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ACIP extends HPV vaccine coverage
according to a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
This change affects males aged 22 through 26 years; the HPV vaccine is currently recommended for males and females aged 11 or 12 years, with catch-up vaccination through age 21 for males and age 26 for females.
The change was supported in part by increased interest in simplifying and harmonizing the vaccine schedule, said Lauri Markowitz, MD, of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), who presented the HPV work group’s considerations.
In addition, the committee voted 10-4 in favor of catch-up HPV vaccination, based on shared clinical decision making, for all adults aged 27 through 45 years.
Although the current program of HPV vaccination for youth has demonstrated effectiveness, data from multiple models suggest that widespread HPV vaccination for adults older than 26 years is much less cost effective, and would yield relatively small additional health benefits, Dr. Markowitz said.
The HPV work group reviewed data from a range of clinical trials, epidemiology, and natural history, as well as results from five different health economic models. They concluded that an assessment of benefits and harms favors expanding the catch-up vaccination to all individuals through 26 years, said Elissa Meites, MD, of the CDC, who presented the official work group opinion. The group’s opinion on the second question was that the additional population level benefit of expanding HPV vaccination to all adults would be minimal and not a reasonable and effective allocation of resources, but that shared clinical decision making would allow flexibility.
The committee expressed strong opinions about the potential for shared clinical decision making as a policy for vaccination for adults older than 26 years. Some felt that this option was a way to include adults at risk for HPV, such as divorced women with new partners, or women getting married for the first time later in life who might not have been exposed to HPV through other relationships. In addition, supporters noted that the shared clinical decision-making option would allow for potential insurance coverage, and would involve discussion between doctors and patients to assess risk.
However, other committee members felt that any recommendation for older adult vaccination would distract clinicians from the importance and value of HPV vaccination for the target age group of 11- and 12-year-olds, and might divert resources from the younger age group in whom it has shown the most benefit.
Resource allocation was a concern voiced by many committee members. Kelly Moore, MD, MPH, of Vanderbilt University, Nashville, Tenn., said she voted no on expanding vaccination to older adults because “we didn’t have details on shared clinical decision making, in the absence of information on what that meant, and in the presence of supply questions, I didn’t feel comfortable expanding vaccination to a huge population,” she said.
Paul Hunter, MD, of the City of Milwaukee Health Department, also voted no, and expressed concern that expanding the HPV vaccination recommendations to older adults would send the message that vaccination for children and teens is not effective or important.
The text of the new recommendations for routine and catch-up vaccination states that the recommendations “also apply to MSM [men who have sex with men], transgender people, and people with immunocompromising conditions.”
The ACIP members had no financial conflicts to disclose.
according to a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
This change affects males aged 22 through 26 years; the HPV vaccine is currently recommended for males and females aged 11 or 12 years, with catch-up vaccination through age 21 for males and age 26 for females.
The change was supported in part by increased interest in simplifying and harmonizing the vaccine schedule, said Lauri Markowitz, MD, of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), who presented the HPV work group’s considerations.
In addition, the committee voted 10-4 in favor of catch-up HPV vaccination, based on shared clinical decision making, for all adults aged 27 through 45 years.
Although the current program of HPV vaccination for youth has demonstrated effectiveness, data from multiple models suggest that widespread HPV vaccination for adults older than 26 years is much less cost effective, and would yield relatively small additional health benefits, Dr. Markowitz said.
The HPV work group reviewed data from a range of clinical trials, epidemiology, and natural history, as well as results from five different health economic models. They concluded that an assessment of benefits and harms favors expanding the catch-up vaccination to all individuals through 26 years, said Elissa Meites, MD, of the CDC, who presented the official work group opinion. The group’s opinion on the second question was that the additional population level benefit of expanding HPV vaccination to all adults would be minimal and not a reasonable and effective allocation of resources, but that shared clinical decision making would allow flexibility.
The committee expressed strong opinions about the potential for shared clinical decision making as a policy for vaccination for adults older than 26 years. Some felt that this option was a way to include adults at risk for HPV, such as divorced women with new partners, or women getting married for the first time later in life who might not have been exposed to HPV through other relationships. In addition, supporters noted that the shared clinical decision-making option would allow for potential insurance coverage, and would involve discussion between doctors and patients to assess risk.
However, other committee members felt that any recommendation for older adult vaccination would distract clinicians from the importance and value of HPV vaccination for the target age group of 11- and 12-year-olds, and might divert resources from the younger age group in whom it has shown the most benefit.
Resource allocation was a concern voiced by many committee members. Kelly Moore, MD, MPH, of Vanderbilt University, Nashville, Tenn., said she voted no on expanding vaccination to older adults because “we didn’t have details on shared clinical decision making, in the absence of information on what that meant, and in the presence of supply questions, I didn’t feel comfortable expanding vaccination to a huge population,” she said.
Paul Hunter, MD, of the City of Milwaukee Health Department, also voted no, and expressed concern that expanding the HPV vaccination recommendations to older adults would send the message that vaccination for children and teens is not effective or important.
The text of the new recommendations for routine and catch-up vaccination states that the recommendations “also apply to MSM [men who have sex with men], transgender people, and people with immunocompromising conditions.”
The ACIP members had no financial conflicts to disclose.
according to a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
This change affects males aged 22 through 26 years; the HPV vaccine is currently recommended for males and females aged 11 or 12 years, with catch-up vaccination through age 21 for males and age 26 for females.
The change was supported in part by increased interest in simplifying and harmonizing the vaccine schedule, said Lauri Markowitz, MD, of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), who presented the HPV work group’s considerations.
In addition, the committee voted 10-4 in favor of catch-up HPV vaccination, based on shared clinical decision making, for all adults aged 27 through 45 years.
Although the current program of HPV vaccination for youth has demonstrated effectiveness, data from multiple models suggest that widespread HPV vaccination for adults older than 26 years is much less cost effective, and would yield relatively small additional health benefits, Dr. Markowitz said.
The HPV work group reviewed data from a range of clinical trials, epidemiology, and natural history, as well as results from five different health economic models. They concluded that an assessment of benefits and harms favors expanding the catch-up vaccination to all individuals through 26 years, said Elissa Meites, MD, of the CDC, who presented the official work group opinion. The group’s opinion on the second question was that the additional population level benefit of expanding HPV vaccination to all adults would be minimal and not a reasonable and effective allocation of resources, but that shared clinical decision making would allow flexibility.
The committee expressed strong opinions about the potential for shared clinical decision making as a policy for vaccination for adults older than 26 years. Some felt that this option was a way to include adults at risk for HPV, such as divorced women with new partners, or women getting married for the first time later in life who might not have been exposed to HPV through other relationships. In addition, supporters noted that the shared clinical decision-making option would allow for potential insurance coverage, and would involve discussion between doctors and patients to assess risk.
However, other committee members felt that any recommendation for older adult vaccination would distract clinicians from the importance and value of HPV vaccination for the target age group of 11- and 12-year-olds, and might divert resources from the younger age group in whom it has shown the most benefit.
Resource allocation was a concern voiced by many committee members. Kelly Moore, MD, MPH, of Vanderbilt University, Nashville, Tenn., said she voted no on expanding vaccination to older adults because “we didn’t have details on shared clinical decision making, in the absence of information on what that meant, and in the presence of supply questions, I didn’t feel comfortable expanding vaccination to a huge population,” she said.
Paul Hunter, MD, of the City of Milwaukee Health Department, also voted no, and expressed concern that expanding the HPV vaccination recommendations to older adults would send the message that vaccination for children and teens is not effective or important.
The text of the new recommendations for routine and catch-up vaccination states that the recommendations “also apply to MSM [men who have sex with men], transgender people, and people with immunocompromising conditions.”
The ACIP members had no financial conflicts to disclose.
REPORTING FROM AN ACIP MEETING
Substantial reductions in HPV infections, CIN2+ after vaccination
The introduction of the human papillomavirus according to a meta-analysis of data from more than 60 million individuals worldwide.
Mélanie Drolet, PhD, from the Centre de recherche du CHU de Québec–Université Laval, and coauthors of the HPV Vaccination Impact Study Group reported the results of a systematic review and meta-analysis of 65 studies showing pre- and postvaccination frequency of at least one HPV-related endpoint published in the Lancet. The studies were conducted in 14 high-income countries, 12 of which were vaccinating only women and girls, with the results at 5-8 years published in the Lancet.
At 5-8 years after a vaccination program was implemented, there was a significant 83% reduction in the prevalence of HPV 16 and 18, both of which are targeted by the vaccine, among girls aged 13-19 years; a 66% reduction among women aged 20-24 years; and a 37% reduction in women aged 25-29 years, even though most of these women were unvaccinated.
There also were significant decreases at 5-8 years in the prevalence of HPV subtypes 31, 33, and 45, which are not included in the vaccine but against which the vaccine appears to offer cross-protection. Among girls aged 13-19 years, there was a significant 54% reduction in the prevalence of these subtypes, among women aged 20-24 years there was a nonsignificant 28% decrease, but among women aged 25-29 years, there was no significant decrease.
The analysis also found significant declines in the prevalence of cervical intraepithelial neoplasias (CINs) of grade 2 or above. At 5-9 years after vaccination was introduced, CIN2+ decreased by 51% among girls aged 15-19 years who also were screened for cervical cancer, and by 31% among women aged 20-24 years.
However, over the same time period, the rates of CIN2+ increased by a significant 19% among mostly unvaccinated women aged 25-29 years and 23% among mostly unvaccinated women aged 30-39 years, despite both groups being screened for cervical abnormalities.
While most of the countries in the study vaccinated only girls and women, two studies did find nonsignificant decreases in the prevalence of HPV 16, 18, 31, 33, and 45 among boys aged 16-19 years, but not among men aged 20-24 years.
HPV vaccination also was associated with significant declines in the incidence of anogenital warts among both males and females. In the first 4 years alone, vaccination was associated with significant reductions in anogenital wart diagnoses among females aged 15-29 years, as well as nonsignificant but “substantial” reductions in unvaccinated boys aged 15-19 years.
After 5-8 years, anogenital wart diagnoses decreased by 67% among girls aged 15-19 years, significantly by 54% among women aged 20-24 years, and 31% among women aged 25-29 years – all significant changes. Among boys aged 15-19 years, anogenital wart diagnoses decreased by a significant 48%, and among men aged 20-24 years they decreased by a significant 32%.
The decreases in anogenital wart diagnoses were even greater in countries that implemented vaccination among multiple cohorts simultaneously and achieved high vaccination coverage, compared with countries that vaccinated only one cohort at a time or had low routine vaccination coverage.
“Our study is the first to show the real-world additional benefit of multicohort HPV vaccination and high routine vaccination coverage, and the fast and substantial herd effects of vaccination in countries which implement these measures,” wrote Dr. Drolet and coauthors. “The greater impact of multicohort vaccination was similar when restricting the analyses to countries with high routine vaccination coverage.”
They pointed to the World Health Organization’s recently revised position on HPV vaccination, which now recommends vaccination of multiple cohorts of girls aged 9-14 years, although they raised the question of what might be the optimal number of age cohorts. “Number needed to vaccinate and cost-effectiveness analyses in high-income countries suggest that vaccinating multiple cohorts of individuals up to 18 years of age is highly efficient and cost effective.”
This analysis by Drolet et al. “provides compelling evidence for HPV vaccine efficacy on all outcomes explored and for almost all age strata,” Dr. Silvia de Sanjose, of PATH in Seattle, and Dr. Sinead Delany-Moretlwe of the Wits Reproductive Health and HIV Institute at the University of Witwatersrand in Johannesburg, said in an accompanying editorial (Lancet. 2019 Jun 26. doi: 10.1016/ S0140-6736[19]30549-5). This study shows just how effective HPV vaccination can be across a range of outcomes and ages, and also demonstrates the herd immunity benefits, particularly when multiple cohorts are vaccinated and there is high vaccination coverage.
One key limitation of this analysis is the lack of data from low- and middle-income countries. The data by Drolet et al. “emphasise the importance of redoubling our efforts to tackle the fiscal, supply, and programmatic barriers that currently limit HPV vaccine programmes; with these efforts, HPV vaccination could become a hallmark investment of cancer prevention in the 21st century,” Dr. de Sanjose and Dr. Delany-Moretlwe concluded.
The study was funded by WHO, Canadian Institutes of Health Research, and Fonds de recherche du Québec–Santé. No conflicts of interest were declared.
Dr. de Sanjose declared previous institutional support from Merck.
SOURCE: Drolet M et al. Lancet 2019 Jun 26. doi: 10.1016/ S0140-6736(19)30298-3.
The introduction of the human papillomavirus according to a meta-analysis of data from more than 60 million individuals worldwide.
Mélanie Drolet, PhD, from the Centre de recherche du CHU de Québec–Université Laval, and coauthors of the HPV Vaccination Impact Study Group reported the results of a systematic review and meta-analysis of 65 studies showing pre- and postvaccination frequency of at least one HPV-related endpoint published in the Lancet. The studies were conducted in 14 high-income countries, 12 of which were vaccinating only women and girls, with the results at 5-8 years published in the Lancet.
At 5-8 years after a vaccination program was implemented, there was a significant 83% reduction in the prevalence of HPV 16 and 18, both of which are targeted by the vaccine, among girls aged 13-19 years; a 66% reduction among women aged 20-24 years; and a 37% reduction in women aged 25-29 years, even though most of these women were unvaccinated.
There also were significant decreases at 5-8 years in the prevalence of HPV subtypes 31, 33, and 45, which are not included in the vaccine but against which the vaccine appears to offer cross-protection. Among girls aged 13-19 years, there was a significant 54% reduction in the prevalence of these subtypes, among women aged 20-24 years there was a nonsignificant 28% decrease, but among women aged 25-29 years, there was no significant decrease.
The analysis also found significant declines in the prevalence of cervical intraepithelial neoplasias (CINs) of grade 2 or above. At 5-9 years after vaccination was introduced, CIN2+ decreased by 51% among girls aged 15-19 years who also were screened for cervical cancer, and by 31% among women aged 20-24 years.
However, over the same time period, the rates of CIN2+ increased by a significant 19% among mostly unvaccinated women aged 25-29 years and 23% among mostly unvaccinated women aged 30-39 years, despite both groups being screened for cervical abnormalities.
While most of the countries in the study vaccinated only girls and women, two studies did find nonsignificant decreases in the prevalence of HPV 16, 18, 31, 33, and 45 among boys aged 16-19 years, but not among men aged 20-24 years.
HPV vaccination also was associated with significant declines in the incidence of anogenital warts among both males and females. In the first 4 years alone, vaccination was associated with significant reductions in anogenital wart diagnoses among females aged 15-29 years, as well as nonsignificant but “substantial” reductions in unvaccinated boys aged 15-19 years.
After 5-8 years, anogenital wart diagnoses decreased by 67% among girls aged 15-19 years, significantly by 54% among women aged 20-24 years, and 31% among women aged 25-29 years – all significant changes. Among boys aged 15-19 years, anogenital wart diagnoses decreased by a significant 48%, and among men aged 20-24 years they decreased by a significant 32%.
The decreases in anogenital wart diagnoses were even greater in countries that implemented vaccination among multiple cohorts simultaneously and achieved high vaccination coverage, compared with countries that vaccinated only one cohort at a time or had low routine vaccination coverage.
“Our study is the first to show the real-world additional benefit of multicohort HPV vaccination and high routine vaccination coverage, and the fast and substantial herd effects of vaccination in countries which implement these measures,” wrote Dr. Drolet and coauthors. “The greater impact of multicohort vaccination was similar when restricting the analyses to countries with high routine vaccination coverage.”
They pointed to the World Health Organization’s recently revised position on HPV vaccination, which now recommends vaccination of multiple cohorts of girls aged 9-14 years, although they raised the question of what might be the optimal number of age cohorts. “Number needed to vaccinate and cost-effectiveness analyses in high-income countries suggest that vaccinating multiple cohorts of individuals up to 18 years of age is highly efficient and cost effective.”
This analysis by Drolet et al. “provides compelling evidence for HPV vaccine efficacy on all outcomes explored and for almost all age strata,” Dr. Silvia de Sanjose, of PATH in Seattle, and Dr. Sinead Delany-Moretlwe of the Wits Reproductive Health and HIV Institute at the University of Witwatersrand in Johannesburg, said in an accompanying editorial (Lancet. 2019 Jun 26. doi: 10.1016/ S0140-6736[19]30549-5). This study shows just how effective HPV vaccination can be across a range of outcomes and ages, and also demonstrates the herd immunity benefits, particularly when multiple cohorts are vaccinated and there is high vaccination coverage.
One key limitation of this analysis is the lack of data from low- and middle-income countries. The data by Drolet et al. “emphasise the importance of redoubling our efforts to tackle the fiscal, supply, and programmatic barriers that currently limit HPV vaccine programmes; with these efforts, HPV vaccination could become a hallmark investment of cancer prevention in the 21st century,” Dr. de Sanjose and Dr. Delany-Moretlwe concluded.
The study was funded by WHO, Canadian Institutes of Health Research, and Fonds de recherche du Québec–Santé. No conflicts of interest were declared.
Dr. de Sanjose declared previous institutional support from Merck.
SOURCE: Drolet M et al. Lancet 2019 Jun 26. doi: 10.1016/ S0140-6736(19)30298-3.
The introduction of the human papillomavirus according to a meta-analysis of data from more than 60 million individuals worldwide.
Mélanie Drolet, PhD, from the Centre de recherche du CHU de Québec–Université Laval, and coauthors of the HPV Vaccination Impact Study Group reported the results of a systematic review and meta-analysis of 65 studies showing pre- and postvaccination frequency of at least one HPV-related endpoint published in the Lancet. The studies were conducted in 14 high-income countries, 12 of which were vaccinating only women and girls, with the results at 5-8 years published in the Lancet.
At 5-8 years after a vaccination program was implemented, there was a significant 83% reduction in the prevalence of HPV 16 and 18, both of which are targeted by the vaccine, among girls aged 13-19 years; a 66% reduction among women aged 20-24 years; and a 37% reduction in women aged 25-29 years, even though most of these women were unvaccinated.
There also were significant decreases at 5-8 years in the prevalence of HPV subtypes 31, 33, and 45, which are not included in the vaccine but against which the vaccine appears to offer cross-protection. Among girls aged 13-19 years, there was a significant 54% reduction in the prevalence of these subtypes, among women aged 20-24 years there was a nonsignificant 28% decrease, but among women aged 25-29 years, there was no significant decrease.
The analysis also found significant declines in the prevalence of cervical intraepithelial neoplasias (CINs) of grade 2 or above. At 5-9 years after vaccination was introduced, CIN2+ decreased by 51% among girls aged 15-19 years who also were screened for cervical cancer, and by 31% among women aged 20-24 years.
However, over the same time period, the rates of CIN2+ increased by a significant 19% among mostly unvaccinated women aged 25-29 years and 23% among mostly unvaccinated women aged 30-39 years, despite both groups being screened for cervical abnormalities.
While most of the countries in the study vaccinated only girls and women, two studies did find nonsignificant decreases in the prevalence of HPV 16, 18, 31, 33, and 45 among boys aged 16-19 years, but not among men aged 20-24 years.
HPV vaccination also was associated with significant declines in the incidence of anogenital warts among both males and females. In the first 4 years alone, vaccination was associated with significant reductions in anogenital wart diagnoses among females aged 15-29 years, as well as nonsignificant but “substantial” reductions in unvaccinated boys aged 15-19 years.
After 5-8 years, anogenital wart diagnoses decreased by 67% among girls aged 15-19 years, significantly by 54% among women aged 20-24 years, and 31% among women aged 25-29 years – all significant changes. Among boys aged 15-19 years, anogenital wart diagnoses decreased by a significant 48%, and among men aged 20-24 years they decreased by a significant 32%.
The decreases in anogenital wart diagnoses were even greater in countries that implemented vaccination among multiple cohorts simultaneously and achieved high vaccination coverage, compared with countries that vaccinated only one cohort at a time or had low routine vaccination coverage.
“Our study is the first to show the real-world additional benefit of multicohort HPV vaccination and high routine vaccination coverage, and the fast and substantial herd effects of vaccination in countries which implement these measures,” wrote Dr. Drolet and coauthors. “The greater impact of multicohort vaccination was similar when restricting the analyses to countries with high routine vaccination coverage.”
They pointed to the World Health Organization’s recently revised position on HPV vaccination, which now recommends vaccination of multiple cohorts of girls aged 9-14 years, although they raised the question of what might be the optimal number of age cohorts. “Number needed to vaccinate and cost-effectiveness analyses in high-income countries suggest that vaccinating multiple cohorts of individuals up to 18 years of age is highly efficient and cost effective.”
This analysis by Drolet et al. “provides compelling evidence for HPV vaccine efficacy on all outcomes explored and for almost all age strata,” Dr. Silvia de Sanjose, of PATH in Seattle, and Dr. Sinead Delany-Moretlwe of the Wits Reproductive Health and HIV Institute at the University of Witwatersrand in Johannesburg, said in an accompanying editorial (Lancet. 2019 Jun 26. doi: 10.1016/ S0140-6736[19]30549-5). This study shows just how effective HPV vaccination can be across a range of outcomes and ages, and also demonstrates the herd immunity benefits, particularly when multiple cohorts are vaccinated and there is high vaccination coverage.
One key limitation of this analysis is the lack of data from low- and middle-income countries. The data by Drolet et al. “emphasise the importance of redoubling our efforts to tackle the fiscal, supply, and programmatic barriers that currently limit HPV vaccine programmes; with these efforts, HPV vaccination could become a hallmark investment of cancer prevention in the 21st century,” Dr. de Sanjose and Dr. Delany-Moretlwe concluded.
The study was funded by WHO, Canadian Institutes of Health Research, and Fonds de recherche du Québec–Santé. No conflicts of interest were declared.
Dr. de Sanjose declared previous institutional support from Merck.
SOURCE: Drolet M et al. Lancet 2019 Jun 26. doi: 10.1016/ S0140-6736(19)30298-3.
FROM THE LANCET
Key clinical point: Significant declines in HPV infections, CIN2+, and anogenital warts have occurred after the introduction of HPV vaccine programs, some because of herd effects.
Major finding: The HPV vaccination program is associated with a significant 83% reduction in the prevalence of HPV 16 and 18 among girls aged 13-19 years in 14 high-income countries.
Study details: Systematic review and meta-analysis of 65 studies involving more than 60 million individuals in 14 countries.
Disclosures: The study was funded by World Health Organization, Canadian Institutes of Health Research, and Fonds de recherche du Québec – Santé. No conflicts of interest were declared.
Source: Drolet M et al. Lancet 2019 Jun 26. doi: 10.1016/ S0140-6736(19)30298-3.
Almost half of Americans express doubts about vaccines
according to the American Osteopathic Association.
In a survey conducted by the Harris Poll on behalf of the AOA, 45% of the 2,007 respondents expressed a negative attitude towards vaccine safety, with online articles (16%) and past secrets/wrongdoings by the pharmaceutical industry (16%) cited as the leading causes, the AOA said.
There was no difference in negative attitude between men and women, but age, region, and parental status each had a notable effect. Doubts of vaccine safety were highest in those aged 18-34 years (55%) and lowest in those aged 65 and older (29%). Those living in the West had the highest rate at 50%, while residents of the Midwest were lowest at 39%, and the negative attitude rate was 55% for adults who had children under age 18 years and 40% for those who did not, the AOA reported.
Respondents to the survey, conducted May 28-30, 2019, also were asked to choose one of five statements that best expressed their view of vaccines, and those data paint a somewhat different picture:
- 2% said vaccines are unsafe and ineffective.
- 6% said that the side-effect risks outweigh the benefits.
- 9% said they were not sure if vaccines are safe and effective.
- 31% said that the benefits outweigh the risks.
- 51% said that vaccines are safe and effective.
Social media were another important source of doubt among respondents, but they have not been effective at countering the spread of vaccine misinformation, said psychiatrist Rachel Shmuts, DO, of Cherry Hill, N.J.
Confirmation bias makes it difficult to convince someone vaccines are safe, effective, and necessary once they believe they are not. “The number of people who believe vaccines are dangerous and refuse to get them is still relatively small. However, online support groups seem to solidify their beliefs, making them less susceptible to influence from their neighbors and real-world communities,” she said in the AOA statement.
Osteopathic family physician Paul Ehrmann, DO, said in the statement, “People know that a lot of practices won’t accept patients who don’t vaccinate, so when they find one that will, they spread the word to their community that it’s a safe place. Whether intentional or not, those doctors are often seen as endorsing anti-vaxxer beliefs.”
In 2017, his home state of Michigan, with other partners, put on a public information campaign. It has “significantly improved vaccination rates across demographics,” according to the statement.
“Beliefs are hard to change especially when they’re based in fear,” Dr. Ehrmann, of Royal Oak, Mich., said in the statement. “But, being responsible for our patients’ health and the public’s health, we can’t afford to give in to those fears. We must insist on evidence-based medicine.”
according to the American Osteopathic Association.
In a survey conducted by the Harris Poll on behalf of the AOA, 45% of the 2,007 respondents expressed a negative attitude towards vaccine safety, with online articles (16%) and past secrets/wrongdoings by the pharmaceutical industry (16%) cited as the leading causes, the AOA said.
There was no difference in negative attitude between men and women, but age, region, and parental status each had a notable effect. Doubts of vaccine safety were highest in those aged 18-34 years (55%) and lowest in those aged 65 and older (29%). Those living in the West had the highest rate at 50%, while residents of the Midwest were lowest at 39%, and the negative attitude rate was 55% for adults who had children under age 18 years and 40% for those who did not, the AOA reported.
Respondents to the survey, conducted May 28-30, 2019, also were asked to choose one of five statements that best expressed their view of vaccines, and those data paint a somewhat different picture:
- 2% said vaccines are unsafe and ineffective.
- 6% said that the side-effect risks outweigh the benefits.
- 9% said they were not sure if vaccines are safe and effective.
- 31% said that the benefits outweigh the risks.
- 51% said that vaccines are safe and effective.
Social media were another important source of doubt among respondents, but they have not been effective at countering the spread of vaccine misinformation, said psychiatrist Rachel Shmuts, DO, of Cherry Hill, N.J.
Confirmation bias makes it difficult to convince someone vaccines are safe, effective, and necessary once they believe they are not. “The number of people who believe vaccines are dangerous and refuse to get them is still relatively small. However, online support groups seem to solidify their beliefs, making them less susceptible to influence from their neighbors and real-world communities,” she said in the AOA statement.
Osteopathic family physician Paul Ehrmann, DO, said in the statement, “People know that a lot of practices won’t accept patients who don’t vaccinate, so when they find one that will, they spread the word to their community that it’s a safe place. Whether intentional or not, those doctors are often seen as endorsing anti-vaxxer beliefs.”
In 2017, his home state of Michigan, with other partners, put on a public information campaign. It has “significantly improved vaccination rates across demographics,” according to the statement.
“Beliefs are hard to change especially when they’re based in fear,” Dr. Ehrmann, of Royal Oak, Mich., said in the statement. “But, being responsible for our patients’ health and the public’s health, we can’t afford to give in to those fears. We must insist on evidence-based medicine.”
according to the American Osteopathic Association.
In a survey conducted by the Harris Poll on behalf of the AOA, 45% of the 2,007 respondents expressed a negative attitude towards vaccine safety, with online articles (16%) and past secrets/wrongdoings by the pharmaceutical industry (16%) cited as the leading causes, the AOA said.
There was no difference in negative attitude between men and women, but age, region, and parental status each had a notable effect. Doubts of vaccine safety were highest in those aged 18-34 years (55%) and lowest in those aged 65 and older (29%). Those living in the West had the highest rate at 50%, while residents of the Midwest were lowest at 39%, and the negative attitude rate was 55% for adults who had children under age 18 years and 40% for those who did not, the AOA reported.
Respondents to the survey, conducted May 28-30, 2019, also were asked to choose one of five statements that best expressed their view of vaccines, and those data paint a somewhat different picture:
- 2% said vaccines are unsafe and ineffective.
- 6% said that the side-effect risks outweigh the benefits.
- 9% said they were not sure if vaccines are safe and effective.
- 31% said that the benefits outweigh the risks.
- 51% said that vaccines are safe and effective.
Social media were another important source of doubt among respondents, but they have not been effective at countering the spread of vaccine misinformation, said psychiatrist Rachel Shmuts, DO, of Cherry Hill, N.J.
Confirmation bias makes it difficult to convince someone vaccines are safe, effective, and necessary once they believe they are not. “The number of people who believe vaccines are dangerous and refuse to get them is still relatively small. However, online support groups seem to solidify their beliefs, making them less susceptible to influence from their neighbors and real-world communities,” she said in the AOA statement.
Osteopathic family physician Paul Ehrmann, DO, said in the statement, “People know that a lot of practices won’t accept patients who don’t vaccinate, so when they find one that will, they spread the word to their community that it’s a safe place. Whether intentional or not, those doctors are often seen as endorsing anti-vaxxer beliefs.”
In 2017, his home state of Michigan, with other partners, put on a public information campaign. It has “significantly improved vaccination rates across demographics,” according to the statement.
“Beliefs are hard to change especially when they’re based in fear,” Dr. Ehrmann, of Royal Oak, Mich., said in the statement. “But, being responsible for our patients’ health and the public’s health, we can’t afford to give in to those fears. We must insist on evidence-based medicine.”
Measles incidence has slowed as summer begins
There were 33 new measles cases reported last week, bringing the U.S. total to 1,077 for the year through June 20, according to the Centers for Disease Control and Prevention.
The number of new cases is an increase from the 22 reported the week before, but weekly incidence has been trending downward since hitting a high of 90 in mid-April, CDC data show.
The two continuing outbreaks in New York State made up more than half of the new cases, as Rockland County reported nine cases and New York City reported eight (seven in Brooklyn and one in Queens). Only one new case was reported in California as of the CDC’s June 20 cutoff, but the Los Angeles County Department of Public Health said on June 22 that it was assessing two possible cases, with potential public exposures occurring in a theater and a restaurant.
In a survey conducted in April, a majority of physicians with experience treating measles said that summer travel would lead to increased measles outbreaks and deaths.
There were 33 new measles cases reported last week, bringing the U.S. total to 1,077 for the year through June 20, according to the Centers for Disease Control and Prevention.
The number of new cases is an increase from the 22 reported the week before, but weekly incidence has been trending downward since hitting a high of 90 in mid-April, CDC data show.
The two continuing outbreaks in New York State made up more than half of the new cases, as Rockland County reported nine cases and New York City reported eight (seven in Brooklyn and one in Queens). Only one new case was reported in California as of the CDC’s June 20 cutoff, but the Los Angeles County Department of Public Health said on June 22 that it was assessing two possible cases, with potential public exposures occurring in a theater and a restaurant.
In a survey conducted in April, a majority of physicians with experience treating measles said that summer travel would lead to increased measles outbreaks and deaths.
There were 33 new measles cases reported last week, bringing the U.S. total to 1,077 for the year through June 20, according to the Centers for Disease Control and Prevention.
The number of new cases is an increase from the 22 reported the week before, but weekly incidence has been trending downward since hitting a high of 90 in mid-April, CDC data show.
The two continuing outbreaks in New York State made up more than half of the new cases, as Rockland County reported nine cases and New York City reported eight (seven in Brooklyn and one in Queens). Only one new case was reported in California as of the CDC’s June 20 cutoff, but the Los Angeles County Department of Public Health said on June 22 that it was assessing two possible cases, with potential public exposures occurring in a theater and a restaurant.
In a survey conducted in April, a majority of physicians with experience treating measles said that summer travel would lead to increased measles outbreaks and deaths.
U.S. travelers to Europe need up to date measles immunization
researchers at the Centers for Disease Control and Prevention recommend in a Pediatrics special report.
More than 41,000 measles cases and 37 deaths – primarily due to low immunization coverage – were reported in the World Health Organization European Region in the first 6 months of 2018, the highest incidence since the 1990s. Typical case counts since 2010 have ranged from 5,000 to 24,000 in this region, wrote Kristina M. Angelo, DO, MPH, of the Centers for Disease Control and Prevention Travelers’ Health Branch in Atlanta, and associates.
France, Italy and Greece – all particularly popular countries for U.S. vacationers to visit – have particularly high numbers of cases, as do Georgia, Russia, Serbia and, comprising the majority of cases, Ukraine. Italy, for example, is the 10th most popular destination worldwide for Americans, with an estimated 2.5 million American visitors in 2015.
“The large number of measles infections in the WHO European Region ... is a global concern because the European continent is the most common travel destination worldwide,” but is not perceived as a place with infectious disease risk. So travelers may not consider the need of a pretravel health consultation, including vaccination, they said.
But they need to, Dr. Angelo and associates state, and health care providers should be vigilant about checking for symptoms of measles among those who have recently returned from overseas. Given how highly contagious measles is, unvaccinated and under vaccinated travelers to Europe are susceptible to infection, as are any people they encounter back in the United States if the travelers come home sick.
Measles was eliminated in the United States in 2000, but that status is in jeopardy, CDC officials recently warned. The number of domestic measles cases has exceeded 1,000 just halfway through 2019, the highest count since 1992, nearly a decade before elimination.
“Avoiding international travel with nonimmune infants and performing early vaccination at 6 to 12 months of age per the ACIP [Advisory Committee on Immunization Practices] recommendations if travel is unavoidable are of utmost importance,” Dr. Angelo and colleagues advised. “Other at-risk populations (e.g., immunocompromised individuals and pregnant women), for whom vaccination against the measles virus is contraindicated, may consider alternative destinations or delay travel to measles-endemic destinations or areas with known, ongoing measles outbreaks.”
“Presumptive immunity to measles is defined as 1 or more of the following: birth before 1957, laboratory evidence of immunity or infection, 1 or more doses of a measles containing vaccine administered for preschool-aged children and low-risk adults, or 2 doses of measles vaccine among school-aged children and high-risk adults, including international travelers,” they explained.
In Europe, measles remains endemic in Belgium, Bosnia and Herzegovina, France, Georgia, Germany, Italy, Romania, the Russian Federation, Serbia and the Ukraine, the authors wrote.
“As long as measles remains endemic in other countries, the United States will be challenged by measles importations,” the authors wrote. Yet at least one past study in 2017 revealed a third of U.S. travelers to Europe left the country without being fully vaccinated against measles, most often due to vaccine refusal.
“The reason one-third of travelers to Europe missed an opportunity for measles vaccination remains unclear,” the authors wrote. “It may represent a lack of concern or awareness on the part of travelers and the health care providers about acquiring measles in Europe.”
Dr. Angelo and colleagues also emphasized the importance of returning U.S. travelers seeking health care if they have symptoms of measles, including fever and a rash.
Health care providers should ask all patients about recent international travel, they stated. “If measles is suspected, health care providers should isolate travelers immediately, placing them on airborne precautions until day 4 of the rash.” Providers may consider administering immunoglobulin for unvaccinated and undervaccinated travelers and monitor them for 21 days for development of measles symptoms.
The statement was funded by the CDC. The authors reported no relevant financial disclosures.
SOURCE: Angelo KM et al. Pediatrics. 2019 Jun 17. doi: /10.1542/peds.2019-0414.
researchers at the Centers for Disease Control and Prevention recommend in a Pediatrics special report.
More than 41,000 measles cases and 37 deaths – primarily due to low immunization coverage – were reported in the World Health Organization European Region in the first 6 months of 2018, the highest incidence since the 1990s. Typical case counts since 2010 have ranged from 5,000 to 24,000 in this region, wrote Kristina M. Angelo, DO, MPH, of the Centers for Disease Control and Prevention Travelers’ Health Branch in Atlanta, and associates.
France, Italy and Greece – all particularly popular countries for U.S. vacationers to visit – have particularly high numbers of cases, as do Georgia, Russia, Serbia and, comprising the majority of cases, Ukraine. Italy, for example, is the 10th most popular destination worldwide for Americans, with an estimated 2.5 million American visitors in 2015.
“The large number of measles infections in the WHO European Region ... is a global concern because the European continent is the most common travel destination worldwide,” but is not perceived as a place with infectious disease risk. So travelers may not consider the need of a pretravel health consultation, including vaccination, they said.
But they need to, Dr. Angelo and associates state, and health care providers should be vigilant about checking for symptoms of measles among those who have recently returned from overseas. Given how highly contagious measles is, unvaccinated and under vaccinated travelers to Europe are susceptible to infection, as are any people they encounter back in the United States if the travelers come home sick.
Measles was eliminated in the United States in 2000, but that status is in jeopardy, CDC officials recently warned. The number of domestic measles cases has exceeded 1,000 just halfway through 2019, the highest count since 1992, nearly a decade before elimination.
“Avoiding international travel with nonimmune infants and performing early vaccination at 6 to 12 months of age per the ACIP [Advisory Committee on Immunization Practices] recommendations if travel is unavoidable are of utmost importance,” Dr. Angelo and colleagues advised. “Other at-risk populations (e.g., immunocompromised individuals and pregnant women), for whom vaccination against the measles virus is contraindicated, may consider alternative destinations or delay travel to measles-endemic destinations or areas with known, ongoing measles outbreaks.”
“Presumptive immunity to measles is defined as 1 or more of the following: birth before 1957, laboratory evidence of immunity or infection, 1 or more doses of a measles containing vaccine administered for preschool-aged children and low-risk adults, or 2 doses of measles vaccine among school-aged children and high-risk adults, including international travelers,” they explained.
In Europe, measles remains endemic in Belgium, Bosnia and Herzegovina, France, Georgia, Germany, Italy, Romania, the Russian Federation, Serbia and the Ukraine, the authors wrote.
“As long as measles remains endemic in other countries, the United States will be challenged by measles importations,” the authors wrote. Yet at least one past study in 2017 revealed a third of U.S. travelers to Europe left the country without being fully vaccinated against measles, most often due to vaccine refusal.
“The reason one-third of travelers to Europe missed an opportunity for measles vaccination remains unclear,” the authors wrote. “It may represent a lack of concern or awareness on the part of travelers and the health care providers about acquiring measles in Europe.”
Dr. Angelo and colleagues also emphasized the importance of returning U.S. travelers seeking health care if they have symptoms of measles, including fever and a rash.
Health care providers should ask all patients about recent international travel, they stated. “If measles is suspected, health care providers should isolate travelers immediately, placing them on airborne precautions until day 4 of the rash.” Providers may consider administering immunoglobulin for unvaccinated and undervaccinated travelers and monitor them for 21 days for development of measles symptoms.
The statement was funded by the CDC. The authors reported no relevant financial disclosures.
SOURCE: Angelo KM et al. Pediatrics. 2019 Jun 17. doi: /10.1542/peds.2019-0414.
researchers at the Centers for Disease Control and Prevention recommend in a Pediatrics special report.
More than 41,000 measles cases and 37 deaths – primarily due to low immunization coverage – were reported in the World Health Organization European Region in the first 6 months of 2018, the highest incidence since the 1990s. Typical case counts since 2010 have ranged from 5,000 to 24,000 in this region, wrote Kristina M. Angelo, DO, MPH, of the Centers for Disease Control and Prevention Travelers’ Health Branch in Atlanta, and associates.
France, Italy and Greece – all particularly popular countries for U.S. vacationers to visit – have particularly high numbers of cases, as do Georgia, Russia, Serbia and, comprising the majority of cases, Ukraine. Italy, for example, is the 10th most popular destination worldwide for Americans, with an estimated 2.5 million American visitors in 2015.
“The large number of measles infections in the WHO European Region ... is a global concern because the European continent is the most common travel destination worldwide,” but is not perceived as a place with infectious disease risk. So travelers may not consider the need of a pretravel health consultation, including vaccination, they said.
But they need to, Dr. Angelo and associates state, and health care providers should be vigilant about checking for symptoms of measles among those who have recently returned from overseas. Given how highly contagious measles is, unvaccinated and under vaccinated travelers to Europe are susceptible to infection, as are any people they encounter back in the United States if the travelers come home sick.
Measles was eliminated in the United States in 2000, but that status is in jeopardy, CDC officials recently warned. The number of domestic measles cases has exceeded 1,000 just halfway through 2019, the highest count since 1992, nearly a decade before elimination.
“Avoiding international travel with nonimmune infants and performing early vaccination at 6 to 12 months of age per the ACIP [Advisory Committee on Immunization Practices] recommendations if travel is unavoidable are of utmost importance,” Dr. Angelo and colleagues advised. “Other at-risk populations (e.g., immunocompromised individuals and pregnant women), for whom vaccination against the measles virus is contraindicated, may consider alternative destinations or delay travel to measles-endemic destinations or areas with known, ongoing measles outbreaks.”
“Presumptive immunity to measles is defined as 1 or more of the following: birth before 1957, laboratory evidence of immunity or infection, 1 or more doses of a measles containing vaccine administered for preschool-aged children and low-risk adults, or 2 doses of measles vaccine among school-aged children and high-risk adults, including international travelers,” they explained.
In Europe, measles remains endemic in Belgium, Bosnia and Herzegovina, France, Georgia, Germany, Italy, Romania, the Russian Federation, Serbia and the Ukraine, the authors wrote.
“As long as measles remains endemic in other countries, the United States will be challenged by measles importations,” the authors wrote. Yet at least one past study in 2017 revealed a third of U.S. travelers to Europe left the country without being fully vaccinated against measles, most often due to vaccine refusal.
“The reason one-third of travelers to Europe missed an opportunity for measles vaccination remains unclear,” the authors wrote. “It may represent a lack of concern or awareness on the part of travelers and the health care providers about acquiring measles in Europe.”
Dr. Angelo and colleagues also emphasized the importance of returning U.S. travelers seeking health care if they have symptoms of measles, including fever and a rash.
Health care providers should ask all patients about recent international travel, they stated. “If measles is suspected, health care providers should isolate travelers immediately, placing them on airborne precautions until day 4 of the rash.” Providers may consider administering immunoglobulin for unvaccinated and undervaccinated travelers and monitor them for 21 days for development of measles symptoms.
The statement was funded by the CDC. The authors reported no relevant financial disclosures.
SOURCE: Angelo KM et al. Pediatrics. 2019 Jun 17. doi: /10.1542/peds.2019-0414.
FROM PEDIATRICS
Booster vaccines found largely safe in children on immunosuppressive drugs
MADRID – Administration of live attenuated booster of the MMR vaccine with or without varicella (MMR/V) was not associated with serious adverse events in children on immunosuppressive therapy for a rheumatic disease, according to data presented at the European Congress of Rheumatology.
“The study implies that patients can receive booster vaccinations regardless of age, diagnosis, or therapy,” reported Veronica Bergonzo Moshe, MD, a pediatric rheumatologist at Meir Medical Center, Kfar Saba, Israel.
In the absence of safety data, the vaccination of children with rheumatic diseases taking immunosuppressive therapies has been controversial. Although these children face communicable and sometimes life-threatening diseases without vaccination, many clinicians are not offering this protection because they fear adverse consequences.
Current Paediatric Rheumatology European Society (PReS) guidelines have been equivocal, recommending that vaccines be considered on a “case-by-case basis” in children with a rheumatic disease if they are taking high doses of disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, or any dose of biologics.
“The fear is that a state of immune suppression might decrease response to the vaccine or lead to a flare of the rheumatologic disease,” Dr. Moshe said.
In the retrospective study presented by Dr. Moshe, data were collected on 234 children with rheumatic diseases who received a live attenuated MMR/V booster. The children were drawn from 12 pediatric rheumatology centers in 10 countries.
In this relatively large series, 82% of the children had oligoarticular or polyarticular juvenile idiopathic arthritis (JIA). A range of other rheumatic diseases, including juvenile dermatomyositis, localized scleroderma, and isolated idiopathic uveitis were represented among the remaining patients. All were taking medication, and 48% were in remission.
When broken down by therapy, there were three localized reactions in 110 (2.7%) children who received the booster while on methotrexate. No other adverse events, including disease flare, were observed.
Similarly, six of the seven adverse events observed in 76 (8%) patients who were taking methotrexate plus a tumor necrosis factor (TNF) inhibitor biologic at the time of vaccination were local reactions. Fever was reported in one patient. All of these events were transient.
In the 39 patients taking a TNF inhibitor alone, there was a single case of transient fever. There were no adverse events reported in the three patients vaccinated while on tocilizumab, seven patients while on anakinra, or five patients while on canakinumab.
Following vaccination, there were no signs of symptoms of the diseases that the vaccines are designed to prevent. In the minority of patients who did develop localized reactions or fever in this series, there was no apparent relationship with disease activity, age, or sex when compared to those who did not develop an adverse event.
These retrospective data are not definitive, but they are reassuring, according to Dr. Moshe. A larger prospective study by the PReS vaccination study group is now planned. The issue of leaving children unvaccinated is topical due to the recent outbreaks of measles in the United States.
“We must have clear guidelines on how to deal with the administration of live vaccines in this patient population so that we can provide the safest and most effective practice,” Dr. Moshe said.
These data are a first step.
“This large retrospective study demonstrates that live attenuated booster vaccine is probably safe in children with rheumatic diseases,” said Dr. Moshe, but she deferred to the PReS guidelines in suggesting that the decision to vaccinate still might best be performed on a case-by-case basis.
MADRID – Administration of live attenuated booster of the MMR vaccine with or without varicella (MMR/V) was not associated with serious adverse events in children on immunosuppressive therapy for a rheumatic disease, according to data presented at the European Congress of Rheumatology.
“The study implies that patients can receive booster vaccinations regardless of age, diagnosis, or therapy,” reported Veronica Bergonzo Moshe, MD, a pediatric rheumatologist at Meir Medical Center, Kfar Saba, Israel.
In the absence of safety data, the vaccination of children with rheumatic diseases taking immunosuppressive therapies has been controversial. Although these children face communicable and sometimes life-threatening diseases without vaccination, many clinicians are not offering this protection because they fear adverse consequences.
Current Paediatric Rheumatology European Society (PReS) guidelines have been equivocal, recommending that vaccines be considered on a “case-by-case basis” in children with a rheumatic disease if they are taking high doses of disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, or any dose of biologics.
“The fear is that a state of immune suppression might decrease response to the vaccine or lead to a flare of the rheumatologic disease,” Dr. Moshe said.
In the retrospective study presented by Dr. Moshe, data were collected on 234 children with rheumatic diseases who received a live attenuated MMR/V booster. The children were drawn from 12 pediatric rheumatology centers in 10 countries.
In this relatively large series, 82% of the children had oligoarticular or polyarticular juvenile idiopathic arthritis (JIA). A range of other rheumatic diseases, including juvenile dermatomyositis, localized scleroderma, and isolated idiopathic uveitis were represented among the remaining patients. All were taking medication, and 48% were in remission.
When broken down by therapy, there were three localized reactions in 110 (2.7%) children who received the booster while on methotrexate. No other adverse events, including disease flare, were observed.
Similarly, six of the seven adverse events observed in 76 (8%) patients who were taking methotrexate plus a tumor necrosis factor (TNF) inhibitor biologic at the time of vaccination were local reactions. Fever was reported in one patient. All of these events were transient.
In the 39 patients taking a TNF inhibitor alone, there was a single case of transient fever. There were no adverse events reported in the three patients vaccinated while on tocilizumab, seven patients while on anakinra, or five patients while on canakinumab.
Following vaccination, there were no signs of symptoms of the diseases that the vaccines are designed to prevent. In the minority of patients who did develop localized reactions or fever in this series, there was no apparent relationship with disease activity, age, or sex when compared to those who did not develop an adverse event.
These retrospective data are not definitive, but they are reassuring, according to Dr. Moshe. A larger prospective study by the PReS vaccination study group is now planned. The issue of leaving children unvaccinated is topical due to the recent outbreaks of measles in the United States.
“We must have clear guidelines on how to deal with the administration of live vaccines in this patient population so that we can provide the safest and most effective practice,” Dr. Moshe said.
These data are a first step.
“This large retrospective study demonstrates that live attenuated booster vaccine is probably safe in children with rheumatic diseases,” said Dr. Moshe, but she deferred to the PReS guidelines in suggesting that the decision to vaccinate still might best be performed on a case-by-case basis.
MADRID – Administration of live attenuated booster of the MMR vaccine with or without varicella (MMR/V) was not associated with serious adverse events in children on immunosuppressive therapy for a rheumatic disease, according to data presented at the European Congress of Rheumatology.
“The study implies that patients can receive booster vaccinations regardless of age, diagnosis, or therapy,” reported Veronica Bergonzo Moshe, MD, a pediatric rheumatologist at Meir Medical Center, Kfar Saba, Israel.
In the absence of safety data, the vaccination of children with rheumatic diseases taking immunosuppressive therapies has been controversial. Although these children face communicable and sometimes life-threatening diseases without vaccination, many clinicians are not offering this protection because they fear adverse consequences.
Current Paediatric Rheumatology European Society (PReS) guidelines have been equivocal, recommending that vaccines be considered on a “case-by-case basis” in children with a rheumatic disease if they are taking high doses of disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, or any dose of biologics.
“The fear is that a state of immune suppression might decrease response to the vaccine or lead to a flare of the rheumatologic disease,” Dr. Moshe said.
In the retrospective study presented by Dr. Moshe, data were collected on 234 children with rheumatic diseases who received a live attenuated MMR/V booster. The children were drawn from 12 pediatric rheumatology centers in 10 countries.
In this relatively large series, 82% of the children had oligoarticular or polyarticular juvenile idiopathic arthritis (JIA). A range of other rheumatic diseases, including juvenile dermatomyositis, localized scleroderma, and isolated idiopathic uveitis were represented among the remaining patients. All were taking medication, and 48% were in remission.
When broken down by therapy, there were three localized reactions in 110 (2.7%) children who received the booster while on methotrexate. No other adverse events, including disease flare, were observed.
Similarly, six of the seven adverse events observed in 76 (8%) patients who were taking methotrexate plus a tumor necrosis factor (TNF) inhibitor biologic at the time of vaccination were local reactions. Fever was reported in one patient. All of these events were transient.
In the 39 patients taking a TNF inhibitor alone, there was a single case of transient fever. There were no adverse events reported in the three patients vaccinated while on tocilizumab, seven patients while on anakinra, or five patients while on canakinumab.
Following vaccination, there were no signs of symptoms of the diseases that the vaccines are designed to prevent. In the minority of patients who did develop localized reactions or fever in this series, there was no apparent relationship with disease activity, age, or sex when compared to those who did not develop an adverse event.
These retrospective data are not definitive, but they are reassuring, according to Dr. Moshe. A larger prospective study by the PReS vaccination study group is now planned. The issue of leaving children unvaccinated is topical due to the recent outbreaks of measles in the United States.
“We must have clear guidelines on how to deal with the administration of live vaccines in this patient population so that we can provide the safest and most effective practice,” Dr. Moshe said.
These data are a first step.
“This large retrospective study demonstrates that live attenuated booster vaccine is probably safe in children with rheumatic diseases,” said Dr. Moshe, but she deferred to the PReS guidelines in suggesting that the decision to vaccinate still might best be performed on a case-by-case basis.
REPORTING FROM EULAR 2019 CONGRESS
Get patients vaccinated: Avoid unwelcome international travel souvenirs
Summer officially began June 21, 2019, but many of your patients already may have departed or will soon be headed to international destinations. Reasons for travel are as variable as their destinations and include but are not limited to family vacations, mission trips, study abroad, parental job relocation, and visiting friends and relatives. The majority of the trips are planned at least 3 months in advance; however, for many travelers and their parents, they suddenly get an aha moment and realize there is/are specific vaccines required to obtain a visa or entry to their final destination. Unfortunately, too much emphasis is focused on required vaccines. The well-informed traveler knows that they may be exposed to multiple diseases and many are vaccine preventable.
The accompanying table lists vaccines traditionally considered to be travel vaccines. Several require multiple doses administered over 21-28 days to provide protection. Others such as cholera and yellow fever must be completed at least 10 days prior to departure to be effective. Typhoid has two formulations: The oral and injectable typhoid vaccines should be completed 1 and 2 weeks, respectively, prior to travel. Several vaccines have age limitations. Routine immunization of all infants against hepatitis A was recommended in 2006. Depending on your region, there may be adolescents who have not been immunized. Fortunately, hepatitis A vaccine works immediately.
One of the challenges you face is identifying someone in your area that provides travel medicine advice and immunizations to children and adolescents. Most children and teens travel with their parents, but today many adolescents travel independently with organized groups. Most of the vaccines listed are not routinely administered at your office, yet you most likely will be the first call a parent makes seeking travel advice.
Let me tell you about a few vaccines in particular.
Japanese encephalitis
This is most common cause of encephalitis in Asia and parts of the western Pacific. Risk generally is limited to rural agricultural areas where the causative virus is transmitted by a mosquito. Fatality rates are 20%-30%. Among survivors, 30%-50% have significant neurologic, cognitive, and psychiatric sequelae. Candidates for this vaccine are long-term travelers and short-term travelers with extensive outdoor rural activities.
Meningococcal conjugate vaccines (MCV4)
All travelers to the Hajj Pilgrimage (Aug. 9-14, 2019) and/or Umrah must show proof of immunization. Vaccine must be received at least 10 days prior to and no greater than 5 years prior to arrival to Saudi Arabia. Conjugate vaccine must clearly be documented for validity of 5 years. For all health entry requirements, go to www.moh.gov.sa/en/hajj/pages/healthregulations.aspx.
Measles
The Advisory Committee on Immunization Practices recommends all infants 6-11 months old receive one dose of MMR prior to international travel regardless of the destination. This should be followed by two additional countable doses. All persons at least 12 months of age and born after 1956 should receive two doses of MMR at least 28 days apart prior to international travel.
Rabies
Rabies is a viral disease endemic in more than 150 countries with approximately 60,000 fatal cases worldwide each year. Asia and Africa are the areas with the highest risk of exposure, and dogs are the principal hosts. Human rabies is almost always fatal once symptoms develop. Preexposure vaccine is recommended for persons with prolonged and/or remote travel to countries where rabies immunoglobulin is unavailable and the occurrence of animal rabies is high. Post exposure vaccination on days 0 and 3 still would be required.*
Typhoid
A bacterial infection caused by Salmonella enterica serotype Typhi and Paratyphi manifests with fever, headache, abdominal pain, diarrhea, or constipation. When bacteremia occurs, it usually is referred to as enteric fever. It is acquired by consumption of food/water contaminated with human feces. Highest risk areas include Africa, Southern Asia, and Southeast Asia
Yellow fever
Risk is limited to sub-Saharan Africa and the tropical areas of South America. It is transmitted by the bite of an infected mosquito. The vaccine is required for entry into at least 16 countries. In a country where yellow fever is present, persons transiting through for more than 12 hours to reach their final destination may actually cause a change in the entry requirements for the destination country. For example, travel from the United States to Tanzania requires no yellow fever vaccine while travel from the United States to Nairobi (more than 12 hours) to Tanzania requires yellow fever vaccine for entry into Tanzania. Travel sequence and duration is extremely important. Check the Centers for Disease Control and Prevention yellow fever site and/or the consulate for the most up-to-date yellow fever vaccine requirements.
YF-Vax (yellow fever vaccine) produced by Sanofi Pasteur in the United States currently is unavailable. The company is building a new facility, and vaccine will not be available for the remainder of 2019. To assure vaccine for U.S. travelers, Stamaril, a yellow fever vaccine produced by Sanofi Pasteur in France has been made available at more than 250 sites nationwide. Because Stamaril is offered at a limited number of locations, persons in need of vaccine should not delay seeking it. Because of increased demand related to summer travel, travelers in some areas have reported delays of several weeks in scheduling an appointment. To locate a Stamaril site in your area, go to wwwnc.cdc.gov/travel/page/search-for-stamaril-clinics.
There are several other diseases transmitted by mosquitoes and ticks including malaria, dengue, Zika and rickettsial diseases. Vigilant use of mosquito repellents is a must. Prophylactic medication is available for only malaria and should be initiated prior to exposure. Frequency and duration depends on the medication selected.
So how do you assist your patients?
Once you’ve identified a travel medicine facility in your area, encourage them to seek pretravel advice 4-6 weeks prior to international travel and make sure their routine immunizations are up to date. Generally, this is not an issue. One challenge is the early administration of MMR. While most practitioners know that early administration for international travel has been recommended for years, many office staff are accustomed to administration at only the 12 month and 4 year visit. When parents call requesting immunization, they often are informed that is it unnecessary and the appointment denied. This is a challenge, especially when coordination of administration of another live vaccine, such as yellow fever, is planned. Familiarizing all members of the health care team with current vaccine recommendations is critical.
For country-specific information, up-to-date travel alerts, and to locate a travel medicine clinic, visit www.cdc.gov/travel.
Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She had no relevant financial disclosures. Email her at [email protected].
*This article was updated 6/18/2019.
Summer officially began June 21, 2019, but many of your patients already may have departed or will soon be headed to international destinations. Reasons for travel are as variable as their destinations and include but are not limited to family vacations, mission trips, study abroad, parental job relocation, and visiting friends and relatives. The majority of the trips are planned at least 3 months in advance; however, for many travelers and their parents, they suddenly get an aha moment and realize there is/are specific vaccines required to obtain a visa or entry to their final destination. Unfortunately, too much emphasis is focused on required vaccines. The well-informed traveler knows that they may be exposed to multiple diseases and many are vaccine preventable.
The accompanying table lists vaccines traditionally considered to be travel vaccines. Several require multiple doses administered over 21-28 days to provide protection. Others such as cholera and yellow fever must be completed at least 10 days prior to departure to be effective. Typhoid has two formulations: The oral and injectable typhoid vaccines should be completed 1 and 2 weeks, respectively, prior to travel. Several vaccines have age limitations. Routine immunization of all infants against hepatitis A was recommended in 2006. Depending on your region, there may be adolescents who have not been immunized. Fortunately, hepatitis A vaccine works immediately.
One of the challenges you face is identifying someone in your area that provides travel medicine advice and immunizations to children and adolescents. Most children and teens travel with their parents, but today many adolescents travel independently with organized groups. Most of the vaccines listed are not routinely administered at your office, yet you most likely will be the first call a parent makes seeking travel advice.
Let me tell you about a few vaccines in particular.
Japanese encephalitis
This is most common cause of encephalitis in Asia and parts of the western Pacific. Risk generally is limited to rural agricultural areas where the causative virus is transmitted by a mosquito. Fatality rates are 20%-30%. Among survivors, 30%-50% have significant neurologic, cognitive, and psychiatric sequelae. Candidates for this vaccine are long-term travelers and short-term travelers with extensive outdoor rural activities.
Meningococcal conjugate vaccines (MCV4)
All travelers to the Hajj Pilgrimage (Aug. 9-14, 2019) and/or Umrah must show proof of immunization. Vaccine must be received at least 10 days prior to and no greater than 5 years prior to arrival to Saudi Arabia. Conjugate vaccine must clearly be documented for validity of 5 years. For all health entry requirements, go to www.moh.gov.sa/en/hajj/pages/healthregulations.aspx.
Measles
The Advisory Committee on Immunization Practices recommends all infants 6-11 months old receive one dose of MMR prior to international travel regardless of the destination. This should be followed by two additional countable doses. All persons at least 12 months of age and born after 1956 should receive two doses of MMR at least 28 days apart prior to international travel.
Rabies
Rabies is a viral disease endemic in more than 150 countries with approximately 60,000 fatal cases worldwide each year. Asia and Africa are the areas with the highest risk of exposure, and dogs are the principal hosts. Human rabies is almost always fatal once symptoms develop. Preexposure vaccine is recommended for persons with prolonged and/or remote travel to countries where rabies immunoglobulin is unavailable and the occurrence of animal rabies is high. Post exposure vaccination on days 0 and 3 still would be required.*
Typhoid
A bacterial infection caused by Salmonella enterica serotype Typhi and Paratyphi manifests with fever, headache, abdominal pain, diarrhea, or constipation. When bacteremia occurs, it usually is referred to as enteric fever. It is acquired by consumption of food/water contaminated with human feces. Highest risk areas include Africa, Southern Asia, and Southeast Asia
Yellow fever
Risk is limited to sub-Saharan Africa and the tropical areas of South America. It is transmitted by the bite of an infected mosquito. The vaccine is required for entry into at least 16 countries. In a country where yellow fever is present, persons transiting through for more than 12 hours to reach their final destination may actually cause a change in the entry requirements for the destination country. For example, travel from the United States to Tanzania requires no yellow fever vaccine while travel from the United States to Nairobi (more than 12 hours) to Tanzania requires yellow fever vaccine for entry into Tanzania. Travel sequence and duration is extremely important. Check the Centers for Disease Control and Prevention yellow fever site and/or the consulate for the most up-to-date yellow fever vaccine requirements.
YF-Vax (yellow fever vaccine) produced by Sanofi Pasteur in the United States currently is unavailable. The company is building a new facility, and vaccine will not be available for the remainder of 2019. To assure vaccine for U.S. travelers, Stamaril, a yellow fever vaccine produced by Sanofi Pasteur in France has been made available at more than 250 sites nationwide. Because Stamaril is offered at a limited number of locations, persons in need of vaccine should not delay seeking it. Because of increased demand related to summer travel, travelers in some areas have reported delays of several weeks in scheduling an appointment. To locate a Stamaril site in your area, go to wwwnc.cdc.gov/travel/page/search-for-stamaril-clinics.
There are several other diseases transmitted by mosquitoes and ticks including malaria, dengue, Zika and rickettsial diseases. Vigilant use of mosquito repellents is a must. Prophylactic medication is available for only malaria and should be initiated prior to exposure. Frequency and duration depends on the medication selected.
So how do you assist your patients?
Once you’ve identified a travel medicine facility in your area, encourage them to seek pretravel advice 4-6 weeks prior to international travel and make sure their routine immunizations are up to date. Generally, this is not an issue. One challenge is the early administration of MMR. While most practitioners know that early administration for international travel has been recommended for years, many office staff are accustomed to administration at only the 12 month and 4 year visit. When parents call requesting immunization, they often are informed that is it unnecessary and the appointment denied. This is a challenge, especially when coordination of administration of another live vaccine, such as yellow fever, is planned. Familiarizing all members of the health care team with current vaccine recommendations is critical.
For country-specific information, up-to-date travel alerts, and to locate a travel medicine clinic, visit www.cdc.gov/travel.
Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She had no relevant financial disclosures. Email her at [email protected].
*This article was updated 6/18/2019.
Summer officially began June 21, 2019, but many of your patients already may have departed or will soon be headed to international destinations. Reasons for travel are as variable as their destinations and include but are not limited to family vacations, mission trips, study abroad, parental job relocation, and visiting friends and relatives. The majority of the trips are planned at least 3 months in advance; however, for many travelers and their parents, they suddenly get an aha moment and realize there is/are specific vaccines required to obtain a visa or entry to their final destination. Unfortunately, too much emphasis is focused on required vaccines. The well-informed traveler knows that they may be exposed to multiple diseases and many are vaccine preventable.
The accompanying table lists vaccines traditionally considered to be travel vaccines. Several require multiple doses administered over 21-28 days to provide protection. Others such as cholera and yellow fever must be completed at least 10 days prior to departure to be effective. Typhoid has two formulations: The oral and injectable typhoid vaccines should be completed 1 and 2 weeks, respectively, prior to travel. Several vaccines have age limitations. Routine immunization of all infants against hepatitis A was recommended in 2006. Depending on your region, there may be adolescents who have not been immunized. Fortunately, hepatitis A vaccine works immediately.
One of the challenges you face is identifying someone in your area that provides travel medicine advice and immunizations to children and adolescents. Most children and teens travel with their parents, but today many adolescents travel independently with organized groups. Most of the vaccines listed are not routinely administered at your office, yet you most likely will be the first call a parent makes seeking travel advice.
Let me tell you about a few vaccines in particular.
Japanese encephalitis
This is most common cause of encephalitis in Asia and parts of the western Pacific. Risk generally is limited to rural agricultural areas where the causative virus is transmitted by a mosquito. Fatality rates are 20%-30%. Among survivors, 30%-50% have significant neurologic, cognitive, and psychiatric sequelae. Candidates for this vaccine are long-term travelers and short-term travelers with extensive outdoor rural activities.
Meningococcal conjugate vaccines (MCV4)
All travelers to the Hajj Pilgrimage (Aug. 9-14, 2019) and/or Umrah must show proof of immunization. Vaccine must be received at least 10 days prior to and no greater than 5 years prior to arrival to Saudi Arabia. Conjugate vaccine must clearly be documented for validity of 5 years. For all health entry requirements, go to www.moh.gov.sa/en/hajj/pages/healthregulations.aspx.
Measles
The Advisory Committee on Immunization Practices recommends all infants 6-11 months old receive one dose of MMR prior to international travel regardless of the destination. This should be followed by two additional countable doses. All persons at least 12 months of age and born after 1956 should receive two doses of MMR at least 28 days apart prior to international travel.
Rabies
Rabies is a viral disease endemic in more than 150 countries with approximately 60,000 fatal cases worldwide each year. Asia and Africa are the areas with the highest risk of exposure, and dogs are the principal hosts. Human rabies is almost always fatal once symptoms develop. Preexposure vaccine is recommended for persons with prolonged and/or remote travel to countries where rabies immunoglobulin is unavailable and the occurrence of animal rabies is high. Post exposure vaccination on days 0 and 3 still would be required.*
Typhoid
A bacterial infection caused by Salmonella enterica serotype Typhi and Paratyphi manifests with fever, headache, abdominal pain, diarrhea, or constipation. When bacteremia occurs, it usually is referred to as enteric fever. It is acquired by consumption of food/water contaminated with human feces. Highest risk areas include Africa, Southern Asia, and Southeast Asia
Yellow fever
Risk is limited to sub-Saharan Africa and the tropical areas of South America. It is transmitted by the bite of an infected mosquito. The vaccine is required for entry into at least 16 countries. In a country where yellow fever is present, persons transiting through for more than 12 hours to reach their final destination may actually cause a change in the entry requirements for the destination country. For example, travel from the United States to Tanzania requires no yellow fever vaccine while travel from the United States to Nairobi (more than 12 hours) to Tanzania requires yellow fever vaccine for entry into Tanzania. Travel sequence and duration is extremely important. Check the Centers for Disease Control and Prevention yellow fever site and/or the consulate for the most up-to-date yellow fever vaccine requirements.
YF-Vax (yellow fever vaccine) produced by Sanofi Pasteur in the United States currently is unavailable. The company is building a new facility, and vaccine will not be available for the remainder of 2019. To assure vaccine for U.S. travelers, Stamaril, a yellow fever vaccine produced by Sanofi Pasteur in France has been made available at more than 250 sites nationwide. Because Stamaril is offered at a limited number of locations, persons in need of vaccine should not delay seeking it. Because of increased demand related to summer travel, travelers in some areas have reported delays of several weeks in scheduling an appointment. To locate a Stamaril site in your area, go to wwwnc.cdc.gov/travel/page/search-for-stamaril-clinics.
There are several other diseases transmitted by mosquitoes and ticks including malaria, dengue, Zika and rickettsial diseases. Vigilant use of mosquito repellents is a must. Prophylactic medication is available for only malaria and should be initiated prior to exposure. Frequency and duration depends on the medication selected.
So how do you assist your patients?
Once you’ve identified a travel medicine facility in your area, encourage them to seek pretravel advice 4-6 weeks prior to international travel and make sure their routine immunizations are up to date. Generally, this is not an issue. One challenge is the early administration of MMR. While most practitioners know that early administration for international travel has been recommended for years, many office staff are accustomed to administration at only the 12 month and 4 year visit. When parents call requesting immunization, they often are informed that is it unnecessary and the appointment denied. This is a challenge, especially when coordination of administration of another live vaccine, such as yellow fever, is planned. Familiarizing all members of the health care team with current vaccine recommendations is critical.
For country-specific information, up-to-date travel alerts, and to locate a travel medicine clinic, visit www.cdc.gov/travel.
Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She had no relevant financial disclosures. Email her at [email protected].
*This article was updated 6/18/2019.
California vaccine exemption proposal gives powerful voices pause
In the past few weeks, Democratic Gov. Gavin Newsom and the members of the Medical Board of California have questioned a bill that would give the California Department of Public Health authority to decide whether a child can skip routine vaccinations.
Anti-vaccine activists have capitalized on these moments, plastering Facebook pages and social media with praise for the officials’ statements.
But those officials are not against vaccinations. In fact, they have made clear they’re committed to vaccines, and to dealing with the problem the bill is supposed to fix — doctors providing kids with medical exemptions for reasons that don’t meet federal standards.
“Having been in public health for a long time, I am a huge supporter of vaccines,” said Michelle Bholat, MD, a family medicine physician in Santa Monica and until recently a member of the medical board, which has oversight over physicians and their licenses.
What concerns her, she said at a late-May meeting of the board, was the measure’s potential effect on doctor-patient relationships and the particulars of who would qualify for a medical exemption.
Pediatrician and State Sen. Richard Pan (D-Sacramento) introduced the bill to address a spike in the number of children who have been granted what he calls “fake” medical exemptions from vaccinations; more than five times as many kids have medical exemptions this past school year than in 2015-16.
SB 276 would give the final say on medical exemption applications to the state public health department, which would be required to follow guidelines established by the Centers for Disease Control and Prevention. Any exemptions provided by doctors would be subject to approval — or denial — by the department.
The only other state that gives control of vaccine exemptions to a public health agency is West Virginia.
The measure passed the state Senate in May and is awaiting consideration in the state Assembly.
The debate over the measure comes as new state data show that the percentage of kindergartners who had all their recommended shots fell for the second straight year, largely due to an increase in medical exemptions written by doctors.
During the past school year, the share of fully vaccinated kindergartners dropped to 94.8%, down from 95.6% in 2016-17, putting the state in potentially dangerous territory — officials recommend 90%-95% coverage for community immunity.
And as vaccination rates dip, measles is spreading nationwide. In the largest outbreak since 1992, more than 1,000 people have been infected across the country this year through June 5, including 51 in California.
Nearly 3 years ago, California enacted a law by Sen. Pan that bars parents from citing personal or religious beliefs to avoid vaccinating their children. Children could be exempted only on medical grounds if the shots were harmful to their health.
That ban improved vaccination rates, though progress has been slipping.
Today, many of the schools that had the highest rates of unvaccinated students before the law took effect still do. Doctors have broad authority to grant medical exemptions from vaccination; some wield that power liberally and sometimes for cash, signing dozens or hundreds of exemptions for children, sometimes in far-off communities.
Sen. Pan’s bill would crack down on this practice and has the strong support of the medical establishment. It was cosponsored by two powerful doctor associations, the American Academy of Pediatrics, California, and the California Medical Association.
“We want to make sure unscrupulous physicians aren’t making medical exemptions for money,” said David Aizuss, MD, president of the California Medical Association. “The idea of the bill is to protect a real personal medical exemption, where kids are on chemotherapy or have an immunological response.”
But it has its critics — and this time, they extend beyond the small but fervent group of people who continue to question the extensive scientific evidence that shows vaccines are safe. And although raising concerns is typical in the legislative process, their criticisms take on outsize importance with a subject as explosive as vaccines.
The biggest name among the new critics is Gov. Newsom, who said he’s worried about interfering with the doctor-patient relationship. “I like doctor-patient relationships. Bureaucratic relationships are more challenging for me,” he said at the state Democratic Party convention in early June.
“I’m a parent; I don’t want someone that the governor of California appointed to make a decision for my family.”
State Sen. Ben Allen (D-Santa Monica), a cosponsor of Sen. Pan’s previous legislation, abstained from voting on the new measure last month, saying he’d made commitments during the previous fight to leave medical exemptions to the discretion of doctors.
Last month, the Medical Board of California offered just lukewarm support, and only to portions of the bill, after listening to 200 members of the public speak against it for more than 2 hours.
The board members called on Sen. Pan to address a variety of concerns, from the potential oversight role the state public health department might play, to the proposed guidelines for medical exemptions.
They agreed on one thing: It should be easier for the board to investigate complaints of questionable medical exemptions. To look into complaints, the board needs to see medical records. To get those records, it generally needs permission from patients or their guardians, something parents who have sought medical exemptions are often unwilling to provide. The bill would give the board access to these records.
One physician, Bob Sears, MD, in Orange County, a well-known opponent to vaccine mandates, was put on probation in 2018 for writing an exemption for a 2-year-old without taking any medical history. Since 2016, at least 173 complaints against physicians for inappropriate exemptions have been filed with the state medical board, with more than 100 currently under investigation, the board said.
Medical exemptions for California kids are clustered in certain communities and schools. In Humboldt County, 5.8% of kindergartners have medical exemptions from shots, according to the new state data. In Nevada County, the rate is 10.6%. All told, nearly one-third of the state’s counties have fallen below 95% immunity from measles.
Dr. Aizuss of the California Medical Association said the organization is working with Gov. Newsom’s office and the medical board, among others, to update the bill so that it will be “workable, effective, and supported by the governor.
“I think that our goal is the same,” he said. “The idea of the bill is to protect ... the sanctity of the true physician-patient relationship, as opposed to a relationship where physicians were granting the medical exemption for a fee, which is not a true physician-patient relationship.”
This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. California Healthline reporter Ana B. Ibarra contributed to this report.
In the past few weeks, Democratic Gov. Gavin Newsom and the members of the Medical Board of California have questioned a bill that would give the California Department of Public Health authority to decide whether a child can skip routine vaccinations.
Anti-vaccine activists have capitalized on these moments, plastering Facebook pages and social media with praise for the officials’ statements.
But those officials are not against vaccinations. In fact, they have made clear they’re committed to vaccines, and to dealing with the problem the bill is supposed to fix — doctors providing kids with medical exemptions for reasons that don’t meet federal standards.
“Having been in public health for a long time, I am a huge supporter of vaccines,” said Michelle Bholat, MD, a family medicine physician in Santa Monica and until recently a member of the medical board, which has oversight over physicians and their licenses.
What concerns her, she said at a late-May meeting of the board, was the measure’s potential effect on doctor-patient relationships and the particulars of who would qualify for a medical exemption.
Pediatrician and State Sen. Richard Pan (D-Sacramento) introduced the bill to address a spike in the number of children who have been granted what he calls “fake” medical exemptions from vaccinations; more than five times as many kids have medical exemptions this past school year than in 2015-16.
SB 276 would give the final say on medical exemption applications to the state public health department, which would be required to follow guidelines established by the Centers for Disease Control and Prevention. Any exemptions provided by doctors would be subject to approval — or denial — by the department.
The only other state that gives control of vaccine exemptions to a public health agency is West Virginia.
The measure passed the state Senate in May and is awaiting consideration in the state Assembly.
The debate over the measure comes as new state data show that the percentage of kindergartners who had all their recommended shots fell for the second straight year, largely due to an increase in medical exemptions written by doctors.
During the past school year, the share of fully vaccinated kindergartners dropped to 94.8%, down from 95.6% in 2016-17, putting the state in potentially dangerous territory — officials recommend 90%-95% coverage for community immunity.
And as vaccination rates dip, measles is spreading nationwide. In the largest outbreak since 1992, more than 1,000 people have been infected across the country this year through June 5, including 51 in California.
Nearly 3 years ago, California enacted a law by Sen. Pan that bars parents from citing personal or religious beliefs to avoid vaccinating their children. Children could be exempted only on medical grounds if the shots were harmful to their health.
That ban improved vaccination rates, though progress has been slipping.
Today, many of the schools that had the highest rates of unvaccinated students before the law took effect still do. Doctors have broad authority to grant medical exemptions from vaccination; some wield that power liberally and sometimes for cash, signing dozens or hundreds of exemptions for children, sometimes in far-off communities.
Sen. Pan’s bill would crack down on this practice and has the strong support of the medical establishment. It was cosponsored by two powerful doctor associations, the American Academy of Pediatrics, California, and the California Medical Association.
“We want to make sure unscrupulous physicians aren’t making medical exemptions for money,” said David Aizuss, MD, president of the California Medical Association. “The idea of the bill is to protect a real personal medical exemption, where kids are on chemotherapy or have an immunological response.”
But it has its critics — and this time, they extend beyond the small but fervent group of people who continue to question the extensive scientific evidence that shows vaccines are safe. And although raising concerns is typical in the legislative process, their criticisms take on outsize importance with a subject as explosive as vaccines.
The biggest name among the new critics is Gov. Newsom, who said he’s worried about interfering with the doctor-patient relationship. “I like doctor-patient relationships. Bureaucratic relationships are more challenging for me,” he said at the state Democratic Party convention in early June.
“I’m a parent; I don’t want someone that the governor of California appointed to make a decision for my family.”
State Sen. Ben Allen (D-Santa Monica), a cosponsor of Sen. Pan’s previous legislation, abstained from voting on the new measure last month, saying he’d made commitments during the previous fight to leave medical exemptions to the discretion of doctors.
Last month, the Medical Board of California offered just lukewarm support, and only to portions of the bill, after listening to 200 members of the public speak against it for more than 2 hours.
The board members called on Sen. Pan to address a variety of concerns, from the potential oversight role the state public health department might play, to the proposed guidelines for medical exemptions.
They agreed on one thing: It should be easier for the board to investigate complaints of questionable medical exemptions. To look into complaints, the board needs to see medical records. To get those records, it generally needs permission from patients or their guardians, something parents who have sought medical exemptions are often unwilling to provide. The bill would give the board access to these records.
One physician, Bob Sears, MD, in Orange County, a well-known opponent to vaccine mandates, was put on probation in 2018 for writing an exemption for a 2-year-old without taking any medical history. Since 2016, at least 173 complaints against physicians for inappropriate exemptions have been filed with the state medical board, with more than 100 currently under investigation, the board said.
Medical exemptions for California kids are clustered in certain communities and schools. In Humboldt County, 5.8% of kindergartners have medical exemptions from shots, according to the new state data. In Nevada County, the rate is 10.6%. All told, nearly one-third of the state’s counties have fallen below 95% immunity from measles.
Dr. Aizuss of the California Medical Association said the organization is working with Gov. Newsom’s office and the medical board, among others, to update the bill so that it will be “workable, effective, and supported by the governor.
“I think that our goal is the same,” he said. “The idea of the bill is to protect ... the sanctity of the true physician-patient relationship, as opposed to a relationship where physicians were granting the medical exemption for a fee, which is not a true physician-patient relationship.”
This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. California Healthline reporter Ana B. Ibarra contributed to this report.
In the past few weeks, Democratic Gov. Gavin Newsom and the members of the Medical Board of California have questioned a bill that would give the California Department of Public Health authority to decide whether a child can skip routine vaccinations.
Anti-vaccine activists have capitalized on these moments, plastering Facebook pages and social media with praise for the officials’ statements.
But those officials are not against vaccinations. In fact, they have made clear they’re committed to vaccines, and to dealing with the problem the bill is supposed to fix — doctors providing kids with medical exemptions for reasons that don’t meet federal standards.
“Having been in public health for a long time, I am a huge supporter of vaccines,” said Michelle Bholat, MD, a family medicine physician in Santa Monica and until recently a member of the medical board, which has oversight over physicians and their licenses.
What concerns her, she said at a late-May meeting of the board, was the measure’s potential effect on doctor-patient relationships and the particulars of who would qualify for a medical exemption.
Pediatrician and State Sen. Richard Pan (D-Sacramento) introduced the bill to address a spike in the number of children who have been granted what he calls “fake” medical exemptions from vaccinations; more than five times as many kids have medical exemptions this past school year than in 2015-16.
SB 276 would give the final say on medical exemption applications to the state public health department, which would be required to follow guidelines established by the Centers for Disease Control and Prevention. Any exemptions provided by doctors would be subject to approval — or denial — by the department.
The only other state that gives control of vaccine exemptions to a public health agency is West Virginia.
The measure passed the state Senate in May and is awaiting consideration in the state Assembly.
The debate over the measure comes as new state data show that the percentage of kindergartners who had all their recommended shots fell for the second straight year, largely due to an increase in medical exemptions written by doctors.
During the past school year, the share of fully vaccinated kindergartners dropped to 94.8%, down from 95.6% in 2016-17, putting the state in potentially dangerous territory — officials recommend 90%-95% coverage for community immunity.
And as vaccination rates dip, measles is spreading nationwide. In the largest outbreak since 1992, more than 1,000 people have been infected across the country this year through June 5, including 51 in California.
Nearly 3 years ago, California enacted a law by Sen. Pan that bars parents from citing personal or religious beliefs to avoid vaccinating their children. Children could be exempted only on medical grounds if the shots were harmful to their health.
That ban improved vaccination rates, though progress has been slipping.
Today, many of the schools that had the highest rates of unvaccinated students before the law took effect still do. Doctors have broad authority to grant medical exemptions from vaccination; some wield that power liberally and sometimes for cash, signing dozens or hundreds of exemptions for children, sometimes in far-off communities.
Sen. Pan’s bill would crack down on this practice and has the strong support of the medical establishment. It was cosponsored by two powerful doctor associations, the American Academy of Pediatrics, California, and the California Medical Association.
“We want to make sure unscrupulous physicians aren’t making medical exemptions for money,” said David Aizuss, MD, president of the California Medical Association. “The idea of the bill is to protect a real personal medical exemption, where kids are on chemotherapy or have an immunological response.”
But it has its critics — and this time, they extend beyond the small but fervent group of people who continue to question the extensive scientific evidence that shows vaccines are safe. And although raising concerns is typical in the legislative process, their criticisms take on outsize importance with a subject as explosive as vaccines.
The biggest name among the new critics is Gov. Newsom, who said he’s worried about interfering with the doctor-patient relationship. “I like doctor-patient relationships. Bureaucratic relationships are more challenging for me,” he said at the state Democratic Party convention in early June.
“I’m a parent; I don’t want someone that the governor of California appointed to make a decision for my family.”
State Sen. Ben Allen (D-Santa Monica), a cosponsor of Sen. Pan’s previous legislation, abstained from voting on the new measure last month, saying he’d made commitments during the previous fight to leave medical exemptions to the discretion of doctors.
Last month, the Medical Board of California offered just lukewarm support, and only to portions of the bill, after listening to 200 members of the public speak against it for more than 2 hours.
The board members called on Sen. Pan to address a variety of concerns, from the potential oversight role the state public health department might play, to the proposed guidelines for medical exemptions.
They agreed on one thing: It should be easier for the board to investigate complaints of questionable medical exemptions. To look into complaints, the board needs to see medical records. To get those records, it generally needs permission from patients or their guardians, something parents who have sought medical exemptions are often unwilling to provide. The bill would give the board access to these records.
One physician, Bob Sears, MD, in Orange County, a well-known opponent to vaccine mandates, was put on probation in 2018 for writing an exemption for a 2-year-old without taking any medical history. Since 2016, at least 173 complaints against physicians for inappropriate exemptions have been filed with the state medical board, with more than 100 currently under investigation, the board said.
Medical exemptions for California kids are clustered in certain communities and schools. In Humboldt County, 5.8% of kindergartners have medical exemptions from shots, according to the new state data. In Nevada County, the rate is 10.6%. All told, nearly one-third of the state’s counties have fallen below 95% immunity from measles.
Dr. Aizuss of the California Medical Association said the organization is working with Gov. Newsom’s office and the medical board, among others, to update the bill so that it will be “workable, effective, and supported by the governor.
“I think that our goal is the same,” he said. “The idea of the bill is to protect ... the sanctity of the true physician-patient relationship, as opposed to a relationship where physicians were granting the medical exemption for a fee, which is not a true physician-patient relationship.”
This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. California Healthline reporter Ana B. Ibarra contributed to this report.
How to have ‘the talk’ with vaccine skeptics
LJUBLJANA, SLOVENIA – An effective strategy in helping vaccine skeptics to come around to accepting immunizations for their children is to pivot the conversation away from vaccine safety and focus instead on the disease itself and its potential consequences, Saad B. Omer, MBBS, PhD, asserted at the annual meeting of the European Society for Paediatric Infectious Diseases.
“Why do we cede ground by focusing too much on the vaccine itself? I call it the disease salience approach,” said Dr. Omer, professor of global health, epidemiology, and pediatrics at Emory University in Atlanta.
It’s a strategy guided by developments in social psychology, persuasion theory, and communication theory. But if applied incorrectly, the disease salience approach can backfire, causing behavioral paralysis and an inability to act, he cautioned.
Dr. Omer explained that it’s a matter of framing.
“Always include a solution to promote self-efficacy and response-efficacy. After you inform parents of disease risks, provide them with actions they can take. Now readdress the vaccine, pointing out that this is the single best way to protect yourself and your baby,” he said. “The lesson is that since vaccines are a social norm, reframe nonvaccination as an active act, rather than vaccination as an active act.”
Don’t attempt to wow parents with statistics on how vaccine complication rates are dwarfed by the disease risk if left unvaccinated, he advised. Studies have shown that‘s generally not effective. What actually works is to provide narratives of disease severity.
“We are excellent linguists, but really, really poor statisticians,” Dr. Omer observed.
Is it ethical to talk to parents about disease risks to influence their behavior? Absolutely, in his view.
“We’re not selling toothpaste. We are in the business of life-saving vaccines. And I would submit that if it’s done correctly it’s entirely ethical to talk about the disease, and sometimes even the severe risks of the disease, instead of the vaccine,” said Dr. Omer.
If parents cite a myth about vaccines, it’s necessary to address it head on without lingering on it. But debunking a myth is tricky because people tend to remember negative information they received earlier.
“If you’re going to debunk a myth, clearly label it as a myth in the headline as you introduce it. State why it’s not true. Replace the myth with the best alternative explanation. Think of it like a blank space where the myth used to reside. That space needs to be filled with an alternative explanation or the myth will come back,” Dr. Omer said.
He is a coauthor of a book titled, ‘The Clinician’s Vaccine Safety Resource Guide: Optimizing Prevention of Vaccine-Preventable Diseases Across the Lifespan.’
LJUBLJANA, SLOVENIA – An effective strategy in helping vaccine skeptics to come around to accepting immunizations for their children is to pivot the conversation away from vaccine safety and focus instead on the disease itself and its potential consequences, Saad B. Omer, MBBS, PhD, asserted at the annual meeting of the European Society for Paediatric Infectious Diseases.
“Why do we cede ground by focusing too much on the vaccine itself? I call it the disease salience approach,” said Dr. Omer, professor of global health, epidemiology, and pediatrics at Emory University in Atlanta.
It’s a strategy guided by developments in social psychology, persuasion theory, and communication theory. But if applied incorrectly, the disease salience approach can backfire, causing behavioral paralysis and an inability to act, he cautioned.
Dr. Omer explained that it’s a matter of framing.
“Always include a solution to promote self-efficacy and response-efficacy. After you inform parents of disease risks, provide them with actions they can take. Now readdress the vaccine, pointing out that this is the single best way to protect yourself and your baby,” he said. “The lesson is that since vaccines are a social norm, reframe nonvaccination as an active act, rather than vaccination as an active act.”
Don’t attempt to wow parents with statistics on how vaccine complication rates are dwarfed by the disease risk if left unvaccinated, he advised. Studies have shown that‘s generally not effective. What actually works is to provide narratives of disease severity.
“We are excellent linguists, but really, really poor statisticians,” Dr. Omer observed.
Is it ethical to talk to parents about disease risks to influence their behavior? Absolutely, in his view.
“We’re not selling toothpaste. We are in the business of life-saving vaccines. And I would submit that if it’s done correctly it’s entirely ethical to talk about the disease, and sometimes even the severe risks of the disease, instead of the vaccine,” said Dr. Omer.
If parents cite a myth about vaccines, it’s necessary to address it head on without lingering on it. But debunking a myth is tricky because people tend to remember negative information they received earlier.
“If you’re going to debunk a myth, clearly label it as a myth in the headline as you introduce it. State why it’s not true. Replace the myth with the best alternative explanation. Think of it like a blank space where the myth used to reside. That space needs to be filled with an alternative explanation or the myth will come back,” Dr. Omer said.
He is a coauthor of a book titled, ‘The Clinician’s Vaccine Safety Resource Guide: Optimizing Prevention of Vaccine-Preventable Diseases Across the Lifespan.’
LJUBLJANA, SLOVENIA – An effective strategy in helping vaccine skeptics to come around to accepting immunizations for their children is to pivot the conversation away from vaccine safety and focus instead on the disease itself and its potential consequences, Saad B. Omer, MBBS, PhD, asserted at the annual meeting of the European Society for Paediatric Infectious Diseases.
“Why do we cede ground by focusing too much on the vaccine itself? I call it the disease salience approach,” said Dr. Omer, professor of global health, epidemiology, and pediatrics at Emory University in Atlanta.
It’s a strategy guided by developments in social psychology, persuasion theory, and communication theory. But if applied incorrectly, the disease salience approach can backfire, causing behavioral paralysis and an inability to act, he cautioned.
Dr. Omer explained that it’s a matter of framing.
“Always include a solution to promote self-efficacy and response-efficacy. After you inform parents of disease risks, provide them with actions they can take. Now readdress the vaccine, pointing out that this is the single best way to protect yourself and your baby,” he said. “The lesson is that since vaccines are a social norm, reframe nonvaccination as an active act, rather than vaccination as an active act.”
Don’t attempt to wow parents with statistics on how vaccine complication rates are dwarfed by the disease risk if left unvaccinated, he advised. Studies have shown that‘s generally not effective. What actually works is to provide narratives of disease severity.
“We are excellent linguists, but really, really poor statisticians,” Dr. Omer observed.
Is it ethical to talk to parents about disease risks to influence their behavior? Absolutely, in his view.
“We’re not selling toothpaste. We are in the business of life-saving vaccines. And I would submit that if it’s done correctly it’s entirely ethical to talk about the disease, and sometimes even the severe risks of the disease, instead of the vaccine,” said Dr. Omer.
If parents cite a myth about vaccines, it’s necessary to address it head on without lingering on it. But debunking a myth is tricky because people tend to remember negative information they received earlier.
“If you’re going to debunk a myth, clearly label it as a myth in the headline as you introduce it. State why it’s not true. Replace the myth with the best alternative explanation. Think of it like a blank space where the myth used to reside. That space needs to be filled with an alternative explanation or the myth will come back,” Dr. Omer said.
He is a coauthor of a book titled, ‘The Clinician’s Vaccine Safety Resource Guide: Optimizing Prevention of Vaccine-Preventable Diseases Across the Lifespan.’
EXPERT ANALYSIS FROM ESPID 2019
Waning pertussis immunity may be linked to acellular vaccine
A large Kaiser Permanente study paints a nuanced picture of the acellular pertussis vaccine, with more cases occurring in fully vaccinated children, but the highest risk of disease occurring among the under- and unvaccinated.
Among nearly half a million children, the unvaccinated were 13 times more likely to develop pertussis than fully vaccinated children, Ousseny Zerbo, PhD, of Kaiser Permanente Northern California in Oakland and colleagues wrote in Pediatrics. But 82% of cases occurred in fully vaccinated children and just 5% in undervaccinated children – and rates increased in both groups the farther they were in time from the last vaccination.
“Within our study population, greater than 80% of pertussis cases occurred among age-appropriately vaccinated children,” the team wrote. “Children who were further away from their last DTaP dose were at increased risk of pertussis, even after controlling for undervaccination. Our results suggest that, in this population, possibly in conjunction with other factors not addressed in this study, suboptimal vaccine efficacy and waning [immunity] played a major role in recent pertussis epidemics.”
The results are consistent with several prior studies, including one finding that the odds of the disease increased by 33% for every additional year after the third or fifth DTaP dose (Pediatrics. 2015;135[2]:331-43).
The current study comprised 469,982 children aged between 3 months and 11 years, who were followed for a mean of 4.6 years. Over the entire study period, there were 738 lab-confirmed pertussis cases. Most of these (515; 70%) occurred in fully vaccinated children. Another 99 (13%) occurred in unvaccinated children, 36 (5%) in undervaccinated children, and 88 (12%) in fully vaccinated plus one dose.
In a multivariate analysis, the risk of pertussis was 13 times higher among the unvaccinated (adjusted hazard ratio, 13) and almost 2 times higher among the undervaccinated (aHR, 1.9), compared with fully vaccinated children. Those who had been fully vaccinated and received a booster had the lowest risk, about half that of fully vaccinated children (aHR, 0.48).
Risk varied according to age, but also was significantly higher among unvaccinated children at each time point. Risk ranged from 4 times higher among those aged 3-5 months to 23 times higher among those aged 19-84 months. Undervaccinated children aged 5-7 months and 19-84 months also were at significantly increased risk for pertussis, compared with fully vaccinated children. Children who were fully vaccinated plus one dose had a significantly reduced risk at 7-19 months and at 19-84 months, compared with the fully vaccinated reference group.
“Across all follow-up and all age groups, VE [vaccine effectiveness] was 86% ... for undervaccinated children, compared with unvaccinated children,” Dr. Zerbo and associates wrote. “VE was even higher for fully vaccinated children [93%] and for those who were fully vaccinated plus one dose [96%].”
But VE waned as time progressed farther from the last DTaP dose. The multivariate model found more than a 100% increased risk for those whose last DTaP was at least 3 years past, compared with less than 1 year past (aHR, 2.58).
The model also found time-bound risk increases among fully vaccinated children, with a more than 300% increased risk among those at least 6 years out from the last DTaP dose, compared with 3 years out (aHR, 4.66).
The results indicate that other factors besides adherence to the recommended vaccine schedule may be at work in recent pertussis outbreaks.
“Although waning immunity is clearly an important factor driving pertussis epidemics in recent years, other factors that we did not evaluate in this study might also contribute to pertussis epidemics individually or in synergy,” Dr. Zerbo and associates wrote. “Results from studies in baboons suggest that the acellular pertussis vaccines are unable to prevent colonization, carriage, and transmission. If this is also true for humans, this could contribute to pertussis epidemics. The causes of recent pertussis epidemics are complex, and we were only able to address some aspects in our study.”
The study was funded by Kaiser Permanente Northern California, the National Institutes of Health, and in part by a National Institute of Allergy and Infectious Diseases grant. One coauthor reported receiving research grant support from Sanofi Pasteur, Novartis, GlaxoSmithKline, Merck, MedImmune, Pfizer, and Dynavax for unrelated studies; the other authors reported no relevant financial disclosures.
SOURCE: Zerbo O et al. Pediatrics. 2019 Jun 10. doi: 10.1542/peds.2018-3466.
Fixing one problem with the pertussis vaccine seemed to have created another, Kathryn M. Edwards, MD, wrote in an accompanying editorial.
The current acellular vaccine was approved in 1997. It was considered a less reactive substitute for the previous whole-cell vaccine, which was associated with injection site pain, swelling, fever, and febrile seizures, Dr. Edwards wrote. “For about a decade, all seemed to be going well with pertussis control. Serological methods were employed to diagnose pertussis infections in adolescents and adults, and polymerase chain reaction methods were devised to more accurately detect pertussis organisms. Thus, the burden of pertussis disease was increasingly appreciated as the diagnostic methods improved.”
But things soon changed. There were pertussis outbreaks, some of them quite large. The increasing disease rates showed that protection conferred by the acellular vaccine waned much more quickly than that conferred by the whole-cell vaccine. “In the current study, Zerbo et al. add to the body of evidence documenting the increase in pertussis risk with time after DTaP vaccination,” she noted.
This has several practical implications, Dr. Edwards wrote.
“First, given the markedly increased risk of pertussis in unvaccinated and undervaccinated children, universal DTaP vaccination should be strongly recommended. Second, the addition of maternal Tdap vaccination administered during pregnancy has been shown to significantly reduce infant disease before primary immunization and should remain the standard,” Dr. Edwards wrote.
More problematic is how to address the waning DTaP immunity now seen. “One option presented [at an international meeting] was a live-attenuated pertussis vaccine administered intranasally that would stimulate local immune responses and prevent colonization with pertussis organisms. This vaccine is currently being studied in adults and might provide a solution for waning immunity seen with DTaP vaccine,” she noted.
Another possibility is adding the live vaccine to the current DTaP, which should, in theory, stimulate more long-lasting immunity. But numerous safety studies in young children would be necessary before adopting such an approach, Dr. Edwards wrote.
Adding more antigens to the acellular vaccine also might work, and investigational vaccines like this are in development.
Studies in animals and humans show that acellular vaccines “generate functionally different T-cell responses than those seen after whole-cell vaccines, with the whole cell vaccines generating more protective T-cell responses. Studies are ongoing to determine if adjuvants can be added to acellular vaccines to modify their T-cell responses to a more protective immune response or whether the T-cell response remains fixed once primed with DTaP vaccine,” she wrote.
Dr. Edwards is a pediatric infectious disease specialist at Vanderbilt University, Nashville, Tenn. She wrote an editorial to accompany Zerbo et al (Pediatrics. 2019. doi: 10.1542/peds.2019-1276). She reported no financial disclosures, and received no funding to write the editorial.
Fixing one problem with the pertussis vaccine seemed to have created another, Kathryn M. Edwards, MD, wrote in an accompanying editorial.
The current acellular vaccine was approved in 1997. It was considered a less reactive substitute for the previous whole-cell vaccine, which was associated with injection site pain, swelling, fever, and febrile seizures, Dr. Edwards wrote. “For about a decade, all seemed to be going well with pertussis control. Serological methods were employed to diagnose pertussis infections in adolescents and adults, and polymerase chain reaction methods were devised to more accurately detect pertussis organisms. Thus, the burden of pertussis disease was increasingly appreciated as the diagnostic methods improved.”
But things soon changed. There were pertussis outbreaks, some of them quite large. The increasing disease rates showed that protection conferred by the acellular vaccine waned much more quickly than that conferred by the whole-cell vaccine. “In the current study, Zerbo et al. add to the body of evidence documenting the increase in pertussis risk with time after DTaP vaccination,” she noted.
This has several practical implications, Dr. Edwards wrote.
“First, given the markedly increased risk of pertussis in unvaccinated and undervaccinated children, universal DTaP vaccination should be strongly recommended. Second, the addition of maternal Tdap vaccination administered during pregnancy has been shown to significantly reduce infant disease before primary immunization and should remain the standard,” Dr. Edwards wrote.
More problematic is how to address the waning DTaP immunity now seen. “One option presented [at an international meeting] was a live-attenuated pertussis vaccine administered intranasally that would stimulate local immune responses and prevent colonization with pertussis organisms. This vaccine is currently being studied in adults and might provide a solution for waning immunity seen with DTaP vaccine,” she noted.
Another possibility is adding the live vaccine to the current DTaP, which should, in theory, stimulate more long-lasting immunity. But numerous safety studies in young children would be necessary before adopting such an approach, Dr. Edwards wrote.
Adding more antigens to the acellular vaccine also might work, and investigational vaccines like this are in development.
Studies in animals and humans show that acellular vaccines “generate functionally different T-cell responses than those seen after whole-cell vaccines, with the whole cell vaccines generating more protective T-cell responses. Studies are ongoing to determine if adjuvants can be added to acellular vaccines to modify their T-cell responses to a more protective immune response or whether the T-cell response remains fixed once primed with DTaP vaccine,” she wrote.
Dr. Edwards is a pediatric infectious disease specialist at Vanderbilt University, Nashville, Tenn. She wrote an editorial to accompany Zerbo et al (Pediatrics. 2019. doi: 10.1542/peds.2019-1276). She reported no financial disclosures, and received no funding to write the editorial.
Fixing one problem with the pertussis vaccine seemed to have created another, Kathryn M. Edwards, MD, wrote in an accompanying editorial.
The current acellular vaccine was approved in 1997. It was considered a less reactive substitute for the previous whole-cell vaccine, which was associated with injection site pain, swelling, fever, and febrile seizures, Dr. Edwards wrote. “For about a decade, all seemed to be going well with pertussis control. Serological methods were employed to diagnose pertussis infections in adolescents and adults, and polymerase chain reaction methods were devised to more accurately detect pertussis organisms. Thus, the burden of pertussis disease was increasingly appreciated as the diagnostic methods improved.”
But things soon changed. There were pertussis outbreaks, some of them quite large. The increasing disease rates showed that protection conferred by the acellular vaccine waned much more quickly than that conferred by the whole-cell vaccine. “In the current study, Zerbo et al. add to the body of evidence documenting the increase in pertussis risk with time after DTaP vaccination,” she noted.
This has several practical implications, Dr. Edwards wrote.
“First, given the markedly increased risk of pertussis in unvaccinated and undervaccinated children, universal DTaP vaccination should be strongly recommended. Second, the addition of maternal Tdap vaccination administered during pregnancy has been shown to significantly reduce infant disease before primary immunization and should remain the standard,” Dr. Edwards wrote.
More problematic is how to address the waning DTaP immunity now seen. “One option presented [at an international meeting] was a live-attenuated pertussis vaccine administered intranasally that would stimulate local immune responses and prevent colonization with pertussis organisms. This vaccine is currently being studied in adults and might provide a solution for waning immunity seen with DTaP vaccine,” she noted.
Another possibility is adding the live vaccine to the current DTaP, which should, in theory, stimulate more long-lasting immunity. But numerous safety studies in young children would be necessary before adopting such an approach, Dr. Edwards wrote.
Adding more antigens to the acellular vaccine also might work, and investigational vaccines like this are in development.
Studies in animals and humans show that acellular vaccines “generate functionally different T-cell responses than those seen after whole-cell vaccines, with the whole cell vaccines generating more protective T-cell responses. Studies are ongoing to determine if adjuvants can be added to acellular vaccines to modify their T-cell responses to a more protective immune response or whether the T-cell response remains fixed once primed with DTaP vaccine,” she wrote.
Dr. Edwards is a pediatric infectious disease specialist at Vanderbilt University, Nashville, Tenn. She wrote an editorial to accompany Zerbo et al (Pediatrics. 2019. doi: 10.1542/peds.2019-1276). She reported no financial disclosures, and received no funding to write the editorial.
A large Kaiser Permanente study paints a nuanced picture of the acellular pertussis vaccine, with more cases occurring in fully vaccinated children, but the highest risk of disease occurring among the under- and unvaccinated.
Among nearly half a million children, the unvaccinated were 13 times more likely to develop pertussis than fully vaccinated children, Ousseny Zerbo, PhD, of Kaiser Permanente Northern California in Oakland and colleagues wrote in Pediatrics. But 82% of cases occurred in fully vaccinated children and just 5% in undervaccinated children – and rates increased in both groups the farther they were in time from the last vaccination.
“Within our study population, greater than 80% of pertussis cases occurred among age-appropriately vaccinated children,” the team wrote. “Children who were further away from their last DTaP dose were at increased risk of pertussis, even after controlling for undervaccination. Our results suggest that, in this population, possibly in conjunction with other factors not addressed in this study, suboptimal vaccine efficacy and waning [immunity] played a major role in recent pertussis epidemics.”
The results are consistent with several prior studies, including one finding that the odds of the disease increased by 33% for every additional year after the third or fifth DTaP dose (Pediatrics. 2015;135[2]:331-43).
The current study comprised 469,982 children aged between 3 months and 11 years, who were followed for a mean of 4.6 years. Over the entire study period, there were 738 lab-confirmed pertussis cases. Most of these (515; 70%) occurred in fully vaccinated children. Another 99 (13%) occurred in unvaccinated children, 36 (5%) in undervaccinated children, and 88 (12%) in fully vaccinated plus one dose.
In a multivariate analysis, the risk of pertussis was 13 times higher among the unvaccinated (adjusted hazard ratio, 13) and almost 2 times higher among the undervaccinated (aHR, 1.9), compared with fully vaccinated children. Those who had been fully vaccinated and received a booster had the lowest risk, about half that of fully vaccinated children (aHR, 0.48).
Risk varied according to age, but also was significantly higher among unvaccinated children at each time point. Risk ranged from 4 times higher among those aged 3-5 months to 23 times higher among those aged 19-84 months. Undervaccinated children aged 5-7 months and 19-84 months also were at significantly increased risk for pertussis, compared with fully vaccinated children. Children who were fully vaccinated plus one dose had a significantly reduced risk at 7-19 months and at 19-84 months, compared with the fully vaccinated reference group.
“Across all follow-up and all age groups, VE [vaccine effectiveness] was 86% ... for undervaccinated children, compared with unvaccinated children,” Dr. Zerbo and associates wrote. “VE was even higher for fully vaccinated children [93%] and for those who were fully vaccinated plus one dose [96%].”
But VE waned as time progressed farther from the last DTaP dose. The multivariate model found more than a 100% increased risk for those whose last DTaP was at least 3 years past, compared with less than 1 year past (aHR, 2.58).
The model also found time-bound risk increases among fully vaccinated children, with a more than 300% increased risk among those at least 6 years out from the last DTaP dose, compared with 3 years out (aHR, 4.66).
The results indicate that other factors besides adherence to the recommended vaccine schedule may be at work in recent pertussis outbreaks.
“Although waning immunity is clearly an important factor driving pertussis epidemics in recent years, other factors that we did not evaluate in this study might also contribute to pertussis epidemics individually or in synergy,” Dr. Zerbo and associates wrote. “Results from studies in baboons suggest that the acellular pertussis vaccines are unable to prevent colonization, carriage, and transmission. If this is also true for humans, this could contribute to pertussis epidemics. The causes of recent pertussis epidemics are complex, and we were only able to address some aspects in our study.”
The study was funded by Kaiser Permanente Northern California, the National Institutes of Health, and in part by a National Institute of Allergy and Infectious Diseases grant. One coauthor reported receiving research grant support from Sanofi Pasteur, Novartis, GlaxoSmithKline, Merck, MedImmune, Pfizer, and Dynavax for unrelated studies; the other authors reported no relevant financial disclosures.
SOURCE: Zerbo O et al. Pediatrics. 2019 Jun 10. doi: 10.1542/peds.2018-3466.
A large Kaiser Permanente study paints a nuanced picture of the acellular pertussis vaccine, with more cases occurring in fully vaccinated children, but the highest risk of disease occurring among the under- and unvaccinated.
Among nearly half a million children, the unvaccinated were 13 times more likely to develop pertussis than fully vaccinated children, Ousseny Zerbo, PhD, of Kaiser Permanente Northern California in Oakland and colleagues wrote in Pediatrics. But 82% of cases occurred in fully vaccinated children and just 5% in undervaccinated children – and rates increased in both groups the farther they were in time from the last vaccination.
“Within our study population, greater than 80% of pertussis cases occurred among age-appropriately vaccinated children,” the team wrote. “Children who were further away from their last DTaP dose were at increased risk of pertussis, even after controlling for undervaccination. Our results suggest that, in this population, possibly in conjunction with other factors not addressed in this study, suboptimal vaccine efficacy and waning [immunity] played a major role in recent pertussis epidemics.”
The results are consistent with several prior studies, including one finding that the odds of the disease increased by 33% for every additional year after the third or fifth DTaP dose (Pediatrics. 2015;135[2]:331-43).
The current study comprised 469,982 children aged between 3 months and 11 years, who were followed for a mean of 4.6 years. Over the entire study period, there were 738 lab-confirmed pertussis cases. Most of these (515; 70%) occurred in fully vaccinated children. Another 99 (13%) occurred in unvaccinated children, 36 (5%) in undervaccinated children, and 88 (12%) in fully vaccinated plus one dose.
In a multivariate analysis, the risk of pertussis was 13 times higher among the unvaccinated (adjusted hazard ratio, 13) and almost 2 times higher among the undervaccinated (aHR, 1.9), compared with fully vaccinated children. Those who had been fully vaccinated and received a booster had the lowest risk, about half that of fully vaccinated children (aHR, 0.48).
Risk varied according to age, but also was significantly higher among unvaccinated children at each time point. Risk ranged from 4 times higher among those aged 3-5 months to 23 times higher among those aged 19-84 months. Undervaccinated children aged 5-7 months and 19-84 months also were at significantly increased risk for pertussis, compared with fully vaccinated children. Children who were fully vaccinated plus one dose had a significantly reduced risk at 7-19 months and at 19-84 months, compared with the fully vaccinated reference group.
“Across all follow-up and all age groups, VE [vaccine effectiveness] was 86% ... for undervaccinated children, compared with unvaccinated children,” Dr. Zerbo and associates wrote. “VE was even higher for fully vaccinated children [93%] and for those who were fully vaccinated plus one dose [96%].”
But VE waned as time progressed farther from the last DTaP dose. The multivariate model found more than a 100% increased risk for those whose last DTaP was at least 3 years past, compared with less than 1 year past (aHR, 2.58).
The model also found time-bound risk increases among fully vaccinated children, with a more than 300% increased risk among those at least 6 years out from the last DTaP dose, compared with 3 years out (aHR, 4.66).
The results indicate that other factors besides adherence to the recommended vaccine schedule may be at work in recent pertussis outbreaks.
“Although waning immunity is clearly an important factor driving pertussis epidemics in recent years, other factors that we did not evaluate in this study might also contribute to pertussis epidemics individually or in synergy,” Dr. Zerbo and associates wrote. “Results from studies in baboons suggest that the acellular pertussis vaccines are unable to prevent colonization, carriage, and transmission. If this is also true for humans, this could contribute to pertussis epidemics. The causes of recent pertussis epidemics are complex, and we were only able to address some aspects in our study.”
The study was funded by Kaiser Permanente Northern California, the National Institutes of Health, and in part by a National Institute of Allergy and Infectious Diseases grant. One coauthor reported receiving research grant support from Sanofi Pasteur, Novartis, GlaxoSmithKline, Merck, MedImmune, Pfizer, and Dynavax for unrelated studies; the other authors reported no relevant financial disclosures.
SOURCE: Zerbo O et al. Pediatrics. 2019 Jun 10. doi: 10.1542/peds.2018-3466.
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