MMR dose anytime more than 1 month after the first dose. And if the child is 9–12 months of age, consider giving a first dose prior to the usual 12 months of age. This will not be a valid dose per current Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics recommendations, but it may save the child from an illness with risks for both immediate and long-term severe pulmonary or neurological complications.
Third, don't miss the disease if it shows up in your patient. Be hypervigilant for the three C's plus high fever, and classic morbilliform rash.
Measles is in the air and until herd immunity is restored, expect cases in every major city in the United States. Hopefully, we as pediatric clinicians, in partnership with our local health departments, can make a difference and minimize these outbreaks.
Physician, Vaccinate Thyself
As physicians who care for children, it's easy for us to become so focused on vaccinating the children in our practices that we neglect our own immunizations. But it's critically important to get vaccinated, not only for our own sakes but for the sake of our patients.
There have been several additions to the adult immunization schedule in the last few years, so I thought it would be useful to review the ones that pediatricians should consider for themselves, and also consider offering to the parents and other caregivers of our pediatric patients:
▸ Tetanus-diphtheria-acellular pertussis. Most physicians are aware that we're now seeing a resurgence of pertussis around the country. The focus has been on California, but there are other pockets as well that have not received as much attention, including recent outbreaks in Ohio and Michigan. But pertussis is also endemic in the United States, so that although we tend to see peaks every 3 years or so, there is no year when it isn't circulating. Most pediatricians also are aware of and endorse the concept of “cocooning” newborns younger than 6 months of age who have not yet received all three doses of DTaP by vaccinating all the people around the infant, including parents, siblings, grandparents, babysitters, child care providers, and yes, physicians who care for children.
The Tdap vaccine is the adolescent-adult formulation containing the same amount of tetanus and diphtheria as the Td vaccine but with lower amounts of pertussis antigen than the pediatric DTaP. The Centers for Disease Control and Prevention recommends Tdap for adults of any age who have not previously received it (including those aged 65 and older) who are in contact with infants younger than age 12 months, and for health care personnel of all ages, including doctors. Last fall, the CDC removed the 2-year interval requirement, so that now Tdap can be given regardless of the interval since the previous Td. After an adult receives one dose of Tdap, a booster of Td should be given every 10 years thereafter.
I recently asked 10 pediatricians if they had received the Tdap, and 8 said no. They ranged in age from those just out of residency to 68 years. Reasons included simply not getting around to it, thinking they didn't need it, or believing that they were already protected from the DTaP they received in childhood. In fact, immunity against pertussis wanes, and DTwP (whole-cell pertussis) and DTaP vaccines don't last forever, which is part of the reason we're seeing these outbreaks.
▸ Influenza. I meet physicians all the time who tell me they haven't received a flu shot. Older physicians sometimes will cite the fear of Guillain-Barré syndrome that initially arose with the 1976 swine flu vaccine debacle. That fear never really went away, and was reignited with the 2009 vaccine that was rapidly manufactured against pandemic H1N1. Many people, including some physicians, fear that the vaccine was not tested sufficiently before it was brought to market during the pandemic. Of course, most of these same physicians do immunize their patients with the vaccine.
The other reason I hear from physicians for not getting the flu vaccine is the mistaken belief that their immune system is strong enough to resist influenza. Although it may be true that as a group, physicians who see sick people all day long are more resistant to viral infections than is the general population, some still may be susceptible. And those who do contract influenza will be contagious for a few days before symptoms appear, even with the use of antivirals.
▸ Pneumococcus. Currently, the only pneumococcal vaccine recommended for adults is the 23-valent polysaccharide vaccine (Pneumovax). It is recommended for everyone aged 65 and older, and for people younger than 65 years who have chronic illness or other risk factors, including chronic cardiac or pulmonary disease (including asthma), chronic liver disease, alcoholism, diabetes, cerebrospinal fluid leaks, and cigarette smoking, as well as candidates for or recipients of cochlear implants and people living in special environments or social settings (including American Indian/Alaska Natives aged 50–64 years if vaccination is recommended by local public health authorities). Certainly, physicians can fall into most of these groups (although we hope not the smoking category).
But stay tuned for the 13-valent conjugate pneumococcal vaccine to be licensed and recommended for adults aged 50 and older. In December 2010, Pfizer announced that it submitted supplemental applications to both the U.S. Food and Drug Administration and the European Medicines Agency (EMA) to expand the use of Prevnar 13 to adults aged 50 years and older for the prevention of pneumococcal disease caused by the 13 serotypes contained in the vaccine. The FDA is expected to respond in October 2011.
Routine use of the 7-valent pneumococcal conjugate vaccine in infants beginning 11 years ago prevented an estimated 211,000 serious pneumococcal infections and 13,000 deaths during 2000–2008, including those among both children and adults. The switch to PCV13 in 2010 is expected to further reduce disease by covering those extra six strains, particularly 19A. The vaccination of adults aged 50 and older will expand that protection. Once PCV13 is approved for adults aged 50 and older, physicians in that age range should get the vaccine.
▸ Human Papillomavirus. Recommended for all previously unvaccinated women through age 26 years, Gardasil or Cervarix should be considered by all young female physicians. Moreover, although not a strict recommendation, Gardasil (but not Cervarix) is also suggested for men through age 26 years in order to reduce the likelihood of acquiring genital warts. The risk is particularly increased among men who have sex with men. There are physicians who fall into the above categories.
▸ Zoster. The zoster vaccine (Zostavax) is recommended for the prevention of shingles in all adults aged 60 years and older, including physicians.
Physician, vaccinate thyself.
As physicians who care for children, it's easy for us to become so focused on vaccinating the children in our practices that we neglect our own immunizations. But it's critically important to get vaccinated, not only for our own sakes but for the sake of our patients.
There have been several additions to the adult immunization schedule in the last few years, so I thought it would be useful to review the ones that pediatricians should consider for themselves, and also consider offering to the parents and other caregivers of our pediatric patients:
▸ Tetanus-diphtheria-acellular pertussis. Most physicians are aware that we're now seeing a resurgence of pertussis around the country. The focus has been on California, but there are other pockets as well that have not received as much attention, including recent outbreaks in Ohio and Michigan. But pertussis is also endemic in the United States, so that although we tend to see peaks every 3 years or so, there is no year when it isn't circulating. Most pediatricians also are aware of and endorse the concept of “cocooning” newborns younger than 6 months of age who have not yet received all three doses of DTaP by vaccinating all the people around the infant, including parents, siblings, grandparents, babysitters, child care providers, and yes, physicians who care for children.
The Tdap vaccine is the adolescent-adult formulation containing the same amount of tetanus and diphtheria as the Td vaccine but with lower amounts of pertussis antigen than the pediatric DTaP. The Centers for Disease Control and Prevention recommends Tdap for adults of any age who have not previously received it (including those aged 65 and older) who are in contact with infants younger than age 12 months, and for health care personnel of all ages, including doctors. Last fall, the CDC removed the 2-year interval requirement, so that now Tdap can be given regardless of the interval since the previous Td. After an adult receives one dose of Tdap, a booster of Td should be given every 10 years thereafter.
I recently asked 10 pediatricians if they had received the Tdap, and 8 said no. They ranged in age from those just out of residency to 68 years. Reasons included simply not getting around to it, thinking they didn't need it, or believing that they were already protected from the DTaP they received in childhood. In fact, immunity against pertussis wanes, and DTwP (whole-cell pertussis) and DTaP vaccines don't last forever, which is part of the reason we're seeing these outbreaks.
▸ Influenza. I meet physicians all the time who tell me they haven't received a flu shot. Older physicians sometimes will cite the fear of Guillain-Barré syndrome that initially arose with the 1976 swine flu vaccine debacle. That fear never really went away, and was reignited with the 2009 vaccine that was rapidly manufactured against pandemic H1N1. Many people, including some physicians, fear that the vaccine was not tested sufficiently before it was brought to market during the pandemic. Of course, most of these same physicians do immunize their patients with the vaccine.
The other reason I hear from physicians for not getting the flu vaccine is the mistaken belief that their immune system is strong enough to resist influenza. Although it may be true that as a group, physicians who see sick people all day long are more resistant to viral infections than is the general population, some still may be susceptible. And those who do contract influenza will be contagious for a few days before symptoms appear, even with the use of antivirals.
▸ Pneumococcus. Currently, the only pneumococcal vaccine recommended for adults is the 23-valent polysaccharide vaccine (Pneumovax). It is recommended for everyone aged 65 and older, and for people younger than 65 years who have chronic illness or other risk factors, including chronic cardiac or pulmonary disease (including asthma), chronic liver disease, alcoholism, diabetes, cerebrospinal fluid leaks, and cigarette smoking, as well as candidates for or recipients of cochlear implants and people living in special environments or social settings (including American Indian/Alaska Natives aged 50–64 years if vaccination is recommended by local public health authorities). Certainly, physicians can fall into most of these groups (although we hope not the smoking category).
But stay tuned for the 13-valent conjugate pneumococcal vaccine to be licensed and recommended for adults aged 50 and older. In December 2010, Pfizer announced that it submitted supplemental applications to both the U.S. Food and Drug Administration and the European Medicines Agency (EMA) to expand the use of Prevnar 13 to adults aged 50 years and older for the prevention of pneumococcal disease caused by the 13 serotypes contained in the vaccine. The FDA is expected to respond in October 2011.
Routine use of the 7-valent pneumococcal conjugate vaccine in infants beginning 11 years ago prevented an estimated 211,000 serious pneumococcal infections and 13,000 deaths during 2000–2008, including those among both children and adults. The switch to PCV13 in 2010 is expected to further reduce disease by covering those extra six strains, particularly 19A. The vaccination of adults aged 50 and older will expand that protection. Once PCV13 is approved for adults aged 50 and older, physicians in that age range should get the vaccine.
▸ Human Papillomavirus. Recommended for all previously unvaccinated women through age 26 years, Gardasil or Cervarix should be considered by all young female physicians. Moreover, although not a strict recommendation, Gardasil (but not Cervarix) is also suggested for men through age 26 years in order to reduce the likelihood of acquiring genital warts. The risk is particularly increased among men who have sex with men. There are physicians who fall into the above categories.
▸ Zoster. The zoster vaccine (Zostavax) is recommended for the prevention of shingles in all adults aged 60 years and older, including physicians.
Physician, vaccinate thyself.
As physicians who care for children, it's easy for us to become so focused on vaccinating the children in our practices that we neglect our own immunizations. But it's critically important to get vaccinated, not only for our own sakes but for the sake of our patients.
There have been several additions to the adult immunization schedule in the last few years, so I thought it would be useful to review the ones that pediatricians should consider for themselves, and also consider offering to the parents and other caregivers of our pediatric patients:
▸ Tetanus-diphtheria-acellular pertussis. Most physicians are aware that we're now seeing a resurgence of pertussis around the country. The focus has been on California, but there are other pockets as well that have not received as much attention, including recent outbreaks in Ohio and Michigan. But pertussis is also endemic in the United States, so that although we tend to see peaks every 3 years or so, there is no year when it isn't circulating. Most pediatricians also are aware of and endorse the concept of “cocooning” newborns younger than 6 months of age who have not yet received all three doses of DTaP by vaccinating all the people around the infant, including parents, siblings, grandparents, babysitters, child care providers, and yes, physicians who care for children.
The Tdap vaccine is the adolescent-adult formulation containing the same amount of tetanus and diphtheria as the Td vaccine but with lower amounts of pertussis antigen than the pediatric DTaP. The Centers for Disease Control and Prevention recommends Tdap for adults of any age who have not previously received it (including those aged 65 and older) who are in contact with infants younger than age 12 months, and for health care personnel of all ages, including doctors. Last fall, the CDC removed the 2-year interval requirement, so that now Tdap can be given regardless of the interval since the previous Td. After an adult receives one dose of Tdap, a booster of Td should be given every 10 years thereafter.
I recently asked 10 pediatricians if they had received the Tdap, and 8 said no. They ranged in age from those just out of residency to 68 years. Reasons included simply not getting around to it, thinking they didn't need it, or believing that they were already protected from the DTaP they received in childhood. In fact, immunity against pertussis wanes, and DTwP (whole-cell pertussis) and DTaP vaccines don't last forever, which is part of the reason we're seeing these outbreaks.
▸ Influenza. I meet physicians all the time who tell me they haven't received a flu shot. Older physicians sometimes will cite the fear of Guillain-Barré syndrome that initially arose with the 1976 swine flu vaccine debacle. That fear never really went away, and was reignited with the 2009 vaccine that was rapidly manufactured against pandemic H1N1. Many people, including some physicians, fear that the vaccine was not tested sufficiently before it was brought to market during the pandemic. Of course, most of these same physicians do immunize their patients with the vaccine.
The other reason I hear from physicians for not getting the flu vaccine is the mistaken belief that their immune system is strong enough to resist influenza. Although it may be true that as a group, physicians who see sick people all day long are more resistant to viral infections than is the general population, some still may be susceptible. And those who do contract influenza will be contagious for a few days before symptoms appear, even with the use of antivirals.
▸ Pneumococcus. Currently, the only pneumococcal vaccine recommended for adults is the 23-valent polysaccharide vaccine (Pneumovax). It is recommended for everyone aged 65 and older, and for people younger than 65 years who have chronic illness or other risk factors, including chronic cardiac or pulmonary disease (including asthma), chronic liver disease, alcoholism, diabetes, cerebrospinal fluid leaks, and cigarette smoking, as well as candidates for or recipients of cochlear implants and people living in special environments or social settings (including American Indian/Alaska Natives aged 50–64 years if vaccination is recommended by local public health authorities). Certainly, physicians can fall into most of these groups (although we hope not the smoking category).
But stay tuned for the 13-valent conjugate pneumococcal vaccine to be licensed and recommended for adults aged 50 and older. In December 2010, Pfizer announced that it submitted supplemental applications to both the U.S. Food and Drug Administration and the European Medicines Agency (EMA) to expand the use of Prevnar 13 to adults aged 50 years and older for the prevention of pneumococcal disease caused by the 13 serotypes contained in the vaccine. The FDA is expected to respond in October 2011.
Routine use of the 7-valent pneumococcal conjugate vaccine in infants beginning 11 years ago prevented an estimated 211,000 serious pneumococcal infections and 13,000 deaths during 2000–2008, including those among both children and adults. The switch to PCV13 in 2010 is expected to further reduce disease by covering those extra six strains, particularly 19A. The vaccination of adults aged 50 and older will expand that protection. Once PCV13 is approved for adults aged 50 and older, physicians in that age range should get the vaccine.
▸ Human Papillomavirus. Recommended for all previously unvaccinated women through age 26 years, Gardasil or Cervarix should be considered by all young female physicians. Moreover, although not a strict recommendation, Gardasil (but not Cervarix) is also suggested for men through age 26 years in order to reduce the likelihood of acquiring genital warts. The risk is particularly increased among men who have sex with men. There are physicians who fall into the above categories.
▸ Zoster. The zoster vaccine (Zostavax) is recommended for the prevention of shingles in all adults aged 60 years and older, including physicians.
Physician, vaccinate thyself.
Time to Expand Definition of a Travel Vaccine
Recent outbreaks of measles in western Europe and of pertussis here in the United States suggest that we consider expanding our definition of a “travel vaccine.”
We typically think of travel vaccines as those that aren't routinely given to children (or adults) but that are given only to our patients who travel to developing countries that lack our standards of medical care. But now that there are large measles outbreaks in places like France and Belgium and pertussis in California and elsewhere in the United States, I think we need to start routinely asking patients about travel plans and ensure that they are fully immunized with the measles-mumps-rubella (MMR) and diphtheria-tetanus-acellular pertussis (DTaP) or tetanus-diphtheria-acellular pertussis (Tdap) vaccines if they aren't already.
This includes accelerating MMR immunization for children younger than 1 year who will be traveling. It appears that not all health care providers are aware of this particular recommendation from the American Academy of Pediatrics' Red Book: While MMR is recommended for routine use in children at age 12 through 15 months with a booster at age 4-6 years, those aged 6 through 11 months who are traveling anywhere outside the United States are advised to receive one dose of MMR vaccine prior to their trip (Red Book;2009:444-55). For these 6- through 11-month-old children, this travel dose is not “valid,” meaning it doesn't officially count toward requirements for school attendance, but it is still in their best interests.
The Advisory Committee of Immunization Practices (ACIP) recommends: “Because serologic response to the measles component of the vaccine varies among infants aged 6–11 months, infants vaccinated before age 12 months should be revaccinated on or after the first birthday with 1 dose of MMR vaccine followed by a second dose at least 28 days later” (MMWR 1998;47[RR-8]:1-57).
This recommendation applies to ANY travel outside the United States except Canada or Australia, not just developing countries. According to the World Health Organization, as of April 18 more than 6,500 measles cases were reported from 33 countries in Europe. France has now passed 5,000 cases of measles and looks to be heading for a record year. It appears that nearly all of the cases in France have been among children with no vaccine doses. They have had at least two deaths – one from encephalitis and one from pneumonia.
There are two other major pockets. One near Belgium that seems to be associated with a religious group of vaccine refusers, while we're not sure what's behind another outbreak near the Spanish border. Other countries that have seen upticks in measles cases include Germany, the former Yugoslav Republic of Macedonia, the Netherlands, Norway, Romania, the Russian Federation, Switzerland, and the United Kingdom.
Measles cases have also been reported in the United States, including 29 during January-February 2011. Of those, 28 were import-associated (either imported or linked to an imported cases), of which 16 were actually imported. Of 13 imported cases among U.S. residents, 7 were children aged 6-23 months, all of whom had traveled internationally. Four of those children were hospitalized for measles-related complications: two with diarrhea and dehydration, one with persistent fever, and one with pneumonia. All four recovered (MMWR 2011;60:397-400).
The diagnosis had been delayed in three of the seven, presumably because measles had not been considered in the differential diagnosis of rash illness, even with a history of international travel. There's an obvious clinical lesson here.
None of those 7 had received MMR vaccine, and only 3 of 47 children aged 6-23 months with imported measles during 2001-2010 had received MMR vaccine. The reasons for nonvaccination of children often are unknown, but contributing to these might be a lack of perceived risk for severe measles. The frequency of imported measles among children aged 6-23 months also suggests that parents and clinicians might not be aware of recommendations to administer MMR vaccine to children as young as age 6 months when they are living or traveling abroad. Likewise, some aren't aware that they should give a second dose to any who have only one MMR dose more than 28 days prior. This “travel dose” can be given to a 13-month-old who had their first dose at 12 months of age. In fact, the parents of one of these 2011 measles patients had asked their pediatrician about vaccination for their child before traveling and were advised that it was unnecessary.
Travelers to the WHO European Region should be aware that measles is endemic in several countries of that region, which was the source of 39% of U.S. measles imports during 2005-2008, according to the Centers for Disease Control and Prevention.
Pertussis is the other vaccine-preventable disease that has been popping up lately and for which we need to consider vaccinating patients who may be traveling to affected areas, even within the United States. As of April 13, the California Department of Public Health reported ongoing pertussis activity, with 733 cases in 2011 for a rate of 6.5/100,000 population. There were 9,273 cases with onset in 2010, or 2.37/100,000, the highest incidence reported in the state since 1958.
Of the 755 hospitalized cases in 2010, more than half (55%) were infants younger than 3 months of age and nearly three-quarters (72%) were infants less than 6 months of age. Of the 10 deaths, 9 were infants.
So far in 2011, the highest rates of pertussis in California have been in the counties of Amador (86/100,000), Sonoma (32.5), and Santa Clara (23.5). Have a patient traveling to California who hasn't received a DTaP within 10 years and never received a Tdap booster? There is no longer a duration limit since the last Td dose. Just go ahead and give the Tdap.
And while we're on the subject, I wanted to mention that I chaired a committee for the Pediatric Infectious Diseases Society that has just published a position statement regarding personal belief exemption from immunization mandates. This document is aimed at helping pediatricians and family physicians who live in states that have laws allowing such exemptions, by providing a resource to support you medicolegally when facing parents who attempt to use misguided laws to avoid immunizing their children. It is available at www.pids.org/news/238-pid-position-statement-on-pbes.html
Recent outbreaks of measles in western Europe and of pertussis here in the United States suggest that we consider expanding our definition of a “travel vaccine.”
We typically think of travel vaccines as those that aren't routinely given to children (or adults) but that are given only to our patients who travel to developing countries that lack our standards of medical care. But now that there are large measles outbreaks in places like France and Belgium and pertussis in California and elsewhere in the United States, I think we need to start routinely asking patients about travel plans and ensure that they are fully immunized with the measles-mumps-rubella (MMR) and diphtheria-tetanus-acellular pertussis (DTaP) or tetanus-diphtheria-acellular pertussis (Tdap) vaccines if they aren't already.
This includes accelerating MMR immunization for children younger than 1 year who will be traveling. It appears that not all health care providers are aware of this particular recommendation from the American Academy of Pediatrics' Red Book: While MMR is recommended for routine use in children at age 12 through 15 months with a booster at age 4-6 years, those aged 6 through 11 months who are traveling anywhere outside the United States are advised to receive one dose of MMR vaccine prior to their trip (Red Book;2009:444-55). For these 6- through 11-month-old children, this travel dose is not “valid,” meaning it doesn't officially count toward requirements for school attendance, but it is still in their best interests.
The Advisory Committee of Immunization Practices (ACIP) recommends: “Because serologic response to the measles component of the vaccine varies among infants aged 6–11 months, infants vaccinated before age 12 months should be revaccinated on or after the first birthday with 1 dose of MMR vaccine followed by a second dose at least 28 days later” (MMWR 1998;47[RR-8]:1-57).
This recommendation applies to ANY travel outside the United States except Canada or Australia, not just developing countries. According to the World Health Organization, as of April 18 more than 6,500 measles cases were reported from 33 countries in Europe. France has now passed 5,000 cases of measles and looks to be heading for a record year. It appears that nearly all of the cases in France have been among children with no vaccine doses. They have had at least two deaths – one from encephalitis and one from pneumonia.
There are two other major pockets. One near Belgium that seems to be associated with a religious group of vaccine refusers, while we're not sure what's behind another outbreak near the Spanish border. Other countries that have seen upticks in measles cases include Germany, the former Yugoslav Republic of Macedonia, the Netherlands, Norway, Romania, the Russian Federation, Switzerland, and the United Kingdom.
Measles cases have also been reported in the United States, including 29 during January-February 2011. Of those, 28 were import-associated (either imported or linked to an imported cases), of which 16 were actually imported. Of 13 imported cases among U.S. residents, 7 were children aged 6-23 months, all of whom had traveled internationally. Four of those children were hospitalized for measles-related complications: two with diarrhea and dehydration, one with persistent fever, and one with pneumonia. All four recovered (MMWR 2011;60:397-400).
The diagnosis had been delayed in three of the seven, presumably because measles had not been considered in the differential diagnosis of rash illness, even with a history of international travel. There's an obvious clinical lesson here.
None of those 7 had received MMR vaccine, and only 3 of 47 children aged 6-23 months with imported measles during 2001-2010 had received MMR vaccine. The reasons for nonvaccination of children often are unknown, but contributing to these might be a lack of perceived risk for severe measles. The frequency of imported measles among children aged 6-23 months also suggests that parents and clinicians might not be aware of recommendations to administer MMR vaccine to children as young as age 6 months when they are living or traveling abroad. Likewise, some aren't aware that they should give a second dose to any who have only one MMR dose more than 28 days prior. This “travel dose” can be given to a 13-month-old who had their first dose at 12 months of age. In fact, the parents of one of these 2011 measles patients had asked their pediatrician about vaccination for their child before traveling and were advised that it was unnecessary.
Travelers to the WHO European Region should be aware that measles is endemic in several countries of that region, which was the source of 39% of U.S. measles imports during 2005-2008, according to the Centers for Disease Control and Prevention.
Pertussis is the other vaccine-preventable disease that has been popping up lately and for which we need to consider vaccinating patients who may be traveling to affected areas, even within the United States. As of April 13, the California Department of Public Health reported ongoing pertussis activity, with 733 cases in 2011 for a rate of 6.5/100,000 population. There were 9,273 cases with onset in 2010, or 2.37/100,000, the highest incidence reported in the state since 1958.
Of the 755 hospitalized cases in 2010, more than half (55%) were infants younger than 3 months of age and nearly three-quarters (72%) were infants less than 6 months of age. Of the 10 deaths, 9 were infants.
So far in 2011, the highest rates of pertussis in California have been in the counties of Amador (86/100,000), Sonoma (32.5), and Santa Clara (23.5). Have a patient traveling to California who hasn't received a DTaP within 10 years and never received a Tdap booster? There is no longer a duration limit since the last Td dose. Just go ahead and give the Tdap.
And while we're on the subject, I wanted to mention that I chaired a committee for the Pediatric Infectious Diseases Society that has just published a position statement regarding personal belief exemption from immunization mandates. This document is aimed at helping pediatricians and family physicians who live in states that have laws allowing such exemptions, by providing a resource to support you medicolegally when facing parents who attempt to use misguided laws to avoid immunizing their children. It is available at www.pids.org/news/238-pid-position-statement-on-pbes.html
Recent outbreaks of measles in western Europe and of pertussis here in the United States suggest that we consider expanding our definition of a “travel vaccine.”
We typically think of travel vaccines as those that aren't routinely given to children (or adults) but that are given only to our patients who travel to developing countries that lack our standards of medical care. But now that there are large measles outbreaks in places like France and Belgium and pertussis in California and elsewhere in the United States, I think we need to start routinely asking patients about travel plans and ensure that they are fully immunized with the measles-mumps-rubella (MMR) and diphtheria-tetanus-acellular pertussis (DTaP) or tetanus-diphtheria-acellular pertussis (Tdap) vaccines if they aren't already.
This includes accelerating MMR immunization for children younger than 1 year who will be traveling. It appears that not all health care providers are aware of this particular recommendation from the American Academy of Pediatrics' Red Book: While MMR is recommended for routine use in children at age 12 through 15 months with a booster at age 4-6 years, those aged 6 through 11 months who are traveling anywhere outside the United States are advised to receive one dose of MMR vaccine prior to their trip (Red Book;2009:444-55). For these 6- through 11-month-old children, this travel dose is not “valid,” meaning it doesn't officially count toward requirements for school attendance, but it is still in their best interests.
The Advisory Committee of Immunization Practices (ACIP) recommends: “Because serologic response to the measles component of the vaccine varies among infants aged 6–11 months, infants vaccinated before age 12 months should be revaccinated on or after the first birthday with 1 dose of MMR vaccine followed by a second dose at least 28 days later” (MMWR 1998;47[RR-8]:1-57).
This recommendation applies to ANY travel outside the United States except Canada or Australia, not just developing countries. According to the World Health Organization, as of April 18 more than 6,500 measles cases were reported from 33 countries in Europe. France has now passed 5,000 cases of measles and looks to be heading for a record year. It appears that nearly all of the cases in France have been among children with no vaccine doses. They have had at least two deaths – one from encephalitis and one from pneumonia.
There are two other major pockets. One near Belgium that seems to be associated with a religious group of vaccine refusers, while we're not sure what's behind another outbreak near the Spanish border. Other countries that have seen upticks in measles cases include Germany, the former Yugoslav Republic of Macedonia, the Netherlands, Norway, Romania, the Russian Federation, Switzerland, and the United Kingdom.
Measles cases have also been reported in the United States, including 29 during January-February 2011. Of those, 28 were import-associated (either imported or linked to an imported cases), of which 16 were actually imported. Of 13 imported cases among U.S. residents, 7 were children aged 6-23 months, all of whom had traveled internationally. Four of those children were hospitalized for measles-related complications: two with diarrhea and dehydration, one with persistent fever, and one with pneumonia. All four recovered (MMWR 2011;60:397-400).
The diagnosis had been delayed in three of the seven, presumably because measles had not been considered in the differential diagnosis of rash illness, even with a history of international travel. There's an obvious clinical lesson here.
None of those 7 had received MMR vaccine, and only 3 of 47 children aged 6-23 months with imported measles during 2001-2010 had received MMR vaccine. The reasons for nonvaccination of children often are unknown, but contributing to these might be a lack of perceived risk for severe measles. The frequency of imported measles among children aged 6-23 months also suggests that parents and clinicians might not be aware of recommendations to administer MMR vaccine to children as young as age 6 months when they are living or traveling abroad. Likewise, some aren't aware that they should give a second dose to any who have only one MMR dose more than 28 days prior. This “travel dose” can be given to a 13-month-old who had their first dose at 12 months of age. In fact, the parents of one of these 2011 measles patients had asked their pediatrician about vaccination for their child before traveling and were advised that it was unnecessary.
Travelers to the WHO European Region should be aware that measles is endemic in several countries of that region, which was the source of 39% of U.S. measles imports during 2005-2008, according to the Centers for Disease Control and Prevention.
Pertussis is the other vaccine-preventable disease that has been popping up lately and for which we need to consider vaccinating patients who may be traveling to affected areas, even within the United States. As of April 13, the California Department of Public Health reported ongoing pertussis activity, with 733 cases in 2011 for a rate of 6.5/100,000 population. There were 9,273 cases with onset in 2010, or 2.37/100,000, the highest incidence reported in the state since 1958.
Of the 755 hospitalized cases in 2010, more than half (55%) were infants younger than 3 months of age and nearly three-quarters (72%) were infants less than 6 months of age. Of the 10 deaths, 9 were infants.
So far in 2011, the highest rates of pertussis in California have been in the counties of Amador (86/100,000), Sonoma (32.5), and Santa Clara (23.5). Have a patient traveling to California who hasn't received a DTaP within 10 years and never received a Tdap booster? There is no longer a duration limit since the last Td dose. Just go ahead and give the Tdap.
And while we're on the subject, I wanted to mention that I chaired a committee for the Pediatric Infectious Diseases Society that has just published a position statement regarding personal belief exemption from immunization mandates. This document is aimed at helping pediatricians and family physicians who live in states that have laws allowing such exemptions, by providing a resource to support you medicolegally when facing parents who attempt to use misguided laws to avoid immunizing their children. It is available at www.pids.org/news/238-pid-position-statement-on-pbes.html
Observation Option for AOM: A Second Look
Two new, well-designed trials published in the New England Journal of Medicine have demonstrated that when acute otitis media is correctly diagnosed, treatment with effective antibiotics is of clear and substantial benefit. To me, this suggests that the confusion about whether antibiotics help children get better faster is about getting the diagnosis right, a challenging task for pediatricians and family physicians with squirming patients and ear canal wax occluding visualization of the eardrum.
All along, I have believed that the American Academy of Pediatrics' 2004 “watchful waiting” option for treating acute otitis media (AOM) was well intentioned but not based on good evidence. In an effort to address the growing problem of antimicrobial resistance, the AAP recommended the “observation option” for otherwise healthy children aged 6 months to 2 years with nonsevere illness and an uncertain diagnosis, and for all children above the age of 2 years who were not systemically ill (Pediatrics 2004;113:1451–65).
Problem is, the studies cited by the AAP as evidence for this recommendation were nearly all seriously flawed, because they excluded children with the very criteria that signal a true AOM diagnosis: a full or bulging eardrum … and in some studies, because it was determined that they were too “unwell” and/or they “needed an antibiotic”! And, many of these trials excluded children younger than 2 years old and included many children who likely did not have AOM at all or had otitis media with effusion.
Dr. Janet R. Casey and I reviewed 25 of the studies in a paper published 3 years ago (Pediatr. Infect. Dis. J. 2008;27:958–62).hWe found so many serious flaws in the inclusion and exclusion criteria, and diagnostic and outcome criteria, that we were obliged to conclude that no evidence-based conclusion could be drawn.
The flaws we found in individual AOM trials call into question the validity of the conclusions of two major meta-analyses cited by the AAP, one involving 5,400 children from 33 randomized trials (J. Pediatr. 1994;124:355–67), the other of 6 studies of children aged 7 months to 15 years (BMJ 1997;314:1526–9), both of which found only modest benefit for the use of antimicrobials.
Now in the New England Journal of Medicine papers, we have two well-designed studies clearly demonstrating that treatment should not be withheld in children with proven AOM.
One of the studies, from the University of Pittsburgh, randomized 291 children aged 6–23 months to receive amoxicillin-clavulanate or placebo for 10 days. To be eligible, patients had to have AOM that was diagnosed on the basis of three criteria:
▸ onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms scale,
▸ presence of middle-ear effusion, and
▸ moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.
Patients also had to have received at least two doses of pneumococcal conjugate vaccine.
Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7, compared with 28%, 54%, and 74% among those who received placebo, respectively. For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, vs. 14%, 36%, and 53% with placebo (N. Engl. J. Med. 2011;364:105–15).
The other trial, from Finland, used equally strict criteria for 319 children aged 6–35 months who were randomized to receive amoxicillin-clavulanate or placebo for 7 days. Treatment failure occurred in 18.6% of the children who received amoxicillin-clavulanate, compared with 44.9% of the children who received placebo, a highly statistically significant difference that was already apparent at the first scheduled visit on day 3 (13.7% vs. 25.3%). Overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (N. Engl. J. Med. 2011;364:116–26).
As I see it, the problem really lies in our inability to adequately diagnose AOM. For one thing, it's essential to clean the wax out of the child's ear in order to visualize the eardrum, given that two-thirds of children diagnosed with AOM have partially or fully occluded ear canals blocking visualization of the eardrum. Yet, physicians often don't do that because it takes time and it's difficult to get the child to hold still. It's far simpler to simply take a quick look and say that the diagnosis is “uncertain,” or to say that the eardrum is “red” in order to justify a diagnosis and antibiotic prescription.
Pediatricians and family physicians should all have a good, high-grade otoscope with a fresh battery and bulb, along with the training and ability to use the pneumatic attachment in order to distinguish between a bulging and retracted eardrum, which often look alike with just the otoscope.
Frankly, I find it embarrassing that with a condition as common as AOM, pediatricians and family physicians receive so little training in diagnosing it and, therefore, just don't do a good job. In otitis media workshops that include testing for competency in diagnosis (Outcomes Management Educational Workshops, West Palm Beach, Fla.), I found that physicians got the diagnosis of AOM wrong at least 50% of the time on video presentation testing. And that was without wax, under ideal classroom conditions.
Diagnosing otitis media needs to become a critical part of medical education, and physicians in practice should be retrained via CME courses. Pharmaceutical companies no longer sponsor those, so now the professional societies such as the American Academy of Pediatrics, the American Academy of Family Physicians, and the nursing organizations need to step up.
With the new evidence from the two well-controlled trials, I don't see how any clinician can withhold antibiotic treatment in good conscience. AOM is a painful condition that infants and toddlers are too young to explain to us. Can you imagine asking an adult to agree to withholding effective treatment when they are in pain and propose they take acetaminophen instead? Or can you imagine telling an adult who seeks care for an earache that the diagnosis is uncertain after examination, so the recommendation is to “observe”?
As advocates for our pediatric patients, how in the world can we allow a child to remain in severe pain for 24–48 hours longer than is necessary and keep parents up all night and away from work for 2–3 extra days?
Once everyone learns how to better diagnose AOM, we will stop overprescribing antibiotics for those children who don't have the condition. For the rest, I contend that treatment is a moral imperative.
Two new, well-designed trials published in the New England Journal of Medicine have demonstrated that when acute otitis media is correctly diagnosed, treatment with effective antibiotics is of clear and substantial benefit. To me, this suggests that the confusion about whether antibiotics help children get better faster is about getting the diagnosis right, a challenging task for pediatricians and family physicians with squirming patients and ear canal wax occluding visualization of the eardrum.
All along, I have believed that the American Academy of Pediatrics' 2004 “watchful waiting” option for treating acute otitis media (AOM) was well intentioned but not based on good evidence. In an effort to address the growing problem of antimicrobial resistance, the AAP recommended the “observation option” for otherwise healthy children aged 6 months to 2 years with nonsevere illness and an uncertain diagnosis, and for all children above the age of 2 years who were not systemically ill (Pediatrics 2004;113:1451–65).
Problem is, the studies cited by the AAP as evidence for this recommendation were nearly all seriously flawed, because they excluded children with the very criteria that signal a true AOM diagnosis: a full or bulging eardrum … and in some studies, because it was determined that they were too “unwell” and/or they “needed an antibiotic”! And, many of these trials excluded children younger than 2 years old and included many children who likely did not have AOM at all or had otitis media with effusion.
Dr. Janet R. Casey and I reviewed 25 of the studies in a paper published 3 years ago (Pediatr. Infect. Dis. J. 2008;27:958–62).hWe found so many serious flaws in the inclusion and exclusion criteria, and diagnostic and outcome criteria, that we were obliged to conclude that no evidence-based conclusion could be drawn.
The flaws we found in individual AOM trials call into question the validity of the conclusions of two major meta-analyses cited by the AAP, one involving 5,400 children from 33 randomized trials (J. Pediatr. 1994;124:355–67), the other of 6 studies of children aged 7 months to 15 years (BMJ 1997;314:1526–9), both of which found only modest benefit for the use of antimicrobials.
Now in the New England Journal of Medicine papers, we have two well-designed studies clearly demonstrating that treatment should not be withheld in children with proven AOM.
One of the studies, from the University of Pittsburgh, randomized 291 children aged 6–23 months to receive amoxicillin-clavulanate or placebo for 10 days. To be eligible, patients had to have AOM that was diagnosed on the basis of three criteria:
▸ onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms scale,
▸ presence of middle-ear effusion, and
▸ moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.
Patients also had to have received at least two doses of pneumococcal conjugate vaccine.
Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7, compared with 28%, 54%, and 74% among those who received placebo, respectively. For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, vs. 14%, 36%, and 53% with placebo (N. Engl. J. Med. 2011;364:105–15).
The other trial, from Finland, used equally strict criteria for 319 children aged 6–35 months who were randomized to receive amoxicillin-clavulanate or placebo for 7 days. Treatment failure occurred in 18.6% of the children who received amoxicillin-clavulanate, compared with 44.9% of the children who received placebo, a highly statistically significant difference that was already apparent at the first scheduled visit on day 3 (13.7% vs. 25.3%). Overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (N. Engl. J. Med. 2011;364:116–26).
As I see it, the problem really lies in our inability to adequately diagnose AOM. For one thing, it's essential to clean the wax out of the child's ear in order to visualize the eardrum, given that two-thirds of children diagnosed with AOM have partially or fully occluded ear canals blocking visualization of the eardrum. Yet, physicians often don't do that because it takes time and it's difficult to get the child to hold still. It's far simpler to simply take a quick look and say that the diagnosis is “uncertain,” or to say that the eardrum is “red” in order to justify a diagnosis and antibiotic prescription.
Pediatricians and family physicians should all have a good, high-grade otoscope with a fresh battery and bulb, along with the training and ability to use the pneumatic attachment in order to distinguish between a bulging and retracted eardrum, which often look alike with just the otoscope.
Frankly, I find it embarrassing that with a condition as common as AOM, pediatricians and family physicians receive so little training in diagnosing it and, therefore, just don't do a good job. In otitis media workshops that include testing for competency in diagnosis (Outcomes Management Educational Workshops, West Palm Beach, Fla.), I found that physicians got the diagnosis of AOM wrong at least 50% of the time on video presentation testing. And that was without wax, under ideal classroom conditions.
Diagnosing otitis media needs to become a critical part of medical education, and physicians in practice should be retrained via CME courses. Pharmaceutical companies no longer sponsor those, so now the professional societies such as the American Academy of Pediatrics, the American Academy of Family Physicians, and the nursing organizations need to step up.
With the new evidence from the two well-controlled trials, I don't see how any clinician can withhold antibiotic treatment in good conscience. AOM is a painful condition that infants and toddlers are too young to explain to us. Can you imagine asking an adult to agree to withholding effective treatment when they are in pain and propose they take acetaminophen instead? Or can you imagine telling an adult who seeks care for an earache that the diagnosis is uncertain after examination, so the recommendation is to “observe”?
As advocates for our pediatric patients, how in the world can we allow a child to remain in severe pain for 24–48 hours longer than is necessary and keep parents up all night and away from work for 2–3 extra days?
Once everyone learns how to better diagnose AOM, we will stop overprescribing antibiotics for those children who don't have the condition. For the rest, I contend that treatment is a moral imperative.
Two new, well-designed trials published in the New England Journal of Medicine have demonstrated that when acute otitis media is correctly diagnosed, treatment with effective antibiotics is of clear and substantial benefit. To me, this suggests that the confusion about whether antibiotics help children get better faster is about getting the diagnosis right, a challenging task for pediatricians and family physicians with squirming patients and ear canal wax occluding visualization of the eardrum.
All along, I have believed that the American Academy of Pediatrics' 2004 “watchful waiting” option for treating acute otitis media (AOM) was well intentioned but not based on good evidence. In an effort to address the growing problem of antimicrobial resistance, the AAP recommended the “observation option” for otherwise healthy children aged 6 months to 2 years with nonsevere illness and an uncertain diagnosis, and for all children above the age of 2 years who were not systemically ill (Pediatrics 2004;113:1451–65).
Problem is, the studies cited by the AAP as evidence for this recommendation were nearly all seriously flawed, because they excluded children with the very criteria that signal a true AOM diagnosis: a full or bulging eardrum … and in some studies, because it was determined that they were too “unwell” and/or they “needed an antibiotic”! And, many of these trials excluded children younger than 2 years old and included many children who likely did not have AOM at all or had otitis media with effusion.
Dr. Janet R. Casey and I reviewed 25 of the studies in a paper published 3 years ago (Pediatr. Infect. Dis. J. 2008;27:958–62).hWe found so many serious flaws in the inclusion and exclusion criteria, and diagnostic and outcome criteria, that we were obliged to conclude that no evidence-based conclusion could be drawn.
The flaws we found in individual AOM trials call into question the validity of the conclusions of two major meta-analyses cited by the AAP, one involving 5,400 children from 33 randomized trials (J. Pediatr. 1994;124:355–67), the other of 6 studies of children aged 7 months to 15 years (BMJ 1997;314:1526–9), both of which found only modest benefit for the use of antimicrobials.
Now in the New England Journal of Medicine papers, we have two well-designed studies clearly demonstrating that treatment should not be withheld in children with proven AOM.
One of the studies, from the University of Pittsburgh, randomized 291 children aged 6–23 months to receive amoxicillin-clavulanate or placebo for 10 days. To be eligible, patients had to have AOM that was diagnosed on the basis of three criteria:
▸ onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms scale,
▸ presence of middle-ear effusion, and
▸ moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.
Patients also had to have received at least two doses of pneumococcal conjugate vaccine.
Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7, compared with 28%, 54%, and 74% among those who received placebo, respectively. For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, vs. 14%, 36%, and 53% with placebo (N. Engl. J. Med. 2011;364:105–15).
The other trial, from Finland, used equally strict criteria for 319 children aged 6–35 months who were randomized to receive amoxicillin-clavulanate or placebo for 7 days. Treatment failure occurred in 18.6% of the children who received amoxicillin-clavulanate, compared with 44.9% of the children who received placebo, a highly statistically significant difference that was already apparent at the first scheduled visit on day 3 (13.7% vs. 25.3%). Overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (N. Engl. J. Med. 2011;364:116–26).
As I see it, the problem really lies in our inability to adequately diagnose AOM. For one thing, it's essential to clean the wax out of the child's ear in order to visualize the eardrum, given that two-thirds of children diagnosed with AOM have partially or fully occluded ear canals blocking visualization of the eardrum. Yet, physicians often don't do that because it takes time and it's difficult to get the child to hold still. It's far simpler to simply take a quick look and say that the diagnosis is “uncertain,” or to say that the eardrum is “red” in order to justify a diagnosis and antibiotic prescription.
Pediatricians and family physicians should all have a good, high-grade otoscope with a fresh battery and bulb, along with the training and ability to use the pneumatic attachment in order to distinguish between a bulging and retracted eardrum, which often look alike with just the otoscope.
Frankly, I find it embarrassing that with a condition as common as AOM, pediatricians and family physicians receive so little training in diagnosing it and, therefore, just don't do a good job. In otitis media workshops that include testing for competency in diagnosis (Outcomes Management Educational Workshops, West Palm Beach, Fla.), I found that physicians got the diagnosis of AOM wrong at least 50% of the time on video presentation testing. And that was without wax, under ideal classroom conditions.
Diagnosing otitis media needs to become a critical part of medical education, and physicians in practice should be retrained via CME courses. Pharmaceutical companies no longer sponsor those, so now the professional societies such as the American Academy of Pediatrics, the American Academy of Family Physicians, and the nursing organizations need to step up.
With the new evidence from the two well-controlled trials, I don't see how any clinician can withhold antibiotic treatment in good conscience. AOM is a painful condition that infants and toddlers are too young to explain to us. Can you imagine asking an adult to agree to withholding effective treatment when they are in pain and propose they take acetaminophen instead? Or can you imagine telling an adult who seeks care for an earache that the diagnosis is uncertain after examination, so the recommendation is to “observe”?
As advocates for our pediatric patients, how in the world can we allow a child to remain in severe pain for 24–48 hours longer than is necessary and keep parents up all night and away from work for 2–3 extra days?
Once everyone learns how to better diagnose AOM, we will stop overprescribing antibiotics for those children who don't have the condition. For the rest, I contend that treatment is a moral imperative.
Travel Medicine
With vacation season approaching, some of our patients' families may be planning travel to areas where they could be exposed to different infectious diseases and other health risks not commonly encountered in the United States. Even more challenging, they won't necessarily mention their plans until the last minute unless you ask.
Today more than ever, travel involves arrival at an international destination. According to the U.S. Office of Travel & Tourism Industries, about 30 million Americans traveled internationally in 2009. Of those, about 8%–9%, or 2.4 million, were children. In 2010, the United Nations World Tourism Organization reported a 7% overall increase in international travel.
Increasingly, children are traveling with parents to visit friends and extended family members in Africa, Asia, and Central and South America, while a growing number of American adolescents are traveling to resource-limited areas doing volunteer work, adventure travel, staying with host families, or as part of religious or civic groups. Opportunities for children and adolescents with chronic medical conditions who travel are associated with additional concerns that are directly related to their underlying condition, susceptibility, and potential interventions.
Unfortunately, health precautions often are simply not on the minds of many people as they make their travel arrangements. While most people plan international trips about 90 days in advance, they often will wait until the last minute to seek advice on immunizations, preventive medications, and other precautions – if they think to do so at all.
This is the case even for families with children. This was revealed in a recent eye-opening study conducted by the GeoSentinel Surveillance Network, a global surveillance network composed of 49 travel/tropical medicine clinics on six continents. The network has previously reported on illnesses in adults (N. Engl. J. Med. 2006;354:119-30).
The study, the first comprehensive analysis of pediatric travel illness, examined data for 1,591 children and 32,668 adults seen at a GeoSentinel clinic. To be included in the database, persons had to have crossed an international border within 10 years and have a laboratory-confirmed or probable diagnosis. Data were collected from Jan. 30, 1997, through Nov. 30, 2007 (Pediatrics 2010;125:e1072-80).
For both children and adults, the three most common world regions visited were Asia, sub-Saharan Africa, and Latin America. While ill adults were more likely than children to have visited Asia, more ill children presented after travel to Europe and the Middle East/North Africa.
Tourism was the most common reason for travel among both children and adults, but children were more likely than adults to be a “VFR,” or “visiting friends and relatives.” Importantly, this and other studies have demonstrated significantly increased health risks among VFR travelers who typically stay in private homes and in less-developed areas, compared with vacationers or adult business travelers who are more likely to be staying in hotels and in urban areas.
In the GeoSentinel study, ill children aged 0–17 years presented earlier than ill adults, required hospitalization more often, had shorter duration of travel, and were less likely to have received medical advice prior to travel. And, in what the authors deemed “alarming,” only half of all the ill non-VFR pediatric travelers (51%) and one-third of those who were VFR (32%) had received pretravel medical advice, compared with nearly two-thirds of the non-VFR adults (59%).
The spectrum of illness also differed considerably between children and adults. The most common categories of illness among the children were diarrheal (28%), dermatologic (25%), systemic febrile (23%), and respiratory (11%). Vaccine-preventable infections accounted for 2% (38) of the diagnoses.
Dermatologic syndromes, animal bites, cutaneous larvae migrans, and respiratory disorders were significantly more common in children than adults, while adults had a significantly higher proportion of nondiarrheal gastrointestinal disorders.
Interestingly, of the 390 children with dermatologic disorders, the two most common were animal bites (24%) and cutaneous larvae migrans (17%). While not vaccine preventable, these unfortunate occurrences can be avoided with common-sense precautions. This is also true of malaria, which accounted for 35% of the systemic febrile illnesses in 358 children. While malaria is not vaccine preventable, administration of appropriate antimalarial prophylactic medications combined with mosquito avoidance measures would decrease the chance of disease acquisition.
Not surprisingly, diagnoses differed by destination. Compared with travelers returning from Europe or North America, dermatologic diagnoses were twice as common in travelers from Latin America. Travel to the Middle East/North Africa was associated with a greater risk of diarrheal disorder, while travelers to sub-Saharan Africa and Asia experienced more systemic febrile illness.
The authors noted that while this study could not determine the reason for lack of pretravel care, it is likely that limited availability of travel-specific immunizations and medications in primary care settings was a likely factor, as well as the lack of insurance coverage for such measures and a lack of perceived risk, particularly among VFR travelers.
It can be challenging for a busy practitioner to stay abreast of the latest developments in non–routinely administered vaccines, disease outbreaks, areas of political instability, or country-specific entry requirements. However, it is important to ask parents who come from other countries if they are planning to visit their homelands and if so, when. Also, asking families with teens whether they plan on traveling for spring break or summer can be incorporated into routine office visits.
Ideally, patients planning international travel should be referred to a travel medicine clinic 1 month prior to travel. Some vaccines take up to 2 weeks to become effective, while others such as yellow fever should be received at least 10 days prior to travel and can be administered only at government-designated sites. Many vaccines, such as those against typhoid or rabies, are not routinely available at the patient's medical home.
Counseling about strategies to avoid insect and animal bites, food and water precautions, motor vehicle and water-related accidents, and interventions as simple as wearing shoes while walking on the beach is as much a part of a pretravel evaluation as are immunizations.
International travel has become so commonplace that it behooves every primary care physician to identify a travel medicine clinic in their area that can provide pretravel advice and immunizations to their patients, and to inquire about potential international travel during patient visits. Making sure the patients' routine immunizations are up to date is another way providers can assist their patients in preparing for international travel.
Not all travel medicine clinics provide services for children, so it's a good idea to find out which ones do in your area. If you are having difficulty locating a clinic, the International Society of Travel Medicine (www.istm.org/www.astmh.org/source/ClinicalDirectory/
The Centers for Disease Control and Prevention's travel site also offers a clinic locator, as well as other resources for practitioners and travelers (www.cdc.gov/travel
With vacation season approaching, some of our patients' families may be planning travel to areas where they could be exposed to different infectious diseases and other health risks not commonly encountered in the United States. Even more challenging, they won't necessarily mention their plans until the last minute unless you ask.
Today more than ever, travel involves arrival at an international destination. According to the U.S. Office of Travel & Tourism Industries, about 30 million Americans traveled internationally in 2009. Of those, about 8%–9%, or 2.4 million, were children. In 2010, the United Nations World Tourism Organization reported a 7% overall increase in international travel.
Increasingly, children are traveling with parents to visit friends and extended family members in Africa, Asia, and Central and South America, while a growing number of American adolescents are traveling to resource-limited areas doing volunteer work, adventure travel, staying with host families, or as part of religious or civic groups. Opportunities for children and adolescents with chronic medical conditions who travel are associated with additional concerns that are directly related to their underlying condition, susceptibility, and potential interventions.
Unfortunately, health precautions often are simply not on the minds of many people as they make their travel arrangements. While most people plan international trips about 90 days in advance, they often will wait until the last minute to seek advice on immunizations, preventive medications, and other precautions – if they think to do so at all.
This is the case even for families with children. This was revealed in a recent eye-opening study conducted by the GeoSentinel Surveillance Network, a global surveillance network composed of 49 travel/tropical medicine clinics on six continents. The network has previously reported on illnesses in adults (N. Engl. J. Med. 2006;354:119-30).
The study, the first comprehensive analysis of pediatric travel illness, examined data for 1,591 children and 32,668 adults seen at a GeoSentinel clinic. To be included in the database, persons had to have crossed an international border within 10 years and have a laboratory-confirmed or probable diagnosis. Data were collected from Jan. 30, 1997, through Nov. 30, 2007 (Pediatrics 2010;125:e1072-80).
For both children and adults, the three most common world regions visited were Asia, sub-Saharan Africa, and Latin America. While ill adults were more likely than children to have visited Asia, more ill children presented after travel to Europe and the Middle East/North Africa.
Tourism was the most common reason for travel among both children and adults, but children were more likely than adults to be a “VFR,” or “visiting friends and relatives.” Importantly, this and other studies have demonstrated significantly increased health risks among VFR travelers who typically stay in private homes and in less-developed areas, compared with vacationers or adult business travelers who are more likely to be staying in hotels and in urban areas.
In the GeoSentinel study, ill children aged 0–17 years presented earlier than ill adults, required hospitalization more often, had shorter duration of travel, and were less likely to have received medical advice prior to travel. And, in what the authors deemed “alarming,” only half of all the ill non-VFR pediatric travelers (51%) and one-third of those who were VFR (32%) had received pretravel medical advice, compared with nearly two-thirds of the non-VFR adults (59%).
The spectrum of illness also differed considerably between children and adults. The most common categories of illness among the children were diarrheal (28%), dermatologic (25%), systemic febrile (23%), and respiratory (11%). Vaccine-preventable infections accounted for 2% (38) of the diagnoses.
Dermatologic syndromes, animal bites, cutaneous larvae migrans, and respiratory disorders were significantly more common in children than adults, while adults had a significantly higher proportion of nondiarrheal gastrointestinal disorders.
Interestingly, of the 390 children with dermatologic disorders, the two most common were animal bites (24%) and cutaneous larvae migrans (17%). While not vaccine preventable, these unfortunate occurrences can be avoided with common-sense precautions. This is also true of malaria, which accounted for 35% of the systemic febrile illnesses in 358 children. While malaria is not vaccine preventable, administration of appropriate antimalarial prophylactic medications combined with mosquito avoidance measures would decrease the chance of disease acquisition.
Not surprisingly, diagnoses differed by destination. Compared with travelers returning from Europe or North America, dermatologic diagnoses were twice as common in travelers from Latin America. Travel to the Middle East/North Africa was associated with a greater risk of diarrheal disorder, while travelers to sub-Saharan Africa and Asia experienced more systemic febrile illness.
The authors noted that while this study could not determine the reason for lack of pretravel care, it is likely that limited availability of travel-specific immunizations and medications in primary care settings was a likely factor, as well as the lack of insurance coverage for such measures and a lack of perceived risk, particularly among VFR travelers.
It can be challenging for a busy practitioner to stay abreast of the latest developments in non–routinely administered vaccines, disease outbreaks, areas of political instability, or country-specific entry requirements. However, it is important to ask parents who come from other countries if they are planning to visit their homelands and if so, when. Also, asking families with teens whether they plan on traveling for spring break or summer can be incorporated into routine office visits.
Ideally, patients planning international travel should be referred to a travel medicine clinic 1 month prior to travel. Some vaccines take up to 2 weeks to become effective, while others such as yellow fever should be received at least 10 days prior to travel and can be administered only at government-designated sites. Many vaccines, such as those against typhoid or rabies, are not routinely available at the patient's medical home.
Counseling about strategies to avoid insect and animal bites, food and water precautions, motor vehicle and water-related accidents, and interventions as simple as wearing shoes while walking on the beach is as much a part of a pretravel evaluation as are immunizations.
International travel has become so commonplace that it behooves every primary care physician to identify a travel medicine clinic in their area that can provide pretravel advice and immunizations to their patients, and to inquire about potential international travel during patient visits. Making sure the patients' routine immunizations are up to date is another way providers can assist their patients in preparing for international travel.
Not all travel medicine clinics provide services for children, so it's a good idea to find out which ones do in your area. If you are having difficulty locating a clinic, the International Society of Travel Medicine (www.istm.org/www.astmh.org/source/ClinicalDirectory/
The Centers for Disease Control and Prevention's travel site also offers a clinic locator, as well as other resources for practitioners and travelers (www.cdc.gov/travel
With vacation season approaching, some of our patients' families may be planning travel to areas where they could be exposed to different infectious diseases and other health risks not commonly encountered in the United States. Even more challenging, they won't necessarily mention their plans until the last minute unless you ask.
Today more than ever, travel involves arrival at an international destination. According to the U.S. Office of Travel & Tourism Industries, about 30 million Americans traveled internationally in 2009. Of those, about 8%–9%, or 2.4 million, were children. In 2010, the United Nations World Tourism Organization reported a 7% overall increase in international travel.
Increasingly, children are traveling with parents to visit friends and extended family members in Africa, Asia, and Central and South America, while a growing number of American adolescents are traveling to resource-limited areas doing volunteer work, adventure travel, staying with host families, or as part of religious or civic groups. Opportunities for children and adolescents with chronic medical conditions who travel are associated with additional concerns that are directly related to their underlying condition, susceptibility, and potential interventions.
Unfortunately, health precautions often are simply not on the minds of many people as they make their travel arrangements. While most people plan international trips about 90 days in advance, they often will wait until the last minute to seek advice on immunizations, preventive medications, and other precautions – if they think to do so at all.
This is the case even for families with children. This was revealed in a recent eye-opening study conducted by the GeoSentinel Surveillance Network, a global surveillance network composed of 49 travel/tropical medicine clinics on six continents. The network has previously reported on illnesses in adults (N. Engl. J. Med. 2006;354:119-30).
The study, the first comprehensive analysis of pediatric travel illness, examined data for 1,591 children and 32,668 adults seen at a GeoSentinel clinic. To be included in the database, persons had to have crossed an international border within 10 years and have a laboratory-confirmed or probable diagnosis. Data were collected from Jan. 30, 1997, through Nov. 30, 2007 (Pediatrics 2010;125:e1072-80).
For both children and adults, the three most common world regions visited were Asia, sub-Saharan Africa, and Latin America. While ill adults were more likely than children to have visited Asia, more ill children presented after travel to Europe and the Middle East/North Africa.
Tourism was the most common reason for travel among both children and adults, but children were more likely than adults to be a “VFR,” or “visiting friends and relatives.” Importantly, this and other studies have demonstrated significantly increased health risks among VFR travelers who typically stay in private homes and in less-developed areas, compared with vacationers or adult business travelers who are more likely to be staying in hotels and in urban areas.
In the GeoSentinel study, ill children aged 0–17 years presented earlier than ill adults, required hospitalization more often, had shorter duration of travel, and were less likely to have received medical advice prior to travel. And, in what the authors deemed “alarming,” only half of all the ill non-VFR pediatric travelers (51%) and one-third of those who were VFR (32%) had received pretravel medical advice, compared with nearly two-thirds of the non-VFR adults (59%).
The spectrum of illness also differed considerably between children and adults. The most common categories of illness among the children were diarrheal (28%), dermatologic (25%), systemic febrile (23%), and respiratory (11%). Vaccine-preventable infections accounted for 2% (38) of the diagnoses.
Dermatologic syndromes, animal bites, cutaneous larvae migrans, and respiratory disorders were significantly more common in children than adults, while adults had a significantly higher proportion of nondiarrheal gastrointestinal disorders.
Interestingly, of the 390 children with dermatologic disorders, the two most common were animal bites (24%) and cutaneous larvae migrans (17%). While not vaccine preventable, these unfortunate occurrences can be avoided with common-sense precautions. This is also true of malaria, which accounted for 35% of the systemic febrile illnesses in 358 children. While malaria is not vaccine preventable, administration of appropriate antimalarial prophylactic medications combined with mosquito avoidance measures would decrease the chance of disease acquisition.
Not surprisingly, diagnoses differed by destination. Compared with travelers returning from Europe or North America, dermatologic diagnoses were twice as common in travelers from Latin America. Travel to the Middle East/North Africa was associated with a greater risk of diarrheal disorder, while travelers to sub-Saharan Africa and Asia experienced more systemic febrile illness.
The authors noted that while this study could not determine the reason for lack of pretravel care, it is likely that limited availability of travel-specific immunizations and medications in primary care settings was a likely factor, as well as the lack of insurance coverage for such measures and a lack of perceived risk, particularly among VFR travelers.
It can be challenging for a busy practitioner to stay abreast of the latest developments in non–routinely administered vaccines, disease outbreaks, areas of political instability, or country-specific entry requirements. However, it is important to ask parents who come from other countries if they are planning to visit their homelands and if so, when. Also, asking families with teens whether they plan on traveling for spring break or summer can be incorporated into routine office visits.
Ideally, patients planning international travel should be referred to a travel medicine clinic 1 month prior to travel. Some vaccines take up to 2 weeks to become effective, while others such as yellow fever should be received at least 10 days prior to travel and can be administered only at government-designated sites. Many vaccines, such as those against typhoid or rabies, are not routinely available at the patient's medical home.
Counseling about strategies to avoid insect and animal bites, food and water precautions, motor vehicle and water-related accidents, and interventions as simple as wearing shoes while walking on the beach is as much a part of a pretravel evaluation as are immunizations.
International travel has become so commonplace that it behooves every primary care physician to identify a travel medicine clinic in their area that can provide pretravel advice and immunizations to their patients, and to inquire about potential international travel during patient visits. Making sure the patients' routine immunizations are up to date is another way providers can assist their patients in preparing for international travel.
Not all travel medicine clinics provide services for children, so it's a good idea to find out which ones do in your area. If you are having difficulty locating a clinic, the International Society of Travel Medicine (www.istm.org/www.astmh.org/source/ClinicalDirectory/
The Centers for Disease Control and Prevention's travel site also offers a clinic locator, as well as other resources for practitioners and travelers (www.cdc.gov/travel
Addressing STDs Crucial to Teen Care
The screening and treatment of sexually transmitted disease is essential to the clinical repertoire of all physicians who care for adolescents.
Any doctor who provides primary health care to teens – whether trained as a pediatrician, family physician, obstetrician-gynecologist, or internist – should assume the responsibility of STD screening and counseling of all adolescent patients as part of anticipatory guidance, along with treatment if necessary.
Recommendations for routine counseling and screening of sexually active adolescents for specific STDs have been made over the last few years by various government agency and professional organizations, but have only now been included in the “Sexually Transmitted Diseases Treatment Guidelines, 2010” published in December by the Centers for Disease Control and Prevention (MMWR 2010;59:[RR-12]).
Of the 11 identified updates in the guidelines (last published in 2006), I would like to focus on those affecting the adolescent. Prevalence of several STDs is highest among this group. Specifically, rates of chlamydia and gonorrhea are highest among females aged 15–19 years, according to the CDC report. Adolescence is also the time when many are first exposed to human papillomavirus virus (HPV).
Why are adolescents at such a high risk for STDs? Risk increases when sexual activity is initiated at a young age, when injected drug use is present, and if male, the sexual encounters are with another male. Additional contributing factors include multiple sexual partners, sequential partners of brief duration (serially monogamous), inconsistent and/or inappropriate use of barrier methods, and challenges to accessing health care.
According to the new CDC STD guidelines, routine screening of Chlamydia trachomatis is recommended annually for all sexually active females aged 25 years and younger. While routine chlamydia screening is not recommended for sexually active young men – based on feasibility, efficacy, and cost-effectiveness – such screening should be considered in high-risk clinical settings such as adolescent clinics, correctional facilities, and STD clinics.
This recommendation, originally from the U.S. Preventive Services Task Force (USPSTF), was published in an internal medicine journal where many pediatricians were not likely to have seen it (Ann. Intern. Med. 2007;147:128-34).
Similarly, routine screening for Neisseria gonorrhoeae also is recommended for all sexually active women less than 25 years of age, the group at greatest risk for the infection. The screening recommendation – also originally from the USPSTF – also applies to women with other risk factors including a previous gonorrhea infection, the presence of other STDs, new or multiple sex partners, inconsistent condom use, commercial sex work, and drug use.
Screening for HIV is not routinely advised, but it should be discussed with all adolescents and encouraged for those who are sexually active and those who use injection drugs.
It is also recommended for all diagnosed with an STD.
Routine screening of adolescents who are asymptomatic for certain STDs – such as syphilis, trichomoniasis, bacterial vaginosis, herpes simplex virus, and hepatitis B virus – is not recommended.
However, young males who have sex with males and pregnant adolescent females might require more thorough evaluation, according to the current CDC recommendations.
It might make us uncomfortable to think about, but our patients are growing up and are not immune to any of these high-risk situations. We have to be prepared to assist them as they transition from childhood to adolescence and ultimately adulthood.
Screening and counseling for sexual activity, STDs, and pregnancy prevention are just some of the quality measures now recommended to assess health services for adolescents.
Many adolescents report that they do not have the opportunity to speak privately with their care provider. Confidentiality is paramount to any discussion, which also should be developmentally appropriate.
Health care providers additionally must feel comfortable obtaining and discussing their patients' sexual history, while at the same time being culturally sensitive and nonjudgmental. They also should be knowledgeable about risky behavior interventions and treatments. All states and the District of Columbia allow adolescents to seek treatment for a presumed STD without parental consent.
But a recent study illustrates why testing must accompany those discussions. Of 14,012 young adults (mean age 21.9 years) who had been interviewed and screened three times beginning in adolescence as part of the National Longitudinal Study of Adolescent Health, 964 tested positive for C. trachomatis, N. gonorrhoeae, and/or Trichomonas vaginalis. Of those, 10.5% reported having abstained from sexual activity during the prior 12 months and, of those, nearly half (5.9% of the total) said they had never had penile/vaginal intercourse in their lives (Pediatrics 2011 Jan. 3 [doi: 10.1542/peds.2009-0892]).
The researchers found no correlation with any sociodemographic factor including age, gender, educational level, or race for discrepancies between STD test results and self-reports among the STD-positive participants. This is the first study that attempts to correlate responses to objective findings.
While self-reported behavior is the mainstay of evaluating intervention strategies, this study suggests the numbers of affected adolescents may be underestimated. The study has several limitations. The participants' baseline STD status was unknown, responses were based on recall, and it only dealt with one type of sexual contact – just to mention a few of the limitations. This is also not the ideal way to evaluate behavioral intervention programs, and such was never the intent of the study.
Other sections of the CDC guidelines address vaccination and counseling, again based on previous published guidelines from federal agencies and medical professional organizations. These include providing the HPV vaccine to 11- to 12-year-old females, hepatitis B vaccine to all adolescents unless already vaccinated, and the hepatitis A vaccine in areas with existing vaccination programs.
Importantly, health care providers who care for children and adolescents should integrate sexuality education into clinical practice. This includes a discussion of both abstinence and consistent, correct condom use. Information regarding HIV infection, testing, transmission, and implications of infection also should be regarded as an essential component of the anticipatory guidance provided to all adolescents as part of health care.
The CDC guidelines include a box with suggested language for initiating a sexual history by asking about the “Five P's”: Partners, Prevention of pregnancy, and Protection from STDs, Practices, and Past history of STDs.
Obtaining a sexual history, educating patients, and/or treating STDs should not have to be referred to other specialists. As primary care physicians, you have a unique opportunity to educate and counsel young patients with whom you already have a well-established relationship. It's not the easiest topic to tackle, but doing so is vital to the health of your patients on their journey to adulthood. The updated treatment guidelines are an excellent resource for every practitioner.
The screening and treatment of sexually transmitted disease is essential to the clinical repertoire of all physicians who care for adolescents.
Any doctor who provides primary health care to teens – whether trained as a pediatrician, family physician, obstetrician-gynecologist, or internist – should assume the responsibility of STD screening and counseling of all adolescent patients as part of anticipatory guidance, along with treatment if necessary.
Recommendations for routine counseling and screening of sexually active adolescents for specific STDs have been made over the last few years by various government agency and professional organizations, but have only now been included in the “Sexually Transmitted Diseases Treatment Guidelines, 2010” published in December by the Centers for Disease Control and Prevention (MMWR 2010;59:[RR-12]).
Of the 11 identified updates in the guidelines (last published in 2006), I would like to focus on those affecting the adolescent. Prevalence of several STDs is highest among this group. Specifically, rates of chlamydia and gonorrhea are highest among females aged 15–19 years, according to the CDC report. Adolescence is also the time when many are first exposed to human papillomavirus virus (HPV).
Why are adolescents at such a high risk for STDs? Risk increases when sexual activity is initiated at a young age, when injected drug use is present, and if male, the sexual encounters are with another male. Additional contributing factors include multiple sexual partners, sequential partners of brief duration (serially monogamous), inconsistent and/or inappropriate use of barrier methods, and challenges to accessing health care.
According to the new CDC STD guidelines, routine screening of Chlamydia trachomatis is recommended annually for all sexually active females aged 25 years and younger. While routine chlamydia screening is not recommended for sexually active young men – based on feasibility, efficacy, and cost-effectiveness – such screening should be considered in high-risk clinical settings such as adolescent clinics, correctional facilities, and STD clinics.
This recommendation, originally from the U.S. Preventive Services Task Force (USPSTF), was published in an internal medicine journal where many pediatricians were not likely to have seen it (Ann. Intern. Med. 2007;147:128-34).
Similarly, routine screening for Neisseria gonorrhoeae also is recommended for all sexually active women less than 25 years of age, the group at greatest risk for the infection. The screening recommendation – also originally from the USPSTF – also applies to women with other risk factors including a previous gonorrhea infection, the presence of other STDs, new or multiple sex partners, inconsistent condom use, commercial sex work, and drug use.
Screening for HIV is not routinely advised, but it should be discussed with all adolescents and encouraged for those who are sexually active and those who use injection drugs.
It is also recommended for all diagnosed with an STD.
Routine screening of adolescents who are asymptomatic for certain STDs – such as syphilis, trichomoniasis, bacterial vaginosis, herpes simplex virus, and hepatitis B virus – is not recommended.
However, young males who have sex with males and pregnant adolescent females might require more thorough evaluation, according to the current CDC recommendations.
It might make us uncomfortable to think about, but our patients are growing up and are not immune to any of these high-risk situations. We have to be prepared to assist them as they transition from childhood to adolescence and ultimately adulthood.
Screening and counseling for sexual activity, STDs, and pregnancy prevention are just some of the quality measures now recommended to assess health services for adolescents.
Many adolescents report that they do not have the opportunity to speak privately with their care provider. Confidentiality is paramount to any discussion, which also should be developmentally appropriate.
Health care providers additionally must feel comfortable obtaining and discussing their patients' sexual history, while at the same time being culturally sensitive and nonjudgmental. They also should be knowledgeable about risky behavior interventions and treatments. All states and the District of Columbia allow adolescents to seek treatment for a presumed STD without parental consent.
But a recent study illustrates why testing must accompany those discussions. Of 14,012 young adults (mean age 21.9 years) who had been interviewed and screened three times beginning in adolescence as part of the National Longitudinal Study of Adolescent Health, 964 tested positive for C. trachomatis, N. gonorrhoeae, and/or Trichomonas vaginalis. Of those, 10.5% reported having abstained from sexual activity during the prior 12 months and, of those, nearly half (5.9% of the total) said they had never had penile/vaginal intercourse in their lives (Pediatrics 2011 Jan. 3 [doi: 10.1542/peds.2009-0892]).
The researchers found no correlation with any sociodemographic factor including age, gender, educational level, or race for discrepancies between STD test results and self-reports among the STD-positive participants. This is the first study that attempts to correlate responses to objective findings.
While self-reported behavior is the mainstay of evaluating intervention strategies, this study suggests the numbers of affected adolescents may be underestimated. The study has several limitations. The participants' baseline STD status was unknown, responses were based on recall, and it only dealt with one type of sexual contact – just to mention a few of the limitations. This is also not the ideal way to evaluate behavioral intervention programs, and such was never the intent of the study.
Other sections of the CDC guidelines address vaccination and counseling, again based on previous published guidelines from federal agencies and medical professional organizations. These include providing the HPV vaccine to 11- to 12-year-old females, hepatitis B vaccine to all adolescents unless already vaccinated, and the hepatitis A vaccine in areas with existing vaccination programs.
Importantly, health care providers who care for children and adolescents should integrate sexuality education into clinical practice. This includes a discussion of both abstinence and consistent, correct condom use. Information regarding HIV infection, testing, transmission, and implications of infection also should be regarded as an essential component of the anticipatory guidance provided to all adolescents as part of health care.
The CDC guidelines include a box with suggested language for initiating a sexual history by asking about the “Five P's”: Partners, Prevention of pregnancy, and Protection from STDs, Practices, and Past history of STDs.
Obtaining a sexual history, educating patients, and/or treating STDs should not have to be referred to other specialists. As primary care physicians, you have a unique opportunity to educate and counsel young patients with whom you already have a well-established relationship. It's not the easiest topic to tackle, but doing so is vital to the health of your patients on their journey to adulthood. The updated treatment guidelines are an excellent resource for every practitioner.
The screening and treatment of sexually transmitted disease is essential to the clinical repertoire of all physicians who care for adolescents.
Any doctor who provides primary health care to teens – whether trained as a pediatrician, family physician, obstetrician-gynecologist, or internist – should assume the responsibility of STD screening and counseling of all adolescent patients as part of anticipatory guidance, along with treatment if necessary.
Recommendations for routine counseling and screening of sexually active adolescents for specific STDs have been made over the last few years by various government agency and professional organizations, but have only now been included in the “Sexually Transmitted Diseases Treatment Guidelines, 2010” published in December by the Centers for Disease Control and Prevention (MMWR 2010;59:[RR-12]).
Of the 11 identified updates in the guidelines (last published in 2006), I would like to focus on those affecting the adolescent. Prevalence of several STDs is highest among this group. Specifically, rates of chlamydia and gonorrhea are highest among females aged 15–19 years, according to the CDC report. Adolescence is also the time when many are first exposed to human papillomavirus virus (HPV).
Why are adolescents at such a high risk for STDs? Risk increases when sexual activity is initiated at a young age, when injected drug use is present, and if male, the sexual encounters are with another male. Additional contributing factors include multiple sexual partners, sequential partners of brief duration (serially monogamous), inconsistent and/or inappropriate use of barrier methods, and challenges to accessing health care.
According to the new CDC STD guidelines, routine screening of Chlamydia trachomatis is recommended annually for all sexually active females aged 25 years and younger. While routine chlamydia screening is not recommended for sexually active young men – based on feasibility, efficacy, and cost-effectiveness – such screening should be considered in high-risk clinical settings such as adolescent clinics, correctional facilities, and STD clinics.
This recommendation, originally from the U.S. Preventive Services Task Force (USPSTF), was published in an internal medicine journal where many pediatricians were not likely to have seen it (Ann. Intern. Med. 2007;147:128-34).
Similarly, routine screening for Neisseria gonorrhoeae also is recommended for all sexually active women less than 25 years of age, the group at greatest risk for the infection. The screening recommendation – also originally from the USPSTF – also applies to women with other risk factors including a previous gonorrhea infection, the presence of other STDs, new or multiple sex partners, inconsistent condom use, commercial sex work, and drug use.
Screening for HIV is not routinely advised, but it should be discussed with all adolescents and encouraged for those who are sexually active and those who use injection drugs.
It is also recommended for all diagnosed with an STD.
Routine screening of adolescents who are asymptomatic for certain STDs – such as syphilis, trichomoniasis, bacterial vaginosis, herpes simplex virus, and hepatitis B virus – is not recommended.
However, young males who have sex with males and pregnant adolescent females might require more thorough evaluation, according to the current CDC recommendations.
It might make us uncomfortable to think about, but our patients are growing up and are not immune to any of these high-risk situations. We have to be prepared to assist them as they transition from childhood to adolescence and ultimately adulthood.
Screening and counseling for sexual activity, STDs, and pregnancy prevention are just some of the quality measures now recommended to assess health services for adolescents.
Many adolescents report that they do not have the opportunity to speak privately with their care provider. Confidentiality is paramount to any discussion, which also should be developmentally appropriate.
Health care providers additionally must feel comfortable obtaining and discussing their patients' sexual history, while at the same time being culturally sensitive and nonjudgmental. They also should be knowledgeable about risky behavior interventions and treatments. All states and the District of Columbia allow adolescents to seek treatment for a presumed STD without parental consent.
But a recent study illustrates why testing must accompany those discussions. Of 14,012 young adults (mean age 21.9 years) who had been interviewed and screened three times beginning in adolescence as part of the National Longitudinal Study of Adolescent Health, 964 tested positive for C. trachomatis, N. gonorrhoeae, and/or Trichomonas vaginalis. Of those, 10.5% reported having abstained from sexual activity during the prior 12 months and, of those, nearly half (5.9% of the total) said they had never had penile/vaginal intercourse in their lives (Pediatrics 2011 Jan. 3 [doi: 10.1542/peds.2009-0892]).
The researchers found no correlation with any sociodemographic factor including age, gender, educational level, or race for discrepancies between STD test results and self-reports among the STD-positive participants. This is the first study that attempts to correlate responses to objective findings.
While self-reported behavior is the mainstay of evaluating intervention strategies, this study suggests the numbers of affected adolescents may be underestimated. The study has several limitations. The participants' baseline STD status was unknown, responses were based on recall, and it only dealt with one type of sexual contact – just to mention a few of the limitations. This is also not the ideal way to evaluate behavioral intervention programs, and such was never the intent of the study.
Other sections of the CDC guidelines address vaccination and counseling, again based on previous published guidelines from federal agencies and medical professional organizations. These include providing the HPV vaccine to 11- to 12-year-old females, hepatitis B vaccine to all adolescents unless already vaccinated, and the hepatitis A vaccine in areas with existing vaccination programs.
Importantly, health care providers who care for children and adolescents should integrate sexuality education into clinical practice. This includes a discussion of both abstinence and consistent, correct condom use. Information regarding HIV infection, testing, transmission, and implications of infection also should be regarded as an essential component of the anticipatory guidance provided to all adolescents as part of health care.
The CDC guidelines include a box with suggested language for initiating a sexual history by asking about the “Five P's”: Partners, Prevention of pregnancy, and Protection from STDs, Practices, and Past history of STDs.
Obtaining a sexual history, educating patients, and/or treating STDs should not have to be referred to other specialists. As primary care physicians, you have a unique opportunity to educate and counsel young patients with whom you already have a well-established relationship. It's not the easiest topic to tackle, but doing so is vital to the health of your patients on their journey to adulthood. The updated treatment guidelines are an excellent resource for every practitioner.
What We'll Be Discussing in 2011
It's hard to believe that it is time to ring in the New Year already! In last year's review column (January 2010, p. 9), the predictions hit the mark on many counts. (My partner, Dr. Angie Myers, calls me “the Amazing Kreskin.”)
In 2010, we did indeed learn valuable lessons from H1N1 influenza. In many hospitals, the national mandate for health care workers and influenza vaccine became a reality. The new palivizumab guidelines and the use of hepatitis A and 13-valent pneumococcal conjugate vaccine have been implemented, and we continued to see a decline in meningococcal and rotaviral infection. Clindamycin resistance rates have increased, although we have not seen the rise in vancomycin intermediate or resistant Staphylococcus aureus, the prospect of which made me wonder if this drug would become passé.
For 2011, I think we will be seriously talking about the following topics:
▸ HPV completion rates for teenage girls. Dr. Lee E. Widdice of Cincinnati Children's Hospital and colleagues noted that only 14% of 3,297 girls completed their vaccine on time, and only 28% within a year of starting the vaccine. The rate of on-time vaccine completions was significantly less for nonwhites, raising concern for the impact of this health care disparity on the epidemiology of cervical cancer (Pediatrics 2010 Dec. 13 [doi:10.1542/peds.2010-0812]).
Investigators at National Institutes of Health–based vaccine evaluation and treatment units across the country are looking at whether the immunogenicity of vaccine is adequate in teens who receive their doses later than recommended. Additional research into the health care disparity issues should be targeted in future studies.
▸ Is the epidemiology of RSV changing? As of late December here in Kansas City, we saw only a modest number of infants hospitalized with bronchiolitis. The onset of respiratory syncytial virus across most of the Unites States is usually in early to mid-November (MMWR 2010;59:230-3).
Dr. Denise Bratcher and I looked at 10 RSV seasons in our institution, and the average onset was indeed Nov. 5 (except in one season when disease began in mid-January), indicating that 2010 was a remarkably slow year for us in terms of RSV disease. Could prevention of influenza with wide scale use of influenza vaccine be impacting RSV rates?
▸ Judicious use of antibiotics will be front and center in the office setting. Practitioners will increasingly be scrutinizing their use of antibiotics to ensure appropriate use by making the correct diagnosis and prescribing the most narrow-spectrum efficacious drug available.
If you want to evaluate antibiotic use in your practice, start with streptococcal pharyngitis. Ensure that you are doing streptococcal testing in the appropriate patient, using amoxicillin as your first-line drug and determining who has a valid penicillin allergy and really requires an alternative agent. Of those who self-report a history of allergy, 90% are not allergic (JAMA 2001;285:2498-505).
▸ No more tuberculin skin testing in patients older than 5 years? Interferon-based tuberculin testing (a simple, albeit expensive, blood test) has proved especially valuable for the older patient who has either just come to the United States (and previously received BCG vaccine), has returned from traveling overseas to a TB-endemic country, or is beginning work in a health care field.
There is a lot of upside to these new tests, although I suspect we will learn more as they become routine and are used on a large scale for the evaluation of health care personnel. However, they have produced indeterminate results in a small subset of health workers. As we learn more about the reliability of such tests as a population-screening tool, I suspect we will see additional recommendations.
▸ Is MRSA going away? It seems that we are seeing fewer children presenting to our emergency department with skin and soft-tissue abscesses, and fewer patients presenting to our infectious disease clinic with recurrent infection. Practitioners may just be getting used to doing the evaluation and treatment of such patients themselves, but the number of children we treat for more serious skeletal infection does not seem to be decreasing. Upcoming evidence-based MRSA-management guidelines from the Infectious Disease Society of America (IDSA) will cover everything from neonatal pustulosis to invasive infection.
▸ Is a new cholera vaccine needed? The devastating effect of the ongoing cholera outbreak in Haiti has raised discussion regarding the need for a more efficacious and readily available cholera vaccine. As of late December, 58,190 hospitalizations and 2,535 deaths have been reported in Haiti. Check out an eloquently written commentary detailing the potential role of the United States in stockpiling and distributing cholera vaccine in cholera-distressed regions of the world (N. Engl. J. Med. 2010;363:2279-82).
▸ Will we have pertussis outbreaks because of reduced vaccine efficacy related to improper storage? Researchers have confirmed that inadvertent freezing of DTaP vaccine (which inactivates the acellular pertussis component) occurred frequently in 54 refrigerators used in the Texas county health system. Typically, this occurred on weekends and at night when the appliances became excessively cold because they were not being opened for retrieval of doses. Investigators were able to correlate the risk of frozen vaccine with increased pertussis rates in specific regions (Am. J. Public Health 2011;101:46-7). Could tackling the problem of continued pertussis outbreaks be as simple as better temperature regulation?
▸ Could standard-dose amoxicillin return for treating otitis media? The epidemiology of pneumococcal disease will continue to evolve following implementation of PCV13. In a few more years, we could potentially see eradication of multidrug-resistant serotype 19A with replacement by other serotypes that are penicillin susceptible. Dr. Doug Swanson from my section has been serotyping our strains for several years, and now is seeing previously uncommon types that are nearly all penicillin susceptible.
▸ IDSA guidelines for treatment of pediatric community-acquired pneumonia are coming your way soon. They are evidence based and have been formulated specifically for the pediatric patient. Look for highlights to include guidance regarding situations in which to obtain blood culture and chest radiography, the first-line agent of choice, and how to identify and handle the patient with complicated disease.
▸ More complicated Clostridium difficile–associated diarrhea (CDAD) makes its way to the pediatric patient. About 2 years ago, when we looked at several years of data to document the epidemiology of CDAD in our pediatric population, we had not encountered many cases of severe CDAD that was associated with increased mortality and a reduced effectiveness of metronidazole.
Recently, however, we cared for an otherwise healthy child with fulminant colitis who was referred for concern that her disease would necessitate emergency colectomy. Fortunately, she recovered without surgery. I fully suspect that community-acquired CDAD without prior antibiotic use will become more familiar to the pediatric practitioner.
My best wishes to you all for a year filled with goodness and peace!
It's hard to believe that it is time to ring in the New Year already! In last year's review column (January 2010, p. 9), the predictions hit the mark on many counts. (My partner, Dr. Angie Myers, calls me “the Amazing Kreskin.”)
In 2010, we did indeed learn valuable lessons from H1N1 influenza. In many hospitals, the national mandate for health care workers and influenza vaccine became a reality. The new palivizumab guidelines and the use of hepatitis A and 13-valent pneumococcal conjugate vaccine have been implemented, and we continued to see a decline in meningococcal and rotaviral infection. Clindamycin resistance rates have increased, although we have not seen the rise in vancomycin intermediate or resistant Staphylococcus aureus, the prospect of which made me wonder if this drug would become passé.
For 2011, I think we will be seriously talking about the following topics:
▸ HPV completion rates for teenage girls. Dr. Lee E. Widdice of Cincinnati Children's Hospital and colleagues noted that only 14% of 3,297 girls completed their vaccine on time, and only 28% within a year of starting the vaccine. The rate of on-time vaccine completions was significantly less for nonwhites, raising concern for the impact of this health care disparity on the epidemiology of cervical cancer (Pediatrics 2010 Dec. 13 [doi:10.1542/peds.2010-0812]).
Investigators at National Institutes of Health–based vaccine evaluation and treatment units across the country are looking at whether the immunogenicity of vaccine is adequate in teens who receive their doses later than recommended. Additional research into the health care disparity issues should be targeted in future studies.
▸ Is the epidemiology of RSV changing? As of late December here in Kansas City, we saw only a modest number of infants hospitalized with bronchiolitis. The onset of respiratory syncytial virus across most of the Unites States is usually in early to mid-November (MMWR 2010;59:230-3).
Dr. Denise Bratcher and I looked at 10 RSV seasons in our institution, and the average onset was indeed Nov. 5 (except in one season when disease began in mid-January), indicating that 2010 was a remarkably slow year for us in terms of RSV disease. Could prevention of influenza with wide scale use of influenza vaccine be impacting RSV rates?
▸ Judicious use of antibiotics will be front and center in the office setting. Practitioners will increasingly be scrutinizing their use of antibiotics to ensure appropriate use by making the correct diagnosis and prescribing the most narrow-spectrum efficacious drug available.
If you want to evaluate antibiotic use in your practice, start with streptococcal pharyngitis. Ensure that you are doing streptococcal testing in the appropriate patient, using amoxicillin as your first-line drug and determining who has a valid penicillin allergy and really requires an alternative agent. Of those who self-report a history of allergy, 90% are not allergic (JAMA 2001;285:2498-505).
▸ No more tuberculin skin testing in patients older than 5 years? Interferon-based tuberculin testing (a simple, albeit expensive, blood test) has proved especially valuable for the older patient who has either just come to the United States (and previously received BCG vaccine), has returned from traveling overseas to a TB-endemic country, or is beginning work in a health care field.
There is a lot of upside to these new tests, although I suspect we will learn more as they become routine and are used on a large scale for the evaluation of health care personnel. However, they have produced indeterminate results in a small subset of health workers. As we learn more about the reliability of such tests as a population-screening tool, I suspect we will see additional recommendations.
▸ Is MRSA going away? It seems that we are seeing fewer children presenting to our emergency department with skin and soft-tissue abscesses, and fewer patients presenting to our infectious disease clinic with recurrent infection. Practitioners may just be getting used to doing the evaluation and treatment of such patients themselves, but the number of children we treat for more serious skeletal infection does not seem to be decreasing. Upcoming evidence-based MRSA-management guidelines from the Infectious Disease Society of America (IDSA) will cover everything from neonatal pustulosis to invasive infection.
▸ Is a new cholera vaccine needed? The devastating effect of the ongoing cholera outbreak in Haiti has raised discussion regarding the need for a more efficacious and readily available cholera vaccine. As of late December, 58,190 hospitalizations and 2,535 deaths have been reported in Haiti. Check out an eloquently written commentary detailing the potential role of the United States in stockpiling and distributing cholera vaccine in cholera-distressed regions of the world (N. Engl. J. Med. 2010;363:2279-82).
▸ Will we have pertussis outbreaks because of reduced vaccine efficacy related to improper storage? Researchers have confirmed that inadvertent freezing of DTaP vaccine (which inactivates the acellular pertussis component) occurred frequently in 54 refrigerators used in the Texas county health system. Typically, this occurred on weekends and at night when the appliances became excessively cold because they were not being opened for retrieval of doses. Investigators were able to correlate the risk of frozen vaccine with increased pertussis rates in specific regions (Am. J. Public Health 2011;101:46-7). Could tackling the problem of continued pertussis outbreaks be as simple as better temperature regulation?
▸ Could standard-dose amoxicillin return for treating otitis media? The epidemiology of pneumococcal disease will continue to evolve following implementation of PCV13. In a few more years, we could potentially see eradication of multidrug-resistant serotype 19A with replacement by other serotypes that are penicillin susceptible. Dr. Doug Swanson from my section has been serotyping our strains for several years, and now is seeing previously uncommon types that are nearly all penicillin susceptible.
▸ IDSA guidelines for treatment of pediatric community-acquired pneumonia are coming your way soon. They are evidence based and have been formulated specifically for the pediatric patient. Look for highlights to include guidance regarding situations in which to obtain blood culture and chest radiography, the first-line agent of choice, and how to identify and handle the patient with complicated disease.
▸ More complicated Clostridium difficile–associated diarrhea (CDAD) makes its way to the pediatric patient. About 2 years ago, when we looked at several years of data to document the epidemiology of CDAD in our pediatric population, we had not encountered many cases of severe CDAD that was associated with increased mortality and a reduced effectiveness of metronidazole.
Recently, however, we cared for an otherwise healthy child with fulminant colitis who was referred for concern that her disease would necessitate emergency colectomy. Fortunately, she recovered without surgery. I fully suspect that community-acquired CDAD without prior antibiotic use will become more familiar to the pediatric practitioner.
My best wishes to you all for a year filled with goodness and peace!
It's hard to believe that it is time to ring in the New Year already! In last year's review column (January 2010, p. 9), the predictions hit the mark on many counts. (My partner, Dr. Angie Myers, calls me “the Amazing Kreskin.”)
In 2010, we did indeed learn valuable lessons from H1N1 influenza. In many hospitals, the national mandate for health care workers and influenza vaccine became a reality. The new palivizumab guidelines and the use of hepatitis A and 13-valent pneumococcal conjugate vaccine have been implemented, and we continued to see a decline in meningococcal and rotaviral infection. Clindamycin resistance rates have increased, although we have not seen the rise in vancomycin intermediate or resistant Staphylococcus aureus, the prospect of which made me wonder if this drug would become passé.
For 2011, I think we will be seriously talking about the following topics:
▸ HPV completion rates for teenage girls. Dr. Lee E. Widdice of Cincinnati Children's Hospital and colleagues noted that only 14% of 3,297 girls completed their vaccine on time, and only 28% within a year of starting the vaccine. The rate of on-time vaccine completions was significantly less for nonwhites, raising concern for the impact of this health care disparity on the epidemiology of cervical cancer (Pediatrics 2010 Dec. 13 [doi:10.1542/peds.2010-0812]).
Investigators at National Institutes of Health–based vaccine evaluation and treatment units across the country are looking at whether the immunogenicity of vaccine is adequate in teens who receive their doses later than recommended. Additional research into the health care disparity issues should be targeted in future studies.
▸ Is the epidemiology of RSV changing? As of late December here in Kansas City, we saw only a modest number of infants hospitalized with bronchiolitis. The onset of respiratory syncytial virus across most of the Unites States is usually in early to mid-November (MMWR 2010;59:230-3).
Dr. Denise Bratcher and I looked at 10 RSV seasons in our institution, and the average onset was indeed Nov. 5 (except in one season when disease began in mid-January), indicating that 2010 was a remarkably slow year for us in terms of RSV disease. Could prevention of influenza with wide scale use of influenza vaccine be impacting RSV rates?
▸ Judicious use of antibiotics will be front and center in the office setting. Practitioners will increasingly be scrutinizing their use of antibiotics to ensure appropriate use by making the correct diagnosis and prescribing the most narrow-spectrum efficacious drug available.
If you want to evaluate antibiotic use in your practice, start with streptococcal pharyngitis. Ensure that you are doing streptococcal testing in the appropriate patient, using amoxicillin as your first-line drug and determining who has a valid penicillin allergy and really requires an alternative agent. Of those who self-report a history of allergy, 90% are not allergic (JAMA 2001;285:2498-505).
▸ No more tuberculin skin testing in patients older than 5 years? Interferon-based tuberculin testing (a simple, albeit expensive, blood test) has proved especially valuable for the older patient who has either just come to the United States (and previously received BCG vaccine), has returned from traveling overseas to a TB-endemic country, or is beginning work in a health care field.
There is a lot of upside to these new tests, although I suspect we will learn more as they become routine and are used on a large scale for the evaluation of health care personnel. However, they have produced indeterminate results in a small subset of health workers. As we learn more about the reliability of such tests as a population-screening tool, I suspect we will see additional recommendations.
▸ Is MRSA going away? It seems that we are seeing fewer children presenting to our emergency department with skin and soft-tissue abscesses, and fewer patients presenting to our infectious disease clinic with recurrent infection. Practitioners may just be getting used to doing the evaluation and treatment of such patients themselves, but the number of children we treat for more serious skeletal infection does not seem to be decreasing. Upcoming evidence-based MRSA-management guidelines from the Infectious Disease Society of America (IDSA) will cover everything from neonatal pustulosis to invasive infection.
▸ Is a new cholera vaccine needed? The devastating effect of the ongoing cholera outbreak in Haiti has raised discussion regarding the need for a more efficacious and readily available cholera vaccine. As of late December, 58,190 hospitalizations and 2,535 deaths have been reported in Haiti. Check out an eloquently written commentary detailing the potential role of the United States in stockpiling and distributing cholera vaccine in cholera-distressed regions of the world (N. Engl. J. Med. 2010;363:2279-82).
▸ Will we have pertussis outbreaks because of reduced vaccine efficacy related to improper storage? Researchers have confirmed that inadvertent freezing of DTaP vaccine (which inactivates the acellular pertussis component) occurred frequently in 54 refrigerators used in the Texas county health system. Typically, this occurred on weekends and at night when the appliances became excessively cold because they were not being opened for retrieval of doses. Investigators were able to correlate the risk of frozen vaccine with increased pertussis rates in specific regions (Am. J. Public Health 2011;101:46-7). Could tackling the problem of continued pertussis outbreaks be as simple as better temperature regulation?
▸ Could standard-dose amoxicillin return for treating otitis media? The epidemiology of pneumococcal disease will continue to evolve following implementation of PCV13. In a few more years, we could potentially see eradication of multidrug-resistant serotype 19A with replacement by other serotypes that are penicillin susceptible. Dr. Doug Swanson from my section has been serotyping our strains for several years, and now is seeing previously uncommon types that are nearly all penicillin susceptible.
▸ IDSA guidelines for treatment of pediatric community-acquired pneumonia are coming your way soon. They are evidence based and have been formulated specifically for the pediatric patient. Look for highlights to include guidance regarding situations in which to obtain blood culture and chest radiography, the first-line agent of choice, and how to identify and handle the patient with complicated disease.
▸ More complicated Clostridium difficile–associated diarrhea (CDAD) makes its way to the pediatric patient. About 2 years ago, when we looked at several years of data to document the epidemiology of CDAD in our pediatric population, we had not encountered many cases of severe CDAD that was associated with increased mortality and a reduced effectiveness of metronidazole.
Recently, however, we cared for an otherwise healthy child with fulminant colitis who was referred for concern that her disease would necessitate emergency colectomy. Fortunately, she recovered without surgery. I fully suspect that community-acquired CDAD without prior antibiotic use will become more familiar to the pediatric practitioner.
My best wishes to you all for a year filled with goodness and peace!
Postvaccination Adverse Events
It's important to keep an open mind when a parent informs you that his or her child has experienced an adverse event following vaccination.
Determining which adverse events are caused by a vaccine and which are mere coincidental associations can be very difficult. As physicians who administer vaccines to children, one of the most important contributions we can make is to report all postimmunization adverse events to the Vaccine Adverse Events Reporting System (http://vaers.hhs.gov/index
The best information we have comes from studies that compare population-based rates of a specific event with the postimmunization rates to see if there is a significant difference. Alternatively, case-control studies can identify whether the odds ratio for receipt of a vaccine is increased among cases. Unfortunately, such studies have been done for only a fraction of all reported postvaccination adverse events.
I'd like to highlight a few prominent adverse events that have been reported following immunization. Some, although unusual, have been causally linked to vaccines. Others, particularly certain severe neurologic outcomes, do not appear to be linked although monitoring continues.
▸ Thigh swelling and the DTaP vaccine. This one is fairly well established. Often confused with cellulitis, swelling of the entire arm or leg following receipt of the diphtheria-tetanus-acellular pertussis (DTaP) vaccine is reported in nearly 2% of all children following the fourth dose, with rates and severity increasing with each successive DTaP dose (Pediatr. Infect. Dis. J. 2008;27:464-5).
However, unlike cellulitis, it is rarely associated with fever or other systemic symptoms, is localized to the vaccinated limb, and usually resolves completely within 48 hours. Although the swelling is likely to occur again with subsequent doses, both the CDC's Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics recommend that the child receive all recommended DTaP doses following appropriate counseling of the parents.
▸ Hair loss and the hepatitis B (and other) vaccines. There have been 60 case reports of hair loss (alopecia) following receipt of vaccines, 46 of them associated with the hepatitis B vaccine. These included 16 in which the hair grew back but then fell out again after re-vaccination. Nine of the patients reported previous medication allergy (JAMA 1997;278:1176-8). This appears to be a true causal effect, although rare considering the tens of millions of hepatitis B doses given over the last decades. But in a small number of genetically predisposed children – most of them female – there does appear to be biological plausibility because hair loss has recurred with second dose and is further supported by the several case reports of alopecia in chronic active hepatitis B viral infection patients.
▸ Idiopathic thrombocytopenic purpura and MMR vaccine. This link is probably also causal. One study utilizing immunization and hospital admission records demonstrated an absolute risk of one case in every 22,300 doses within 6 weeks of MMR vaccination (Arch. Dis. Child. 2001;84:227-9). Another study, which attempted to control for the effect of viral infections, found a similar idiopathic thrombocytopenic purpura (ITP) risk of about 1 in 30,000 MMR immunizations. That population-based analysis of 506 consecutive pediatric ITP patients also found that the thrombocytopenia disappeared within a month in 74% of patients and lasted longer than 6 months in only 10% (Vaccine 2007;25:1838-40).
▸ Myocarditis after vaccination. Inflammatory myocarditis was reported in 10 of approximately 240,000 military recipients of the smallpox vaccine and in 2 additional civilian cases during the widespread pre-event immunization program in 2001. Although it was not definitively linked to the vaccine, ACIP nonetheless recommended that those with heart disease or at risk for it should not receive the vaccine (MMWR 2003;52:282-4).
In children, there have been two reported cases of myocarditis following immunization, one following the hepatitis B vaccine in a previously healthy 12-year-old girl, the other after receipt of meningococcal C conjugate vaccine in a 14-year-old boy. Both showed eosinophilic infiltrates on myocardial biopsies, consistent with an allergic reaction to the vaccine (Pediatr. Infect. Dis. J. 2008;27:831-5). I think the jury is still out on this one. Certainly if you see a case, be sure to report it to VAERS.
▸ Acute disseminated encephalomyelitis and vaccination. These reports have been coming in since the 1970s, for a variety of different vaccines. Examples include Guillain-Barré syndrome (GBS) following the Haemophilus influenzae B conjugate vaccine (Eur. J. Pediatr. 1993;152:613-4), central nervous system inflammatory demyelination following hepatitis B vaccination (Neurology 2009;72:2053), and transverse myelitis with oral polio vaccine (J. Paediatr. Child Health 2006;42:155-9).
Without knowing the background rates of these neurologic complications among unvaccinated individuals, it is impossible to ascertain causality. An excellent data analysis conducted by Dr. Steven Black and colleagues provided very helpful estimates of the numbers of specific severe adverse events that would be expected following receipt of the 2009 H1N1 influenza vaccine.
Based on background rates, they determined that within 6 weeks of vaccination there would be 21.5 coincident cases of GBS per 10 million vaccine recipients, and 86.3 cases of optic neuritis per 10 million female vaccinees. Spontaneous abortions would occur in 16,684 of every 1 million vaccinated pregnant women, and sudden death within 1 hour of any symptom onset in 5.75 of every 10 million people vaccinated (Lancet 2009;374:2115-22).
Another important analysis was conducted by the CDC to determine whether 33 reported cases of GBS in 11- to 19-year-olds within 42 days of receipt of meningococcal conjugate vaccine were causally linked. Background data from the 2000–2004 Healthcare Cost and Utilization project estimated that there would be very close to 36 cases for the entire age cohort, suggesting there was no causal link. However, just 20 cases would be expected among 15- to 19-year-olds, but the actual number was 26.
Although not statistically significant, this difference was enough to merit continued monitoring by the CDC, which advised that children with prior GBS not receive the vaccine (MMWR 2006;55:364-6).
Finally, a population-based case-control study from France investigated cases of acute disseminated encephalomyelitis, optic neuritis, and transverse myelitis in children younger than 16 years of age between 1994 and 2003, using 12 controls per case matched for age, sex, and geographic location. Rates of hepatitis B vaccination were 24% in cases and 27% in controls, for an adjusted odds ratio of 0.74 (Neurology 2009;73:1426-7). One might conclude from this that hepatitis B vaccine is actually protective, but the result was not statistically significant.
It's important to keep an open mind when a parent informs you that his or her child has experienced an adverse event following vaccination.
Determining which adverse events are caused by a vaccine and which are mere coincidental associations can be very difficult. As physicians who administer vaccines to children, one of the most important contributions we can make is to report all postimmunization adverse events to the Vaccine Adverse Events Reporting System (http://vaers.hhs.gov/index
The best information we have comes from studies that compare population-based rates of a specific event with the postimmunization rates to see if there is a significant difference. Alternatively, case-control studies can identify whether the odds ratio for receipt of a vaccine is increased among cases. Unfortunately, such studies have been done for only a fraction of all reported postvaccination adverse events.
I'd like to highlight a few prominent adverse events that have been reported following immunization. Some, although unusual, have been causally linked to vaccines. Others, particularly certain severe neurologic outcomes, do not appear to be linked although monitoring continues.
▸ Thigh swelling and the DTaP vaccine. This one is fairly well established. Often confused with cellulitis, swelling of the entire arm or leg following receipt of the diphtheria-tetanus-acellular pertussis (DTaP) vaccine is reported in nearly 2% of all children following the fourth dose, with rates and severity increasing with each successive DTaP dose (Pediatr. Infect. Dis. J. 2008;27:464-5).
However, unlike cellulitis, it is rarely associated with fever or other systemic symptoms, is localized to the vaccinated limb, and usually resolves completely within 48 hours. Although the swelling is likely to occur again with subsequent doses, both the CDC's Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics recommend that the child receive all recommended DTaP doses following appropriate counseling of the parents.
▸ Hair loss and the hepatitis B (and other) vaccines. There have been 60 case reports of hair loss (alopecia) following receipt of vaccines, 46 of them associated with the hepatitis B vaccine. These included 16 in which the hair grew back but then fell out again after re-vaccination. Nine of the patients reported previous medication allergy (JAMA 1997;278:1176-8). This appears to be a true causal effect, although rare considering the tens of millions of hepatitis B doses given over the last decades. But in a small number of genetically predisposed children – most of them female – there does appear to be biological plausibility because hair loss has recurred with second dose and is further supported by the several case reports of alopecia in chronic active hepatitis B viral infection patients.
▸ Idiopathic thrombocytopenic purpura and MMR vaccine. This link is probably also causal. One study utilizing immunization and hospital admission records demonstrated an absolute risk of one case in every 22,300 doses within 6 weeks of MMR vaccination (Arch. Dis. Child. 2001;84:227-9). Another study, which attempted to control for the effect of viral infections, found a similar idiopathic thrombocytopenic purpura (ITP) risk of about 1 in 30,000 MMR immunizations. That population-based analysis of 506 consecutive pediatric ITP patients also found that the thrombocytopenia disappeared within a month in 74% of patients and lasted longer than 6 months in only 10% (Vaccine 2007;25:1838-40).
▸ Myocarditis after vaccination. Inflammatory myocarditis was reported in 10 of approximately 240,000 military recipients of the smallpox vaccine and in 2 additional civilian cases during the widespread pre-event immunization program in 2001. Although it was not definitively linked to the vaccine, ACIP nonetheless recommended that those with heart disease or at risk for it should not receive the vaccine (MMWR 2003;52:282-4).
In children, there have been two reported cases of myocarditis following immunization, one following the hepatitis B vaccine in a previously healthy 12-year-old girl, the other after receipt of meningococcal C conjugate vaccine in a 14-year-old boy. Both showed eosinophilic infiltrates on myocardial biopsies, consistent with an allergic reaction to the vaccine (Pediatr. Infect. Dis. J. 2008;27:831-5). I think the jury is still out on this one. Certainly if you see a case, be sure to report it to VAERS.
▸ Acute disseminated encephalomyelitis and vaccination. These reports have been coming in since the 1970s, for a variety of different vaccines. Examples include Guillain-Barré syndrome (GBS) following the Haemophilus influenzae B conjugate vaccine (Eur. J. Pediatr. 1993;152:613-4), central nervous system inflammatory demyelination following hepatitis B vaccination (Neurology 2009;72:2053), and transverse myelitis with oral polio vaccine (J. Paediatr. Child Health 2006;42:155-9).
Without knowing the background rates of these neurologic complications among unvaccinated individuals, it is impossible to ascertain causality. An excellent data analysis conducted by Dr. Steven Black and colleagues provided very helpful estimates of the numbers of specific severe adverse events that would be expected following receipt of the 2009 H1N1 influenza vaccine.
Based on background rates, they determined that within 6 weeks of vaccination there would be 21.5 coincident cases of GBS per 10 million vaccine recipients, and 86.3 cases of optic neuritis per 10 million female vaccinees. Spontaneous abortions would occur in 16,684 of every 1 million vaccinated pregnant women, and sudden death within 1 hour of any symptom onset in 5.75 of every 10 million people vaccinated (Lancet 2009;374:2115-22).
Another important analysis was conducted by the CDC to determine whether 33 reported cases of GBS in 11- to 19-year-olds within 42 days of receipt of meningococcal conjugate vaccine were causally linked. Background data from the 2000–2004 Healthcare Cost and Utilization project estimated that there would be very close to 36 cases for the entire age cohort, suggesting there was no causal link. However, just 20 cases would be expected among 15- to 19-year-olds, but the actual number was 26.
Although not statistically significant, this difference was enough to merit continued monitoring by the CDC, which advised that children with prior GBS not receive the vaccine (MMWR 2006;55:364-6).
Finally, a population-based case-control study from France investigated cases of acute disseminated encephalomyelitis, optic neuritis, and transverse myelitis in children younger than 16 years of age between 1994 and 2003, using 12 controls per case matched for age, sex, and geographic location. Rates of hepatitis B vaccination were 24% in cases and 27% in controls, for an adjusted odds ratio of 0.74 (Neurology 2009;73:1426-7). One might conclude from this that hepatitis B vaccine is actually protective, but the result was not statistically significant.
It's important to keep an open mind when a parent informs you that his or her child has experienced an adverse event following vaccination.
Determining which adverse events are caused by a vaccine and which are mere coincidental associations can be very difficult. As physicians who administer vaccines to children, one of the most important contributions we can make is to report all postimmunization adverse events to the Vaccine Adverse Events Reporting System (http://vaers.hhs.gov/index
The best information we have comes from studies that compare population-based rates of a specific event with the postimmunization rates to see if there is a significant difference. Alternatively, case-control studies can identify whether the odds ratio for receipt of a vaccine is increased among cases. Unfortunately, such studies have been done for only a fraction of all reported postvaccination adverse events.
I'd like to highlight a few prominent adverse events that have been reported following immunization. Some, although unusual, have been causally linked to vaccines. Others, particularly certain severe neurologic outcomes, do not appear to be linked although monitoring continues.
▸ Thigh swelling and the DTaP vaccine. This one is fairly well established. Often confused with cellulitis, swelling of the entire arm or leg following receipt of the diphtheria-tetanus-acellular pertussis (DTaP) vaccine is reported in nearly 2% of all children following the fourth dose, with rates and severity increasing with each successive DTaP dose (Pediatr. Infect. Dis. J. 2008;27:464-5).
However, unlike cellulitis, it is rarely associated with fever or other systemic symptoms, is localized to the vaccinated limb, and usually resolves completely within 48 hours. Although the swelling is likely to occur again with subsequent doses, both the CDC's Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics recommend that the child receive all recommended DTaP doses following appropriate counseling of the parents.
▸ Hair loss and the hepatitis B (and other) vaccines. There have been 60 case reports of hair loss (alopecia) following receipt of vaccines, 46 of them associated with the hepatitis B vaccine. These included 16 in which the hair grew back but then fell out again after re-vaccination. Nine of the patients reported previous medication allergy (JAMA 1997;278:1176-8). This appears to be a true causal effect, although rare considering the tens of millions of hepatitis B doses given over the last decades. But in a small number of genetically predisposed children – most of them female – there does appear to be biological plausibility because hair loss has recurred with second dose and is further supported by the several case reports of alopecia in chronic active hepatitis B viral infection patients.
▸ Idiopathic thrombocytopenic purpura and MMR vaccine. This link is probably also causal. One study utilizing immunization and hospital admission records demonstrated an absolute risk of one case in every 22,300 doses within 6 weeks of MMR vaccination (Arch. Dis. Child. 2001;84:227-9). Another study, which attempted to control for the effect of viral infections, found a similar idiopathic thrombocytopenic purpura (ITP) risk of about 1 in 30,000 MMR immunizations. That population-based analysis of 506 consecutive pediatric ITP patients also found that the thrombocytopenia disappeared within a month in 74% of patients and lasted longer than 6 months in only 10% (Vaccine 2007;25:1838-40).
▸ Myocarditis after vaccination. Inflammatory myocarditis was reported in 10 of approximately 240,000 military recipients of the smallpox vaccine and in 2 additional civilian cases during the widespread pre-event immunization program in 2001. Although it was not definitively linked to the vaccine, ACIP nonetheless recommended that those with heart disease or at risk for it should not receive the vaccine (MMWR 2003;52:282-4).
In children, there have been two reported cases of myocarditis following immunization, one following the hepatitis B vaccine in a previously healthy 12-year-old girl, the other after receipt of meningococcal C conjugate vaccine in a 14-year-old boy. Both showed eosinophilic infiltrates on myocardial biopsies, consistent with an allergic reaction to the vaccine (Pediatr. Infect. Dis. J. 2008;27:831-5). I think the jury is still out on this one. Certainly if you see a case, be sure to report it to VAERS.
▸ Acute disseminated encephalomyelitis and vaccination. These reports have been coming in since the 1970s, for a variety of different vaccines. Examples include Guillain-Barré syndrome (GBS) following the Haemophilus influenzae B conjugate vaccine (Eur. J. Pediatr. 1993;152:613-4), central nervous system inflammatory demyelination following hepatitis B vaccination (Neurology 2009;72:2053), and transverse myelitis with oral polio vaccine (J. Paediatr. Child Health 2006;42:155-9).
Without knowing the background rates of these neurologic complications among unvaccinated individuals, it is impossible to ascertain causality. An excellent data analysis conducted by Dr. Steven Black and colleagues provided very helpful estimates of the numbers of specific severe adverse events that would be expected following receipt of the 2009 H1N1 influenza vaccine.
Based on background rates, they determined that within 6 weeks of vaccination there would be 21.5 coincident cases of GBS per 10 million vaccine recipients, and 86.3 cases of optic neuritis per 10 million female vaccinees. Spontaneous abortions would occur in 16,684 of every 1 million vaccinated pregnant women, and sudden death within 1 hour of any symptom onset in 5.75 of every 10 million people vaccinated (Lancet 2009;374:2115-22).
Another important analysis was conducted by the CDC to determine whether 33 reported cases of GBS in 11- to 19-year-olds within 42 days of receipt of meningococcal conjugate vaccine were causally linked. Background data from the 2000–2004 Healthcare Cost and Utilization project estimated that there would be very close to 36 cases for the entire age cohort, suggesting there was no causal link. However, just 20 cases would be expected among 15- to 19-year-olds, but the actual number was 26.
Although not statistically significant, this difference was enough to merit continued monitoring by the CDC, which advised that children with prior GBS not receive the vaccine (MMWR 2006;55:364-6).
Finally, a population-based case-control study from France investigated cases of acute disseminated encephalomyelitis, optic neuritis, and transverse myelitis in children younger than 16 years of age between 1994 and 2003, using 12 controls per case matched for age, sex, and geographic location. Rates of hepatitis B vaccination were 24% in cases and 27% in controls, for an adjusted odds ratio of 0.74 (Neurology 2009;73:1426-7). One might conclude from this that hepatitis B vaccine is actually protective, but the result was not statistically significant.