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Taking steps to slow the upswing in oral and pharyngeal cancers
A recent report by the Centers for Disease Control and Prevention (CDC) documents the trends in oral and pharyngeal cancers (OPC) in the United States over a 10-year period, 2007-2016.1 The rate of OPC began to increase in 1999 and has been increasing ever since. The age-adjusted rate in 2007 was 10.89/100,000 compared with 11.7/100,000 in 2016 (TABLE 11). This is an annual relative increase of about 6% per year. In absolute numbers, there were 35,076 cases in 2007 and 44,419 in 2016.1 The trends in incidence of OPC vary by anatomical site, with some increasing and others declining.
There are 3 known causal factors related to OPC: tobacco use, alcohol use, and human papillomavirus (HPV) infection. The CDC estimates that, overall, 70% of OPCs are caused by HPV.2 However, while cancers at some oropharyngeal sites are likely related to HPV infection, cancers at other sites are not. The rising overall incidence of OPC is being driven by increases in HPV-related cancers at an average rate of 2.1% per year, while the rates at non-HPV-associated sites have been declining by 0.4% per year.1 It is also important to appreciate that HPV causes cancer at other anatomical sites (TABLE 22) and is responsible for an estimated 35,000 cancers per year.2
Other trends of note in all OPCs combined are increasing rates among non-Hispanic whites and Asian-Pacific Islanders; decreasing rates among Hispanics and African Americans; increasing rates among males with no real change in rates among females; increasing rates in those 50 to 79 years of age; decreasing rates among those 40 to 49 years of age; and unchanged rates in other age groups.1
The role of the family physician
Preventing OPC and all HPV-related cancers begins by encouraging patients to reduce alcohol and tobacco use and by emphasizing the importance of HPV vaccination. Educate teens and parents/guardians about HPV vaccine and its safety. Screen for tobacco and alcohol use, and offer brief clinical interventions as needed to decrease usage.
Recommendations by the US Preventive Services Task Force regarding screening for, and reducing use of, tobacco and alcohol, as well as screening for cervical cancer, are listed in TABLE 3.3-6 Remember that cervical cancer screening is both a primary and secondary intervention: It can reduce mortality by preventing cervical cancer (via treatment of precancerous lesions) and by detecting cervical cancer early at more treatable stages.
HPV vaccination essentials. CDC recommendations for the use of HPV vaccine and the vaccine dosing schedule appear in TABLE 4.7 While it is true that the best evidence for HPV vaccine’s prevention of cancer comes from the study of cervical and anal cancers, it is reasonable to expect that it will also be proven over time to prevent other HPV-caused cancers as the rate of HPV infections declines.
HPV vaccine is underused. In a 2018 survey, only 68.1% of adolescents had received 1 or more doses of HPV vaccine, and only 51.1% were up to date.8 In contrast, 86.6% had received 1 or more doses of quadrivalent meningococcal vaccine; 88.9% had received 1 or more doses of tetanus, diphtheria & acellular pertussis vaccine; 91.9% were up to date with 2 or more doses of measles, mumps & rubella vaccine; and 92.1% were up to date with hepatitis B vaccine, with 3 or more doses.8
Continue to: Address parental concerns, including these 5 false beliefs
Address parental concerns, including these 5 false beliefs
One study found 5 major false beliefs parents hold about HPV vaccine9:
- Vaccination is not effective at preventing cancer.
- Pap smears are sufficient to prevent cervical cancer.
- HPV vaccination is not safe.
- HPV vaccination is not needed since most infections are naturally cleared by the immune system.
- Eleven to 12 years of age is too young to vaccinate.
There is some evidence that if clinicians actively engage with parents about these concerns and address them head on, same-day vaccination rates can improve.10
We can expect to see HPV-associated OPC decline in the coming years due to the delayed effects on cancer incidence by the HPV vaccine. These anticipated declines will be more dramatic if we can increase the uptake of the HPV vaccine.
1. Ellington TD, Henley SJ, Senkomago V, et al. Trends in the incidence of cancers of the oral cavity and pharynx—United States 2007-2016. MMWR Morb Mortal Wkly Rep. 2020;69:433-438.
2. CDC. HPV and cancer. 2019. https://www.cdc.gov/cancer/hpv/statistics/cases.htm. Accessed June 29, 2020.
3. USPSTF. Unhealthy alcohol use in adolescents and adults: screening and behavioral counseling interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/unhealthy-alcohol-use-in-adolescents-and-adults-screening-and-behavioral-counseling-interventions. Accessed June 29, 2020.
4. USPSTF. Prevention and cessation of tobacco use in children and adolescents: primary care interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions. Accessed June 29, 2020.
5. USPSTF. Tobacco smoking cessation in adults, including pregnant women: behavioral and pharmacotherapy interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions. Accessed June 29, 2020.
6. USPSTF. Cervical cancer: screening. www.uspreventiveservicestaskforce.org/uspstf/recommendation/cervical-cancer-screening. Accessed June 29, 2020.
7. CDC. Vaccines and preventable diseases. HPV vaccine recommendations. 2020. www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html. Accessed June 29, 2020.
8. Walker TY, Elam-Evans LD, Yankey D, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years-United States, 2018. MMWR Morb Mortal Wkly Rep. 2019:68:718-723.
9. Bednarczyk RA. Addressing HPV vaccine myths: practical information for healthcare providers. Hum Vaccin Immunother. 2019;15:1628-1638.
10. Shay LA, Baldwin AS, Betts AC, et al. Parent-provider communication of HPV vaccine hesitancy. Pediatrics 2018;141:e20172312.
A recent report by the Centers for Disease Control and Prevention (CDC) documents the trends in oral and pharyngeal cancers (OPC) in the United States over a 10-year period, 2007-2016.1 The rate of OPC began to increase in 1999 and has been increasing ever since. The age-adjusted rate in 2007 was 10.89/100,000 compared with 11.7/100,000 in 2016 (TABLE 11). This is an annual relative increase of about 6% per year. In absolute numbers, there were 35,076 cases in 2007 and 44,419 in 2016.1 The trends in incidence of OPC vary by anatomical site, with some increasing and others declining.
There are 3 known causal factors related to OPC: tobacco use, alcohol use, and human papillomavirus (HPV) infection. The CDC estimates that, overall, 70% of OPCs are caused by HPV.2 However, while cancers at some oropharyngeal sites are likely related to HPV infection, cancers at other sites are not. The rising overall incidence of OPC is being driven by increases in HPV-related cancers at an average rate of 2.1% per year, while the rates at non-HPV-associated sites have been declining by 0.4% per year.1 It is also important to appreciate that HPV causes cancer at other anatomical sites (TABLE 22) and is responsible for an estimated 35,000 cancers per year.2
Other trends of note in all OPCs combined are increasing rates among non-Hispanic whites and Asian-Pacific Islanders; decreasing rates among Hispanics and African Americans; increasing rates among males with no real change in rates among females; increasing rates in those 50 to 79 years of age; decreasing rates among those 40 to 49 years of age; and unchanged rates in other age groups.1
The role of the family physician
Preventing OPC and all HPV-related cancers begins by encouraging patients to reduce alcohol and tobacco use and by emphasizing the importance of HPV vaccination. Educate teens and parents/guardians about HPV vaccine and its safety. Screen for tobacco and alcohol use, and offer brief clinical interventions as needed to decrease usage.
Recommendations by the US Preventive Services Task Force regarding screening for, and reducing use of, tobacco and alcohol, as well as screening for cervical cancer, are listed in TABLE 3.3-6 Remember that cervical cancer screening is both a primary and secondary intervention: It can reduce mortality by preventing cervical cancer (via treatment of precancerous lesions) and by detecting cervical cancer early at more treatable stages.
HPV vaccination essentials. CDC recommendations for the use of HPV vaccine and the vaccine dosing schedule appear in TABLE 4.7 While it is true that the best evidence for HPV vaccine’s prevention of cancer comes from the study of cervical and anal cancers, it is reasonable to expect that it will also be proven over time to prevent other HPV-caused cancers as the rate of HPV infections declines.
HPV vaccine is underused. In a 2018 survey, only 68.1% of adolescents had received 1 or more doses of HPV vaccine, and only 51.1% were up to date.8 In contrast, 86.6% had received 1 or more doses of quadrivalent meningococcal vaccine; 88.9% had received 1 or more doses of tetanus, diphtheria & acellular pertussis vaccine; 91.9% were up to date with 2 or more doses of measles, mumps & rubella vaccine; and 92.1% were up to date with hepatitis B vaccine, with 3 or more doses.8
Continue to: Address parental concerns, including these 5 false beliefs
Address parental concerns, including these 5 false beliefs
One study found 5 major false beliefs parents hold about HPV vaccine9:
- Vaccination is not effective at preventing cancer.
- Pap smears are sufficient to prevent cervical cancer.
- HPV vaccination is not safe.
- HPV vaccination is not needed since most infections are naturally cleared by the immune system.
- Eleven to 12 years of age is too young to vaccinate.
There is some evidence that if clinicians actively engage with parents about these concerns and address them head on, same-day vaccination rates can improve.10
We can expect to see HPV-associated OPC decline in the coming years due to the delayed effects on cancer incidence by the HPV vaccine. These anticipated declines will be more dramatic if we can increase the uptake of the HPV vaccine.
A recent report by the Centers for Disease Control and Prevention (CDC) documents the trends in oral and pharyngeal cancers (OPC) in the United States over a 10-year period, 2007-2016.1 The rate of OPC began to increase in 1999 and has been increasing ever since. The age-adjusted rate in 2007 was 10.89/100,000 compared with 11.7/100,000 in 2016 (TABLE 11). This is an annual relative increase of about 6% per year. In absolute numbers, there were 35,076 cases in 2007 and 44,419 in 2016.1 The trends in incidence of OPC vary by anatomical site, with some increasing and others declining.
There are 3 known causal factors related to OPC: tobacco use, alcohol use, and human papillomavirus (HPV) infection. The CDC estimates that, overall, 70% of OPCs are caused by HPV.2 However, while cancers at some oropharyngeal sites are likely related to HPV infection, cancers at other sites are not. The rising overall incidence of OPC is being driven by increases in HPV-related cancers at an average rate of 2.1% per year, while the rates at non-HPV-associated sites have been declining by 0.4% per year.1 It is also important to appreciate that HPV causes cancer at other anatomical sites (TABLE 22) and is responsible for an estimated 35,000 cancers per year.2
Other trends of note in all OPCs combined are increasing rates among non-Hispanic whites and Asian-Pacific Islanders; decreasing rates among Hispanics and African Americans; increasing rates among males with no real change in rates among females; increasing rates in those 50 to 79 years of age; decreasing rates among those 40 to 49 years of age; and unchanged rates in other age groups.1
The role of the family physician
Preventing OPC and all HPV-related cancers begins by encouraging patients to reduce alcohol and tobacco use and by emphasizing the importance of HPV vaccination. Educate teens and parents/guardians about HPV vaccine and its safety. Screen for tobacco and alcohol use, and offer brief clinical interventions as needed to decrease usage.
Recommendations by the US Preventive Services Task Force regarding screening for, and reducing use of, tobacco and alcohol, as well as screening for cervical cancer, are listed in TABLE 3.3-6 Remember that cervical cancer screening is both a primary and secondary intervention: It can reduce mortality by preventing cervical cancer (via treatment of precancerous lesions) and by detecting cervical cancer early at more treatable stages.
HPV vaccination essentials. CDC recommendations for the use of HPV vaccine and the vaccine dosing schedule appear in TABLE 4.7 While it is true that the best evidence for HPV vaccine’s prevention of cancer comes from the study of cervical and anal cancers, it is reasonable to expect that it will also be proven over time to prevent other HPV-caused cancers as the rate of HPV infections declines.
HPV vaccine is underused. In a 2018 survey, only 68.1% of adolescents had received 1 or more doses of HPV vaccine, and only 51.1% were up to date.8 In contrast, 86.6% had received 1 or more doses of quadrivalent meningococcal vaccine; 88.9% had received 1 or more doses of tetanus, diphtheria & acellular pertussis vaccine; 91.9% were up to date with 2 or more doses of measles, mumps & rubella vaccine; and 92.1% were up to date with hepatitis B vaccine, with 3 or more doses.8
Continue to: Address parental concerns, including these 5 false beliefs
Address parental concerns, including these 5 false beliefs
One study found 5 major false beliefs parents hold about HPV vaccine9:
- Vaccination is not effective at preventing cancer.
- Pap smears are sufficient to prevent cervical cancer.
- HPV vaccination is not safe.
- HPV vaccination is not needed since most infections are naturally cleared by the immune system.
- Eleven to 12 years of age is too young to vaccinate.
There is some evidence that if clinicians actively engage with parents about these concerns and address them head on, same-day vaccination rates can improve.10
We can expect to see HPV-associated OPC decline in the coming years due to the delayed effects on cancer incidence by the HPV vaccine. These anticipated declines will be more dramatic if we can increase the uptake of the HPV vaccine.
1. Ellington TD, Henley SJ, Senkomago V, et al. Trends in the incidence of cancers of the oral cavity and pharynx—United States 2007-2016. MMWR Morb Mortal Wkly Rep. 2020;69:433-438.
2. CDC. HPV and cancer. 2019. https://www.cdc.gov/cancer/hpv/statistics/cases.htm. Accessed June 29, 2020.
3. USPSTF. Unhealthy alcohol use in adolescents and adults: screening and behavioral counseling interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/unhealthy-alcohol-use-in-adolescents-and-adults-screening-and-behavioral-counseling-interventions. Accessed June 29, 2020.
4. USPSTF. Prevention and cessation of tobacco use in children and adolescents: primary care interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions. Accessed June 29, 2020.
5. USPSTF. Tobacco smoking cessation in adults, including pregnant women: behavioral and pharmacotherapy interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions. Accessed June 29, 2020.
6. USPSTF. Cervical cancer: screening. www.uspreventiveservicestaskforce.org/uspstf/recommendation/cervical-cancer-screening. Accessed June 29, 2020.
7. CDC. Vaccines and preventable diseases. HPV vaccine recommendations. 2020. www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html. Accessed June 29, 2020.
8. Walker TY, Elam-Evans LD, Yankey D, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years-United States, 2018. MMWR Morb Mortal Wkly Rep. 2019:68:718-723.
9. Bednarczyk RA. Addressing HPV vaccine myths: practical information for healthcare providers. Hum Vaccin Immunother. 2019;15:1628-1638.
10. Shay LA, Baldwin AS, Betts AC, et al. Parent-provider communication of HPV vaccine hesitancy. Pediatrics 2018;141:e20172312.
1. Ellington TD, Henley SJ, Senkomago V, et al. Trends in the incidence of cancers of the oral cavity and pharynx—United States 2007-2016. MMWR Morb Mortal Wkly Rep. 2020;69:433-438.
2. CDC. HPV and cancer. 2019. https://www.cdc.gov/cancer/hpv/statistics/cases.htm. Accessed June 29, 2020.
3. USPSTF. Unhealthy alcohol use in adolescents and adults: screening and behavioral counseling interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/unhealthy-alcohol-use-in-adolescents-and-adults-screening-and-behavioral-counseling-interventions. Accessed June 29, 2020.
4. USPSTF. Prevention and cessation of tobacco use in children and adolescents: primary care interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions. Accessed June 29, 2020.
5. USPSTF. Tobacco smoking cessation in adults, including pregnant women: behavioral and pharmacotherapy interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions. Accessed June 29, 2020.
6. USPSTF. Cervical cancer: screening. www.uspreventiveservicestaskforce.org/uspstf/recommendation/cervical-cancer-screening. Accessed June 29, 2020.
7. CDC. Vaccines and preventable diseases. HPV vaccine recommendations. 2020. www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html. Accessed June 29, 2020.
8. Walker TY, Elam-Evans LD, Yankey D, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years-United States, 2018. MMWR Morb Mortal Wkly Rep. 2019:68:718-723.
9. Bednarczyk RA. Addressing HPV vaccine myths: practical information for healthcare providers. Hum Vaccin Immunother. 2019;15:1628-1638.
10. Shay LA, Baldwin AS, Betts AC, et al. Parent-provider communication of HPV vaccine hesitancy. Pediatrics 2018;141:e20172312.
About one-third of older Americans receive shingles vaccine
The number of Americans aged 60 years and older who report receiving shingles vaccination had risen steadily since 2008 and has leveled off during the past few years, new data from the Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics reveal.
The proportion of people in this age group who were vaccinated rose from 6.7% in 2008 to 34.5% in 2018, for example.
Emily Terlizzi, MPH, told Medscape Medical News.
The report was published online July 9 in NCHS Data Brief.
Similar rates for men and women
Rates of people who reported receiving at least one vaccination with Zostavax (Merck) or Shingrix (GlaxoSmithKline) varied by factors that included Hispanic origin, education, and family income. An unexpected finding was that rates did not vary significantly between men and women.
“One finding that I would say surprised me was that, although the percentage who had ever received a shingles vaccine among women aged 60 and over was higher than that among men in this age group, this difference was not statistically significant,” said Ms. Terlizzi, a health statistician in the Data Analysis and Quality Assurance Branch, Division of Health Interview Statistics, the CDC National Center for Health Statistics. In 2018, for example, 35.4% of women and 33.5% of men reported ever receiving a shingles vaccine.
The similarity of rates was less of a surprise to Len Horovitz, MD, a pulmonary specialist at Lenox Hill Hospital in New York, who was not affiliated with the report. “In my anecdotal experience, I don’t see a preponderance of one sex getting shingles more than another. It’s pretty evenly distributed,” he said in an interview.
Ms. Terlizzi and coauthor Lindsey I. Black, MPH, say their findings align with prior research. However, they noted: “Our report uses more recent data from a large, nationally representative data source to update these estimates and describe these disparities.” Data come from results of the annual National Health Interview Survey of households nationwide.
Multiple factors explain vaccination differences
Non-Hispanic White adults were more likely to report receiving the vaccine than were Hispanic and non-Hispanic Black survey respondents. Non-Hispanic White adults were about twice as likely to report vaccination – 38.6% – compared with 19.5% of Hispanic adults and 18.8% of non-Hispanic Black adults.
The disparity in vaccination by race was “disappointing news,” Kenneth E. Schmader, MD, said in an interview.
“The health disparity with regard to lower vaccination rates in Hispanic and non-Hispanic Black populations is reported with other vaccines as well and points to the need for better efforts to vaccinate Hispanic and non-Hispanic Black populations,” added Dr. Schmader, a professor of medicine at Duke University in Durham, N.C.
On a positive note, “It was good to see increasing use of shingles vaccination over time, given how devastating zoster can be in older adults and the fact that the vaccines are effective,” said Dr. Schmader, who also serves on the working groups for the Herpes Zoster, Influenza and General Adult Immunization Guidelines for the CDC Advisory Committee on Immunization Practices (ACIP).
Self-reports of receiving vaccination increased in association with higher education and family income levels. For example, 39.9% of respondents who had more than a high school diploma or GED (General Educational Development) reported receiving the shingles vaccine. In contrast, only 21.2% of people with lower educational attainment reported receiving a vaccine.
In terms of income, 20.4% of poor adults reported being vaccinated, compared with 38.4% of adults who were not poor.
The investigators also evaluated the data by geographic region. They found that rates of vaccinations varied from 26.3% in the East South Central part of the United States (which includes Tennessee, Kentucky, and Alabama) to 42.8% in the West North Central region (which includes the Dakotas, Minnesota, and Nebraska).
Clinical and research considerations
For most of the decade evaluated in the study, ACIP recommended vaccination against shingles for Americans aged 60 years and older. The current findings, therefore, do not account for ACIP’s expanding its recommendations in 2017 to include adults aged 50 years and older.
Zostavax is expected to be discontinued this year. It was the only shingles vaccine available before the approval of Shingrix in 2018. The shift to a single product could alter vaccination patterns further.
Ms. Terlizzi plans to continue monitoring trends to “see what changes occur in the next few years,” she said.
Compliance a concern
Data on vaccination rates for shingles are important given the large proportion of the population at risk, Dr. Horovitz said. “People over age 50 who have had chickenpox have a one third chance over their lifetimes to get shingles. That is a lot of people.”
Multiple factors could be contributing to the fact that vaccination rates have hovered around 34% in recent years, he said. “Whenever you see variations in vaccination rates, you have to think about cultural differences and questions about differences in access, accessibility, and attitudes. Attitudes toward vaccines vary widely – from people who don’t believe in vaccination to people who are eager to take vaccinations.
“I don’t know how to dissect all that out of these data,” he added.
Compliance with recommendations also contributes to vaccination rates, Dr. Horovitz said. The fact that in about 10% of people, a flulike syndrome develops the day after being vaccinated with Shingrix can cause some to postpone or rethink immunization, he added. In addition, Shingrix requires two shots. “People have to come back, and that always sets up an issue with recalling someone.”
Marketplace shortages of the Shingrix vaccine could also contribute to lower vaccination rates. However, Dr. Horovitz said that, in his practice, availability was only a problem during the first year after approval in 2017.
On a related note, manufacturer GlaxoSmithKline announced that a decrease in vaccination demand during the COVID-19 pandemic has allowed the supply to catch up. Shingrix no longer qualifies for the CDC’s shortages list, according to a July 9 report.
Ms. Terlizzi, Dr. Horovitz, and Dr. Schmader have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The number of Americans aged 60 years and older who report receiving shingles vaccination had risen steadily since 2008 and has leveled off during the past few years, new data from the Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics reveal.
The proportion of people in this age group who were vaccinated rose from 6.7% in 2008 to 34.5% in 2018, for example.
Emily Terlizzi, MPH, told Medscape Medical News.
The report was published online July 9 in NCHS Data Brief.
Similar rates for men and women
Rates of people who reported receiving at least one vaccination with Zostavax (Merck) or Shingrix (GlaxoSmithKline) varied by factors that included Hispanic origin, education, and family income. An unexpected finding was that rates did not vary significantly between men and women.
“One finding that I would say surprised me was that, although the percentage who had ever received a shingles vaccine among women aged 60 and over was higher than that among men in this age group, this difference was not statistically significant,” said Ms. Terlizzi, a health statistician in the Data Analysis and Quality Assurance Branch, Division of Health Interview Statistics, the CDC National Center for Health Statistics. In 2018, for example, 35.4% of women and 33.5% of men reported ever receiving a shingles vaccine.
The similarity of rates was less of a surprise to Len Horovitz, MD, a pulmonary specialist at Lenox Hill Hospital in New York, who was not affiliated with the report. “In my anecdotal experience, I don’t see a preponderance of one sex getting shingles more than another. It’s pretty evenly distributed,” he said in an interview.
Ms. Terlizzi and coauthor Lindsey I. Black, MPH, say their findings align with prior research. However, they noted: “Our report uses more recent data from a large, nationally representative data source to update these estimates and describe these disparities.” Data come from results of the annual National Health Interview Survey of households nationwide.
Multiple factors explain vaccination differences
Non-Hispanic White adults were more likely to report receiving the vaccine than were Hispanic and non-Hispanic Black survey respondents. Non-Hispanic White adults were about twice as likely to report vaccination – 38.6% – compared with 19.5% of Hispanic adults and 18.8% of non-Hispanic Black adults.
The disparity in vaccination by race was “disappointing news,” Kenneth E. Schmader, MD, said in an interview.
“The health disparity with regard to lower vaccination rates in Hispanic and non-Hispanic Black populations is reported with other vaccines as well and points to the need for better efforts to vaccinate Hispanic and non-Hispanic Black populations,” added Dr. Schmader, a professor of medicine at Duke University in Durham, N.C.
On a positive note, “It was good to see increasing use of shingles vaccination over time, given how devastating zoster can be in older adults and the fact that the vaccines are effective,” said Dr. Schmader, who also serves on the working groups for the Herpes Zoster, Influenza and General Adult Immunization Guidelines for the CDC Advisory Committee on Immunization Practices (ACIP).
Self-reports of receiving vaccination increased in association with higher education and family income levels. For example, 39.9% of respondents who had more than a high school diploma or GED (General Educational Development) reported receiving the shingles vaccine. In contrast, only 21.2% of people with lower educational attainment reported receiving a vaccine.
In terms of income, 20.4% of poor adults reported being vaccinated, compared with 38.4% of adults who were not poor.
The investigators also evaluated the data by geographic region. They found that rates of vaccinations varied from 26.3% in the East South Central part of the United States (which includes Tennessee, Kentucky, and Alabama) to 42.8% in the West North Central region (which includes the Dakotas, Minnesota, and Nebraska).
Clinical and research considerations
For most of the decade evaluated in the study, ACIP recommended vaccination against shingles for Americans aged 60 years and older. The current findings, therefore, do not account for ACIP’s expanding its recommendations in 2017 to include adults aged 50 years and older.
Zostavax is expected to be discontinued this year. It was the only shingles vaccine available before the approval of Shingrix in 2018. The shift to a single product could alter vaccination patterns further.
Ms. Terlizzi plans to continue monitoring trends to “see what changes occur in the next few years,” she said.
Compliance a concern
Data on vaccination rates for shingles are important given the large proportion of the population at risk, Dr. Horovitz said. “People over age 50 who have had chickenpox have a one third chance over their lifetimes to get shingles. That is a lot of people.”
Multiple factors could be contributing to the fact that vaccination rates have hovered around 34% in recent years, he said. “Whenever you see variations in vaccination rates, you have to think about cultural differences and questions about differences in access, accessibility, and attitudes. Attitudes toward vaccines vary widely – from people who don’t believe in vaccination to people who are eager to take vaccinations.
“I don’t know how to dissect all that out of these data,” he added.
Compliance with recommendations also contributes to vaccination rates, Dr. Horovitz said. The fact that in about 10% of people, a flulike syndrome develops the day after being vaccinated with Shingrix can cause some to postpone or rethink immunization, he added. In addition, Shingrix requires two shots. “People have to come back, and that always sets up an issue with recalling someone.”
Marketplace shortages of the Shingrix vaccine could also contribute to lower vaccination rates. However, Dr. Horovitz said that, in his practice, availability was only a problem during the first year after approval in 2017.
On a related note, manufacturer GlaxoSmithKline announced that a decrease in vaccination demand during the COVID-19 pandemic has allowed the supply to catch up. Shingrix no longer qualifies for the CDC’s shortages list, according to a July 9 report.
Ms. Terlizzi, Dr. Horovitz, and Dr. Schmader have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The number of Americans aged 60 years and older who report receiving shingles vaccination had risen steadily since 2008 and has leveled off during the past few years, new data from the Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics reveal.
The proportion of people in this age group who were vaccinated rose from 6.7% in 2008 to 34.5% in 2018, for example.
Emily Terlizzi, MPH, told Medscape Medical News.
The report was published online July 9 in NCHS Data Brief.
Similar rates for men and women
Rates of people who reported receiving at least one vaccination with Zostavax (Merck) or Shingrix (GlaxoSmithKline) varied by factors that included Hispanic origin, education, and family income. An unexpected finding was that rates did not vary significantly between men and women.
“One finding that I would say surprised me was that, although the percentage who had ever received a shingles vaccine among women aged 60 and over was higher than that among men in this age group, this difference was not statistically significant,” said Ms. Terlizzi, a health statistician in the Data Analysis and Quality Assurance Branch, Division of Health Interview Statistics, the CDC National Center for Health Statistics. In 2018, for example, 35.4% of women and 33.5% of men reported ever receiving a shingles vaccine.
The similarity of rates was less of a surprise to Len Horovitz, MD, a pulmonary specialist at Lenox Hill Hospital in New York, who was not affiliated with the report. “In my anecdotal experience, I don’t see a preponderance of one sex getting shingles more than another. It’s pretty evenly distributed,” he said in an interview.
Ms. Terlizzi and coauthor Lindsey I. Black, MPH, say their findings align with prior research. However, they noted: “Our report uses more recent data from a large, nationally representative data source to update these estimates and describe these disparities.” Data come from results of the annual National Health Interview Survey of households nationwide.
Multiple factors explain vaccination differences
Non-Hispanic White adults were more likely to report receiving the vaccine than were Hispanic and non-Hispanic Black survey respondents. Non-Hispanic White adults were about twice as likely to report vaccination – 38.6% – compared with 19.5% of Hispanic adults and 18.8% of non-Hispanic Black adults.
The disparity in vaccination by race was “disappointing news,” Kenneth E. Schmader, MD, said in an interview.
“The health disparity with regard to lower vaccination rates in Hispanic and non-Hispanic Black populations is reported with other vaccines as well and points to the need for better efforts to vaccinate Hispanic and non-Hispanic Black populations,” added Dr. Schmader, a professor of medicine at Duke University in Durham, N.C.
On a positive note, “It was good to see increasing use of shingles vaccination over time, given how devastating zoster can be in older adults and the fact that the vaccines are effective,” said Dr. Schmader, who also serves on the working groups for the Herpes Zoster, Influenza and General Adult Immunization Guidelines for the CDC Advisory Committee on Immunization Practices (ACIP).
Self-reports of receiving vaccination increased in association with higher education and family income levels. For example, 39.9% of respondents who had more than a high school diploma or GED (General Educational Development) reported receiving the shingles vaccine. In contrast, only 21.2% of people with lower educational attainment reported receiving a vaccine.
In terms of income, 20.4% of poor adults reported being vaccinated, compared with 38.4% of adults who were not poor.
The investigators also evaluated the data by geographic region. They found that rates of vaccinations varied from 26.3% in the East South Central part of the United States (which includes Tennessee, Kentucky, and Alabama) to 42.8% in the West North Central region (which includes the Dakotas, Minnesota, and Nebraska).
Clinical and research considerations
For most of the decade evaluated in the study, ACIP recommended vaccination against shingles for Americans aged 60 years and older. The current findings, therefore, do not account for ACIP’s expanding its recommendations in 2017 to include adults aged 50 years and older.
Zostavax is expected to be discontinued this year. It was the only shingles vaccine available before the approval of Shingrix in 2018. The shift to a single product could alter vaccination patterns further.
Ms. Terlizzi plans to continue monitoring trends to “see what changes occur in the next few years,” she said.
Compliance a concern
Data on vaccination rates for shingles are important given the large proportion of the population at risk, Dr. Horovitz said. “People over age 50 who have had chickenpox have a one third chance over their lifetimes to get shingles. That is a lot of people.”
Multiple factors could be contributing to the fact that vaccination rates have hovered around 34% in recent years, he said. “Whenever you see variations in vaccination rates, you have to think about cultural differences and questions about differences in access, accessibility, and attitudes. Attitudes toward vaccines vary widely – from people who don’t believe in vaccination to people who are eager to take vaccinations.
“I don’t know how to dissect all that out of these data,” he added.
Compliance with recommendations also contributes to vaccination rates, Dr. Horovitz said. The fact that in about 10% of people, a flulike syndrome develops the day after being vaccinated with Shingrix can cause some to postpone or rethink immunization, he added. In addition, Shingrix requires two shots. “People have to come back, and that always sets up an issue with recalling someone.”
Marketplace shortages of the Shingrix vaccine could also contribute to lower vaccination rates. However, Dr. Horovitz said that, in his practice, availability was only a problem during the first year after approval in 2017.
On a related note, manufacturer GlaxoSmithKline announced that a decrease in vaccination demand during the COVID-19 pandemic has allowed the supply to catch up. Shingrix no longer qualifies for the CDC’s shortages list, according to a July 9 report.
Ms. Terlizzi, Dr. Horovitz, and Dr. Schmader have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Influenza vaccine efficacy called undiminished in MS
, Jackie Nguyen reported at the virtual annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC). She presented a systematic review and meta-analysis of nine published cohort studies including 417 MS patients and more than 500 healthy controls, all of whom received inactivated seasonal influenza vaccine.
The impetus for this project was a recognition that the great majority of the research on the impact of influenza vaccine in patients with MS has focused on safety and MS relapse rates. In contrast, the nine studies included in the meta-analysis contained data on influenza vaccine efficacy as reflected in the ability to mount an adequate immune response. This was defined in standard fashion either by seroconversion, which required at least a fourfold increase in antibody titers following vaccination, or seroprotection, with a postvaccination antihemagglutination immunoglobulin G titer of at least 40. The analysis included patients with MS irrespective of disease duration or severity or treatment regimen, noted Ms. Nguyen, a third-year medical student at Nova Southeastern University College of Allopathic Medicine in Davie, Fla.
The researchers found that there was no significant difference between patients with MS and healthy controls in the rates of an adequate immune response for influenza H1N1, H3N2, or influenza B virus. “The vaccine should thus continue to be recommended for MS patients, as the data shows it to be efficacious,” she said.
Her conclusion is consistent with guidance provided in the American Academy of Neurology’s 2019 practice guideline update on immunization in MS, highlighted elsewhere at CMSC 2020 in a presentation by Marijean Buhse, PhD, of Stony Brook University in New York.
The guideline, updated for the first time in 17 years, states that all MS patients should be advised to receive influenza vaccine annually: “With known risks of exacerbation and other morbidity with influenza infection and no identified risks of exacerbation with influenza vaccines, benefits of influenza vaccination outweigh the risks in most scenarios. The exception involves the relatively few MS patients having a specific contraindication to the influenza vaccine, such as a previous severe reaction, noted Dr. Buhse, who wasn’t involved in developing the evidence-based guidelines.
The available evidence indicates that some but not all disease-modifying therapies for MS reduce the effectiveness of vaccination against influenza.
According to the guideline, “it is possible” that persons with MS being treated with glatiramer acetate have a reduced likelihood of seroprotection from influenza vaccine, a conclusion the guidelines committee drew with “low confidence in the evidence.” Further, the guideline states that “it is probable” MS patients on fingolimod have a lower likelihood of obtaining seroprotection from influenza vaccine than patients not on the drug, with moderate confidence in the evidence. Also, it is deemed probable that patients with MS who are taking mitoxantrone have a reduced likelihood of response to influenza vaccination, compared with healthy controls. But it is probable that patients with MS who are receiving interferon-beta have no diminution in the likelihood of seroprotection. According to the guideline, there is insufficient evidence to say whether patients with MS who are on natalizumab, teriflunomide, or methotrexate have a diminished response to influenza vaccination.
Dr. Buhse noted that rituximab is off-label therapy for MS, so there are no data available regarding the likelihood of seroprotection in response to influenza vaccination in that setting. However, rituximab profoundly decreases the immunogenicity of influenza and pneumococcal vaccines in rheumatoid arthritis patients. It is therefore recommended that inactivated influenza vaccine be given to patients with MS at least 2 weeks prior to starting rituximab or 6 months after the last dose in order to optimize the humoral results. Ms. Nguyen reported having no financial conflicts regarding her presentation. Dr. Buhse reported having received honoraria from Genzyme and Biogen.
, Jackie Nguyen reported at the virtual annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC). She presented a systematic review and meta-analysis of nine published cohort studies including 417 MS patients and more than 500 healthy controls, all of whom received inactivated seasonal influenza vaccine.
The impetus for this project was a recognition that the great majority of the research on the impact of influenza vaccine in patients with MS has focused on safety and MS relapse rates. In contrast, the nine studies included in the meta-analysis contained data on influenza vaccine efficacy as reflected in the ability to mount an adequate immune response. This was defined in standard fashion either by seroconversion, which required at least a fourfold increase in antibody titers following vaccination, or seroprotection, with a postvaccination antihemagglutination immunoglobulin G titer of at least 40. The analysis included patients with MS irrespective of disease duration or severity or treatment regimen, noted Ms. Nguyen, a third-year medical student at Nova Southeastern University College of Allopathic Medicine in Davie, Fla.
The researchers found that there was no significant difference between patients with MS and healthy controls in the rates of an adequate immune response for influenza H1N1, H3N2, or influenza B virus. “The vaccine should thus continue to be recommended for MS patients, as the data shows it to be efficacious,” she said.
Her conclusion is consistent with guidance provided in the American Academy of Neurology’s 2019 practice guideline update on immunization in MS, highlighted elsewhere at CMSC 2020 in a presentation by Marijean Buhse, PhD, of Stony Brook University in New York.
The guideline, updated for the first time in 17 years, states that all MS patients should be advised to receive influenza vaccine annually: “With known risks of exacerbation and other morbidity with influenza infection and no identified risks of exacerbation with influenza vaccines, benefits of influenza vaccination outweigh the risks in most scenarios. The exception involves the relatively few MS patients having a specific contraindication to the influenza vaccine, such as a previous severe reaction, noted Dr. Buhse, who wasn’t involved in developing the evidence-based guidelines.
The available evidence indicates that some but not all disease-modifying therapies for MS reduce the effectiveness of vaccination against influenza.
According to the guideline, “it is possible” that persons with MS being treated with glatiramer acetate have a reduced likelihood of seroprotection from influenza vaccine, a conclusion the guidelines committee drew with “low confidence in the evidence.” Further, the guideline states that “it is probable” MS patients on fingolimod have a lower likelihood of obtaining seroprotection from influenza vaccine than patients not on the drug, with moderate confidence in the evidence. Also, it is deemed probable that patients with MS who are taking mitoxantrone have a reduced likelihood of response to influenza vaccination, compared with healthy controls. But it is probable that patients with MS who are receiving interferon-beta have no diminution in the likelihood of seroprotection. According to the guideline, there is insufficient evidence to say whether patients with MS who are on natalizumab, teriflunomide, or methotrexate have a diminished response to influenza vaccination.
Dr. Buhse noted that rituximab is off-label therapy for MS, so there are no data available regarding the likelihood of seroprotection in response to influenza vaccination in that setting. However, rituximab profoundly decreases the immunogenicity of influenza and pneumococcal vaccines in rheumatoid arthritis patients. It is therefore recommended that inactivated influenza vaccine be given to patients with MS at least 2 weeks prior to starting rituximab or 6 months after the last dose in order to optimize the humoral results. Ms. Nguyen reported having no financial conflicts regarding her presentation. Dr. Buhse reported having received honoraria from Genzyme and Biogen.
, Jackie Nguyen reported at the virtual annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC). She presented a systematic review and meta-analysis of nine published cohort studies including 417 MS patients and more than 500 healthy controls, all of whom received inactivated seasonal influenza vaccine.
The impetus for this project was a recognition that the great majority of the research on the impact of influenza vaccine in patients with MS has focused on safety and MS relapse rates. In contrast, the nine studies included in the meta-analysis contained data on influenza vaccine efficacy as reflected in the ability to mount an adequate immune response. This was defined in standard fashion either by seroconversion, which required at least a fourfold increase in antibody titers following vaccination, or seroprotection, with a postvaccination antihemagglutination immunoglobulin G titer of at least 40. The analysis included patients with MS irrespective of disease duration or severity or treatment regimen, noted Ms. Nguyen, a third-year medical student at Nova Southeastern University College of Allopathic Medicine in Davie, Fla.
The researchers found that there was no significant difference between patients with MS and healthy controls in the rates of an adequate immune response for influenza H1N1, H3N2, or influenza B virus. “The vaccine should thus continue to be recommended for MS patients, as the data shows it to be efficacious,” she said.
Her conclusion is consistent with guidance provided in the American Academy of Neurology’s 2019 practice guideline update on immunization in MS, highlighted elsewhere at CMSC 2020 in a presentation by Marijean Buhse, PhD, of Stony Brook University in New York.
The guideline, updated for the first time in 17 years, states that all MS patients should be advised to receive influenza vaccine annually: “With known risks of exacerbation and other morbidity with influenza infection and no identified risks of exacerbation with influenza vaccines, benefits of influenza vaccination outweigh the risks in most scenarios. The exception involves the relatively few MS patients having a specific contraindication to the influenza vaccine, such as a previous severe reaction, noted Dr. Buhse, who wasn’t involved in developing the evidence-based guidelines.
The available evidence indicates that some but not all disease-modifying therapies for MS reduce the effectiveness of vaccination against influenza.
According to the guideline, “it is possible” that persons with MS being treated with glatiramer acetate have a reduced likelihood of seroprotection from influenza vaccine, a conclusion the guidelines committee drew with “low confidence in the evidence.” Further, the guideline states that “it is probable” MS patients on fingolimod have a lower likelihood of obtaining seroprotection from influenza vaccine than patients not on the drug, with moderate confidence in the evidence. Also, it is deemed probable that patients with MS who are taking mitoxantrone have a reduced likelihood of response to influenza vaccination, compared with healthy controls. But it is probable that patients with MS who are receiving interferon-beta have no diminution in the likelihood of seroprotection. According to the guideline, there is insufficient evidence to say whether patients with MS who are on natalizumab, teriflunomide, or methotrexate have a diminished response to influenza vaccination.
Dr. Buhse noted that rituximab is off-label therapy for MS, so there are no data available regarding the likelihood of seroprotection in response to influenza vaccination in that setting. However, rituximab profoundly decreases the immunogenicity of influenza and pneumococcal vaccines in rheumatoid arthritis patients. It is therefore recommended that inactivated influenza vaccine be given to patients with MS at least 2 weeks prior to starting rituximab or 6 months after the last dose in order to optimize the humoral results. Ms. Nguyen reported having no financial conflicts regarding her presentation. Dr. Buhse reported having received honoraria from Genzyme and Biogen.
REPORTING FROM CMSC 2020
Phase 3 COVID-19 vaccine trials launching in July, expert says
The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.
According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”
Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”
Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”
Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”
Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”
“Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”
The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”
A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”
Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”
Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”
Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”
The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.
According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”
Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”
Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”
Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”
Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”
“Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”
The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”
A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”
Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”
Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”
Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”
The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.
According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”
Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”
Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”
Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”
Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”
“Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”
The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”
A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”
Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”
Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”
Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”
FROM PEDIATRIC DERMATOLOGY 2020
ACIP plans priority groups in advance of COVID-19 vaccine
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.
Encourage parents to follow pediatric plans for vaccination
Outpatient medical care has been severely disrupted during the COVID-19 pandemic with a reduction of nearly 70% in outpatient visits since March before starting to rebound, Melinda Wharton, MD, said at the virtual meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
Pediatrics was among the hardest hit specialties, with a 62% reduction in outpatient visits by April 5, said Dr. Wharton, director of the immunization services division at the CDC’s National Center for Immunization and Respiratory Diseases. However, visits for all pediatric age groups increased in May, compared with April, and the CDC emphasized the need to educate families about the importance of routine vaccination and well-child visits, Dr. Wharton said.
The CDC strategies to support routine childhood vaccination include monitoring vaccination service delivery to inform targeted interventions, said Dr. Wharton. In addition, the CDC will continue to support providers by identifying gaps in the Vaccines For Children (VFC) program network, increasing VFC funding, developing guidance materials, and identifying policy interventions.
Many small practices have struggled during the pandemic, and financial support is available through the Provider Relief Fund, which is now available to all Medicaid and Children’s Health Insurance Program (CHIP) providers, said Dr. Wharton.
because more families may now qualify for the program because of changes in job status and income, and parents may not be aware that their children may be eligible, she said.
“Vaccination is an essential medical service for all children and adolescents, ideally in the medical home,” Dr. Wharton said. The CDC’s interim guidance for immunization during the COVID-19 pandemic calls for administering all current or overdue vaccines according to the routine immunization schedule during the same visit, and implementing strategies to get patients caught up, prioritizing newborns, infants, and children up to age 24 months. The guidance includes details on safe delivery of vaccines, including physical distance and the use of personal protective equipment.
In addition, encourage parents to return for well-child visits, and use reminder systems to help keep patients current on visits and vaccines. “Discuss the safety protocols that have been put in place,” Dr. Wharton emphasized. The CDC also offers resources for providers to help communicate with parents about routine vaccination.
Looking ahead, back-to-school vaccination requirements “provide a critical checkpoint for children’s vaccination status,” Dr. Wharton said. Catch-up vaccination during the summer will help clinical capacity manage back-to-school and influenza vaccination in the fall, she emphasized. “Influenza vaccination will be an important strategy to decrease stress on our health care system.”
Flu vaccination strategies should focus on adults at higher risk for COVID-19 infections, such as health care providers. In addition, identifying and reducing disparities will be important for future COVID-19 vaccines, as well as for the flu this season, she noted.
View the complete guidance online.
Dr. Wharton had no relevant financial disclosures.
Outpatient medical care has been severely disrupted during the COVID-19 pandemic with a reduction of nearly 70% in outpatient visits since March before starting to rebound, Melinda Wharton, MD, said at the virtual meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
Pediatrics was among the hardest hit specialties, with a 62% reduction in outpatient visits by April 5, said Dr. Wharton, director of the immunization services division at the CDC’s National Center for Immunization and Respiratory Diseases. However, visits for all pediatric age groups increased in May, compared with April, and the CDC emphasized the need to educate families about the importance of routine vaccination and well-child visits, Dr. Wharton said.
The CDC strategies to support routine childhood vaccination include monitoring vaccination service delivery to inform targeted interventions, said Dr. Wharton. In addition, the CDC will continue to support providers by identifying gaps in the Vaccines For Children (VFC) program network, increasing VFC funding, developing guidance materials, and identifying policy interventions.
Many small practices have struggled during the pandemic, and financial support is available through the Provider Relief Fund, which is now available to all Medicaid and Children’s Health Insurance Program (CHIP) providers, said Dr. Wharton.
because more families may now qualify for the program because of changes in job status and income, and parents may not be aware that their children may be eligible, she said.
“Vaccination is an essential medical service for all children and adolescents, ideally in the medical home,” Dr. Wharton said. The CDC’s interim guidance for immunization during the COVID-19 pandemic calls for administering all current or overdue vaccines according to the routine immunization schedule during the same visit, and implementing strategies to get patients caught up, prioritizing newborns, infants, and children up to age 24 months. The guidance includes details on safe delivery of vaccines, including physical distance and the use of personal protective equipment.
In addition, encourage parents to return for well-child visits, and use reminder systems to help keep patients current on visits and vaccines. “Discuss the safety protocols that have been put in place,” Dr. Wharton emphasized. The CDC also offers resources for providers to help communicate with parents about routine vaccination.
Looking ahead, back-to-school vaccination requirements “provide a critical checkpoint for children’s vaccination status,” Dr. Wharton said. Catch-up vaccination during the summer will help clinical capacity manage back-to-school and influenza vaccination in the fall, she emphasized. “Influenza vaccination will be an important strategy to decrease stress on our health care system.”
Flu vaccination strategies should focus on adults at higher risk for COVID-19 infections, such as health care providers. In addition, identifying and reducing disparities will be important for future COVID-19 vaccines, as well as for the flu this season, she noted.
View the complete guidance online.
Dr. Wharton had no relevant financial disclosures.
Outpatient medical care has been severely disrupted during the COVID-19 pandemic with a reduction of nearly 70% in outpatient visits since March before starting to rebound, Melinda Wharton, MD, said at the virtual meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
Pediatrics was among the hardest hit specialties, with a 62% reduction in outpatient visits by April 5, said Dr. Wharton, director of the immunization services division at the CDC’s National Center for Immunization and Respiratory Diseases. However, visits for all pediatric age groups increased in May, compared with April, and the CDC emphasized the need to educate families about the importance of routine vaccination and well-child visits, Dr. Wharton said.
The CDC strategies to support routine childhood vaccination include monitoring vaccination service delivery to inform targeted interventions, said Dr. Wharton. In addition, the CDC will continue to support providers by identifying gaps in the Vaccines For Children (VFC) program network, increasing VFC funding, developing guidance materials, and identifying policy interventions.
Many small practices have struggled during the pandemic, and financial support is available through the Provider Relief Fund, which is now available to all Medicaid and Children’s Health Insurance Program (CHIP) providers, said Dr. Wharton.
because more families may now qualify for the program because of changes in job status and income, and parents may not be aware that their children may be eligible, she said.
“Vaccination is an essential medical service for all children and adolescents, ideally in the medical home,” Dr. Wharton said. The CDC’s interim guidance for immunization during the COVID-19 pandemic calls for administering all current or overdue vaccines according to the routine immunization schedule during the same visit, and implementing strategies to get patients caught up, prioritizing newborns, infants, and children up to age 24 months. The guidance includes details on safe delivery of vaccines, including physical distance and the use of personal protective equipment.
In addition, encourage parents to return for well-child visits, and use reminder systems to help keep patients current on visits and vaccines. “Discuss the safety protocols that have been put in place,” Dr. Wharton emphasized. The CDC also offers resources for providers to help communicate with parents about routine vaccination.
Looking ahead, back-to-school vaccination requirements “provide a critical checkpoint for children’s vaccination status,” Dr. Wharton said. Catch-up vaccination during the summer will help clinical capacity manage back-to-school and influenza vaccination in the fall, she emphasized. “Influenza vaccination will be an important strategy to decrease stress on our health care system.”
Flu vaccination strategies should focus on adults at higher risk for COVID-19 infections, such as health care providers. In addition, identifying and reducing disparities will be important for future COVID-19 vaccines, as well as for the flu this season, she noted.
View the complete guidance online.
Dr. Wharton had no relevant financial disclosures.
ACIP approves flu vaccine recommendations for 2020-2021
– Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.
The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.
The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.
Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.
Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.
Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.
ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”
The ACIP members had no financial conflicts to disclose.
– Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.
The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.
The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.
Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.
Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.
Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.
ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”
The ACIP members had no financial conflicts to disclose.
– Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.
The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.
The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.
Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.
Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.
Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.
ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”
The ACIP members had no financial conflicts to disclose.
New quadrivalent meningococcal vaccine joins VFC arsenal
No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.
The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.
Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.
Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”
The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.
ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.
Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.
The committee members and Dr. McNamara had no relevant financial conflicts to disclose.
No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.
The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.
Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.
Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”
The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.
ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.
Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.
The committee members and Dr. McNamara had no relevant financial conflicts to disclose.
No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.
The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.
Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.
Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”
The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.
ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.
Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.
The committee members and Dr. McNamara had no relevant financial conflicts to disclose.
Survey: 26% of parents hesitant about influenza vaccine
according to a nationally representative survey.
Influenza vaccination hesitancy may be driven by concerns about vaccine effectiveness, researchers wrote in Pediatrics. These findings “underscore the importance of better communicating to providers and parents the effectiveness of influenza vaccines in reducing severity and morbidity from influenza, even in years when the vaccine has relatively low effectiveness,” noted Allison Kempe, MD, MPH, professor of pediatrics and director of the Adult and Child Consortium for Health Outcomes Research and Delivery Science at the University of Colorado at Denver, Aurora, and colleagues.
The World Health Organization considers vaccine hesitancy a leading threat to global health, but national data about vaccine hesitancy in the United States are limited. To assess hesitancy about routine childhood and influenza vaccinations and related factors, Dr. Kempe and colleagues surveyed more than 2,000 parents in February 2019.
The investigators used an online panel to survey a nationally representative sample of families with children aged between 6 months and 18 years. Parents completed a modified version of the Vaccine Hesitancy Scale, which measures confidence in and concerns about vaccines. Parents with an average score greater than 3 on the scale were considered hesitant.
Factors associated with vaccine hesitancy
Of 4,445 parents sampled, 2,176 completed the survey and 2,052 were eligible respondents. For routine childhood vaccines, the average score on the modified Vaccine Hesitancy Scale was 2 and the percentage of hesitant parents was 6%. For influenza vaccine, the average score was 2 and the percentage of hesitant parents was 26%.
Among hesitant parents, 68% had deferred or refused routine childhood vaccination, compared with 9% of nonhesitant parents (risk ratio, 8.0). For the influenza vaccine, 70% of hesitant parents had deferred or refused influenza vaccination for their child versus 10% of nonhesitant parents (RR, 7.0). Parents were more likely to strongly agree that routine childhood vaccines are effective, compared with the influenza vaccine (70% vs. 26%). “Hesitancy about influenza vaccination is largely driven by concerns about low vaccine effectiveness,” Dr. Kempe and associates wrote.
Although concern about serious side effects was the factor most associated with hesitancy, the percentage of parents who were strongly (12%) or somewhat (27%) concerned about serious side effects was the same for routine childhood vaccines and influenza vaccines. Other factors associated with hesitancy for both routine childhood vaccines and influenza vaccines included lower educational level and household income less than 400% of the federal poverty level.
The survey data may be subject to reporting bias based on social desirability, the authors noted. In addition, the exclusion of infants younger than 6 months may have resulted in an underestimate of hesitancy.
“Although influenza vaccine could be included as a ‘routine’ vaccine, in that it is recommended yearly, we hypothesized that parents view it differently from other childhood vaccines because each year it needs to be given again, its content and effectiveness vary, and it addresses a disease that is often perceived as minor, compared with other childhood diseases,” Dr. Kempe and colleagues wrote. Interventions to counter hesitancy have “a surprising lack of evidence,” and “more work needs to be done to develop methods that are practical and effective for convincing vaccine-hesitant parents to vaccinate.”
Logical next step
“From the pragmatic standpoint of improving immunization rates and disease control, determining the correct evidence-based messaging to counter these perceptions is the next logical step,” Annabelle de St. Maurice, MD, MPH, an assistant professor of pediatrics in the division of infectious diseases at University of California, Los Angeles, and Kathryn Edwards, MD, a professor of pediatrics and director of the vaccine research program at Vanderbilt University, Nashville, wrote in an accompanying editorial.
“Communications should be focused on the burden of influenza in children, rebranding influenza vaccine as a ‘routine’ childhood immunization, reassurance on influenza vaccine safety, and discussion of the efficacy of influenza vaccine in preventing severe disease,” they wrote. “Even in the years when there is a poor match, the vaccine is impactful.”
The research was supported by the National Institutes of Health. Two study authors disclosed financial ties to Sanofi Pasteur, with one also disclosing financial ties to Merck, for work related to vaccinations. The remaining investigators had no relevant financial disclosures. Dr. de St. Maurice indicated that she had no relevant financial disclosures. Dr. Edwards disclosed grants from the Centers for Disease Control and Prevention and the NIH; consulting for Merck, Bionet, and IBM; and serving on data safety and monitoring boards for Sanofi, X4 Pharmaceuticals, Seqirus, Moderna, and Pfizer.
SOURCE: Kempe A et al. Pediatrics. 2020 Jun 15. doi: 10.1542/peds.2019-3852.
according to a nationally representative survey.
Influenza vaccination hesitancy may be driven by concerns about vaccine effectiveness, researchers wrote in Pediatrics. These findings “underscore the importance of better communicating to providers and parents the effectiveness of influenza vaccines in reducing severity and morbidity from influenza, even in years when the vaccine has relatively low effectiveness,” noted Allison Kempe, MD, MPH, professor of pediatrics and director of the Adult and Child Consortium for Health Outcomes Research and Delivery Science at the University of Colorado at Denver, Aurora, and colleagues.
The World Health Organization considers vaccine hesitancy a leading threat to global health, but national data about vaccine hesitancy in the United States are limited. To assess hesitancy about routine childhood and influenza vaccinations and related factors, Dr. Kempe and colleagues surveyed more than 2,000 parents in February 2019.
The investigators used an online panel to survey a nationally representative sample of families with children aged between 6 months and 18 years. Parents completed a modified version of the Vaccine Hesitancy Scale, which measures confidence in and concerns about vaccines. Parents with an average score greater than 3 on the scale were considered hesitant.
Factors associated with vaccine hesitancy
Of 4,445 parents sampled, 2,176 completed the survey and 2,052 were eligible respondents. For routine childhood vaccines, the average score on the modified Vaccine Hesitancy Scale was 2 and the percentage of hesitant parents was 6%. For influenza vaccine, the average score was 2 and the percentage of hesitant parents was 26%.
Among hesitant parents, 68% had deferred or refused routine childhood vaccination, compared with 9% of nonhesitant parents (risk ratio, 8.0). For the influenza vaccine, 70% of hesitant parents had deferred or refused influenza vaccination for their child versus 10% of nonhesitant parents (RR, 7.0). Parents were more likely to strongly agree that routine childhood vaccines are effective, compared with the influenza vaccine (70% vs. 26%). “Hesitancy about influenza vaccination is largely driven by concerns about low vaccine effectiveness,” Dr. Kempe and associates wrote.
Although concern about serious side effects was the factor most associated with hesitancy, the percentage of parents who were strongly (12%) or somewhat (27%) concerned about serious side effects was the same for routine childhood vaccines and influenza vaccines. Other factors associated with hesitancy for both routine childhood vaccines and influenza vaccines included lower educational level and household income less than 400% of the federal poverty level.
The survey data may be subject to reporting bias based on social desirability, the authors noted. In addition, the exclusion of infants younger than 6 months may have resulted in an underestimate of hesitancy.
“Although influenza vaccine could be included as a ‘routine’ vaccine, in that it is recommended yearly, we hypothesized that parents view it differently from other childhood vaccines because each year it needs to be given again, its content and effectiveness vary, and it addresses a disease that is often perceived as minor, compared with other childhood diseases,” Dr. Kempe and colleagues wrote. Interventions to counter hesitancy have “a surprising lack of evidence,” and “more work needs to be done to develop methods that are practical and effective for convincing vaccine-hesitant parents to vaccinate.”
Logical next step
“From the pragmatic standpoint of improving immunization rates and disease control, determining the correct evidence-based messaging to counter these perceptions is the next logical step,” Annabelle de St. Maurice, MD, MPH, an assistant professor of pediatrics in the division of infectious diseases at University of California, Los Angeles, and Kathryn Edwards, MD, a professor of pediatrics and director of the vaccine research program at Vanderbilt University, Nashville, wrote in an accompanying editorial.
“Communications should be focused on the burden of influenza in children, rebranding influenza vaccine as a ‘routine’ childhood immunization, reassurance on influenza vaccine safety, and discussion of the efficacy of influenza vaccine in preventing severe disease,” they wrote. “Even in the years when there is a poor match, the vaccine is impactful.”
The research was supported by the National Institutes of Health. Two study authors disclosed financial ties to Sanofi Pasteur, with one also disclosing financial ties to Merck, for work related to vaccinations. The remaining investigators had no relevant financial disclosures. Dr. de St. Maurice indicated that she had no relevant financial disclosures. Dr. Edwards disclosed grants from the Centers for Disease Control and Prevention and the NIH; consulting for Merck, Bionet, and IBM; and serving on data safety and monitoring boards for Sanofi, X4 Pharmaceuticals, Seqirus, Moderna, and Pfizer.
SOURCE: Kempe A et al. Pediatrics. 2020 Jun 15. doi: 10.1542/peds.2019-3852.
according to a nationally representative survey.
Influenza vaccination hesitancy may be driven by concerns about vaccine effectiveness, researchers wrote in Pediatrics. These findings “underscore the importance of better communicating to providers and parents the effectiveness of influenza vaccines in reducing severity and morbidity from influenza, even in years when the vaccine has relatively low effectiveness,” noted Allison Kempe, MD, MPH, professor of pediatrics and director of the Adult and Child Consortium for Health Outcomes Research and Delivery Science at the University of Colorado at Denver, Aurora, and colleagues.
The World Health Organization considers vaccine hesitancy a leading threat to global health, but national data about vaccine hesitancy in the United States are limited. To assess hesitancy about routine childhood and influenza vaccinations and related factors, Dr. Kempe and colleagues surveyed more than 2,000 parents in February 2019.
The investigators used an online panel to survey a nationally representative sample of families with children aged between 6 months and 18 years. Parents completed a modified version of the Vaccine Hesitancy Scale, which measures confidence in and concerns about vaccines. Parents with an average score greater than 3 on the scale were considered hesitant.
Factors associated with vaccine hesitancy
Of 4,445 parents sampled, 2,176 completed the survey and 2,052 were eligible respondents. For routine childhood vaccines, the average score on the modified Vaccine Hesitancy Scale was 2 and the percentage of hesitant parents was 6%. For influenza vaccine, the average score was 2 and the percentage of hesitant parents was 26%.
Among hesitant parents, 68% had deferred or refused routine childhood vaccination, compared with 9% of nonhesitant parents (risk ratio, 8.0). For the influenza vaccine, 70% of hesitant parents had deferred or refused influenza vaccination for their child versus 10% of nonhesitant parents (RR, 7.0). Parents were more likely to strongly agree that routine childhood vaccines are effective, compared with the influenza vaccine (70% vs. 26%). “Hesitancy about influenza vaccination is largely driven by concerns about low vaccine effectiveness,” Dr. Kempe and associates wrote.
Although concern about serious side effects was the factor most associated with hesitancy, the percentage of parents who were strongly (12%) or somewhat (27%) concerned about serious side effects was the same for routine childhood vaccines and influenza vaccines. Other factors associated with hesitancy for both routine childhood vaccines and influenza vaccines included lower educational level and household income less than 400% of the federal poverty level.
The survey data may be subject to reporting bias based on social desirability, the authors noted. In addition, the exclusion of infants younger than 6 months may have resulted in an underestimate of hesitancy.
“Although influenza vaccine could be included as a ‘routine’ vaccine, in that it is recommended yearly, we hypothesized that parents view it differently from other childhood vaccines because each year it needs to be given again, its content and effectiveness vary, and it addresses a disease that is often perceived as minor, compared with other childhood diseases,” Dr. Kempe and colleagues wrote. Interventions to counter hesitancy have “a surprising lack of evidence,” and “more work needs to be done to develop methods that are practical and effective for convincing vaccine-hesitant parents to vaccinate.”
Logical next step
“From the pragmatic standpoint of improving immunization rates and disease control, determining the correct evidence-based messaging to counter these perceptions is the next logical step,” Annabelle de St. Maurice, MD, MPH, an assistant professor of pediatrics in the division of infectious diseases at University of California, Los Angeles, and Kathryn Edwards, MD, a professor of pediatrics and director of the vaccine research program at Vanderbilt University, Nashville, wrote in an accompanying editorial.
“Communications should be focused on the burden of influenza in children, rebranding influenza vaccine as a ‘routine’ childhood immunization, reassurance on influenza vaccine safety, and discussion of the efficacy of influenza vaccine in preventing severe disease,” they wrote. “Even in the years when there is a poor match, the vaccine is impactful.”
The research was supported by the National Institutes of Health. Two study authors disclosed financial ties to Sanofi Pasteur, with one also disclosing financial ties to Merck, for work related to vaccinations. The remaining investigators had no relevant financial disclosures. Dr. de St. Maurice indicated that she had no relevant financial disclosures. Dr. Edwards disclosed grants from the Centers for Disease Control and Prevention and the NIH; consulting for Merck, Bionet, and IBM; and serving on data safety and monitoring boards for Sanofi, X4 Pharmaceuticals, Seqirus, Moderna, and Pfizer.
SOURCE: Kempe A et al. Pediatrics. 2020 Jun 15. doi: 10.1542/peds.2019-3852.
FROM PEDIATRICS
Half of Americans would get COVID-19 vaccine, poll shows
About half of Americans say they would get a COVID-19 vaccine if one is available, according to the Associated Press.
The poll was conducted May 14-18 and released May 27.
A massive national and international effort is underway to develop a vaccine for the coronavirus. According to the poll, 20% of Americans believe a vaccine will be available before the end of 2020. Another 61% think it will arrive in 2021, and 17% say it will take longer.
“It’s always better to under-promise and over-deliver,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, told the AP.
Americans over age 60 were more likely to say they’ll get a coronavirus vaccine when it’s available. Those who worry that they or someone in their household could become infected with the virus were also more likely to say they’ll get a vaccine. However, Black Americans were more likely than were Hispanic or white responders to say that they don’t plan to get a vaccine.
Among those who plan to get a vaccine, 93% said they want to protect themselves, and 88% said they want to protect their family. About 72% said “life won’t go back to normal until most people are vaccinated,” and 33% said they have a chronic health condition such as asthma or diabetes and believe it’s important to receive a vaccine.
Among those who don’t plan to get a vaccine, 70% said they’re concerned about side effects. Another 42% are worried about getting the coronavirus from the vaccine. Others say they’re not concerned about getting seriously ill from the coronavirus, they don’t think vaccines work well, the COVID-19 outbreak isn’t serious, or they don’t like needles.
The National Institutes of Health says that safety is the top priority and is creating a plan to test the vaccine in thousands of people for safety and efficacy in coming months, according to the AP.
“I would not want people to think that we’re cutting corners because that would be a big mistake,” NIH director Francis Collins, MD, told AP earlier this month. “I think this is an effort to try to achieve efficiencies but not to sacrifice rigor.”
This article first appeared on WebMD.com.
About half of Americans say they would get a COVID-19 vaccine if one is available, according to the Associated Press.
The poll was conducted May 14-18 and released May 27.
A massive national and international effort is underway to develop a vaccine for the coronavirus. According to the poll, 20% of Americans believe a vaccine will be available before the end of 2020. Another 61% think it will arrive in 2021, and 17% say it will take longer.
“It’s always better to under-promise and over-deliver,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, told the AP.
Americans over age 60 were more likely to say they’ll get a coronavirus vaccine when it’s available. Those who worry that they or someone in their household could become infected with the virus were also more likely to say they’ll get a vaccine. However, Black Americans were more likely than were Hispanic or white responders to say that they don’t plan to get a vaccine.
Among those who plan to get a vaccine, 93% said they want to protect themselves, and 88% said they want to protect their family. About 72% said “life won’t go back to normal until most people are vaccinated,” and 33% said they have a chronic health condition such as asthma or diabetes and believe it’s important to receive a vaccine.
Among those who don’t plan to get a vaccine, 70% said they’re concerned about side effects. Another 42% are worried about getting the coronavirus from the vaccine. Others say they’re not concerned about getting seriously ill from the coronavirus, they don’t think vaccines work well, the COVID-19 outbreak isn’t serious, or they don’t like needles.
The National Institutes of Health says that safety is the top priority and is creating a plan to test the vaccine in thousands of people for safety and efficacy in coming months, according to the AP.
“I would not want people to think that we’re cutting corners because that would be a big mistake,” NIH director Francis Collins, MD, told AP earlier this month. “I think this is an effort to try to achieve efficiencies but not to sacrifice rigor.”
This article first appeared on WebMD.com.
About half of Americans say they would get a COVID-19 vaccine if one is available, according to the Associated Press.
The poll was conducted May 14-18 and released May 27.
A massive national and international effort is underway to develop a vaccine for the coronavirus. According to the poll, 20% of Americans believe a vaccine will be available before the end of 2020. Another 61% think it will arrive in 2021, and 17% say it will take longer.
“It’s always better to under-promise and over-deliver,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, told the AP.
Americans over age 60 were more likely to say they’ll get a coronavirus vaccine when it’s available. Those who worry that they or someone in their household could become infected with the virus were also more likely to say they’ll get a vaccine. However, Black Americans were more likely than were Hispanic or white responders to say that they don’t plan to get a vaccine.
Among those who plan to get a vaccine, 93% said they want to protect themselves, and 88% said they want to protect their family. About 72% said “life won’t go back to normal until most people are vaccinated,” and 33% said they have a chronic health condition such as asthma or diabetes and believe it’s important to receive a vaccine.
Among those who don’t plan to get a vaccine, 70% said they’re concerned about side effects. Another 42% are worried about getting the coronavirus from the vaccine. Others say they’re not concerned about getting seriously ill from the coronavirus, they don’t think vaccines work well, the COVID-19 outbreak isn’t serious, or they don’t like needles.
The National Institutes of Health says that safety is the top priority and is creating a plan to test the vaccine in thousands of people for safety and efficacy in coming months, according to the AP.
“I would not want people to think that we’re cutting corners because that would be a big mistake,” NIH director Francis Collins, MD, told AP earlier this month. “I think this is an effort to try to achieve efficiencies but not to sacrifice rigor.”
This article first appeared on WebMD.com.