ID Consult

[email protected]

It is time for the 2010 ID Consult predictions. Instead of starting with my usual Yogi Berra quote, this year I thought I'd tap “Dilbert” creator Scott Adams: “There are many methods for predicting the future. For example, you can read horoscopes, tea leaves, tarot cards, or crystal balls. Collectively, these methods are known as nutty methods. Or you can put well-researched facts into sophisticated computer 'models, more commonly referred to as a complete waste of time.'” Maybe this explains why pandemic influenza was not on my list last year!

Indeed, although I have almost always had something to say about influenza for the last several years in my January “predictions” column, I did not correctly predict the emergence of pandemic influenza, which came on like a sledge hammer in April 2009. One major lesson learned from this unprecedented experience was the importance of collaboration.

In our institution, our emergency department and urgent care volume peaked at levels never seen before. Finding additional space to see patients, scheduling additional providers, and streamlining documentation were major problems that required innovative solutions. The mix of the high volume of worried well with the occasional very sick patient required vigilance on everyone's part.

Subspecialty and community providers also rose to the challenge, and for now, everyone is relieved that disease rates have decreased steadily over the last 4 weeks. Still, we are seeing admissions that exceed what we would usually see for this time of year and expect this to continue through April.

Here are my predictions, with the first two based on our influenza experience:

1. All lessons learned will benefit us, if and when the next outbreak occurs (and it will not necessarily be influenza).

2. Influenza vaccine will be nationally mandated for all health care workers (HCWs). Our institution utilized a mandated policy that required that all HCWs had to have vaccine or a declination signed by Dec. 1. We were able to get 91% of our HCWs immunized, compared with 82% in the last couple years, which is great. Yet, there were still gaps in coverage in certain high-risk units and in individual physicians and nurses. Among those who declined vaccination, some said they would not get vaccine unless it was mandated. Protecting the vulnerable child within our hospitals while also keeping our colleagues well is a major motivation to utilize a mandated policy. I think next year will be the year.

3. More data will focus on the use of palivizumab. Major changes in the American Academy of Pediatrics' Red Book included standardization of a start date and maximum number of doses, as well as changes in eligibility criteria focusing on gestation and age at the start of the season. There is no question we will be revisiting some of these issues in the future.

4. Meningococcal disease will continue to decline in the United States. Meningococcal infections have steadily decreased in the United States over the last 12 years, although the reasons for this are not entirely clear. In 1997, the incidence was 1.1/100,000 population, decreasing to 0.8/100,000 in 2000 and down to 0.3/100,000 in 2008. The implementation of vaccine in and of itself does not explain this decline, because no vaccine is effective against serogroup B and its population-based rates also decreased.

5. Rotavirus cases will continue to decrease. Simpler guidelines for dosing the rotavirus vaccines will result in better coverage and a continued decrease in disease. It is still amazing to me that residents in this era may not care for a single hospitalized child with rotavirus gastroenteritis.

6. Practitioners will more proactively utilize hepatitis A vaccine for the close contacts of adopted infants arriving from high-risk countries. Several reported cases of adults who had not traveled internationally but became infected with hepatitis A within 60 days after the arrival of an international adoptee have prompted new recommendations. Practitioners should identify all who will provide care for the new arrival (including grandparents and babysitters) and ensure they receive hepatitis A immunization before the child arrives, preferably referring them as soon as the plan for adoption is made.

7. The 13-valent pneumococcal conjugate vaccine (PCV13/Prevnar 13) will be here by spring. The emergence of pneumococcus serotype 19A with its typical pattern of multidrug resistance fast-tracked this vaccine, and it looks like it will be ready for implementation soon. Straightforward recommendations from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will be available, and we hope to see the impact of this strategy within the next couple of years. Will new serotypes emerge once again?

8. Clindamycin resistance rates for Staphylococcus aureus will continue to rise. In our institution, 25% of pneumococcal strains and 12% of S. aureus are resistant. My colleague Dr. Christopher Harrison believes that if pneumococcal serotype 19A decreases with PCV 13, clindamycin resistance rates for pneumococcus in general may decrease. The level of resistance at which recommendations for treatment of staphylococcal infection will need to be changed is not clear. Some think alternative treatment should be considered at above 10%.

9. Speaking of resistance, vancomycin may no longer be the cornerstone of therapy for methicillin-resistant S. aureus (MRSA) infection by year's end. In the past, a typical S. aureus minimum inhibitory concentration (MIC) for vancomycin was 0.25–0.5 μg/mL. More recently, MICs of 1 (now 60% or so of isolates) or higher (still just 1%) have been seen, a phenomenon that has been termed “MIC creep.” Data in the adult population suggest that even if dosing is pushed to 60 mg/kg per day—the dosing typically used for CNS infections—clinical failures may occur at higher MICs.

10. We will need better evidence to support the utility of newer antistaphylococcal drugs including linezolid, daptomycin, telavancin, and ceftobiprole. Linezolid remains a very expensive drug choice with predictable adverse reactions, particularly neutropenia. Dosing for daptomycin (a lipopeptide), telavancin (a lipoglycopeptide), and ceftobiprole (our first fifth generation cephalosporin) are still not set.

Lastly, I predict—or at least hope for—a happy, healthy, and productive 2010 for all

[email protected]

It is time for the 2010 ID Consult predictions. Instead of starting with my usual Yogi Berra quote, this year I thought I'd tap “Dilbert” creator Scott Adams: “There are many methods for predicting the future. For example, you can read horoscopes, tea leaves, tarot cards, or crystal balls. Collectively, these methods are known as nutty methods. Or you can put well-researched facts into sophisticated computer 'models, more commonly referred to as a complete waste of time.'” Maybe this explains why pandemic influenza was not on my list last year!

Indeed, although I have almost always had something to say about influenza for the last several years in my January “predictions” column, I did not correctly predict the emergence of pandemic influenza, which came on like a sledge hammer in April 2009. One major lesson learned from this unprecedented experience was the importance of collaboration.

In our institution, our emergency department and urgent care volume peaked at levels never seen before. Finding additional space to see patients, scheduling additional providers, and streamlining documentation were major problems that required innovative solutions. The mix of the high volume of worried well with the occasional very sick patient required vigilance on everyone's part.

Subspecialty and community providers also rose to the challenge, and for now, everyone is relieved that disease rates have decreased steadily over the last 4 weeks. Still, we are seeing admissions that exceed what we would usually see for this time of year and expect this to continue through April.

Here are my predictions, with the first two based on our influenza experience:

1. All lessons learned will benefit us, if and when the next outbreak occurs (and it will not necessarily be influenza).

2. Influenza vaccine will be nationally mandated for all health care workers (HCWs). Our institution utilized a mandated policy that required that all HCWs had to have vaccine or a declination signed by Dec. 1. We were able to get 91% of our HCWs immunized, compared with 82% in the last couple years, which is great. Yet, there were still gaps in coverage in certain high-risk units and in individual physicians and nurses. Among those who declined vaccination, some said they would not get vaccine unless it was mandated. Protecting the vulnerable child within our hospitals while also keeping our colleagues well is a major motivation to utilize a mandated policy. I think next year will be the year.

3. More data will focus on the use of palivizumab. Major changes in the American Academy of Pediatrics' Red Book included standardization of a start date and maximum number of doses, as well as changes in eligibility criteria focusing on gestation and age at the start of the season. There is no question we will be revisiting some of these issues in the future.

4. Meningococcal disease will continue to decline in the United States. Meningococcal infections have steadily decreased in the United States over the last 12 years, although the reasons for this are not entirely clear. In 1997, the incidence was 1.1/100,000 population, decreasing to 0.8/100,000 in 2000 and down to 0.3/100,000 in 2008. The implementation of vaccine in and of itself does not explain this decline, because no vaccine is effective against serogroup B and its population-based rates also decreased.

5. Rotavirus cases will continue to decrease. Simpler guidelines for dosing the rotavirus vaccines will result in better coverage and a continued decrease in disease. It is still amazing to me that residents in this era may not care for a single hospitalized child with rotavirus gastroenteritis.

6. Practitioners will more proactively utilize hepatitis A vaccine for the close contacts of adopted infants arriving from high-risk countries. Several reported cases of adults who had not traveled internationally but became infected with hepatitis A within 60 days after the arrival of an international adoptee have prompted new recommendations. Practitioners should identify all who will provide care for the new arrival (including grandparents and babysitters) and ensure they receive hepatitis A immunization before the child arrives, preferably referring them as soon as the plan for adoption is made.

7. The 13-valent pneumococcal conjugate vaccine (PCV13/Prevnar 13) will be here by spring. The emergence of pneumococcus serotype 19A with its typical pattern of multidrug resistance fast-tracked this vaccine, and it looks like it will be ready for implementation soon. Straightforward recommendations from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will be available, and we hope to see the impact of this strategy within the next couple of years. Will new serotypes emerge once again?

8. Clindamycin resistance rates for Staphylococcus aureus will continue to rise. In our institution, 25% of pneumococcal strains and 12% of S. aureus are resistant. My colleague Dr. Christopher Harrison believes that if pneumococcal serotype 19A decreases with PCV 13, clindamycin resistance rates for pneumococcus in general may decrease. The level of resistance at which recommendations for treatment of staphylococcal infection will need to be changed is not clear. Some think alternative treatment should be considered at above 10%.

9. Speaking of resistance, vancomycin may no longer be the cornerstone of therapy for methicillin-resistant S. aureus (MRSA) infection by year's end. In the past, a typical S. aureus minimum inhibitory concentration (MIC) for vancomycin was 0.25–0.5 μg/mL. More recently, MICs of 1 (now 60% or so of isolates) or higher (still just 1%) have been seen, a phenomenon that has been termed “MIC creep.” Data in the adult population suggest that even if dosing is pushed to 60 mg/kg per day—the dosing typically used for CNS infections—clinical failures may occur at higher MICs.

10. We will need better evidence to support the utility of newer antistaphylococcal drugs including linezolid, daptomycin, telavancin, and ceftobiprole. Linezolid remains a very expensive drug choice with predictable adverse reactions, particularly neutropenia. Dosing for daptomycin (a lipopeptide), telavancin (a lipoglycopeptide), and ceftobiprole (our first fifth generation cephalosporin) are still not set.

Lastly, I predict—or at least hope for—a happy, healthy, and productive 2010 for all

[email protected]

It is time for the 2010 ID Consult predictions. Instead of starting with my usual Yogi Berra quote, this year I thought I'd tap “Dilbert” creator Scott Adams: “There are many methods for predicting the future. For example, you can read horoscopes, tea leaves, tarot cards, or crystal balls. Collectively, these methods are known as nutty methods. Or you can put well-researched facts into sophisticated computer 'models, more commonly referred to as a complete waste of time.'” Maybe this explains why pandemic influenza was not on my list last year!

Indeed, although I have almost always had something to say about influenza for the last several years in my January “predictions” column, I did not correctly predict the emergence of pandemic influenza, which came on like a sledge hammer in April 2009. One major lesson learned from this unprecedented experience was the importance of collaboration.

In our institution, our emergency department and urgent care volume peaked at levels never seen before. Finding additional space to see patients, scheduling additional providers, and streamlining documentation were major problems that required innovative solutions. The mix of the high volume of worried well with the occasional very sick patient required vigilance on everyone's part.

Subspecialty and community providers also rose to the challenge, and for now, everyone is relieved that disease rates have decreased steadily over the last 4 weeks. Still, we are seeing admissions that exceed what we would usually see for this time of year and expect this to continue through April.

Here are my predictions, with the first two based on our influenza experience:

1. All lessons learned will benefit us, if and when the next outbreak occurs (and it will not necessarily be influenza).

2. Influenza vaccine will be nationally mandated for all health care workers (HCWs). Our institution utilized a mandated policy that required that all HCWs had to have vaccine or a declination signed by Dec. 1. We were able to get 91% of our HCWs immunized, compared with 82% in the last couple years, which is great. Yet, there were still gaps in coverage in certain high-risk units and in individual physicians and nurses. Among those who declined vaccination, some said they would not get vaccine unless it was mandated. Protecting the vulnerable child within our hospitals while also keeping our colleagues well is a major motivation to utilize a mandated policy. I think next year will be the year.

3. More data will focus on the use of palivizumab. Major changes in the American Academy of Pediatrics' Red Book included standardization of a start date and maximum number of doses, as well as changes in eligibility criteria focusing on gestation and age at the start of the season. There is no question we will be revisiting some of these issues in the future.

4. Meningococcal disease will continue to decline in the United States. Meningococcal infections have steadily decreased in the United States over the last 12 years, although the reasons for this are not entirely clear. In 1997, the incidence was 1.1/100,000 population, decreasing to 0.8/100,000 in 2000 and down to 0.3/100,000 in 2008. The implementation of vaccine in and of itself does not explain this decline, because no vaccine is effective against serogroup B and its population-based rates also decreased.

5. Rotavirus cases will continue to decrease. Simpler guidelines for dosing the rotavirus vaccines will result in better coverage and a continued decrease in disease. It is still amazing to me that residents in this era may not care for a single hospitalized child with rotavirus gastroenteritis.

6. Practitioners will more proactively utilize hepatitis A vaccine for the close contacts of adopted infants arriving from high-risk countries. Several reported cases of adults who had not traveled internationally but became infected with hepatitis A within 60 days after the arrival of an international adoptee have prompted new recommendations. Practitioners should identify all who will provide care for the new arrival (including grandparents and babysitters) and ensure they receive hepatitis A immunization before the child arrives, preferably referring them as soon as the plan for adoption is made.

7. The 13-valent pneumococcal conjugate vaccine (PCV13/Prevnar 13) will be here by spring. The emergence of pneumococcus serotype 19A with its typical pattern of multidrug resistance fast-tracked this vaccine, and it looks like it will be ready for implementation soon. Straightforward recommendations from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will be available, and we hope to see the impact of this strategy within the next couple of years. Will new serotypes emerge once again?

8. Clindamycin resistance rates for Staphylococcus aureus will continue to rise. In our institution, 25% of pneumococcal strains and 12% of S. aureus are resistant. My colleague Dr. Christopher Harrison believes that if pneumococcal serotype 19A decreases with PCV 13, clindamycin resistance rates for pneumococcus in general may decrease. The level of resistance at which recommendations for treatment of staphylococcal infection will need to be changed is not clear. Some think alternative treatment should be considered at above 10%.

9. Speaking of resistance, vancomycin may no longer be the cornerstone of therapy for methicillin-resistant S. aureus (MRSA) infection by year's end. In the past, a typical S. aureus minimum inhibitory concentration (MIC) for vancomycin was 0.25–0.5 μg/mL. More recently, MICs of 1 (now 60% or so of isolates) or higher (still just 1%) have been seen, a phenomenon that has been termed “MIC creep.” Data in the adult population suggest that even if dosing is pushed to 60 mg/kg per day—the dosing typically used for CNS infections—clinical failures may occur at higher MICs.

10. We will need better evidence to support the utility of newer antistaphylococcal drugs including linezolid, daptomycin, telavancin, and ceftobiprole. Linezolid remains a very expensive drug choice with predictable adverse reactions, particularly neutropenia. Dosing for daptomycin (a lipopeptide), telavancin (a lipoglycopeptide), and ceftobiprole (our first fifth generation cephalosporin) are still not set.

Lastly, I predict—or at least hope for—a happy, healthy, and productive 2010 for all

[email protected]

With the licensure of GlaxoSmithKline's human papillomavirus vaccine Cervarix in October, we will soon have two vaccines that prevent cervical cancer in women. But they're not interchangeable, and this could lead to problems.

Cervarix is expected to join Merck's Gardasil on the U.S. market in February 2010. For the first time ever in vaccine history, we will have a situation in which two competing vaccines have very different components and adjuvants that could complicate the decision for practicing physicians—as well as insurers and buying groups—regarding which one to use. I think we need to view human papillomavirus (HPV) vaccines as exceptions to the usual rules of “equivalent and interchangeable” and consider stocking both. Parents should be informed of the features of each vaccine, and the decision to use one or the other should be made with informed consent.

Most clinicians know that both vaccines protect against HPV serotypes 16 and 18, the dominant causes of cervical cancer. But Gardasil also protects against HPV-6 and −11, primarily associated with genital warts, and has recently received approval for use in males, which Cervarix has not. But other differences between the two vaccines are less well recognized, and I believe will turn out to be important.

Although both vaccines are manufactured with similar technology using viruslike particles, Cervarix contains a novel adjuvant, ASO4, that is believed to be responsible for its ability to generate a greater antibody response to HPV-16 and −18, compared with Gardasil. According to a head-to-head comparison conducted by GSK, geometric mean titers of serum neutralizing antibodies ranged from 2.3- to 4.8-fold higher for HPV-16 and 6.8- to 9.1-fold higher for HPV-18 after vaccination with Cervarix, compared with Gardasil, across all ages (Hum. Vaccin. 2009;5:705-19).

Although not proven, we might infer from those data that Cervarix might provide longer-lasting protection against HPV serotypes 16 and 18 and, therefore, a longer duration of time before a booster is needed. Both companies are studying duration of protection with their respective vaccines, and a just-published study showed sustained efficacy and immunogenicity of Cervarix up to 6.4 years (Lancet 2009 Dec. 3 [doi:10.1016/S0140-6736(09)61567-1]). For both vaccines, we should have answers before current vaccinees begin to lose protection.

Both vaccines are indicated for the prevention of cervical cancer and cervical intraepithelial neoplasia (CIN) grades 1–3 due to HPV-16 and −18, and cervical adenocarcinoma in situ. However, Gardasil also has indications for the prevention of vulvar and vaginal intraepithelial neoplasias, which Cervarix does not.

Although not specifically mentioned in Gardasil's label (www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf

Meanwhile, data included in the label for Cervarix (http://us.gsk.com/products/assets/us_cervarix.pdf

These differences may seem slight, but consider a case in which a young woman who received Gardasil later develops a case of cervical cancer due to HPV-31. Might she be quite upset that she wasn't informed that there was another vaccine that could have prevented it? Conversely, a male or female patient given Cervarix later develops genital warts, or a female develops cervical atypia associated with HPV-6 or −11. Might these patients similarly feel that they were denied the chance to have prevented those outcomes?

Who decides which vaccine is used? In managed care settings, the decision is often made based on cost when vaccines are equivalent, but what about the HPV vaccines where the products are not equivalent?

The same goes for the manufacturer-run vaccine buying groups that offer discounts to increasing numbers of participating physicians who sign contracts that impose strict limits on the amount of vaccine that can be purchased outside of the specified brands.

This has not happened before with vaccines: The two competing brands are not interchangeable. I believe that health plans and vaccine buying groups need to recognize these factors and grant an exception to HPV vaccines.

I think we all should stock both vaccines in our practices, and explain the differences to parents. I plan to distribute pamphlets to patients and families and let them choose, with signatures confirming informed consent. I serve as a consultant to both GSK and Merck & Co. and have shared this information with both companies.

This is going to be complicated.

[email protected]

With the licensure of GlaxoSmithKline's human papillomavirus vaccine Cervarix in October, we will soon have two vaccines that prevent cervical cancer in women. But they're not interchangeable, and this could lead to problems.

Cervarix is expected to join Merck's Gardasil on the U.S. market in February 2010. For the first time ever in vaccine history, we will have a situation in which two competing vaccines have very different components and adjuvants that could complicate the decision for practicing physicians—as well as insurers and buying groups—regarding which one to use. I think we need to view human papillomavirus (HPV) vaccines as exceptions to the usual rules of “equivalent and interchangeable” and consider stocking both. Parents should be informed of the features of each vaccine, and the decision to use one or the other should be made with informed consent.

Most clinicians know that both vaccines protect against HPV serotypes 16 and 18, the dominant causes of cervical cancer. But Gardasil also protects against HPV-6 and −11, primarily associated with genital warts, and has recently received approval for use in males, which Cervarix has not. But other differences between the two vaccines are less well recognized, and I believe will turn out to be important.

Although both vaccines are manufactured with similar technology using viruslike particles, Cervarix contains a novel adjuvant, ASO4, that is believed to be responsible for its ability to generate a greater antibody response to HPV-16 and −18, compared with Gardasil. According to a head-to-head comparison conducted by GSK, geometric mean titers of serum neutralizing antibodies ranged from 2.3- to 4.8-fold higher for HPV-16 and 6.8- to 9.1-fold higher for HPV-18 after vaccination with Cervarix, compared with Gardasil, across all ages (Hum. Vaccin. 2009;5:705-19).

Although not proven, we might infer from those data that Cervarix might provide longer-lasting protection against HPV serotypes 16 and 18 and, therefore, a longer duration of time before a booster is needed. Both companies are studying duration of protection with their respective vaccines, and a just-published study showed sustained efficacy and immunogenicity of Cervarix up to 6.4 years (Lancet 2009 Dec. 3 [doi:10.1016/S0140-6736(09)61567-1]). For both vaccines, we should have answers before current vaccinees begin to lose protection.

Both vaccines are indicated for the prevention of cervical cancer and cervical intraepithelial neoplasia (CIN) grades 1–3 due to HPV-16 and −18, and cervical adenocarcinoma in situ. However, Gardasil also has indications for the prevention of vulvar and vaginal intraepithelial neoplasias, which Cervarix does not.

Although not specifically mentioned in Gardasil's label (www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf

Meanwhile, data included in the label for Cervarix (http://us.gsk.com/products/assets/us_cervarix.pdf

These differences may seem slight, but consider a case in which a young woman who received Gardasil later develops a case of cervical cancer due to HPV-31. Might she be quite upset that she wasn't informed that there was another vaccine that could have prevented it? Conversely, a male or female patient given Cervarix later develops genital warts, or a female develops cervical atypia associated with HPV-6 or −11. Might these patients similarly feel that they were denied the chance to have prevented those outcomes?

Who decides which vaccine is used? In managed care settings, the decision is often made based on cost when vaccines are equivalent, but what about the HPV vaccines where the products are not equivalent?

The same goes for the manufacturer-run vaccine buying groups that offer discounts to increasing numbers of participating physicians who sign contracts that impose strict limits on the amount of vaccine that can be purchased outside of the specified brands.

This has not happened before with vaccines: The two competing brands are not interchangeable. I believe that health plans and vaccine buying groups need to recognize these factors and grant an exception to HPV vaccines.

I think we all should stock both vaccines in our practices, and explain the differences to parents. I plan to distribute pamphlets to patients and families and let them choose, with signatures confirming informed consent. I serve as a consultant to both GSK and Merck & Co. and have shared this information with both companies.

This is going to be complicated.

[email protected]

With the licensure of GlaxoSmithKline's human papillomavirus vaccine Cervarix in October, we will soon have two vaccines that prevent cervical cancer in women. But they're not interchangeable, and this could lead to problems.

Cervarix is expected to join Merck's Gardasil on the U.S. market in February 2010. For the first time ever in vaccine history, we will have a situation in which two competing vaccines have very different components and adjuvants that could complicate the decision for practicing physicians—as well as insurers and buying groups—regarding which one to use. I think we need to view human papillomavirus (HPV) vaccines as exceptions to the usual rules of “equivalent and interchangeable” and consider stocking both. Parents should be informed of the features of each vaccine, and the decision to use one or the other should be made with informed consent.

Most clinicians know that both vaccines protect against HPV serotypes 16 and 18, the dominant causes of cervical cancer. But Gardasil also protects against HPV-6 and −11, primarily associated with genital warts, and has recently received approval for use in males, which Cervarix has not. But other differences between the two vaccines are less well recognized, and I believe will turn out to be important.

Although both vaccines are manufactured with similar technology using viruslike particles, Cervarix contains a novel adjuvant, ASO4, that is believed to be responsible for its ability to generate a greater antibody response to HPV-16 and −18, compared with Gardasil. According to a head-to-head comparison conducted by GSK, geometric mean titers of serum neutralizing antibodies ranged from 2.3- to 4.8-fold higher for HPV-16 and 6.8- to 9.1-fold higher for HPV-18 after vaccination with Cervarix, compared with Gardasil, across all ages (Hum. Vaccin. 2009;5:705-19).

Although not proven, we might infer from those data that Cervarix might provide longer-lasting protection against HPV serotypes 16 and 18 and, therefore, a longer duration of time before a booster is needed. Both companies are studying duration of protection with their respective vaccines, and a just-published study showed sustained efficacy and immunogenicity of Cervarix up to 6.4 years (Lancet 2009 Dec. 3 [doi:10.1016/S0140-6736(09)61567-1]). For both vaccines, we should have answers before current vaccinees begin to lose protection.

Both vaccines are indicated for the prevention of cervical cancer and cervical intraepithelial neoplasia (CIN) grades 1–3 due to HPV-16 and −18, and cervical adenocarcinoma in situ. However, Gardasil also has indications for the prevention of vulvar and vaginal intraepithelial neoplasias, which Cervarix does not.

Although not specifically mentioned in Gardasil's label (www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf

Meanwhile, data included in the label for Cervarix (http://us.gsk.com/products/assets/us_cervarix.pdf

These differences may seem slight, but consider a case in which a young woman who received Gardasil later develops a case of cervical cancer due to HPV-31. Might she be quite upset that she wasn't informed that there was another vaccine that could have prevented it? Conversely, a male or female patient given Cervarix later develops genital warts, or a female develops cervical atypia associated with HPV-6 or −11. Might these patients similarly feel that they were denied the chance to have prevented those outcomes?

Who decides which vaccine is used? In managed care settings, the decision is often made based on cost when vaccines are equivalent, but what about the HPV vaccines where the products are not equivalent?

The same goes for the manufacturer-run vaccine buying groups that offer discounts to increasing numbers of participating physicians who sign contracts that impose strict limits on the amount of vaccine that can be purchased outside of the specified brands.

This has not happened before with vaccines: The two competing brands are not interchangeable. I believe that health plans and vaccine buying groups need to recognize these factors and grant an exception to HPV vaccines.

I think we all should stock both vaccines in our practices, and explain the differences to parents. I plan to distribute pamphlets to patients and families and let them choose, with signatures confirming informed consent. I serve as a consultant to both GSK and Merck & Co. and have shared this information with both companies.

This is going to be complicated.

[email protected]

I believe the time has come to consider cost-effectiveness when deciding which vaccines the government—that's your tax dollars—will pay for.

At its October meeting, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention made a paradoxical decision: The committee gave a “permissive” recommendation for use of Merck's quadrivalent human papillomavirus (HPV) vaccine (Gardasil) in males aged 9–26 years, but then voted for coverage of the vaccine under the federal Vaccines for Children (VFC) program, which provides free vaccine to children up through 18 years of age who fall into certain need categories. The program covers approximately 48% of all U.S. children.

A permissive recommendation generally indicates that the vaccine is safe and effective but not cost effective. Permissive recommendations usually are not voted into the VFC program. Although the permissive recommendation still awaits approval by the CDC's director, ACIP's vote for VFC coverage is binding, so it is now official. We will have to wait and see what insurance companies do with the dichotomous signal.

A decade ago, ACIP rarely discussed cost when making its vaccine use recommendations. Now, cost-effectiveness analyses are routine. At the October ACIP meeting, Harrell Chesson, Ph.D., of the CDC, presented data from six studies—four published, two unpublished—demonstrating wide variation in cost per quality-adjusted life year (QALY) estimates for use of Gardasil in adolescent and young adult men, depending in large part on the vaccination status of the female population. In general, he showed that as coverage of Gardasil among females increases, the cost per QALY gained by male vaccination decreases.

Use of the vaccine in males is aimed primarily at preventing warts caused by HPV serotypes 6 and 11. The rates of penile and head/neck cancer caused by the cervical cancer HPV serotypes 16 and 18 are miniscule and do not even factor into the cost calculation. Prevention of transmission of HPV-16 and −18 to females through sexual contact is also a goal of the vaccine, but if it's already being routinely offered to females, the data suggest that there's very little additional gain costwise from giving it to males.

Indeed, Dr. Chesson concluded, “In most scenarios, adding male vaccination to female-only vaccination is not the most cost-effective use of public health resources. Improving vaccination coverage of females is likely to be a more effective—and cost-effective—strategy to reduce the overall burden of HPV-associated conditions.”

As readers who follow this column and my other writings know, I am a strong proponent of vaccines. In fact, I serve on the advisory boards for both Merck & Co. and GlaxoSmithKline, which manufactures the bivalent HPV vaccine Cervarix. But in an era where we're debating how to provide even basic health insurance for uninsured Americans, I am becoming concerned about whether our country can afford every vaccine for every person.

I'm looking ahead to other vaccines in the very near pipeline. In December we're likely to see approval of the 13-valent pneumococcal conjugate vaccine for the U.S. market. That vaccine is expected to cost more than the current PCV7 (Prevnar), thus raising the overall costs of routine immunization when the switch is made to the new vaccine. Beyond that we will need to provide catch-up vaccination as well for kids who already received PCV7 in order to provide protection against the newly emerging, virulent, and multidrug-resistant serotype 19A, which is included in PCV13 but not PCV7. This new “superbug” causes fatal sepsis, meningitis, and pneumonia. How can ACIP not vote that into VFC as well?

On the heels of PCV13, there are two new meningococcal conjugate vaccines awaiting licensure: GSK's Haemophilus influenzae type b (Hib)–Neisseria meningitidis serogroups C (MenC) and Y (MenY)–tetanus toxoid combination, and Novartis's MenACWY-CRM (Menveo). The Hib-MenCY-TT conjugate is likely to be licensed for infants at 2, 4, and 6 months of age, with a booster at 15–18 months. Menveo, which will compete with Menactra, is expected to first be licensed for use in adolescents, then toddlers, then infants. These vaccines also prevent a significant amount of serious and potentially fatal disease.

Although competition usually lowers cost in the marketplace, the same phenomenon generally isn't seen when new vaccine competitors enter the market. Rather, the major companies with competing vaccines make combination products with ingredients that differ from others so that staying within their family of products is more convenient than switching between companies.

Moreover, companies also provide price advantages to physicians through national buying groups that provide bigger discounts to those who purchase vaccines within their own family of products. This impacts any price reduction that might occur with brand competition.

So where should we draw the line? At one point or another, ACIP may have to say the government can't afford to pay for vaccines that do not have a strong cost-benefit argument behind them. Yes, the alternative is a two-tiered system where those who can afford the vaccine can get it, and those who can't, don't. ACIP has tried to avoid that scenario in the past, but I fear it won't be able to do so much longer.

[email protected]

I believe the time has come to consider cost-effectiveness when deciding which vaccines the government—that's your tax dollars—will pay for.

At its October meeting, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention made a paradoxical decision: The committee gave a “permissive” recommendation for use of Merck's quadrivalent human papillomavirus (HPV) vaccine (Gardasil) in males aged 9–26 years, but then voted for coverage of the vaccine under the federal Vaccines for Children (VFC) program, which provides free vaccine to children up through 18 years of age who fall into certain need categories. The program covers approximately 48% of all U.S. children.

A permissive recommendation generally indicates that the vaccine is safe and effective but not cost effective. Permissive recommendations usually are not voted into the VFC program. Although the permissive recommendation still awaits approval by the CDC's director, ACIP's vote for VFC coverage is binding, so it is now official. We will have to wait and see what insurance companies do with the dichotomous signal.

A decade ago, ACIP rarely discussed cost when making its vaccine use recommendations. Now, cost-effectiveness analyses are routine. At the October ACIP meeting, Harrell Chesson, Ph.D., of the CDC, presented data from six studies—four published, two unpublished—demonstrating wide variation in cost per quality-adjusted life year (QALY) estimates for use of Gardasil in adolescent and young adult men, depending in large part on the vaccination status of the female population. In general, he showed that as coverage of Gardasil among females increases, the cost per QALY gained by male vaccination decreases.

Use of the vaccine in males is aimed primarily at preventing warts caused by HPV serotypes 6 and 11. The rates of penile and head/neck cancer caused by the cervical cancer HPV serotypes 16 and 18 are miniscule and do not even factor into the cost calculation. Prevention of transmission of HPV-16 and −18 to females through sexual contact is also a goal of the vaccine, but if it's already being routinely offered to females, the data suggest that there's very little additional gain costwise from giving it to males.

Indeed, Dr. Chesson concluded, “In most scenarios, adding male vaccination to female-only vaccination is not the most cost-effective use of public health resources. Improving vaccination coverage of females is likely to be a more effective—and cost-effective—strategy to reduce the overall burden of HPV-associated conditions.”

As readers who follow this column and my other writings know, I am a strong proponent of vaccines. In fact, I serve on the advisory boards for both Merck & Co. and GlaxoSmithKline, which manufactures the bivalent HPV vaccine Cervarix. But in an era where we're debating how to provide even basic health insurance for uninsured Americans, I am becoming concerned about whether our country can afford every vaccine for every person.

I'm looking ahead to other vaccines in the very near pipeline. In December we're likely to see approval of the 13-valent pneumococcal conjugate vaccine for the U.S. market. That vaccine is expected to cost more than the current PCV7 (Prevnar), thus raising the overall costs of routine immunization when the switch is made to the new vaccine. Beyond that we will need to provide catch-up vaccination as well for kids who already received PCV7 in order to provide protection against the newly emerging, virulent, and multidrug-resistant serotype 19A, which is included in PCV13 but not PCV7. This new “superbug” causes fatal sepsis, meningitis, and pneumonia. How can ACIP not vote that into VFC as well?

On the heels of PCV13, there are two new meningococcal conjugate vaccines awaiting licensure: GSK's Haemophilus influenzae type b (Hib)–Neisseria meningitidis serogroups C (MenC) and Y (MenY)–tetanus toxoid combination, and Novartis's MenACWY-CRM (Menveo). The Hib-MenCY-TT conjugate is likely to be licensed for infants at 2, 4, and 6 months of age, with a booster at 15–18 months. Menveo, which will compete with Menactra, is expected to first be licensed for use in adolescents, then toddlers, then infants. These vaccines also prevent a significant amount of serious and potentially fatal disease.

Although competition usually lowers cost in the marketplace, the same phenomenon generally isn't seen when new vaccine competitors enter the market. Rather, the major companies with competing vaccines make combination products with ingredients that differ from others so that staying within their family of products is more convenient than switching between companies.

Moreover, companies also provide price advantages to physicians through national buying groups that provide bigger discounts to those who purchase vaccines within their own family of products. This impacts any price reduction that might occur with brand competition.

So where should we draw the line? At one point or another, ACIP may have to say the government can't afford to pay for vaccines that do not have a strong cost-benefit argument behind them. Yes, the alternative is a two-tiered system where those who can afford the vaccine can get it, and those who can't, don't. ACIP has tried to avoid that scenario in the past, but I fear it won't be able to do so much longer.

[email protected]

I believe the time has come to consider cost-effectiveness when deciding which vaccines the government—that's your tax dollars—will pay for.

At its October meeting, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention made a paradoxical decision: The committee gave a “permissive” recommendation for use of Merck's quadrivalent human papillomavirus (HPV) vaccine (Gardasil) in males aged 9–26 years, but then voted for coverage of the vaccine under the federal Vaccines for Children (VFC) program, which provides free vaccine to children up through 18 years of age who fall into certain need categories. The program covers approximately 48% of all U.S. children.

A permissive recommendation generally indicates that the vaccine is safe and effective but not cost effective. Permissive recommendations usually are not voted into the VFC program. Although the permissive recommendation still awaits approval by the CDC's director, ACIP's vote for VFC coverage is binding, so it is now official. We will have to wait and see what insurance companies do with the dichotomous signal.

A decade ago, ACIP rarely discussed cost when making its vaccine use recommendations. Now, cost-effectiveness analyses are routine. At the October ACIP meeting, Harrell Chesson, Ph.D., of the CDC, presented data from six studies—four published, two unpublished—demonstrating wide variation in cost per quality-adjusted life year (QALY) estimates for use of Gardasil in adolescent and young adult men, depending in large part on the vaccination status of the female population. In general, he showed that as coverage of Gardasil among females increases, the cost per QALY gained by male vaccination decreases.

Use of the vaccine in males is aimed primarily at preventing warts caused by HPV serotypes 6 and 11. The rates of penile and head/neck cancer caused by the cervical cancer HPV serotypes 16 and 18 are miniscule and do not even factor into the cost calculation. Prevention of transmission of HPV-16 and −18 to females through sexual contact is also a goal of the vaccine, but if it's already being routinely offered to females, the data suggest that there's very little additional gain costwise from giving it to males.

Indeed, Dr. Chesson concluded, “In most scenarios, adding male vaccination to female-only vaccination is not the most cost-effective use of public health resources. Improving vaccination coverage of females is likely to be a more effective—and cost-effective—strategy to reduce the overall burden of HPV-associated conditions.”

As readers who follow this column and my other writings know, I am a strong proponent of vaccines. In fact, I serve on the advisory boards for both Merck & Co. and GlaxoSmithKline, which manufactures the bivalent HPV vaccine Cervarix. But in an era where we're debating how to provide even basic health insurance for uninsured Americans, I am becoming concerned about whether our country can afford every vaccine for every person.

I'm looking ahead to other vaccines in the very near pipeline. In December we're likely to see approval of the 13-valent pneumococcal conjugate vaccine for the U.S. market. That vaccine is expected to cost more than the current PCV7 (Prevnar), thus raising the overall costs of routine immunization when the switch is made to the new vaccine. Beyond that we will need to provide catch-up vaccination as well for kids who already received PCV7 in order to provide protection against the newly emerging, virulent, and multidrug-resistant serotype 19A, which is included in PCV13 but not PCV7. This new “superbug” causes fatal sepsis, meningitis, and pneumonia. How can ACIP not vote that into VFC as well?

On the heels of PCV13, there are two new meningococcal conjugate vaccines awaiting licensure: GSK's Haemophilus influenzae type b (Hib)–Neisseria meningitidis serogroups C (MenC) and Y (MenY)–tetanus toxoid combination, and Novartis's MenACWY-CRM (Menveo). The Hib-MenCY-TT conjugate is likely to be licensed for infants at 2, 4, and 6 months of age, with a booster at 15–18 months. Menveo, which will compete with Menactra, is expected to first be licensed for use in adolescents, then toddlers, then infants. These vaccines also prevent a significant amount of serious and potentially fatal disease.

Although competition usually lowers cost in the marketplace, the same phenomenon generally isn't seen when new vaccine competitors enter the market. Rather, the major companies with competing vaccines make combination products with ingredients that differ from others so that staying within their family of products is more convenient than switching between companies.

Moreover, companies also provide price advantages to physicians through national buying groups that provide bigger discounts to those who purchase vaccines within their own family of products. This impacts any price reduction that might occur with brand competition.

So where should we draw the line? At one point or another, ACIP may have to say the government can't afford to pay for vaccines that do not have a strong cost-benefit argument behind them. Yes, the alternative is a two-tiered system where those who can afford the vaccine can get it, and those who can't, don't. ACIP has tried to avoid that scenario in the past, but I fear it won't be able to do so much longer.

[email protected]

We are facing an unprecedented influenza season with the confluence of seasonal influenza and pandemic influenza A(H1N1).

Health care workers are morally and ethically—if not legally—bound to be immunized against influenza, especially this year.

The scenario is still unfolding, and there are many things we do not know about how it will play out. But we do know one thing: Health care workers (HCWs) are a high-risk group. Not only do they have a greater chance than ordinary citizens of becoming infected, they can also transmit the virus to patients even if they themselves aren't exhibiting symptoms. Yet, despite the wide availability of free and convenient immunization for influenza at many hospitals and other health institutions, health care workers traditionally have been one of the least well immunized of all high-risk groups.

Part of the problem may be that health care workers don't perceive themselves at high risk—after all, we're the healers, not the sick. But in a survey conducted at my hospital—led by my colleagues, Dr. Angela L. Myers and Dr. John Lantos—we found that health care providers, even in a large freestanding children's hospital, harbor some of the same misconceptions about the flu vaccine as does the general public: that you can get the flu from the vaccine, that it doesn't work, or that it isn't important. Many nurses and allied health professionals are young women of childbearing age and are fearful of receiving the flu vaccine while pregnant, even though the risk to them from the pandemic H1N1 influenza appears particularly high and the risk of getting the flu is much higher than the risk of getting the flu shot. And of course, even health care workers can have a fear of needles.

Some states, including Alabama, Arkansas, California, and Kentucky, have passed laws mandating influenza immunizations. These laws have resulted in increased participation by health care workers, but there still isn't 100% compliance. In many places, the mandate has been extended to include vaccination against the pandemic H1N1 influenza when that vaccine becomes available. However, these state laws all allow exemptions for employees who sign a special written declination, with or without a physician's note providing a medical reason for the refusal.

These requirements may soon become even stricter. Recently, there has been discussion by some health departments that a more stringent regulation be adopted. They recommend that all health care workers in inpatient, outpatient, and home health care settings be required to be vaccinated against both the seasonal and pandemic H1N1 strains of influenza or face dismissal from their jobs. The only exemption would be for a defined medical reason. There would be no religious or philosophical exemptions.

To evaluate health care worker attitudes regarding influenza vaccine, we surveyed about 1,000 employees at our 317-bed children's hospital. We got responses from 62 physicians, 177 nurses, and 346 other employees, a group that included nonclinical staff such as researchers, maintenance, security, and cafeteria workers, as well as care assistants and phlebotomists. The study was initiated in the spring of 2009, and the last surveys were completed 2 weeks after the onset of the pandemic H1N1 flu outbreak.

Physicians and nurses were significantly more likely to receive influenza vaccine than other employees. The physicians were more knowledgeable than other groups regarding immunization recommendations, communicability, high-risk groups, effectiveness, and vaccine safety. Physicians and nurses were more likely than other employees to understand the risk of severe influenza illness in patients with comorbidities.

No group scored well on questions about disease communicability prior to symptom onset. One-third of physicians and two-thirds of other employees did not know that the disease could be spread before the onset of symptoms. If these people are not immunized, and think that they could protect patients by simply not coming in to work if they are sick, they could spread influenza to patients during the presymptomatic phase of their illness. Fewer than two-thirds of physician and nurse respondents and fewer than half of other employee respondents answered this question correctly.

Physicians were more likely than nurses or other employees to agree that a hospital should mandate influenza vaccine for all employees. Overall, 2% of employee respondents reported that they would rather quit their job than comply with a policy that mandated yearly influenza vaccine. There were no physicians in this group.

Attitudes about influenza vaccine were correlated with attitudes about childhood vaccines. Physicians were more likely than nurses and others to agree with the statement: “Children should be required to get all currently recommended childhood vaccines, unless they have a medical reason not to.” When asked to agree or disagree with the statement, “I think parents should be free to decide which vaccines, if any, their children receive,” other employees and nurses were much more likely than physicians to agree or strongly agree.

Almost all employees who had children less than 10 years of age reported that their children were up to date on routine childhood immunizations. However, far fewer had their children immunized against influenza in the prior year.

At our institution, there is an extensive campaign launched every fall to provide education about influenza and vaccine to all employees. We also provide around-the-clock vaccine availability free of charge. Although immunization is not yet mandatory at our hospital, we ask all employees who decline vaccine to fill out and sign a declination form. Typically, a high number of our health care workers are immunized against the seasonal flu; last year, 85% were immunized with 11% signing declinations. We would like to reach 100%.

Our study found that many myths and misconceptions remain regarding influenza immunization. These myths and misconceptions make it likely that many people will refuse influenza immunization even if it is offered free of charge in a program that includes education. Eighty-five percent coverage may be as good as it gets with voluntary programs.

In this unprecedented year of pandemic H1N1 influenza activity, the success of efforts to control the spread of disease and the resulting morbidity and mortality will depend on achieving good immunization coverage. Based on our national numbers, this is unlikely through voluntary programs. Firm mandates may be necessary.

[email protected]

We are facing an unprecedented influenza season with the confluence of seasonal influenza and pandemic influenza A(H1N1).

Health care workers are morally and ethically—if not legally—bound to be immunized against influenza, especially this year.

The scenario is still unfolding, and there are many things we do not know about how it will play out. But we do know one thing: Health care workers (HCWs) are a high-risk group. Not only do they have a greater chance than ordinary citizens of becoming infected, they can also transmit the virus to patients even if they themselves aren't exhibiting symptoms. Yet, despite the wide availability of free and convenient immunization for influenza at many hospitals and other health institutions, health care workers traditionally have been one of the least well immunized of all high-risk groups.

Part of the problem may be that health care workers don't perceive themselves at high risk—after all, we're the healers, not the sick. But in a survey conducted at my hospital—led by my colleagues, Dr. Angela L. Myers and Dr. John Lantos—we found that health care providers, even in a large freestanding children's hospital, harbor some of the same misconceptions about the flu vaccine as does the general public: that you can get the flu from the vaccine, that it doesn't work, or that it isn't important. Many nurses and allied health professionals are young women of childbearing age and are fearful of receiving the flu vaccine while pregnant, even though the risk to them from the pandemic H1N1 influenza appears particularly high and the risk of getting the flu is much higher than the risk of getting the flu shot. And of course, even health care workers can have a fear of needles.

Some states, including Alabama, Arkansas, California, and Kentucky, have passed laws mandating influenza immunizations. These laws have resulted in increased participation by health care workers, but there still isn't 100% compliance. In many places, the mandate has been extended to include vaccination against the pandemic H1N1 influenza when that vaccine becomes available. However, these state laws all allow exemptions for employees who sign a special written declination, with or without a physician's note providing a medical reason for the refusal.

These requirements may soon become even stricter. Recently, there has been discussion by some health departments that a more stringent regulation be adopted. They recommend that all health care workers in inpatient, outpatient, and home health care settings be required to be vaccinated against both the seasonal and pandemic H1N1 strains of influenza or face dismissal from their jobs. The only exemption would be for a defined medical reason. There would be no religious or philosophical exemptions.

To evaluate health care worker attitudes regarding influenza vaccine, we surveyed about 1,000 employees at our 317-bed children's hospital. We got responses from 62 physicians, 177 nurses, and 346 other employees, a group that included nonclinical staff such as researchers, maintenance, security, and cafeteria workers, as well as care assistants and phlebotomists. The study was initiated in the spring of 2009, and the last surveys were completed 2 weeks after the onset of the pandemic H1N1 flu outbreak.

Physicians and nurses were significantly more likely to receive influenza vaccine than other employees. The physicians were more knowledgeable than other groups regarding immunization recommendations, communicability, high-risk groups, effectiveness, and vaccine safety. Physicians and nurses were more likely than other employees to understand the risk of severe influenza illness in patients with comorbidities.

No group scored well on questions about disease communicability prior to symptom onset. One-third of physicians and two-thirds of other employees did not know that the disease could be spread before the onset of symptoms. If these people are not immunized, and think that they could protect patients by simply not coming in to work if they are sick, they could spread influenza to patients during the presymptomatic phase of their illness. Fewer than two-thirds of physician and nurse respondents and fewer than half of other employee respondents answered this question correctly.

Physicians were more likely than nurses or other employees to agree that a hospital should mandate influenza vaccine for all employees. Overall, 2% of employee respondents reported that they would rather quit their job than comply with a policy that mandated yearly influenza vaccine. There were no physicians in this group.

Attitudes about influenza vaccine were correlated with attitudes about childhood vaccines. Physicians were more likely than nurses and others to agree with the statement: “Children should be required to get all currently recommended childhood vaccines, unless they have a medical reason not to.” When asked to agree or disagree with the statement, “I think parents should be free to decide which vaccines, if any, their children receive,” other employees and nurses were much more likely than physicians to agree or strongly agree.

Almost all employees who had children less than 10 years of age reported that their children were up to date on routine childhood immunizations. However, far fewer had their children immunized against influenza in the prior year.

At our institution, there is an extensive campaign launched every fall to provide education about influenza and vaccine to all employees. We also provide around-the-clock vaccine availability free of charge. Although immunization is not yet mandatory at our hospital, we ask all employees who decline vaccine to fill out and sign a declination form. Typically, a high number of our health care workers are immunized against the seasonal flu; last year, 85% were immunized with 11% signing declinations. We would like to reach 100%.

Our study found that many myths and misconceptions remain regarding influenza immunization. These myths and misconceptions make it likely that many people will refuse influenza immunization even if it is offered free of charge in a program that includes education. Eighty-five percent coverage may be as good as it gets with voluntary programs.

In this unprecedented year of pandemic H1N1 influenza activity, the success of efforts to control the spread of disease and the resulting morbidity and mortality will depend on achieving good immunization coverage. Based on our national numbers, this is unlikely through voluntary programs. Firm mandates may be necessary.

[email protected]

We are facing an unprecedented influenza season with the confluence of seasonal influenza and pandemic influenza A(H1N1).

Health care workers are morally and ethically—if not legally—bound to be immunized against influenza, especially this year.

The scenario is still unfolding, and there are many things we do not know about how it will play out. But we do know one thing: Health care workers (HCWs) are a high-risk group. Not only do they have a greater chance than ordinary citizens of becoming infected, they can also transmit the virus to patients even if they themselves aren't exhibiting symptoms. Yet, despite the wide availability of free and convenient immunization for influenza at many hospitals and other health institutions, health care workers traditionally have been one of the least well immunized of all high-risk groups.

Part of the problem may be that health care workers don't perceive themselves at high risk—after all, we're the healers, not the sick. But in a survey conducted at my hospital—led by my colleagues, Dr. Angela L. Myers and Dr. John Lantos—we found that health care providers, even in a large freestanding children's hospital, harbor some of the same misconceptions about the flu vaccine as does the general public: that you can get the flu from the vaccine, that it doesn't work, or that it isn't important. Many nurses and allied health professionals are young women of childbearing age and are fearful of receiving the flu vaccine while pregnant, even though the risk to them from the pandemic H1N1 influenza appears particularly high and the risk of getting the flu is much higher than the risk of getting the flu shot. And of course, even health care workers can have a fear of needles.

Some states, including Alabama, Arkansas, California, and Kentucky, have passed laws mandating influenza immunizations. These laws have resulted in increased participation by health care workers, but there still isn't 100% compliance. In many places, the mandate has been extended to include vaccination against the pandemic H1N1 influenza when that vaccine becomes available. However, these state laws all allow exemptions for employees who sign a special written declination, with or without a physician's note providing a medical reason for the refusal.

These requirements may soon become even stricter. Recently, there has been discussion by some health departments that a more stringent regulation be adopted. They recommend that all health care workers in inpatient, outpatient, and home health care settings be required to be vaccinated against both the seasonal and pandemic H1N1 strains of influenza or face dismissal from their jobs. The only exemption would be for a defined medical reason. There would be no religious or philosophical exemptions.

To evaluate health care worker attitudes regarding influenza vaccine, we surveyed about 1,000 employees at our 317-bed children's hospital. We got responses from 62 physicians, 177 nurses, and 346 other employees, a group that included nonclinical staff such as researchers, maintenance, security, and cafeteria workers, as well as care assistants and phlebotomists. The study was initiated in the spring of 2009, and the last surveys were completed 2 weeks after the onset of the pandemic H1N1 flu outbreak.

Physicians and nurses were significantly more likely to receive influenza vaccine than other employees. The physicians were more knowledgeable than other groups regarding immunization recommendations, communicability, high-risk groups, effectiveness, and vaccine safety. Physicians and nurses were more likely than other employees to understand the risk of severe influenza illness in patients with comorbidities.

No group scored well on questions about disease communicability prior to symptom onset. One-third of physicians and two-thirds of other employees did not know that the disease could be spread before the onset of symptoms. If these people are not immunized, and think that they could protect patients by simply not coming in to work if they are sick, they could spread influenza to patients during the presymptomatic phase of their illness. Fewer than two-thirds of physician and nurse respondents and fewer than half of other employee respondents answered this question correctly.

Physicians were more likely than nurses or other employees to agree that a hospital should mandate influenza vaccine for all employees. Overall, 2% of employee respondents reported that they would rather quit their job than comply with a policy that mandated yearly influenza vaccine. There were no physicians in this group.

Attitudes about influenza vaccine were correlated with attitudes about childhood vaccines. Physicians were more likely than nurses and others to agree with the statement: “Children should be required to get all currently recommended childhood vaccines, unless they have a medical reason not to.” When asked to agree or disagree with the statement, “I think parents should be free to decide which vaccines, if any, their children receive,” other employees and nurses were much more likely than physicians to agree or strongly agree.

Almost all employees who had children less than 10 years of age reported that their children were up to date on routine childhood immunizations. However, far fewer had their children immunized against influenza in the prior year.

At our institution, there is an extensive campaign launched every fall to provide education about influenza and vaccine to all employees. We also provide around-the-clock vaccine availability free of charge. Although immunization is not yet mandatory at our hospital, we ask all employees who decline vaccine to fill out and sign a declination form. Typically, a high number of our health care workers are immunized against the seasonal flu; last year, 85% were immunized with 11% signing declinations. We would like to reach 100%.

Our study found that many myths and misconceptions remain regarding influenza immunization. These myths and misconceptions make it likely that many people will refuse influenza immunization even if it is offered free of charge in a program that includes education. Eighty-five percent coverage may be as good as it gets with voluntary programs.

In this unprecedented year of pandemic H1N1 influenza activity, the success of efforts to control the spread of disease and the resulting morbidity and mortality will depend on achieving good immunization coverage. Based on our national numbers, this is unlikely through voluntary programs. Firm mandates may be necessary.

Pustular infections due to Staphylococcus aureus in the newborn nursery are preventable. Approximately 4% of all newborns develop an infection in the first 30 days of life. Of these, pustulosis is the second most common (after nonpneumonia respiratory tract infections), occurring in about 1 in every 100-200 newborns with a peak onset at 10-15 days of life. Most of these infections are due to S. aureus, and increasingly, methicillin-resistant S. aureus (MRSA).

Indeed, outbreaks of neonatal pustular disease should prompt concern about MRSA in the community. Colonization with S. aureus requires very little exposure—just a few colonies of bacteria can initiate colonization in newborns. The problem can often be traced to crowding and failures of standard infection control practices in the newborn nursery, along with two other specific recently identified risk factors: circumcision and the use of multidose lidocaine vials.

A case-control study investigated 11 newborns who had onset of MRSA skin and soft-tissue infection within 21 days after discharge from a well-infant nursery at a community hospital over an 8-month period. All were term male infants with pustular-vesicular lesions in the groin, Dr. Dao Nguyen and associates at the Centers for Disease Control and Prevention reported (Infect. Control Hosp. Epidemiol. 2007;28:406-11).

Risk factors associated with the MRSA infections were length of stay, circumcision in the nursery, and receipt of lidocaine injections used to anesthetize for the circumcision procedure. Inspection revealed uncovered circumcision equipment, multiple-dose lidocaine vials, and inadequate hand hygiene practices.

A literature review of 10 articles reporting on staphylococcal colonization and infection in the newborn period revealed that male infants have a greater risk than do female infants, and that the male to female ratio is even higher in studies performed where most of the boys are circumcised as infants (Clin. Pediatr. 2007;46:356-8).

But the answer to the neonatal staphylococcal problem is not to stop circumcising baby boys. Policies and attitudes toward circumcision are currently being revisited. After a decade or so in which a large body of evidence indicating that the procedure reduces the risk for the development of a variety of sexually transmitted diseases including human immunodeficiency virus, herpes simplex virus type 2, and human papillomavirus, as well as urinary tract infections, was largely ignored, the American Academy of Pediatrics is reviewing its policy on the medical benefits of the procedure.

What's needed is better attention to surgical technique and hygiene during circumcision procedures, along with the use of single-dose lidocaine vials. The benefits of circumcision have been established and in certain populations outweigh the risks when done properly.

For newborns who do develop pustular disease in the diaper area, lower abdomen, or any other area, the approach to management varies considerably. Some infants are hospitalized and treated systemically while others are managed with local or topical therapy. An individualized approach would appear necessary as the spectrum of clinical disease is broad.

First, the child should be evaluated for other possible etiologies such as herpetic lesions, erythema toxicum neonatorum, and infection with Malassezia species.

If staphylococcal disease is suspected, the presence or absence of systemic signs, abscess, or local cellulitis will help determine whether systemic therapy is needed or if initial local management is appropriate. In all cases, close follow-up is needed to ensure that resolution occurs.

Pustular infections due to Staphylococcus aureus in the newborn nursery are preventable. Approximately 4% of all newborns develop an infection in the first 30 days of life. Of these, pustulosis is the second most common (after nonpneumonia respiratory tract infections), occurring in about 1 in every 100-200 newborns with a peak onset at 10-15 days of life. Most of these infections are due to S. aureus, and increasingly, methicillin-resistant S. aureus (MRSA).

Indeed, outbreaks of neonatal pustular disease should prompt concern about MRSA in the community. Colonization with S. aureus requires very little exposure—just a few colonies of bacteria can initiate colonization in newborns. The problem can often be traced to crowding and failures of standard infection control practices in the newborn nursery, along with two other specific recently identified risk factors: circumcision and the use of multidose lidocaine vials.

A case-control study investigated 11 newborns who had onset of MRSA skin and soft-tissue infection within 21 days after discharge from a well-infant nursery at a community hospital over an 8-month period. All were term male infants with pustular-vesicular lesions in the groin, Dr. Dao Nguyen and associates at the Centers for Disease Control and Prevention reported (Infect. Control Hosp. Epidemiol. 2007;28:406-11).

Risk factors associated with the MRSA infections were length of stay, circumcision in the nursery, and receipt of lidocaine injections used to anesthetize for the circumcision procedure. Inspection revealed uncovered circumcision equipment, multiple-dose lidocaine vials, and inadequate hand hygiene practices.

A literature review of 10 articles reporting on staphylococcal colonization and infection in the newborn period revealed that male infants have a greater risk than do female infants, and that the male to female ratio is even higher in studies performed where most of the boys are circumcised as infants (Clin. Pediatr. 2007;46:356-8).

But the answer to the neonatal staphylococcal problem is not to stop circumcising baby boys. Policies and attitudes toward circumcision are currently being revisited. After a decade or so in which a large body of evidence indicating that the procedure reduces the risk for the development of a variety of sexually transmitted diseases including human immunodeficiency virus, herpes simplex virus type 2, and human papillomavirus, as well as urinary tract infections, was largely ignored, the American Academy of Pediatrics is reviewing its policy on the medical benefits of the procedure.

What's needed is better attention to surgical technique and hygiene during circumcision procedures, along with the use of single-dose lidocaine vials. The benefits of circumcision have been established and in certain populations outweigh the risks when done properly.

For newborns who do develop pustular disease in the diaper area, lower abdomen, or any other area, the approach to management varies considerably. Some infants are hospitalized and treated systemically while others are managed with local or topical therapy. An individualized approach would appear necessary as the spectrum of clinical disease is broad.

First, the child should be evaluated for other possible etiologies such as herpetic lesions, erythema toxicum neonatorum, and infection with Malassezia species.

If staphylococcal disease is suspected, the presence or absence of systemic signs, abscess, or local cellulitis will help determine whether systemic therapy is needed or if initial local management is appropriate. In all cases, close follow-up is needed to ensure that resolution occurs.

Pustular infections due to Staphylococcus aureus in the newborn nursery are preventable. Approximately 4% of all newborns develop an infection in the first 30 days of life. Of these, pustulosis is the second most common (after nonpneumonia respiratory tract infections), occurring in about 1 in every 100-200 newborns with a peak onset at 10-15 days of life. Most of these infections are due to S. aureus, and increasingly, methicillin-resistant S. aureus (MRSA).

Indeed, outbreaks of neonatal pustular disease should prompt concern about MRSA in the community. Colonization with S. aureus requires very little exposure—just a few colonies of bacteria can initiate colonization in newborns. The problem can often be traced to crowding and failures of standard infection control practices in the newborn nursery, along with two other specific recently identified risk factors: circumcision and the use of multidose lidocaine vials.

A case-control study investigated 11 newborns who had onset of MRSA skin and soft-tissue infection within 21 days after discharge from a well-infant nursery at a community hospital over an 8-month period. All were term male infants with pustular-vesicular lesions in the groin, Dr. Dao Nguyen and associates at the Centers for Disease Control and Prevention reported (Infect. Control Hosp. Epidemiol. 2007;28:406-11).

Risk factors associated with the MRSA infections were length of stay, circumcision in the nursery, and receipt of lidocaine injections used to anesthetize for the circumcision procedure. Inspection revealed uncovered circumcision equipment, multiple-dose lidocaine vials, and inadequate hand hygiene practices.

A literature review of 10 articles reporting on staphylococcal colonization and infection in the newborn period revealed that male infants have a greater risk than do female infants, and that the male to female ratio is even higher in studies performed where most of the boys are circumcised as infants (Clin. Pediatr. 2007;46:356-8).

But the answer to the neonatal staphylococcal problem is not to stop circumcising baby boys. Policies and attitudes toward circumcision are currently being revisited. After a decade or so in which a large body of evidence indicating that the procedure reduces the risk for the development of a variety of sexually transmitted diseases including human immunodeficiency virus, herpes simplex virus type 2, and human papillomavirus, as well as urinary tract infections, was largely ignored, the American Academy of Pediatrics is reviewing its policy on the medical benefits of the procedure.

What's needed is better attention to surgical technique and hygiene during circumcision procedures, along with the use of single-dose lidocaine vials. The benefits of circumcision have been established and in certain populations outweigh the risks when done properly.

For newborns who do develop pustular disease in the diaper area, lower abdomen, or any other area, the approach to management varies considerably. Some infants are hospitalized and treated systemically while others are managed with local or topical therapy. An individualized approach would appear necessary as the spectrum of clinical disease is broad.

First, the child should be evaluated for other possible etiologies such as herpetic lesions, erythema toxicum neonatorum, and infection with Malassezia species.

If staphylococcal disease is suspected, the presence or absence of systemic signs, abscess, or local cellulitis will help determine whether systemic therapy is needed or if initial local management is appropriate. In all cases, close follow-up is needed to ensure that resolution occurs.

[email protected]

We're seeing a lot of new viruses lately, but that's nothing new.

The novel pandemic H1N1 flu is just one of many emerging viruses that we're seeing clinically, although we may not always recognize them. Metapneumovirus, bocavirus, and norovirus are three others. But new viruses have been emerging since time began. One of my favorite books, Jared Diamond's “Guns, Germs, and Steel: The Fates of Human Societies” (New York: W.W. Norton & Co., 1997), describes how the Europeans who conquered the New World were aided in large part by the diseases they brought with them to a vulnerable population, a weapon at least as successful as those designed for warfare.

Diamond, a geography professor at the University of California, Los Angeles, who won a Pulitzer prize for his book, also points out that from the beginning of time, humans have acquired mutated germs from animals, resulting in disease of varying severity. The Europeans conquered by spreading new disease.

Of course, the current pandemic influenza A(H1N1) strain that we're dealing with now didn't come from human conquerors, but it did come from animals—more than one type, in fact. The virus was originally referred to as swine flu because laboratory testing showed that many of its genes were similar to those of influenza viruses that normally occur in pigs in North America.

However, now it is clear that this new virus is different from that which normally circulates in North American pigs, and actually includes genes from influenza viruses that normally circulate in pigs in Europe and Asia, along with avian genes and human genes, according to the Centers for Disease Control and Prevention.

Although this influenza strain surprised us in a couple of ways—it didn't come from birds and it isn't as virulent as we would have expected from a genetically “shifted” virus—the fact that a novel strain has arisen and is being transmitted from human to human is not a surprise.

Clinically, we are hoping that we have a safe and effective vaccine against the new H1N1 strain and that the supply will be sufficient to allow us to vaccinate all of our patients in a timely manner. In the meantime, the CDC's Advisory Committee on Immunization Practices has drafted new recommendations for the use of antivirals in the upcoming influenza season.

A second emerging virus, human metapneumovirus, was first isolated just 8 years ago, in previously virus-negative nasopharyngeal aspirates from children with respiratory tract infections. Since then, it has been seen worldwide, mainly circulating during the winter and spring. It is closely related to respiratory syncytial virus (RSV), and its clinical appearance resembles that of RSV in many ways, ranging from mild upper respiratory tract infections to wheezing to bronchiolitis, particularly in children less than 1 year of age. Metapneumovirus is generally milder than RSV, although the two infections often occur together.

The two infections are also essentially managed the same way—supportively, or with oxygen if the child becomes hypoxic. But this approach is far less likely with metapneumovirus than with RSV.

In a child with a clinical picture suggesting viral bronchiolitis in the hospital setting, a rapid test for RSV can help to determine whether the child can room with another child who also has RSV. If the test is negative, assume that you're dealing with metapneumovirus alone, and keep the child away from RSV-infected children. In the ambulatory setting, such testing is unlikely to be helpful.

Be aware that like RSV, metapneumovirus can also exacerbate asthma symptoms.

Bocavirus, another newly identified viral pathogen, is closely related to the parvovirus that pediatricians know as the cause of Fifth disease. Clinically, bocavirus is another RSV mimic. Children often present with wheezing in the context of an upper respiratory infection, which can easily be mistaken for asthma. In terms of severity, it probably ranks about the same as metapneumovirus.

Finally, norovirus is an emerging gastrointestinal virus that's been in the news a lot in recent years as the cause of gastritis on cruise ships. Symptoms include diarrhea, abdominal pain, and vomiting. In young children, it's fast surpassing rotavirus as the most common cause of this clinical picture, now that rotavirus vaccination is routine. Like rotavirus, norovirus is highly contagious. It may be transmitted through food, and is the likely culprit when more than one family member is affected. On the bright side, the course of illness for norovirus is shorter than that of rotavirus. Symptoms are usually gone after 1–2 days, as opposed to 5–7 days for rotavirus.

If you haven't had a chance, I highly recommend “Germs, Guns, and Steel.” It came out in 1997, but still resonates today. Diamond's 2005 book, “Collapse: How Societies Choose to Fail or Succeed” (New York: Penguin Group [USA] Inc.) is also worth reading. While the first book shows us how societies succeed, the 2005 book discusses how they can fail. We certainly see both sides in our battles with emerging and ongoing infections.

[email protected]

We're seeing a lot of new viruses lately, but that's nothing new.

The novel pandemic H1N1 flu is just one of many emerging viruses that we're seeing clinically, although we may not always recognize them. Metapneumovirus, bocavirus, and norovirus are three others. But new viruses have been emerging since time began. One of my favorite books, Jared Diamond's “Guns, Germs, and Steel: The Fates of Human Societies” (New York: W.W. Norton & Co., 1997), describes how the Europeans who conquered the New World were aided in large part by the diseases they brought with them to a vulnerable population, a weapon at least as successful as those designed for warfare.

Diamond, a geography professor at the University of California, Los Angeles, who won a Pulitzer prize for his book, also points out that from the beginning of time, humans have acquired mutated germs from animals, resulting in disease of varying severity. The Europeans conquered by spreading new disease.

Of course, the current pandemic influenza A(H1N1) strain that we're dealing with now didn't come from human conquerors, but it did come from animals—more than one type, in fact. The virus was originally referred to as swine flu because laboratory testing showed that many of its genes were similar to those of influenza viruses that normally occur in pigs in North America.

However, now it is clear that this new virus is different from that which normally circulates in North American pigs, and actually includes genes from influenza viruses that normally circulate in pigs in Europe and Asia, along with avian genes and human genes, according to the Centers for Disease Control and Prevention.

Although this influenza strain surprised us in a couple of ways—it didn't come from birds and it isn't as virulent as we would have expected from a genetically “shifted” virus—the fact that a novel strain has arisen and is being transmitted from human to human is not a surprise.

Clinically, we are hoping that we have a safe and effective vaccine against the new H1N1 strain and that the supply will be sufficient to allow us to vaccinate all of our patients in a timely manner. In the meantime, the CDC's Advisory Committee on Immunization Practices has drafted new recommendations for the use of antivirals in the upcoming influenza season.

A second emerging virus, human metapneumovirus, was first isolated just 8 years ago, in previously virus-negative nasopharyngeal aspirates from children with respiratory tract infections. Since then, it has been seen worldwide, mainly circulating during the winter and spring. It is closely related to respiratory syncytial virus (RSV), and its clinical appearance resembles that of RSV in many ways, ranging from mild upper respiratory tract infections to wheezing to bronchiolitis, particularly in children less than 1 year of age. Metapneumovirus is generally milder than RSV, although the two infections often occur together.

The two infections are also essentially managed the same way—supportively, or with oxygen if the child becomes hypoxic. But this approach is far less likely with metapneumovirus than with RSV.

In a child with a clinical picture suggesting viral bronchiolitis in the hospital setting, a rapid test for RSV can help to determine whether the child can room with another child who also has RSV. If the test is negative, assume that you're dealing with metapneumovirus alone, and keep the child away from RSV-infected children. In the ambulatory setting, such testing is unlikely to be helpful.

Be aware that like RSV, metapneumovirus can also exacerbate asthma symptoms.

Bocavirus, another newly identified viral pathogen, is closely related to the parvovirus that pediatricians know as the cause of Fifth disease. Clinically, bocavirus is another RSV mimic. Children often present with wheezing in the context of an upper respiratory infection, which can easily be mistaken for asthma. In terms of severity, it probably ranks about the same as metapneumovirus.

Finally, norovirus is an emerging gastrointestinal virus that's been in the news a lot in recent years as the cause of gastritis on cruise ships. Symptoms include diarrhea, abdominal pain, and vomiting. In young children, it's fast surpassing rotavirus as the most common cause of this clinical picture, now that rotavirus vaccination is routine. Like rotavirus, norovirus is highly contagious. It may be transmitted through food, and is the likely culprit when more than one family member is affected. On the bright side, the course of illness for norovirus is shorter than that of rotavirus. Symptoms are usually gone after 1–2 days, as opposed to 5–7 days for rotavirus.

If you haven't had a chance, I highly recommend “Germs, Guns, and Steel.” It came out in 1997, but still resonates today. Diamond's 2005 book, “Collapse: How Societies Choose to Fail or Succeed” (New York: Penguin Group [USA] Inc.) is also worth reading. While the first book shows us how societies succeed, the 2005 book discusses how they can fail. We certainly see both sides in our battles with emerging and ongoing infections.

[email protected]

We're seeing a lot of new viruses lately, but that's nothing new.

The novel pandemic H1N1 flu is just one of many emerging viruses that we're seeing clinically, although we may not always recognize them. Metapneumovirus, bocavirus, and norovirus are three others. But new viruses have been emerging since time began. One of my favorite books, Jared Diamond's “Guns, Germs, and Steel: The Fates of Human Societies” (New York: W.W. Norton & Co., 1997), describes how the Europeans who conquered the New World were aided in large part by the diseases they brought with them to a vulnerable population, a weapon at least as successful as those designed for warfare.

Diamond, a geography professor at the University of California, Los Angeles, who won a Pulitzer prize for his book, also points out that from the beginning of time, humans have acquired mutated germs from animals, resulting in disease of varying severity. The Europeans conquered by spreading new disease.

Of course, the current pandemic influenza A(H1N1) strain that we're dealing with now didn't come from human conquerors, but it did come from animals—more than one type, in fact. The virus was originally referred to as swine flu because laboratory testing showed that many of its genes were similar to those of influenza viruses that normally occur in pigs in North America.

However, now it is clear that this new virus is different from that which normally circulates in North American pigs, and actually includes genes from influenza viruses that normally circulate in pigs in Europe and Asia, along with avian genes and human genes, according to the Centers for Disease Control and Prevention.

Although this influenza strain surprised us in a couple of ways—it didn't come from birds and it isn't as virulent as we would have expected from a genetically “shifted” virus—the fact that a novel strain has arisen and is being transmitted from human to human is not a surprise.

Clinically, we are hoping that we have a safe and effective vaccine against the new H1N1 strain and that the supply will be sufficient to allow us to vaccinate all of our patients in a timely manner. In the meantime, the CDC's Advisory Committee on Immunization Practices has drafted new recommendations for the use of antivirals in the upcoming influenza season.

A second emerging virus, human metapneumovirus, was first isolated just 8 years ago, in previously virus-negative nasopharyngeal aspirates from children with respiratory tract infections. Since then, it has been seen worldwide, mainly circulating during the winter and spring. It is closely related to respiratory syncytial virus (RSV), and its clinical appearance resembles that of RSV in many ways, ranging from mild upper respiratory tract infections to wheezing to bronchiolitis, particularly in children less than 1 year of age. Metapneumovirus is generally milder than RSV, although the two infections often occur together.

The two infections are also essentially managed the same way—supportively, or with oxygen if the child becomes hypoxic. But this approach is far less likely with metapneumovirus than with RSV.

In a child with a clinical picture suggesting viral bronchiolitis in the hospital setting, a rapid test for RSV can help to determine whether the child can room with another child who also has RSV. If the test is negative, assume that you're dealing with metapneumovirus alone, and keep the child away from RSV-infected children. In the ambulatory setting, such testing is unlikely to be helpful.

Be aware that like RSV, metapneumovirus can also exacerbate asthma symptoms.

Bocavirus, another newly identified viral pathogen, is closely related to the parvovirus that pediatricians know as the cause of Fifth disease. Clinically, bocavirus is another RSV mimic. Children often present with wheezing in the context of an upper respiratory infection, which can easily be mistaken for asthma. In terms of severity, it probably ranks about the same as metapneumovirus.

Finally, norovirus is an emerging gastrointestinal virus that's been in the news a lot in recent years as the cause of gastritis on cruise ships. Symptoms include diarrhea, abdominal pain, and vomiting. In young children, it's fast surpassing rotavirus as the most common cause of this clinical picture, now that rotavirus vaccination is routine. Like rotavirus, norovirus is highly contagious. It may be transmitted through food, and is the likely culprit when more than one family member is affected. On the bright side, the course of illness for norovirus is shorter than that of rotavirus. Symptoms are usually gone after 1–2 days, as opposed to 5–7 days for rotavirus.

If you haven't had a chance, I highly recommend “Germs, Guns, and Steel.” It came out in 1997, but still resonates today. Diamond's 2005 book, “Collapse: How Societies Choose to Fail or Succeed” (New York: Penguin Group [USA] Inc.) is also worth reading. While the first book shows us how societies succeed, the 2005 book discusses how they can fail. We certainly see both sides in our battles with emerging and ongoing infections.

[email protected]

We are learning more daily about the 2009-H1N1 influenza, now also called the novel H1N1 flu, as the outbreak unfolds. It will be critical for us as clinicians to stay on top of developments so that we can tailor our patient care accordingly. Although disease activity seems to be decreasing, taking what we know today and preparing for fall is imperative.

As the name suggests, this strain of the virus has never circulated in the population before, but there has been some speculation that the low rate of disease in persons older than age 50 years may relate to circulation of a closely related strain decades ago.

Public health officials' main concern has been that with a large susceptible population, the outbreak will evolve into a major global pandemic with high morbidity and mortality, as occurred in 1918. Estimates from the Centers for Disease Control and Prevention suggest that even if this outbreak is a moderate one, up to 35% of the U.S. population could be infected and up to 207,000 people could die.

What is important to us as pediatricians is that in times of pandemic flu, mortality has been highest among the young and healthy. Some investigators propose as an explanation that the virus provokes a cytokine storm in people with a robust immune system, resulting in a kind of immunologic paralysis. Indeed, initial reports from Mexico suggested that most flu deaths were occurring in otherwise healthy individuals; authorities there are now reviewing their data to better assess who may be at greatest risk.

The clinical picture of influenza is usually easy to recognize: an abrupt onset of fever, cough, sore throat, and rhinitis. In a recent study from Finland, myalgia and headache were less common in children than they were in adults. At our institution, in the recent outbreak, we have gotten more selective about which children we test for influenza because we found that using the CDC criteria of a fever of at least 37.8° C and a runny nose, we picked up a lot of common colds and croup. In our first 15 pediatric cases of this flu, the mean fever was much higher at 39.8° C. So the low-grade fever used to guide testing in adults is probably not going to be reliable in children.

Another discovery has been that our rapid influenza test is not sensitive for the H1N1 virus; therefore, such testing may not aid in diagnosis. The take-home message is that it's wise to check with your local infectious disease specialists about the diagnostic performance of the rapid test used by your laboratory. In contrast, we have found that the multiplex polymerase chain reaction test that we use has reliably picked up all cases of H1N1 flu, although it identifies them as influenza A isolates that are not able to be subtyped using standard H1N1 primers.

Education will be key in responding to this outbreak. The worried well are flocking to their doctors' offices and sitting in waiting rooms next to those with mild influenza, who also don't need to be there. At our institution, we are distributing a handout to parents that explains that influenza testing and antiviral therapy are not needed for mild influenza. We instruct them in how to provide home care and about warning signs that mean they should seek care for their child.

At this point, antiviral therapy among children with influenza is mainly being restricted to those admitted to the hospital and those at high risk for complications. The latter group includes, among others, children younger than age 5 years, but particularly those younger than age 2. If more than 48 hours have elapsed since symptom onset, the therapy may have little effect, so symptomatic management alone is reasonable. Antiviral prophylaxis should be considered for exposed siblings who are at high risk for influenza complications.

Pediatricians need to be vigilant and prepared for the known possible complications of influenza, especially superinfection including bacterial pneumonia. Some of the less common complications can have tricky presentations in the pediatric population. For example, in children, influenza-related encephalopathy can manifest as aphasia, and in some children with influenza-associated myositis, parents may contact their provider with the concern that their child has an acute onset of paralysis as the child refuses to walk.

In contrast to adults with influenza, who are infectious to others for roughly 6 days, children are infectious for at least 10 days. This is going to be problematic because it may be necessary to maintain barrier protection for hospitalized children for longer than a week.

The novel H1N1 outbreak has clearly been taxing the health care system and health care providers, especially on the outpatient side. Although we have been preparing for such an event for years, several logistical problems have emerged. One is a shortage of N95 masks, a required piece of personal protective equipment when caring for hospitalized patients with pandemic influenza. Another is a shortage of staff, as personnel with suspected or confirmed infection must stay home.

We are anticipating that a vaccine against the 2009-H1N1 virus could be available by September or October. It's likely going to require two shots, in addition to the standard seasonal influenza shot. This might be a hard sell to vaccine-hesitant parents under usual circumstances, but it is too soon to tell what the reception will be like in the context of the current outbreak.

Public health officials are hoping transmission of the virus will decrease naturally with the end of the school year. However, resurgence of the 2009-H1N1 disease in the fall is a possibility that we need to be prepared for, particularly if new mutations increase its virulence.

[email protected]

We are learning more daily about the 2009-H1N1 influenza, now also called the novel H1N1 flu, as the outbreak unfolds. It will be critical for us as clinicians to stay on top of developments so that we can tailor our patient care accordingly. Although disease activity seems to be decreasing, taking what we know today and preparing for fall is imperative.

As the name suggests, this strain of the virus has never circulated in the population before, but there has been some speculation that the low rate of disease in persons older than age 50 years may relate to circulation of a closely related strain decades ago.

Public health officials' main concern has been that with a large susceptible population, the outbreak will evolve into a major global pandemic with high morbidity and mortality, as occurred in 1918. Estimates from the Centers for Disease Control and Prevention suggest that even if this outbreak is a moderate one, up to 35% of the U.S. population could be infected and up to 207,000 people could die.

What is important to us as pediatricians is that in times of pandemic flu, mortality has been highest among the young and healthy. Some investigators propose as an explanation that the virus provokes a cytokine storm in people with a robust immune system, resulting in a kind of immunologic paralysis. Indeed, initial reports from Mexico suggested that most flu deaths were occurring in otherwise healthy individuals; authorities there are now reviewing their data to better assess who may be at greatest risk.

The clinical picture of influenza is usually easy to recognize: an abrupt onset of fever, cough, sore throat, and rhinitis. In a recent study from Finland, myalgia and headache were less common in children than they were in adults. At our institution, in the recent outbreak, we have gotten more selective about which children we test for influenza because we found that using the CDC criteria of a fever of at least 37.8° C and a runny nose, we picked up a lot of common colds and croup. In our first 15 pediatric cases of this flu, the mean fever was much higher at 39.8° C. So the low-grade fever used to guide testing in adults is probably not going to be reliable in children.

Another discovery has been that our rapid influenza test is not sensitive for the H1N1 virus; therefore, such testing may not aid in diagnosis. The take-home message is that it's wise to check with your local infectious disease specialists about the diagnostic performance of the rapid test used by your laboratory. In contrast, we have found that the multiplex polymerase chain reaction test that we use has reliably picked up all cases of H1N1 flu, although it identifies them as influenza A isolates that are not able to be subtyped using standard H1N1 primers.

Education will be key in responding to this outbreak. The worried well are flocking to their doctors' offices and sitting in waiting rooms next to those with mild influenza, who also don't need to be there. At our institution, we are distributing a handout to parents that explains that influenza testing and antiviral therapy are not needed for mild influenza. We instruct them in how to provide home care and about warning signs that mean they should seek care for their child.

At this point, antiviral therapy among children with influenza is mainly being restricted to those admitted to the hospital and those at high risk for complications. The latter group includes, among others, children younger than age 5 years, but particularly those younger than age 2. If more than 48 hours have elapsed since symptom onset, the therapy may have little effect, so symptomatic management alone is reasonable. Antiviral prophylaxis should be considered for exposed siblings who are at high risk for influenza complications.

Pediatricians need to be vigilant and prepared for the known possible complications of influenza, especially superinfection including bacterial pneumonia. Some of the less common complications can have tricky presentations in the pediatric population. For example, in children, influenza-related encephalopathy can manifest as aphasia, and in some children with influenza-associated myositis, parents may contact their provider with the concern that their child has an acute onset of paralysis as the child refuses to walk.

In contrast to adults with influenza, who are infectious to others for roughly 6 days, children are infectious for at least 10 days. This is going to be problematic because it may be necessary to maintain barrier protection for hospitalized children for longer than a week.

The novel H1N1 outbreak has clearly been taxing the health care system and health care providers, especially on the outpatient side. Although we have been preparing for such an event for years, several logistical problems have emerged. One is a shortage of N95 masks, a required piece of personal protective equipment when caring for hospitalized patients with pandemic influenza. Another is a shortage of staff, as personnel with suspected or confirmed infection must stay home.

We are anticipating that a vaccine against the 2009-H1N1 virus could be available by September or October. It's likely going to require two shots, in addition to the standard seasonal influenza shot. This might be a hard sell to vaccine-hesitant parents under usual circumstances, but it is too soon to tell what the reception will be like in the context of the current outbreak.

Public health officials are hoping transmission of the virus will decrease naturally with the end of the school year. However, resurgence of the 2009-H1N1 disease in the fall is a possibility that we need to be prepared for, particularly if new mutations increase its virulence.

[email protected]

We are learning more daily about the 2009-H1N1 influenza, now also called the novel H1N1 flu, as the outbreak unfolds. It will be critical for us as clinicians to stay on top of developments so that we can tailor our patient care accordingly. Although disease activity seems to be decreasing, taking what we know today and preparing for fall is imperative.

As the name suggests, this strain of the virus has never circulated in the population before, but there has been some speculation that the low rate of disease in persons older than age 50 years may relate to circulation of a closely related strain decades ago.

Public health officials' main concern has been that with a large susceptible population, the outbreak will evolve into a major global pandemic with high morbidity and mortality, as occurred in 1918. Estimates from the Centers for Disease Control and Prevention suggest that even if this outbreak is a moderate one, up to 35% of the U.S. population could be infected and up to 207,000 people could die.

What is important to us as pediatricians is that in times of pandemic flu, mortality has been highest among the young and healthy. Some investigators propose as an explanation that the virus provokes a cytokine storm in people with a robust immune system, resulting in a kind of immunologic paralysis. Indeed, initial reports from Mexico suggested that most flu deaths were occurring in otherwise healthy individuals; authorities there are now reviewing their data to better assess who may be at greatest risk.

The clinical picture of influenza is usually easy to recognize: an abrupt onset of fever, cough, sore throat, and rhinitis. In a recent study from Finland, myalgia and headache were less common in children than they were in adults. At our institution, in the recent outbreak, we have gotten more selective about which children we test for influenza because we found that using the CDC criteria of a fever of at least 37.8° C and a runny nose, we picked up a lot of common colds and croup. In our first 15 pediatric cases of this flu, the mean fever was much higher at 39.8° C. So the low-grade fever used to guide testing in adults is probably not going to be reliable in children.

Another discovery has been that our rapid influenza test is not sensitive for the H1N1 virus; therefore, such testing may not aid in diagnosis. The take-home message is that it's wise to check with your local infectious disease specialists about the diagnostic performance of the rapid test used by your laboratory. In contrast, we have found that the multiplex polymerase chain reaction test that we use has reliably picked up all cases of H1N1 flu, although it identifies them as influenza A isolates that are not able to be subtyped using standard H1N1 primers.

Education will be key in responding to this outbreak. The worried well are flocking to their doctors' offices and sitting in waiting rooms next to those with mild influenza, who also don't need to be there. At our institution, we are distributing a handout to parents that explains that influenza testing and antiviral therapy are not needed for mild influenza. We instruct them in how to provide home care and about warning signs that mean they should seek care for their child.

At this point, antiviral therapy among children with influenza is mainly being restricted to those admitted to the hospital and those at high risk for complications. The latter group includes, among others, children younger than age 5 years, but particularly those younger than age 2. If more than 48 hours have elapsed since symptom onset, the therapy may have little effect, so symptomatic management alone is reasonable. Antiviral prophylaxis should be considered for exposed siblings who are at high risk for influenza complications.

Pediatricians need to be vigilant and prepared for the known possible complications of influenza, especially superinfection including bacterial pneumonia. Some of the less common complications can have tricky presentations in the pediatric population. For example, in children, influenza-related encephalopathy can manifest as aphasia, and in some children with influenza-associated myositis, parents may contact their provider with the concern that their child has an acute onset of paralysis as the child refuses to walk.

In contrast to adults with influenza, who are infectious to others for roughly 6 days, children are infectious for at least 10 days. This is going to be problematic because it may be necessary to maintain barrier protection for hospitalized children for longer than a week.

The novel H1N1 outbreak has clearly been taxing the health care system and health care providers, especially on the outpatient side. Although we have been preparing for such an event for years, several logistical problems have emerged. One is a shortage of N95 masks, a required piece of personal protective equipment when caring for hospitalized patients with pandemic influenza. Another is a shortage of staff, as personnel with suspected or confirmed infection must stay home.

We are anticipating that a vaccine against the 2009-H1N1 virus could be available by September or October. It's likely going to require two shots, in addition to the standard seasonal influenza shot. This might be a hard sell to vaccine-hesitant parents under usual circumstances, but it is too soon to tell what the reception will be like in the context of the current outbreak.

Public health officials are hoping transmission of the virus will decrease naturally with the end of the school year. However, resurgence of the 2009-H1N1 disease in the fall is a possibility that we need to be prepared for, particularly if new mutations increase its virulence.

[email protected]

In this era of increased hesitancy about immunization, it's important for us to be as educated as possible about the vaccines we're giving—including their true possible adverse effects—and to be willing to share that information with our patients and their families.

There's been a lot of press lately about adverse effects associated with the four-valent human papillomavirus vaccine (HPV4, Gardasil). Some of these reports are accurate, but many are not. Practitioners are better prepared to talk to families about this and other vaccines if they are well informed themselves.

To date, more than 20 million doses of HPV4 vaccine have been administered. Between June 30, 2006, and August 31, 2008, a total of 10,346 adverse events following receipt of HPV4 vaccine were reported to the Vaccine Adverse Events Reporting System (VAERS). The number sounds high, but if you do the math, this is much less than 1% and the vast majority are nonserious events.

There have been 27 reported deaths from a variety of causes including acute myocarditis, influenza B, pulmonary embolism, drug overdose, and diabetic ketoacidosis. To date, no clustering by age group, onset interval, dose number, or clinical conditions has been noted that preceded or caused death.

Dizziness and syncopal events associated with HPV4 immunization are among the events that practitioners should be aware of. The fact that fainting is associated with a medical event is not surprising because most vasovagal events follow some type of trigger, such as the sight of blood or some other type of emotionally stressful event.

Fainting events are most often noted in adolescents and young adults. One study that looked at a medical student population found that 3% of men and 3.5% of women had experienced a vasovagal event in the past. It would not be surprising then that fainting following vaccination occurs, particularly among adolescents and young adults.

There is no clear evidence that fainting is more common following HPV4 vaccine than any other vaccine.

Indeed, an increase in syncope reported to VAERS between 2005 and 2007 coincided with the licensure and recommendation of other vaccines often given during adolescence, including meningococcal conjugate vaccine (MCV4) and the adolescent/adult version of the tetanus/diphtheria/acellular pertussis vaccine (Tdap), in addition to the HPV4 vaccine.

Although HPV4 vaccine was the most frequently reported vaccine associated with syncope when only one vaccine was given (52%), that is likely due to the fact that three doses of this vaccine are given (as opposed to one each for MCV4 and Tdap), as well as to the increased publicity and media attention surrounding HPV4 vaccine.

A subsequent active surveillance evaluation done by the Centers for Disease Control and Prevention using the Vaccine Safety Datalink (VSD) derived from managed care data for 3% of the U.S. population did not detect a “safety signal” for syncope among 377,960 administered doses of HPV4 vaccine.

How should practitioners use this information? Ask your patients before immunization or blood draw if they have ever fainted. If they have, ask if they experienced a particular prodrome. Individuals who have had syncopal episodes usually have an excellent idea of what prodromal symptoms to expect. Most can articulate the warning signs pretty well, describing visual disturbances, buzzing in the ears, lightheadedness, sweating, and nausea.

Importantly, one can prevent virtually 100% of these episodes by having patients lie down and elevate their legs while they receive the injection.

Emergency departments have learned these lessons well and routinely advise against letting parents stand while watching their children being sutured, or letting patients stand for venipunctures.

Even for patients who have never had a syncopal event, having them sit or lie down in your office for 15 minutes after receiving the vaccine is recommended.

The CDC's Advisory Committee on Immunization Practices in 2006 recommended that all recipients of all vaccines be observed for 15 minutes after vaccination (MMWR 2006;55[RR15]:1–48), although HPV4 vaccine is the only one to also contain the 15-minute wait recommendation in its package label, per the Food and Drug Administration.

The timing recommendation comes from analysis of 41 syncope reports following immunization during January 2005-July 2007 where secondary injuries occurred. The time from vaccination to syncope onset was less than 5 minutes in 49% and less than 15 minutes in 80% of the reports.

The 15-minute waiting period is intended to prevent serious injury associated with falling due to the vasovagal event, which has been linked to at least one documented death.

The CDC is now beginning a survey of providers to assess their attitudes about and adherence to this recommendation.

The bottom line: HPV4 appears safe and effective. Fainting can occur with any vaccine, but be particularly alert to this in the teenage population. It can be averted in those who are known to be prone to vasovagal events by having the patient lie down for blood draws and shots. It is expected that most injuries can be avoided with the use of a waiting period following vaccine receipt.

[email protected]

In this era of increased hesitancy about immunization, it's important for us to be as educated as possible about the vaccines we're giving—including their true possible adverse effects—and to be willing to share that information with our patients and their families.

There's been a lot of press lately about adverse effects associated with the four-valent human papillomavirus vaccine (HPV4, Gardasil). Some of these reports are accurate, but many are not. Practitioners are better prepared to talk to families about this and other vaccines if they are well informed themselves.

To date, more than 20 million doses of HPV4 vaccine have been administered. Between June 30, 2006, and August 31, 2008, a total of 10,346 adverse events following receipt of HPV4 vaccine were reported to the Vaccine Adverse Events Reporting System (VAERS). The number sounds high, but if you do the math, this is much less than 1% and the vast majority are nonserious events.

There have been 27 reported deaths from a variety of causes including acute myocarditis, influenza B, pulmonary embolism, drug overdose, and diabetic ketoacidosis. To date, no clustering by age group, onset interval, dose number, or clinical conditions has been noted that preceded or caused death.

Dizziness and syncopal events associated with HPV4 immunization are among the events that practitioners should be aware of. The fact that fainting is associated with a medical event is not surprising because most vasovagal events follow some type of trigger, such as the sight of blood or some other type of emotionally stressful event.

Fainting events are most often noted in adolescents and young adults. One study that looked at a medical student population found that 3% of men and 3.5% of women had experienced a vasovagal event in the past. It would not be surprising then that fainting following vaccination occurs, particularly among adolescents and young adults.

There is no clear evidence that fainting is more common following HPV4 vaccine than any other vaccine.

Indeed, an increase in syncope reported to VAERS between 2005 and 2007 coincided with the licensure and recommendation of other vaccines often given during adolescence, including meningococcal conjugate vaccine (MCV4) and the adolescent/adult version of the tetanus/diphtheria/acellular pertussis vaccine (Tdap), in addition to the HPV4 vaccine.

Although HPV4 vaccine was the most frequently reported vaccine associated with syncope when only one vaccine was given (52%), that is likely due to the fact that three doses of this vaccine are given (as opposed to one each for MCV4 and Tdap), as well as to the increased publicity and media attention surrounding HPV4 vaccine.

A subsequent active surveillance evaluation done by the Centers for Disease Control and Prevention using the Vaccine Safety Datalink (VSD) derived from managed care data for 3% of the U.S. population did not detect a “safety signal” for syncope among 377,960 administered doses of HPV4 vaccine.

How should practitioners use this information? Ask your patients before immunization or blood draw if they have ever fainted. If they have, ask if they experienced a particular prodrome. Individuals who have had syncopal episodes usually have an excellent idea of what prodromal symptoms to expect. Most can articulate the warning signs pretty well, describing visual disturbances, buzzing in the ears, lightheadedness, sweating, and nausea.

Importantly, one can prevent virtually 100% of these episodes by having patients lie down and elevate their legs while they receive the injection.

Emergency departments have learned these lessons well and routinely advise against letting parents stand while watching their children being sutured, or letting patients stand for venipunctures.

Even for patients who have never had a syncopal event, having them sit or lie down in your office for 15 minutes after receiving the vaccine is recommended.

The CDC's Advisory Committee on Immunization Practices in 2006 recommended that all recipients of all vaccines be observed for 15 minutes after vaccination (MMWR 2006;55[RR15]:1–48), although HPV4 vaccine is the only one to also contain the 15-minute wait recommendation in its package label, per the Food and Drug Administration.

The timing recommendation comes from analysis of 41 syncope reports following immunization during January 2005-July 2007 where secondary injuries occurred. The time from vaccination to syncope onset was less than 5 minutes in 49% and less than 15 minutes in 80% of the reports.

The 15-minute waiting period is intended to prevent serious injury associated with falling due to the vasovagal event, which has been linked to at least one documented death.

The CDC is now beginning a survey of providers to assess their attitudes about and adherence to this recommendation.

The bottom line: HPV4 appears safe and effective. Fainting can occur with any vaccine, but be particularly alert to this in the teenage population. It can be averted in those who are known to be prone to vasovagal events by having the patient lie down for blood draws and shots. It is expected that most injuries can be avoided with the use of a waiting period following vaccine receipt.

[email protected]

In this era of increased hesitancy about immunization, it's important for us to be as educated as possible about the vaccines we're giving—including their true possible adverse effects—and to be willing to share that information with our patients and their families.

There's been a lot of press lately about adverse effects associated with the four-valent human papillomavirus vaccine (HPV4, Gardasil). Some of these reports are accurate, but many are not. Practitioners are better prepared to talk to families about this and other vaccines if they are well informed themselves.

To date, more than 20 million doses of HPV4 vaccine have been administered. Between June 30, 2006, and August 31, 2008, a total of 10,346 adverse events following receipt of HPV4 vaccine were reported to the Vaccine Adverse Events Reporting System (VAERS). The number sounds high, but if you do the math, this is much less than 1% and the vast majority are nonserious events.

There have been 27 reported deaths from a variety of causes including acute myocarditis, influenza B, pulmonary embolism, drug overdose, and diabetic ketoacidosis. To date, no clustering by age group, onset interval, dose number, or clinical conditions has been noted that preceded or caused death.

Dizziness and syncopal events associated with HPV4 immunization are among the events that practitioners should be aware of. The fact that fainting is associated with a medical event is not surprising because most vasovagal events follow some type of trigger, such as the sight of blood or some other type of emotionally stressful event.

Fainting events are most often noted in adolescents and young adults. One study that looked at a medical student population found that 3% of men and 3.5% of women had experienced a vasovagal event in the past. It would not be surprising then that fainting following vaccination occurs, particularly among adolescents and young adults.

There is no clear evidence that fainting is more common following HPV4 vaccine than any other vaccine.

Indeed, an increase in syncope reported to VAERS between 2005 and 2007 coincided with the licensure and recommendation of other vaccines often given during adolescence, including meningococcal conjugate vaccine (MCV4) and the adolescent/adult version of the tetanus/diphtheria/acellular pertussis vaccine (Tdap), in addition to the HPV4 vaccine.

Although HPV4 vaccine was the most frequently reported vaccine associated with syncope when only one vaccine was given (52%), that is likely due to the fact that three doses of this vaccine are given (as opposed to one each for MCV4 and Tdap), as well as to the increased publicity and media attention surrounding HPV4 vaccine.

A subsequent active surveillance evaluation done by the Centers for Disease Control and Prevention using the Vaccine Safety Datalink (VSD) derived from managed care data for 3% of the U.S. population did not detect a “safety signal” for syncope among 377,960 administered doses of HPV4 vaccine.

How should practitioners use this information? Ask your patients before immunization or blood draw if they have ever fainted. If they have, ask if they experienced a particular prodrome. Individuals who have had syncopal episodes usually have an excellent idea of what prodromal symptoms to expect. Most can articulate the warning signs pretty well, describing visual disturbances, buzzing in the ears, lightheadedness, sweating, and nausea.

Importantly, one can prevent virtually 100% of these episodes by having patients lie down and elevate their legs while they receive the injection.

Emergency departments have learned these lessons well and routinely advise against letting parents stand while watching their children being sutured, or letting patients stand for venipunctures.

Even for patients who have never had a syncopal event, having them sit or lie down in your office for 15 minutes after receiving the vaccine is recommended.

The CDC's Advisory Committee on Immunization Practices in 2006 recommended that all recipients of all vaccines be observed for 15 minutes after vaccination (MMWR 2006;55[RR15]:1–48), although HPV4 vaccine is the only one to also contain the 15-minute wait recommendation in its package label, per the Food and Drug Administration.

The timing recommendation comes from analysis of 41 syncope reports following immunization during January 2005-July 2007 where secondary injuries occurred. The time from vaccination to syncope onset was less than 5 minutes in 49% and less than 15 minutes in 80% of the reports.

The 15-minute waiting period is intended to prevent serious injury associated with falling due to the vasovagal event, which has been linked to at least one documented death.

The CDC is now beginning a survey of providers to assess their attitudes about and adherence to this recommendation.

The bottom line: HPV4 appears safe and effective. Fainting can occur with any vaccine, but be particularly alert to this in the teenage population. It can be averted in those who are known to be prone to vasovagal events by having the patient lie down for blood draws and shots. It is expected that most injuries can be avoided with the use of a waiting period following vaccine receipt.

[email protected]

Here's an important message for the vaccine-hesitant parents in your practice: Delaying immunizations places your infant at risk for serious infection.

Physicians who care for children have been increasingly encountering parents who are fearful about vaccines and reluctant to allow their children to be vaccinated. A new, worrisome concept circulating on the Internet and elsewhere is that instead of skipping vaccines altogether, children can be vaccinated on “selective” or “alternative” schedules that either eliminate some vaccines or spread the schedule out over a longer period of time. To many parents and perhaps even some physicians, these schedules may sound attractive, but they are not, because they leave young infants unprotected at the very time they are most vulnerable to vaccine-preventable diseases and their complications.

The idea that the currently recommended childhood immunization schedule can be successfully altered is being fostered by a pediatrician named Robert W. Sears—aka “Dr. Bob”—who has written a book entitled, “The Vaccine Book: Making the Right Decision for Your Child.” In it, he presents two immunization schedules that differ substantially from the one recommended by the Centers for Disease Control and Prevention, the American Academy of Pediatrics, and the American Academy of Family Physicians. He promotes these schedules as acceptable alternatives for the vaccine-adverse family.

Both Dr. Bob's selective and alternative schedules involve spreading out fewer vaccines over a period of six visits in the first 7 months of life (at 2, 3, 4, 5, 6, and 7 months), an inconvenience that in and of itself may further challenge the administration of timely immunizations. Both of his schedules delay the first pneumococcal conjugate vaccine dose until 3 months. Influenza vaccination isn't included at all in his selective schedule, and doesn't appear until 21 months of age on the alternative schedule.

But perhaps even more disturbing than selective or alternative schedules that fail to incorporate age-related epidemiology and risk for complications is Dr. Sears's perspective on parents who choose to delay all vaccinations until their child is 6 months or older. Although he states in his book that he doesn't advise this, he also tells parents that if they choose to postpone immunizations until the child is 2 years old, “it doesn't make sense to then go ahead and catch up with all the shots,” thus giving parents the idea that skipping early immunizations altogether is an acceptable and perhaps even sensible option.

He also recommends certain “precautions to take if you don't vaccinate,” including “ensuring a healthy immune system” through omega-3 oil supplements and other vitamins.

In my opinion, immunizing young infants is very important, and age-related epidemiology and risk for complications support early vaccination. This is particularly true for the following four vaccine-preventable diseases for which there is still significant risk of exposure and evidence that severity is greater in the first year of life:

▸ Pertussis. A single dose of pertussis vaccine does not appear to offer significant protection. Infants with pertussis who received fewer diphtheria-tetanus-pertussis doses were significantly more likely to be hospitalized, demonstrating that underimmunized infants have more serious disease (JAMA 2003;290:2968-75).

In the United States, there were approximately 140 pertussis deaths in infants less than 3 months old between 2000 and 2006 and approximately 100 times as many hospitalizations, often requiring intensive care. We see sharp declines in disease morbidity after 4 months of age, most likely because that's when children receive a second dose of pertussis-containing vaccine. Thus, prevention of early disease is critical and vaccination is part of that strategy, in conjunction with the adolescent/adult vaccine formulation (Tdap) for parents and teenagers.

▸ Invasive pneumococcal disease. Here again, we have data showing that a single dose of pneumococcal conjugate vaccine does not offer significant disease protection (Vaccine 2006;24:2514-20). In Massachusetts, where we have been tracking invasive pneumococcal disease (IPD) in children younger than 18 years old, mortality from IPD in children less than 1 year of age is approximately 10 times higher than for those aged 1-10 years—about 3% of those who develop IPD (Hsu, K., et al., submitted for publication).

▸ Influenza. Children less than 2 years of age are at greater risk for influenza than are older children and are hospitalized with it more often (MMWR 2008;57[RR07]:1-60). Children younger than 2 years also may have higher concentrations of virus in the nasopharynx as well as longer durations of shedding, thus frequently rendering them sources of contagion to household and day care contacts.

Because there is no influenza vaccine for children less than 6 months of age, vaccinating their siblings and all adults around them—a process known as “cocooning”—is the only current strategy for reducing exposure among the most vulnerable children in the community. Starting influenza immunization at 6 months of age, with a second dose 1 month later, provides protection against influenza disease and potentially against bacterial pathogens that tend to take advantage of weakened host defenses during influenza infection.

▸ Varicella. It's a widespread misconception that varicella is serious only in adults. In fact, prior to the licensure of the vaccine, the case-fatality rate from pneumonia, encephalitis, and secondary bacterial sepsis among children less than 1 year of age with chicken pox was 7 times higher than that of those aged 1-10 years, at 6.23 versus 0.75 cases per 100,000 children (MMWR 1996;45[RR-11]:1-36). During the 1990's, the combination of varicella and group A streptococcus was a deadly one, often leading to extensive necrotizing infection or sepsis, hospitalization, and death. Currently, there is concern that methicillin-resistant Staphylococcus aureus (MRSA) also may be an opportunistic pathogen any time there is a break in the skin.

According to the alternative schedule, it's okay to delay varicella vaccine until 18 months; the selective schedule advises waiting until the child is 10 years old, ordering antibody titers, and immunizing only if the child is found susceptible. Clearly, these approaches do not provide early protection from disease. Fortunately, there is little wild-type varicella currently circulating in the community, and the cases that do break through in vaccinated children are usually mild, with small numbers of lesions. However, if immunization rates fall and wild-type varicella becomes more common, more cases complicated by MRSA are likely to occur.

That is one reason why I am particularly concerned with the recent trend of parents organizing “chicken pox parties” to deliberately expose their children to varicella, under the mistaken belief that this is a good way to achieve protection without immunization.

Because there is still no chicken pox vaccine available for children less than 1 year of age, the only way to prevent disease in this high-risk group is to prevent exposure by immunizing their siblings, day care contacts, babysitters, and anyone else with whom they come into regular contact. Not only do the chicken pox parties demonstrate a lack of understanding of the potential seriousness of varicella, but they completely ignore the potential for secondary cases within a household in susceptible adults or infants. Please do your best to educate parents in your practice about the risks of wild-type varicella in young infants and the potential for MRSA suprainfection.

While delaying immunization may make some people feel good, it leaves the most vulnerable of our patients at great risk. It will take time to explain to parents that the currently recommended vaccine schedule incorporates our knowledge about age-related susceptibility, morbidity, and mortality. Delay is not in their child's interest.

[email protected]

Here's an important message for the vaccine-hesitant parents in your practice: Delaying immunizations places your infant at risk for serious infection.

Physicians who care for children have been increasingly encountering parents who are fearful about vaccines and reluctant to allow their children to be vaccinated. A new, worrisome concept circulating on the Internet and elsewhere is that instead of skipping vaccines altogether, children can be vaccinated on “selective” or “alternative” schedules that either eliminate some vaccines or spread the schedule out over a longer period of time. To many parents and perhaps even some physicians, these schedules may sound attractive, but they are not, because they leave young infants unprotected at the very time they are most vulnerable to vaccine-preventable diseases and their complications.

The idea that the currently recommended childhood immunization schedule can be successfully altered is being fostered by a pediatrician named Robert W. Sears—aka “Dr. Bob”—who has written a book entitled, “The Vaccine Book: Making the Right Decision for Your Child.” In it, he presents two immunization schedules that differ substantially from the one recommended by the Centers for Disease Control and Prevention, the American Academy of Pediatrics, and the American Academy of Family Physicians. He promotes these schedules as acceptable alternatives for the vaccine-adverse family.

Both Dr. Bob's selective and alternative schedules involve spreading out fewer vaccines over a period of six visits in the first 7 months of life (at 2, 3, 4, 5, 6, and 7 months), an inconvenience that in and of itself may further challenge the administration of timely immunizations. Both of his schedules delay the first pneumococcal conjugate vaccine dose until 3 months. Influenza vaccination isn't included at all in his selective schedule, and doesn't appear until 21 months of age on the alternative schedule.

But perhaps even more disturbing than selective or alternative schedules that fail to incorporate age-related epidemiology and risk for complications is Dr. Sears's perspective on parents who choose to delay all vaccinations until their child is 6 months or older. Although he states in his book that he doesn't advise this, he also tells parents that if they choose to postpone immunizations until the child is 2 years old, “it doesn't make sense to then go ahead and catch up with all the shots,” thus giving parents the idea that skipping early immunizations altogether is an acceptable and perhaps even sensible option.

He also recommends certain “precautions to take if you don't vaccinate,” including “ensuring a healthy immune system” through omega-3 oil supplements and other vitamins.

In my opinion, immunizing young infants is very important, and age-related epidemiology and risk for complications support early vaccination. This is particularly true for the following four vaccine-preventable diseases for which there is still significant risk of exposure and evidence that severity is greater in the first year of life:

▸ Pertussis. A single dose of pertussis vaccine does not appear to offer significant protection. Infants with pertussis who received fewer diphtheria-tetanus-pertussis doses were significantly more likely to be hospitalized, demonstrating that underimmunized infants have more serious disease (JAMA 2003;290:2968-75).

In the United States, there were approximately 140 pertussis deaths in infants less than 3 months old between 2000 and 2006 and approximately 100 times as many hospitalizations, often requiring intensive care. We see sharp declines in disease morbidity after 4 months of age, most likely because that's when children receive a second dose of pertussis-containing vaccine. Thus, prevention of early disease is critical and vaccination is part of that strategy, in conjunction with the adolescent/adult vaccine formulation (Tdap) for parents and teenagers.

▸ Invasive pneumococcal disease. Here again, we have data showing that a single dose of pneumococcal conjugate vaccine does not offer significant disease protection (Vaccine 2006;24:2514-20). In Massachusetts, where we have been tracking invasive pneumococcal disease (IPD) in children younger than 18 years old, mortality from IPD in children less than 1 year of age is approximately 10 times higher than for those aged 1-10 years—about 3% of those who develop IPD (Hsu, K., et al., submitted for publication).

▸ Influenza. Children less than 2 years of age are at greater risk for influenza than are older children and are hospitalized with it more often (MMWR 2008;57[RR07]:1-60). Children younger than 2 years also may have higher concentrations of virus in the nasopharynx as well as longer durations of shedding, thus frequently rendering them sources of contagion to household and day care contacts.

Because there is no influenza vaccine for children less than 6 months of age, vaccinating their siblings and all adults around them—a process known as “cocooning”—is the only current strategy for reducing exposure among the most vulnerable children in the community. Starting influenza immunization at 6 months of age, with a second dose 1 month later, provides protection against influenza disease and potentially against bacterial pathogens that tend to take advantage of weakened host defenses during influenza infection.

▸ Varicella. It's a widespread misconception that varicella is serious only in adults. In fact, prior to the licensure of the vaccine, the case-fatality rate from pneumonia, encephalitis, and secondary bacterial sepsis among children less than 1 year of age with chicken pox was 7 times higher than that of those aged 1-10 years, at 6.23 versus 0.75 cases per 100,000 children (MMWR 1996;45[RR-11]:1-36). During the 1990's, the combination of varicella and group A streptococcus was a deadly one, often leading to extensive necrotizing infection or sepsis, hospitalization, and death. Currently, there is concern that methicillin-resistant Staphylococcus aureus (MRSA) also may be an opportunistic pathogen any time there is a break in the skin.

According to the alternative schedule, it's okay to delay varicella vaccine until 18 months; the selective schedule advises waiting until the child is 10 years old, ordering antibody titers, and immunizing only if the child is found susceptible. Clearly, these approaches do not provide early protection from disease. Fortunately, there is little wild-type varicella currently circulating in the community, and the cases that do break through in vaccinated children are usually mild, with small numbers of lesions. However, if immunization rates fall and wild-type varicella becomes more common, more cases complicated by MRSA are likely to occur.

That is one reason why I am particularly concerned with the recent trend of parents organizing “chicken pox parties” to deliberately expose their children to varicella, under the mistaken belief that this is a good way to achieve protection without immunization.

Because there is still no chicken pox vaccine available for children less than 1 year of age, the only way to prevent disease in this high-risk group is to prevent exposure by immunizing their siblings, day care contacts, babysitters, and anyone else with whom they come into regular contact. Not only do the chicken pox parties demonstrate a lack of understanding of the potential seriousness of varicella, but they completely ignore the potential for secondary cases within a household in susceptible adults or infants. Please do your best to educate parents in your practice about the risks of wild-type varicella in young infants and the potential for MRSA suprainfection.

While delaying immunization may make some people feel good, it leaves the most vulnerable of our patients at great risk. It will take time to explain to parents that the currently recommended vaccine schedule incorporates our knowledge about age-related susceptibility, morbidity, and mortality. Delay is not in their child's interest.

[email protected]

Here's an important message for the vaccine-hesitant parents in your practice: Delaying immunizations places your infant at risk for serious infection.

Physicians who care for children have been increasingly encountering parents who are fearful about vaccines and reluctant to allow their children to be vaccinated. A new, worrisome concept circulating on the Internet and elsewhere is that instead of skipping vaccines altogether, children can be vaccinated on “selective” or “alternative” schedules that either eliminate some vaccines or spread the schedule out over a longer period of time. To many parents and perhaps even some physicians, these schedules may sound attractive, but they are not, because they leave young infants unprotected at the very time they are most vulnerable to vaccine-preventable diseases and their complications.

The idea that the currently recommended childhood immunization schedule can be successfully altered is being fostered by a pediatrician named Robert W. Sears—aka “Dr. Bob”—who has written a book entitled, “The Vaccine Book: Making the Right Decision for Your Child.” In it, he presents two immunization schedules that differ substantially from the one recommended by the Centers for Disease Control and Prevention, the American Academy of Pediatrics, and the American Academy of Family Physicians. He promotes these schedules as acceptable alternatives for the vaccine-adverse family.

Both Dr. Bob's selective and alternative schedules involve spreading out fewer vaccines over a period of six visits in the first 7 months of life (at 2, 3, 4, 5, 6, and 7 months), an inconvenience that in and of itself may further challenge the administration of timely immunizations. Both of his schedules delay the first pneumococcal conjugate vaccine dose until 3 months. Influenza vaccination isn't included at all in his selective schedule, and doesn't appear until 21 months of age on the alternative schedule.

But perhaps even more disturbing than selective or alternative schedules that fail to incorporate age-related epidemiology and risk for complications is Dr. Sears's perspective on parents who choose to delay all vaccinations until their child is 6 months or older. Although he states in his book that he doesn't advise this, he also tells parents that if they choose to postpone immunizations until the child is 2 years old, “it doesn't make sense to then go ahead and catch up with all the shots,” thus giving parents the idea that skipping early immunizations altogether is an acceptable and perhaps even sensible option.

He also recommends certain “precautions to take if you don't vaccinate,” including “ensuring a healthy immune system” through omega-3 oil supplements and other vitamins.

In my opinion, immunizing young infants is very important, and age-related epidemiology and risk for complications support early vaccination. This is particularly true for the following four vaccine-preventable diseases for which there is still significant risk of exposure and evidence that severity is greater in the first year of life:

▸ Pertussis. A single dose of pertussis vaccine does not appear to offer significant protection. Infants with pertussis who received fewer diphtheria-tetanus-pertussis doses were significantly more likely to be hospitalized, demonstrating that underimmunized infants have more serious disease (JAMA 2003;290:2968-75).

In the United States, there were approximately 140 pertussis deaths in infants less than 3 months old between 2000 and 2006 and approximately 100 times as many hospitalizations, often requiring intensive care. We see sharp declines in disease morbidity after 4 months of age, most likely because that's when children receive a second dose of pertussis-containing vaccine. Thus, prevention of early disease is critical and vaccination is part of that strategy, in conjunction with the adolescent/adult vaccine formulation (Tdap) for parents and teenagers.

▸ Invasive pneumococcal disease. Here again, we have data showing that a single dose of pneumococcal conjugate vaccine does not offer significant disease protection (Vaccine 2006;24:2514-20). In Massachusetts, where we have been tracking invasive pneumococcal disease (IPD) in children younger than 18 years old, mortality from IPD in children less than 1 year of age is approximately 10 times higher than for those aged 1-10 years—about 3% of those who develop IPD (Hsu, K., et al., submitted for publication).

▸ Influenza. Children less than 2 years of age are at greater risk for influenza than are older children and are hospitalized with it more often (MMWR 2008;57[RR07]:1-60). Children younger than 2 years also may have higher concentrations of virus in the nasopharynx as well as longer durations of shedding, thus frequently rendering them sources of contagion to household and day care contacts.

Because there is no influenza vaccine for children less than 6 months of age, vaccinating their siblings and all adults around them—a process known as “cocooning”—is the only current strategy for reducing exposure among the most vulnerable children in the community. Starting influenza immunization at 6 months of age, with a second dose 1 month later, provides protection against influenza disease and potentially against bacterial pathogens that tend to take advantage of weakened host defenses during influenza infection.

▸ Varicella. It's a widespread misconception that varicella is serious only in adults. In fact, prior to the licensure of the vaccine, the case-fatality rate from pneumonia, encephalitis, and secondary bacterial sepsis among children less than 1 year of age with chicken pox was 7 times higher than that of those aged 1-10 years, at 6.23 versus 0.75 cases per 100,000 children (MMWR 1996;45[RR-11]:1-36). During the 1990's, the combination of varicella and group A streptococcus was a deadly one, often leading to extensive necrotizing infection or sepsis, hospitalization, and death. Currently, there is concern that methicillin-resistant Staphylococcus aureus (MRSA) also may be an opportunistic pathogen any time there is a break in the skin.

According to the alternative schedule, it's okay to delay varicella vaccine until 18 months; the selective schedule advises waiting until the child is 10 years old, ordering antibody titers, and immunizing only if the child is found susceptible. Clearly, these approaches do not provide early protection from disease. Fortunately, there is little wild-type varicella currently circulating in the community, and the cases that do break through in vaccinated children are usually mild, with small numbers of lesions. However, if immunization rates fall and wild-type varicella becomes more common, more cases complicated by MRSA are likely to occur.

That is one reason why I am particularly concerned with the recent trend of parents organizing “chicken pox parties” to deliberately expose their children to varicella, under the mistaken belief that this is a good way to achieve protection without immunization.

Because there is still no chicken pox vaccine available for children less than 1 year of age, the only way to prevent disease in this high-risk group is to prevent exposure by immunizing their siblings, day care contacts, babysitters, and anyone else with whom they come into regular contact. Not only do the chicken pox parties demonstrate a lack of understanding of the potential seriousness of varicella, but they completely ignore the potential for secondary cases within a household in susceptible adults or infants. Please do your best to educate parents in your practice about the risks of wild-type varicella in young infants and the potential for MRSA suprainfection.

While delaying immunization may make some people feel good, it leaves the most vulnerable of our patients at great risk. It will take time to explain to parents that the currently recommended vaccine schedule incorporates our knowledge about age-related susceptibility, morbidity, and mortality. Delay is not in their child's interest.

[email protected]

This year's influenza season, while mild so far, comes with a few of Mother Nature's curveballs that will impact our approach to prevention and treatment.

Normally, peak influenza activity hits by mid-January, and as of mid-January this year, the Centers for Disease Control and Prevention (CDC) had reported influenza in 49 of the 50 states. However, only one state (Virginia) has had widespread influenza activity, 5 have had regional activity, and 10 have had local disease activity. Sporadic activity has been reported in 33 states, the District of Columbia, and Puerto Rico. But at this writing in early February, we're just now seeing a notable increase in influenza-like illnesses and culture documentation that both influenza A and B have arrived here in Kansas City.

This late start sends a clear message about prevention: It's not too late to vaccinate. All children aged 6 months and older now are recommended to receive influenza vaccination. But because infants younger than 6 months are not eligible for influenza vaccine and antiviral medications are not indicated for those younger than 1 year, a “cocoon” strategy is best for infants. This approach works by immunizing the persons most in contact with infants—mostly family members, but ideally also the day care personnel, babysitters, etc., thereby creating a “zone of protection” around the child.

The CDC's Advisory Committee on Immunization Practices (ACIP) is moving toward a universal recommendation for all persons over age 6 months to receive the influenza vaccine. Expect that recommendation to be made within the next year. In the meantime, recent data suggest that cross-protection and protection in general is likely to be superior with intranasal vaccine, compared with injected vaccine. Unfortunately, the intranasal vaccine (FluMist) is not approved for use in children under 2 years old or adults older than 50 years. I'd like all health care staff to be able to receive it, and I wish the ACIP would recommend its use in the 50-plus age group, despite current labeling.

To date it appears that this season's influenza vaccines match the circulating A strains, while the influenza B match may not be quite as good. However, it's still too early to predict for certain because the number of isolates is small and so far mostly from only three states.

With regard to influenza treatment, the circulating strains thus far are presenting us with a clinical conundrum: For the last 2 years, we've been told to stop using rimantadine and amantadine because they don't work on influenza A (they were never effective for influenza B), and to restrict antiviral therapy to two available products, oseltamivir and zanamivir. Now we find that we need to partially reverse course. This year, two-thirds of typed circulating strains are H1N1 strains that are resistant to oseltamivir but surprisingly susceptible to rimantadine/amantadine.

Of the strains currently circulating, one-quarter is influenza B and is still susceptible to oseltamivir and zanamivir. Less than 10% of all circulating strains have been H3N2, and these also are still susceptible to oseltamivir and zanamivir, but resistant to rimantadine/amantadine, similar to last year. So far, the proportions of types A vs. B in Kansas City have been the same as the proportions reported nationally by the CDC.

So here's how it could work clinically: If the patient presents within 48 hours of fever onset and a rapid antigen test shows influenza B, you can proceed as in the last 2 years and treat with oseltamivir or zanamivir.

But if it's influenza A, it gets tricky: About 90% of the influenza As—the H1N1s—will be susceptible to rimantadine and resistant to oseltamivir, but the reverse is true for the 10% or so that are H3N2s. So for influenza A, it seems reasonable to offer rimantadine but explain that there's a 10% chance it won't work. Amantadine also is an option, although it has more frequent and often more severe side effects.

If the patient desires 100% certainty, the CDC says to consider both antivirals—rimantadine plus oseltamivir. We don't have prospective controlled data for using these two together, because this particular problem previously was not on our radar screen. Doing so also doubles the cost of treatment.

And here's another odd twist: Zanamivir, the neuraminidase-inhibitor cousin of oseltamivir, is still active against all circulating strains we've seen so far, including those that are resistant to oseltamivir. The problem with zanamivir, though, is that it's not approved in children under 7 years of age. Also, it is administered via rotahaler (also called a diskhaler), which can be tricky to manipulate. But if your patient is skilled in or capable of using this device, zanamivir is another option.

Remember, though, that these antiviral drugs are likely to reduce the duration of illness in otherwise normal influenza patients only if started within 2 days of fever onset, so the earlier we can intervene, the better. One study showed that starting oseltamivir within the first 12 hours of fever reduced illness by 3 days (41%) more than starting it at 48 hours of fever.

To be able to distinguish among the H1 and H3 influenza A strains, the most widely available tool is multiplex polymerase chain reaction. However, this can be expensive, ranging from $600 to $1,200 depending on the lab. Despite the conundrum posed by this year's A-strain divergent resistance, I don't think that these tests are worth the cost in outpatients. Consider such testing, however, in hospitalized patients or those at high risk for influenza complications, such as immunocompromised patients.

You can keep track of changes in influenza activity or resistance at www.cdc.gov/fluwww2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00279

[email protected]

This year's influenza season, while mild so far, comes with a few of Mother Nature's curveballs that will impact our approach to prevention and treatment.

Normally, peak influenza activity hits by mid-January, and as of mid-January this year, the Centers for Disease Control and Prevention (CDC) had reported influenza in 49 of the 50 states. However, only one state (Virginia) has had widespread influenza activity, 5 have had regional activity, and 10 have had local disease activity. Sporadic activity has been reported in 33 states, the District of Columbia, and Puerto Rico. But at this writing in early February, we're just now seeing a notable increase in influenza-like illnesses and culture documentation that both influenza A and B have arrived here in Kansas City.

This late start sends a clear message about prevention: It's not too late to vaccinate. All children aged 6 months and older now are recommended to receive influenza vaccination. But because infants younger than 6 months are not eligible for influenza vaccine and antiviral medications are not indicated for those younger than 1 year, a “cocoon” strategy is best for infants. This approach works by immunizing the persons most in contact with infants—mostly family members, but ideally also the day care personnel, babysitters, etc., thereby creating a “zone of protection” around the child.

The CDC's Advisory Committee on Immunization Practices (ACIP) is moving toward a universal recommendation for all persons over age 6 months to receive the influenza vaccine. Expect that recommendation to be made within the next year. In the meantime, recent data suggest that cross-protection and protection in general is likely to be superior with intranasal vaccine, compared with injected vaccine. Unfortunately, the intranasal vaccine (FluMist) is not approved for use in children under 2 years old or adults older than 50 years. I'd like all health care staff to be able to receive it, and I wish the ACIP would recommend its use in the 50-plus age group, despite current labeling.

To date it appears that this season's influenza vaccines match the circulating A strains, while the influenza B match may not be quite as good. However, it's still too early to predict for certain because the number of isolates is small and so far mostly from only three states.

With regard to influenza treatment, the circulating strains thus far are presenting us with a clinical conundrum: For the last 2 years, we've been told to stop using rimantadine and amantadine because they don't work on influenza A (they were never effective for influenza B), and to restrict antiviral therapy to two available products, oseltamivir and zanamivir. Now we find that we need to partially reverse course. This year, two-thirds of typed circulating strains are H1N1 strains that are resistant to oseltamivir but surprisingly susceptible to rimantadine/amantadine.

Of the strains currently circulating, one-quarter is influenza B and is still susceptible to oseltamivir and zanamivir. Less than 10% of all circulating strains have been H3N2, and these also are still susceptible to oseltamivir and zanamivir, but resistant to rimantadine/amantadine, similar to last year. So far, the proportions of types A vs. B in Kansas City have been the same as the proportions reported nationally by the CDC.

So here's how it could work clinically: If the patient presents within 48 hours of fever onset and a rapid antigen test shows influenza B, you can proceed as in the last 2 years and treat with oseltamivir or zanamivir.

But if it's influenza A, it gets tricky: About 90% of the influenza As—the H1N1s—will be susceptible to rimantadine and resistant to oseltamivir, but the reverse is true for the 10% or so that are H3N2s. So for influenza A, it seems reasonable to offer rimantadine but explain that there's a 10% chance it won't work. Amantadine also is an option, although it has more frequent and often more severe side effects.

If the patient desires 100% certainty, the CDC says to consider both antivirals—rimantadine plus oseltamivir. We don't have prospective controlled data for using these two together, because this particular problem previously was not on our radar screen. Doing so also doubles the cost of treatment.

And here's another odd twist: Zanamivir, the neuraminidase-inhibitor cousin of oseltamivir, is still active against all circulating strains we've seen so far, including those that are resistant to oseltamivir. The problem with zanamivir, though, is that it's not approved in children under 7 years of age. Also, it is administered via rotahaler (also called a diskhaler), which can be tricky to manipulate. But if your patient is skilled in or capable of using this device, zanamivir is another option.

Remember, though, that these antiviral drugs are likely to reduce the duration of illness in otherwise normal influenza patients only if started within 2 days of fever onset, so the earlier we can intervene, the better. One study showed that starting oseltamivir within the first 12 hours of fever reduced illness by 3 days (41%) more than starting it at 48 hours of fever.

To be able to distinguish among the H1 and H3 influenza A strains, the most widely available tool is multiplex polymerase chain reaction. However, this can be expensive, ranging from $600 to $1,200 depending on the lab. Despite the conundrum posed by this year's A-strain divergent resistance, I don't think that these tests are worth the cost in outpatients. Consider such testing, however, in hospitalized patients or those at high risk for influenza complications, such as immunocompromised patients.

You can keep track of changes in influenza activity or resistance at www.cdc.gov/fluwww2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00279

[email protected]

This year's influenza season, while mild so far, comes with a few of Mother Nature's curveballs that will impact our approach to prevention and treatment.

Normally, peak influenza activity hits by mid-January, and as of mid-January this year, the Centers for Disease Control and Prevention (CDC) had reported influenza in 49 of the 50 states. However, only one state (Virginia) has had widespread influenza activity, 5 have had regional activity, and 10 have had local disease activity. Sporadic activity has been reported in 33 states, the District of Columbia, and Puerto Rico. But at this writing in early February, we're just now seeing a notable increase in influenza-like illnesses and culture documentation that both influenza A and B have arrived here in Kansas City.

This late start sends a clear message about prevention: It's not too late to vaccinate. All children aged 6 months and older now are recommended to receive influenza vaccination. But because infants younger than 6 months are not eligible for influenza vaccine and antiviral medications are not indicated for those younger than 1 year, a “cocoon” strategy is best for infants. This approach works by immunizing the persons most in contact with infants—mostly family members, but ideally also the day care personnel, babysitters, etc., thereby creating a “zone of protection” around the child.

The CDC's Advisory Committee on Immunization Practices (ACIP) is moving toward a universal recommendation for all persons over age 6 months to receive the influenza vaccine. Expect that recommendation to be made within the next year. In the meantime, recent data suggest that cross-protection and protection in general is likely to be superior with intranasal vaccine, compared with injected vaccine. Unfortunately, the intranasal vaccine (FluMist) is not approved for use in children under 2 years old or adults older than 50 years. I'd like all health care staff to be able to receive it, and I wish the ACIP would recommend its use in the 50-plus age group, despite current labeling.

To date it appears that this season's influenza vaccines match the circulating A strains, while the influenza B match may not be quite as good. However, it's still too early to predict for certain because the number of isolates is small and so far mostly from only three states.

With regard to influenza treatment, the circulating strains thus far are presenting us with a clinical conundrum: For the last 2 years, we've been told to stop using rimantadine and amantadine because they don't work on influenza A (they were never effective for influenza B), and to restrict antiviral therapy to two available products, oseltamivir and zanamivir. Now we find that we need to partially reverse course. This year, two-thirds of typed circulating strains are H1N1 strains that are resistant to oseltamivir but surprisingly susceptible to rimantadine/amantadine.

Of the strains currently circulating, one-quarter is influenza B and is still susceptible to oseltamivir and zanamivir. Less than 10% of all circulating strains have been H3N2, and these also are still susceptible to oseltamivir and zanamivir, but resistant to rimantadine/amantadine, similar to last year. So far, the proportions of types A vs. B in Kansas City have been the same as the proportions reported nationally by the CDC.

So here's how it could work clinically: If the patient presents within 48 hours of fever onset and a rapid antigen test shows influenza B, you can proceed as in the last 2 years and treat with oseltamivir or zanamivir.

But if it's influenza A, it gets tricky: About 90% of the influenza As—the H1N1s—will be susceptible to rimantadine and resistant to oseltamivir, but the reverse is true for the 10% or so that are H3N2s. So for influenza A, it seems reasonable to offer rimantadine but explain that there's a 10% chance it won't work. Amantadine also is an option, although it has more frequent and often more severe side effects.

If the patient desires 100% certainty, the CDC says to consider both antivirals—rimantadine plus oseltamivir. We don't have prospective controlled data for using these two together, because this particular problem previously was not on our radar screen. Doing so also doubles the cost of treatment.

And here's another odd twist: Zanamivir, the neuraminidase-inhibitor cousin of oseltamivir, is still active against all circulating strains we've seen so far, including those that are resistant to oseltamivir. The problem with zanamivir, though, is that it's not approved in children under 7 years of age. Also, it is administered via rotahaler (also called a diskhaler), which can be tricky to manipulate. But if your patient is skilled in or capable of using this device, zanamivir is another option.

Remember, though, that these antiviral drugs are likely to reduce the duration of illness in otherwise normal influenza patients only if started within 2 days of fever onset, so the earlier we can intervene, the better. One study showed that starting oseltamivir within the first 12 hours of fever reduced illness by 3 days (41%) more than starting it at 48 hours of fever.

To be able to distinguish among the H1 and H3 influenza A strains, the most widely available tool is multiplex polymerase chain reaction. However, this can be expensive, ranging from $600 to $1,200 depending on the lab. Despite the conundrum posed by this year's A-strain divergent resistance, I don't think that these tests are worth the cost in outpatients. Consider such testing, however, in hospitalized patients or those at high risk for influenza complications, such as immunocompromised patients.

You can keep track of changes in influenza activity or resistance at www.cdc.gov/fluwww2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00279