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Action and awareness are needed to increase immunization rates
August was National Immunization Awareness Month. ... just in time to address the precipitous drop in immunization delivered during the early months of the pandemic.
In May, the Centers for Disease Control and Prevention reported substantial reductions in vaccine doses ordered through the Vaccines for Children program after the declaration of national emergency because of COVID-19 on March 13. Approximately 2.5 million fewer doses of routine, noninfluenza vaccines were administered between Jan. 6 and April 2020, compared with a similar period last year (MMWR Morb Mortal Wkly Rep. 2020 May 15;69[19]:591-3). Declines in immunization rates were echoed by states and municipalities across the United States. Last month, the health system in which I work reported 40,000 children behind on at least one vaccine.
We all know that, when immunization rates drop, outbreaks of vaccine-preventable diseases follow. In order and that is going to take more than a single month.
Identify patients who’ve missed vaccinations
Simply being open and ready to vaccinate is not enough. The Centers for Disease Control and Prevention urges providers to identify patients who have missed vaccines, and call them to schedule in-person visits. Proactively let parents know about strategies implemented in your office to ensure a safe environment.
Pediatricians are accustomed to an influx of patients in the summer, as parents make sure their children have all of the vaccines required for school attendance. As noted in a Washington Post article from Aug. 4, 2020, schools have traditionally served as a backstop for immunization rates. But as many school districts opt to take education online this fall, the implications for vaccine requirements are unclear. District of Columbia public schools continue to require immunization for virtual school attendance, but it is not clear how easily this can be enforced. To read about how other school districts have chosen to address – or not address – immunization requirements for school, visit the the Immunization Action Coalition’s Repository of Resources for Maintaining Immunization during the COVID-19 Pandemic. The repository links to international, national, and state-level policies and guidance and advocacy materials, including talking points, webinars, press releases, media articles from around the United States and social media posts, as well as telehealth resources.
Get some inspiration to talk about vaccination
Need a little inspiration for talking to parents about vaccines? Check out the CDC’s #HowIRecommend video series. These are short videos, most under a minute in length, that explain the importance of vaccination, how to effectively address questions from parents about vaccine safety, and how clinicians routinely recommend same day vaccination to their patients. These videos are part of the CDC’s National Immunization Awareness Month (NIAM) toolkit for communication with health care professionals. A companion toolkit for communicating with parents and patients contains sample social media messages with graphics, along with educational resources to share with parents.
The “Comprehensive Vaccine Education Program – From Training to Practice,” a free online program offered by the Pediatric Infectious Diseases Society, takes a deeper dive into strategies to combat vaccine misinformation and address vaccine hesitancy. Available modules cover vaccine fundamentals, vaccine safety, clinical manifestations of vaccine-preventable diseases, and communication skills that lead to more effective conversations with patients and parents. The curriculum also includes the newest edition of The Vaccine Handbook app, a comprehensive source of practical information for vaccine providers.
Educate young children about vaccines
Don’t leave young children out of the conversation. Vax-Force is a children’s book that explores how vaccination works inside the human body. Dr. Vaxson the pediatrician explains how trusted doctors and scientists made Vicky the Vaccine. Her mission is to tell Willy the White Blood Cell and his Antibuddies how to find and fight bad-guy germs like measles, tetanus, and polio. The book was written by Kelsey Rowe, MD, while she was a medical student at Saint Louis University School of Medicine. Dr. Rowe, now a pediatric resident, notes, “In a world where anti-vaccination rhetoric threatens the health of our global community, this book’s mission is to teach children and adults alike that getting vaccinations is a safe, effective, and even exciting thing to do.” The book is available for purchase at https://www.vax-force.com/, and a small part of every sale is donated to Unicef USA.
Consider vaccination advocacy in your communities
Vaccinate Your Family, a national, nonprofit organization dedicated to protecting people of all ages from vaccine-preventable diseases, suggests that health care providers need to take an active role in raising immunization rates, not just in their own practices, but in their communities. One way to do this is to submit an opinion piece or letter to the editor to a local newspaper describing why it’s important for parents to make sure their child’s immunizations are current. Those who have never written an opinion-editorial should look at the guidance developed by Voices for Vaccines.
How are we doing?
Early data suggest a rebound in immunization rates in May and June, but that is unlikely to close the gap created by disruptions in health care delivery earlier in the year. Collectively, we need to set ambitious goals. Are we just trying to reach prepandemic immunization levels? In Kentucky, where I practice, only 71% of kids aged 19-45 months had received all doses of seven routinely recommended vaccines (≥4 DTaP doses, ≥3 polio doses, ≥1 MMR dose, Hib full series, ≥3 HepB doses, ≥1 varicella dose, and ≥4 PCV doses) based on 2017 National Immunization Survey data. The Healthy People 2020 target goal is 80%. Only 55% of Kentucky girls aged 13-17 years received at least one dose of HPV vaccine, and rates in boys were even lower. Flu vaccine coverage in children 6 months to 17 years also was 55%. The status quo sets the bar too low. To see how your state is doing, check out the interactive map developed by the American Academy of Pediatrics.
Are we attempting to avoid disaster or can we seize the opportunity to protect more children than ever from vaccine-preventable diseases? The latter would really be something to celebrate.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].
August was National Immunization Awareness Month. ... just in time to address the precipitous drop in immunization delivered during the early months of the pandemic.
In May, the Centers for Disease Control and Prevention reported substantial reductions in vaccine doses ordered through the Vaccines for Children program after the declaration of national emergency because of COVID-19 on March 13. Approximately 2.5 million fewer doses of routine, noninfluenza vaccines were administered between Jan. 6 and April 2020, compared with a similar period last year (MMWR Morb Mortal Wkly Rep. 2020 May 15;69[19]:591-3). Declines in immunization rates were echoed by states and municipalities across the United States. Last month, the health system in which I work reported 40,000 children behind on at least one vaccine.
We all know that, when immunization rates drop, outbreaks of vaccine-preventable diseases follow. In order and that is going to take more than a single month.
Identify patients who’ve missed vaccinations
Simply being open and ready to vaccinate is not enough. The Centers for Disease Control and Prevention urges providers to identify patients who have missed vaccines, and call them to schedule in-person visits. Proactively let parents know about strategies implemented in your office to ensure a safe environment.
Pediatricians are accustomed to an influx of patients in the summer, as parents make sure their children have all of the vaccines required for school attendance. As noted in a Washington Post article from Aug. 4, 2020, schools have traditionally served as a backstop for immunization rates. But as many school districts opt to take education online this fall, the implications for vaccine requirements are unclear. District of Columbia public schools continue to require immunization for virtual school attendance, but it is not clear how easily this can be enforced. To read about how other school districts have chosen to address – or not address – immunization requirements for school, visit the the Immunization Action Coalition’s Repository of Resources for Maintaining Immunization during the COVID-19 Pandemic. The repository links to international, national, and state-level policies and guidance and advocacy materials, including talking points, webinars, press releases, media articles from around the United States and social media posts, as well as telehealth resources.
Get some inspiration to talk about vaccination
Need a little inspiration for talking to parents about vaccines? Check out the CDC’s #HowIRecommend video series. These are short videos, most under a minute in length, that explain the importance of vaccination, how to effectively address questions from parents about vaccine safety, and how clinicians routinely recommend same day vaccination to their patients. These videos are part of the CDC’s National Immunization Awareness Month (NIAM) toolkit for communication with health care professionals. A companion toolkit for communicating with parents and patients contains sample social media messages with graphics, along with educational resources to share with parents.
The “Comprehensive Vaccine Education Program – From Training to Practice,” a free online program offered by the Pediatric Infectious Diseases Society, takes a deeper dive into strategies to combat vaccine misinformation and address vaccine hesitancy. Available modules cover vaccine fundamentals, vaccine safety, clinical manifestations of vaccine-preventable diseases, and communication skills that lead to more effective conversations with patients and parents. The curriculum also includes the newest edition of The Vaccine Handbook app, a comprehensive source of practical information for vaccine providers.
Educate young children about vaccines
Don’t leave young children out of the conversation. Vax-Force is a children’s book that explores how vaccination works inside the human body. Dr. Vaxson the pediatrician explains how trusted doctors and scientists made Vicky the Vaccine. Her mission is to tell Willy the White Blood Cell and his Antibuddies how to find and fight bad-guy germs like measles, tetanus, and polio. The book was written by Kelsey Rowe, MD, while she was a medical student at Saint Louis University School of Medicine. Dr. Rowe, now a pediatric resident, notes, “In a world where anti-vaccination rhetoric threatens the health of our global community, this book’s mission is to teach children and adults alike that getting vaccinations is a safe, effective, and even exciting thing to do.” The book is available for purchase at https://www.vax-force.com/, and a small part of every sale is donated to Unicef USA.
Consider vaccination advocacy in your communities
Vaccinate Your Family, a national, nonprofit organization dedicated to protecting people of all ages from vaccine-preventable diseases, suggests that health care providers need to take an active role in raising immunization rates, not just in their own practices, but in their communities. One way to do this is to submit an opinion piece or letter to the editor to a local newspaper describing why it’s important for parents to make sure their child’s immunizations are current. Those who have never written an opinion-editorial should look at the guidance developed by Voices for Vaccines.
How are we doing?
Early data suggest a rebound in immunization rates in May and June, but that is unlikely to close the gap created by disruptions in health care delivery earlier in the year. Collectively, we need to set ambitious goals. Are we just trying to reach prepandemic immunization levels? In Kentucky, where I practice, only 71% of kids aged 19-45 months had received all doses of seven routinely recommended vaccines (≥4 DTaP doses, ≥3 polio doses, ≥1 MMR dose, Hib full series, ≥3 HepB doses, ≥1 varicella dose, and ≥4 PCV doses) based on 2017 National Immunization Survey data. The Healthy People 2020 target goal is 80%. Only 55% of Kentucky girls aged 13-17 years received at least one dose of HPV vaccine, and rates in boys were even lower. Flu vaccine coverage in children 6 months to 17 years also was 55%. The status quo sets the bar too low. To see how your state is doing, check out the interactive map developed by the American Academy of Pediatrics.
Are we attempting to avoid disaster or can we seize the opportunity to protect more children than ever from vaccine-preventable diseases? The latter would really be something to celebrate.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].
August was National Immunization Awareness Month. ... just in time to address the precipitous drop in immunization delivered during the early months of the pandemic.
In May, the Centers for Disease Control and Prevention reported substantial reductions in vaccine doses ordered through the Vaccines for Children program after the declaration of national emergency because of COVID-19 on March 13. Approximately 2.5 million fewer doses of routine, noninfluenza vaccines were administered between Jan. 6 and April 2020, compared with a similar period last year (MMWR Morb Mortal Wkly Rep. 2020 May 15;69[19]:591-3). Declines in immunization rates were echoed by states and municipalities across the United States. Last month, the health system in which I work reported 40,000 children behind on at least one vaccine.
We all know that, when immunization rates drop, outbreaks of vaccine-preventable diseases follow. In order and that is going to take more than a single month.
Identify patients who’ve missed vaccinations
Simply being open and ready to vaccinate is not enough. The Centers for Disease Control and Prevention urges providers to identify patients who have missed vaccines, and call them to schedule in-person visits. Proactively let parents know about strategies implemented in your office to ensure a safe environment.
Pediatricians are accustomed to an influx of patients in the summer, as parents make sure their children have all of the vaccines required for school attendance. As noted in a Washington Post article from Aug. 4, 2020, schools have traditionally served as a backstop for immunization rates. But as many school districts opt to take education online this fall, the implications for vaccine requirements are unclear. District of Columbia public schools continue to require immunization for virtual school attendance, but it is not clear how easily this can be enforced. To read about how other school districts have chosen to address – or not address – immunization requirements for school, visit the the Immunization Action Coalition’s Repository of Resources for Maintaining Immunization during the COVID-19 Pandemic. The repository links to international, national, and state-level policies and guidance and advocacy materials, including talking points, webinars, press releases, media articles from around the United States and social media posts, as well as telehealth resources.
Get some inspiration to talk about vaccination
Need a little inspiration for talking to parents about vaccines? Check out the CDC’s #HowIRecommend video series. These are short videos, most under a minute in length, that explain the importance of vaccination, how to effectively address questions from parents about vaccine safety, and how clinicians routinely recommend same day vaccination to their patients. These videos are part of the CDC’s National Immunization Awareness Month (NIAM) toolkit for communication with health care professionals. A companion toolkit for communicating with parents and patients contains sample social media messages with graphics, along with educational resources to share with parents.
The “Comprehensive Vaccine Education Program – From Training to Practice,” a free online program offered by the Pediatric Infectious Diseases Society, takes a deeper dive into strategies to combat vaccine misinformation and address vaccine hesitancy. Available modules cover vaccine fundamentals, vaccine safety, clinical manifestations of vaccine-preventable diseases, and communication skills that lead to more effective conversations with patients and parents. The curriculum also includes the newest edition of The Vaccine Handbook app, a comprehensive source of practical information for vaccine providers.
Educate young children about vaccines
Don’t leave young children out of the conversation. Vax-Force is a children’s book that explores how vaccination works inside the human body. Dr. Vaxson the pediatrician explains how trusted doctors and scientists made Vicky the Vaccine. Her mission is to tell Willy the White Blood Cell and his Antibuddies how to find and fight bad-guy germs like measles, tetanus, and polio. The book was written by Kelsey Rowe, MD, while she was a medical student at Saint Louis University School of Medicine. Dr. Rowe, now a pediatric resident, notes, “In a world where anti-vaccination rhetoric threatens the health of our global community, this book’s mission is to teach children and adults alike that getting vaccinations is a safe, effective, and even exciting thing to do.” The book is available for purchase at https://www.vax-force.com/, and a small part of every sale is donated to Unicef USA.
Consider vaccination advocacy in your communities
Vaccinate Your Family, a national, nonprofit organization dedicated to protecting people of all ages from vaccine-preventable diseases, suggests that health care providers need to take an active role in raising immunization rates, not just in their own practices, but in their communities. One way to do this is to submit an opinion piece or letter to the editor to a local newspaper describing why it’s important for parents to make sure their child’s immunizations are current. Those who have never written an opinion-editorial should look at the guidance developed by Voices for Vaccines.
How are we doing?
Early data suggest a rebound in immunization rates in May and June, but that is unlikely to close the gap created by disruptions in health care delivery earlier in the year. Collectively, we need to set ambitious goals. Are we just trying to reach prepandemic immunization levels? In Kentucky, where I practice, only 71% of kids aged 19-45 months had received all doses of seven routinely recommended vaccines (≥4 DTaP doses, ≥3 polio doses, ≥1 MMR dose, Hib full series, ≥3 HepB doses, ≥1 varicella dose, and ≥4 PCV doses) based on 2017 National Immunization Survey data. The Healthy People 2020 target goal is 80%. Only 55% of Kentucky girls aged 13-17 years received at least one dose of HPV vaccine, and rates in boys were even lower. Flu vaccine coverage in children 6 months to 17 years also was 55%. The status quo sets the bar too low. To see how your state is doing, check out the interactive map developed by the American Academy of Pediatrics.
Are we attempting to avoid disaster or can we seize the opportunity to protect more children than ever from vaccine-preventable diseases? The latter would really be something to celebrate.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].
ACS disagrees with CDC on HPV vaccination in adults
The ACS has endorsed two recommendations made by the CDC’s Advisory Committee on Immunization Practices, but the ACS does not agree with a third recommendation for older adults.
The ACIP recommends shared clinical decision-making regarding human papillomavirus (HPV) vaccination in some adults aged 27-45 years who are not adequately vaccinated. The ACS does not endorse this recommendation “because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision-making on patients and clinicians, and the lack of sufficient guidance on the selection of individuals who might benefit,” wrote Debbie Saslow, PhD, of the ACS’s section on human papillomavirus and gynecologic cancers, and colleagues.
Dr. Saslow and colleagues detailed the ACS recommendations in CA: A Cancer Journal for Clinicians.
The HPV vaccine protects against the virus that can cause cervical, oropharyngeal, anal, vaginal, vulvar, and penile cancers. For younger people, the ACIP recommends routine HPV vaccination of boys and girls aged 9-12 years and catch-up vaccination in everyone up to age 26 who has not been fully immunized against HPV.
The ACS endorses both of these recommendations. It also advises clinicians to tell patients aged 22-26 years who haven’t received the HPV vaccine or completed the series that the vaccine is less effective at reducing the risk of cancer at older ages.
After the Food and Drug Administration approved the HPV vaccine for adults aged 27-45 years, the ACIP updated its recommendations to state that routine catch-up vaccination is not recommended for anyone aged over 26 years. However, the ACIP recommended that these older adults talk with their providers about the risks and benefits of the vaccine to determine whether to get it.
The ACS subsequently conducted a methodological review of the ACIP’s recommendations and published its own adapted guidance, stating that the ACS does not endorse the shared decision-making. Administering the HPV vaccine to adults aged over 26 years would only prevent an estimated 0.5% of additional cancer cases, 0.4% additional cases of cervical precancer, and 0.3% additional cases of genital warts over the next 100 years, compared with vaccination under age 26.
“In addition to the low effectiveness and low cancer prevention potential of vaccination in this age group, other considerations included the burden of decision-making on patients and clinicians and the lack of sufficient guidance on the selection of individuals who might benefit,” according to the guidance. The ACS also expressed concern that these provider-patient discussions could interfere with the public health goal of increasing HPV vaccination in younger people.
HPV vaccination rates have lagged substantially behind other routinely recommended childhood vaccinations. Just over half (51%) of U.S. teens aged 13-17 years were up to date with HPV vaccination, and 68% had received one dose of the vaccine in 2018, according to the National Immunization Survey.
It’s very uncommon for a professional medical organization to not endorse recommendations from the CDC, particularly with vaccines, according to Robert A. Bednarczyk, PhD, an assistant professor of public health at Emory University, Atlanta, who specializes in HPV vaccination research but was not involved with the ACS statement or the ACIP recommendations.
“Often, for vaccination recommendations, there is a harmonization between health care provider organizations, such as the American Academy of Pediatrics, American Academy of Family Physicians, etc., when new vaccination schedules are released,” Dr. Bednarczyk said.
He acknowledged the ACS’s reasons for not endorsing the ACIP’s HPV recommendations in older adults: the burden of shared decision-making given the communication issues, the vaccine’s lower effectiveness in this population, and the ongoing HPV vaccine shortage.
But Dr. Bednarczyk also pointed out that the ACIP’s recommendation opens the door to these discussions when they may actually be needed, such as in adults at greater risk for HPV. He cited data suggesting that, in 2015, divorces occurred in 24 out of 1,000 married people aged 25-39 years and 21 out of 1,000 people aged 40-49.
“When you consider these marriages that end, in addition to marriages that end when one spouse dies, there is a potential for individuals who previously had a low risk of HPV acquisition now entering into new potential sexual relationships,” Dr. Bednarczyk said. “Additionally, it has been estimated that approximately 4% of the U.S. population are in open or consensually nonmonogamous relationships, where exposure to more sexual partners may increase their risk for HPV. These are just some examples of where conversations with health care providers, and shared clinical decision-making, can help with a targeted reduction of HPV risk.”
The ACIP recommendation regarding adults aged 27-45 years also provides people in this age group with insurance coverage for the HPV vaccine if they choose to get it, Dr. Bednarczyk pointed out. Insurance companies may not be required to cover HPV vaccination in people aged over 26 years without the CDC’s recommendation, even if it’s not for routine immunization.
Dr. Bednarczyk agreed, however, with how the ACS adapted the CDC’s recommendation for routine vaccination in youth. The CDC’s routine recommendation is at ages 11-12 but can begin at 9 years, according to the ACIP. The ACS guidance qualifies this statement to place more emphasis on encouraging the vaccine earlier.
“Routine HPV vaccination between ages 9-12 is expected to achieve higher on-time vaccination rates, resulting in increased numbers of cancers prevented,” according to the ACS. “Health care providers are encouraged to start offering the HPV vaccine at age 9 or 10.”
Dr. Bednarczyk pointed to some of his past research finding low proportions of teens fully vaccinated against HPV by age 13 years (J Infect Dis. 2019 Jul 31;220[5]:730-4). Therefore, “any efforts to encourage vaccination, including starting the series at ages 9-10 years may help,” he said.
He also agreed that there may be diminished effectiveness with vaccinating adults aged 22-26, “but this should also be considered relative to an individual’s risk of acquiring HPV.”
While an HPV vaccine shortage is a major concern and HPV vaccination efforts should remain most focused on young teens, adults should not necessarily be neglected, Dr. Bednarczyk noted.
“Given how common HPV infection is in the population, open discussion between patients and health care providers can help identify those adults for whom HPV vaccination can be effective,” he said.
The development of the ACS guideline was supported by ACS operational funds. The ACS has received an independent educational grant from Merck Sharp & Dohme for a project intended to increase HPV vaccination rates. Dr. Saslow is the principal investigator for a cooperative agreement between the ACS and the CDC to support the National HPV Vaccination Roundtable and is coprincipal investigator of a cooperative agreement between the ACS and CDC to support initiatives to increase HPV vaccination. The remaining authors and Dr. Bednarczyk reported no relevant disclosures.
SOURCE: Saslow D et al. CA Cancer J Clin. 2020 Jul 8. doi: 10.3322/caac.21616.
The ACS has endorsed two recommendations made by the CDC’s Advisory Committee on Immunization Practices, but the ACS does not agree with a third recommendation for older adults.
The ACIP recommends shared clinical decision-making regarding human papillomavirus (HPV) vaccination in some adults aged 27-45 years who are not adequately vaccinated. The ACS does not endorse this recommendation “because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision-making on patients and clinicians, and the lack of sufficient guidance on the selection of individuals who might benefit,” wrote Debbie Saslow, PhD, of the ACS’s section on human papillomavirus and gynecologic cancers, and colleagues.
Dr. Saslow and colleagues detailed the ACS recommendations in CA: A Cancer Journal for Clinicians.
The HPV vaccine protects against the virus that can cause cervical, oropharyngeal, anal, vaginal, vulvar, and penile cancers. For younger people, the ACIP recommends routine HPV vaccination of boys and girls aged 9-12 years and catch-up vaccination in everyone up to age 26 who has not been fully immunized against HPV.
The ACS endorses both of these recommendations. It also advises clinicians to tell patients aged 22-26 years who haven’t received the HPV vaccine or completed the series that the vaccine is less effective at reducing the risk of cancer at older ages.
After the Food and Drug Administration approved the HPV vaccine for adults aged 27-45 years, the ACIP updated its recommendations to state that routine catch-up vaccination is not recommended for anyone aged over 26 years. However, the ACIP recommended that these older adults talk with their providers about the risks and benefits of the vaccine to determine whether to get it.
The ACS subsequently conducted a methodological review of the ACIP’s recommendations and published its own adapted guidance, stating that the ACS does not endorse the shared decision-making. Administering the HPV vaccine to adults aged over 26 years would only prevent an estimated 0.5% of additional cancer cases, 0.4% additional cases of cervical precancer, and 0.3% additional cases of genital warts over the next 100 years, compared with vaccination under age 26.
“In addition to the low effectiveness and low cancer prevention potential of vaccination in this age group, other considerations included the burden of decision-making on patients and clinicians and the lack of sufficient guidance on the selection of individuals who might benefit,” according to the guidance. The ACS also expressed concern that these provider-patient discussions could interfere with the public health goal of increasing HPV vaccination in younger people.
HPV vaccination rates have lagged substantially behind other routinely recommended childhood vaccinations. Just over half (51%) of U.S. teens aged 13-17 years were up to date with HPV vaccination, and 68% had received one dose of the vaccine in 2018, according to the National Immunization Survey.
It’s very uncommon for a professional medical organization to not endorse recommendations from the CDC, particularly with vaccines, according to Robert A. Bednarczyk, PhD, an assistant professor of public health at Emory University, Atlanta, who specializes in HPV vaccination research but was not involved with the ACS statement or the ACIP recommendations.
“Often, for vaccination recommendations, there is a harmonization between health care provider organizations, such as the American Academy of Pediatrics, American Academy of Family Physicians, etc., when new vaccination schedules are released,” Dr. Bednarczyk said.
He acknowledged the ACS’s reasons for not endorsing the ACIP’s HPV recommendations in older adults: the burden of shared decision-making given the communication issues, the vaccine’s lower effectiveness in this population, and the ongoing HPV vaccine shortage.
But Dr. Bednarczyk also pointed out that the ACIP’s recommendation opens the door to these discussions when they may actually be needed, such as in adults at greater risk for HPV. He cited data suggesting that, in 2015, divorces occurred in 24 out of 1,000 married people aged 25-39 years and 21 out of 1,000 people aged 40-49.
“When you consider these marriages that end, in addition to marriages that end when one spouse dies, there is a potential for individuals who previously had a low risk of HPV acquisition now entering into new potential sexual relationships,” Dr. Bednarczyk said. “Additionally, it has been estimated that approximately 4% of the U.S. population are in open or consensually nonmonogamous relationships, where exposure to more sexual partners may increase their risk for HPV. These are just some examples of where conversations with health care providers, and shared clinical decision-making, can help with a targeted reduction of HPV risk.”
The ACIP recommendation regarding adults aged 27-45 years also provides people in this age group with insurance coverage for the HPV vaccine if they choose to get it, Dr. Bednarczyk pointed out. Insurance companies may not be required to cover HPV vaccination in people aged over 26 years without the CDC’s recommendation, even if it’s not for routine immunization.
Dr. Bednarczyk agreed, however, with how the ACS adapted the CDC’s recommendation for routine vaccination in youth. The CDC’s routine recommendation is at ages 11-12 but can begin at 9 years, according to the ACIP. The ACS guidance qualifies this statement to place more emphasis on encouraging the vaccine earlier.
“Routine HPV vaccination between ages 9-12 is expected to achieve higher on-time vaccination rates, resulting in increased numbers of cancers prevented,” according to the ACS. “Health care providers are encouraged to start offering the HPV vaccine at age 9 or 10.”
Dr. Bednarczyk pointed to some of his past research finding low proportions of teens fully vaccinated against HPV by age 13 years (J Infect Dis. 2019 Jul 31;220[5]:730-4). Therefore, “any efforts to encourage vaccination, including starting the series at ages 9-10 years may help,” he said.
He also agreed that there may be diminished effectiveness with vaccinating adults aged 22-26, “but this should also be considered relative to an individual’s risk of acquiring HPV.”
While an HPV vaccine shortage is a major concern and HPV vaccination efforts should remain most focused on young teens, adults should not necessarily be neglected, Dr. Bednarczyk noted.
“Given how common HPV infection is in the population, open discussion between patients and health care providers can help identify those adults for whom HPV vaccination can be effective,” he said.
The development of the ACS guideline was supported by ACS operational funds. The ACS has received an independent educational grant from Merck Sharp & Dohme for a project intended to increase HPV vaccination rates. Dr. Saslow is the principal investigator for a cooperative agreement between the ACS and the CDC to support the National HPV Vaccination Roundtable and is coprincipal investigator of a cooperative agreement between the ACS and CDC to support initiatives to increase HPV vaccination. The remaining authors and Dr. Bednarczyk reported no relevant disclosures.
SOURCE: Saslow D et al. CA Cancer J Clin. 2020 Jul 8. doi: 10.3322/caac.21616.
The ACS has endorsed two recommendations made by the CDC’s Advisory Committee on Immunization Practices, but the ACS does not agree with a third recommendation for older adults.
The ACIP recommends shared clinical decision-making regarding human papillomavirus (HPV) vaccination in some adults aged 27-45 years who are not adequately vaccinated. The ACS does not endorse this recommendation “because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision-making on patients and clinicians, and the lack of sufficient guidance on the selection of individuals who might benefit,” wrote Debbie Saslow, PhD, of the ACS’s section on human papillomavirus and gynecologic cancers, and colleagues.
Dr. Saslow and colleagues detailed the ACS recommendations in CA: A Cancer Journal for Clinicians.
The HPV vaccine protects against the virus that can cause cervical, oropharyngeal, anal, vaginal, vulvar, and penile cancers. For younger people, the ACIP recommends routine HPV vaccination of boys and girls aged 9-12 years and catch-up vaccination in everyone up to age 26 who has not been fully immunized against HPV.
The ACS endorses both of these recommendations. It also advises clinicians to tell patients aged 22-26 years who haven’t received the HPV vaccine or completed the series that the vaccine is less effective at reducing the risk of cancer at older ages.
After the Food and Drug Administration approved the HPV vaccine for adults aged 27-45 years, the ACIP updated its recommendations to state that routine catch-up vaccination is not recommended for anyone aged over 26 years. However, the ACIP recommended that these older adults talk with their providers about the risks and benefits of the vaccine to determine whether to get it.
The ACS subsequently conducted a methodological review of the ACIP’s recommendations and published its own adapted guidance, stating that the ACS does not endorse the shared decision-making. Administering the HPV vaccine to adults aged over 26 years would only prevent an estimated 0.5% of additional cancer cases, 0.4% additional cases of cervical precancer, and 0.3% additional cases of genital warts over the next 100 years, compared with vaccination under age 26.
“In addition to the low effectiveness and low cancer prevention potential of vaccination in this age group, other considerations included the burden of decision-making on patients and clinicians and the lack of sufficient guidance on the selection of individuals who might benefit,” according to the guidance. The ACS also expressed concern that these provider-patient discussions could interfere with the public health goal of increasing HPV vaccination in younger people.
HPV vaccination rates have lagged substantially behind other routinely recommended childhood vaccinations. Just over half (51%) of U.S. teens aged 13-17 years were up to date with HPV vaccination, and 68% had received one dose of the vaccine in 2018, according to the National Immunization Survey.
It’s very uncommon for a professional medical organization to not endorse recommendations from the CDC, particularly with vaccines, according to Robert A. Bednarczyk, PhD, an assistant professor of public health at Emory University, Atlanta, who specializes in HPV vaccination research but was not involved with the ACS statement or the ACIP recommendations.
“Often, for vaccination recommendations, there is a harmonization between health care provider organizations, such as the American Academy of Pediatrics, American Academy of Family Physicians, etc., when new vaccination schedules are released,” Dr. Bednarczyk said.
He acknowledged the ACS’s reasons for not endorsing the ACIP’s HPV recommendations in older adults: the burden of shared decision-making given the communication issues, the vaccine’s lower effectiveness in this population, and the ongoing HPV vaccine shortage.
But Dr. Bednarczyk also pointed out that the ACIP’s recommendation opens the door to these discussions when they may actually be needed, such as in adults at greater risk for HPV. He cited data suggesting that, in 2015, divorces occurred in 24 out of 1,000 married people aged 25-39 years and 21 out of 1,000 people aged 40-49.
“When you consider these marriages that end, in addition to marriages that end when one spouse dies, there is a potential for individuals who previously had a low risk of HPV acquisition now entering into new potential sexual relationships,” Dr. Bednarczyk said. “Additionally, it has been estimated that approximately 4% of the U.S. population are in open or consensually nonmonogamous relationships, where exposure to more sexual partners may increase their risk for HPV. These are just some examples of where conversations with health care providers, and shared clinical decision-making, can help with a targeted reduction of HPV risk.”
The ACIP recommendation regarding adults aged 27-45 years also provides people in this age group with insurance coverage for the HPV vaccine if they choose to get it, Dr. Bednarczyk pointed out. Insurance companies may not be required to cover HPV vaccination in people aged over 26 years without the CDC’s recommendation, even if it’s not for routine immunization.
Dr. Bednarczyk agreed, however, with how the ACS adapted the CDC’s recommendation for routine vaccination in youth. The CDC’s routine recommendation is at ages 11-12 but can begin at 9 years, according to the ACIP. The ACS guidance qualifies this statement to place more emphasis on encouraging the vaccine earlier.
“Routine HPV vaccination between ages 9-12 is expected to achieve higher on-time vaccination rates, resulting in increased numbers of cancers prevented,” according to the ACS. “Health care providers are encouraged to start offering the HPV vaccine at age 9 or 10.”
Dr. Bednarczyk pointed to some of his past research finding low proportions of teens fully vaccinated against HPV by age 13 years (J Infect Dis. 2019 Jul 31;220[5]:730-4). Therefore, “any efforts to encourage vaccination, including starting the series at ages 9-10 years may help,” he said.
He also agreed that there may be diminished effectiveness with vaccinating adults aged 22-26, “but this should also be considered relative to an individual’s risk of acquiring HPV.”
While an HPV vaccine shortage is a major concern and HPV vaccination efforts should remain most focused on young teens, adults should not necessarily be neglected, Dr. Bednarczyk noted.
“Given how common HPV infection is in the population, open discussion between patients and health care providers can help identify those adults for whom HPV vaccination can be effective,” he said.
The development of the ACS guideline was supported by ACS operational funds. The ACS has received an independent educational grant from Merck Sharp & Dohme for a project intended to increase HPV vaccination rates. Dr. Saslow is the principal investigator for a cooperative agreement between the ACS and the CDC to support the National HPV Vaccination Roundtable and is coprincipal investigator of a cooperative agreement between the ACS and CDC to support initiatives to increase HPV vaccination. The remaining authors and Dr. Bednarczyk reported no relevant disclosures.
SOURCE: Saslow D et al. CA Cancer J Clin. 2020 Jul 8. doi: 10.3322/caac.21616.
FROM CA: A CANCER JOURNAL FOR CLINICIANS
Are you SARS-CoV-2 vaccine hesitant?
When the pandemic was just emerging from its infancy and we were just beginning to think about social distancing, I was sitting around enjoying an adult beverage and some gluten free (not my choice) snacks with some friends. A retired nurse who had just celebrated her 80th birthday said, “I can’t wait until they’ve developed a vaccine.” A former electrical engineer sitting just short of 2 meters to her left responded, “Don’t save me a place near the front of the line for something that is being developed in a program called Warp Speed.”
How do you feel about the potential SARS-CoV-2 vaccine? Are you going to roll up your sleeve as soon as the vaccine becomes available in your community? What are you going to suggest to your patients, your children? I suspect many of you will answer, “It depends.”
Will it make any difference to you which biochemical-immune-bending strategy is being used to make the vaccine? All of them will probably be the result of a clever sounding but novel technique, all of them with a track record that is measured in months and not years. Will you be swayed by how large the trials were? Or how long the follow-up lasted? How effective must the vaccine be to convince you that it is worth receiving or recommending? Do you have the tools and experience to make a decision like that? I know I don’t. And should you and I even be put in a position to make that decision?
In the past, you and I may have relied on the Centers for Disease Control and Prevention for advice. But given the somewhat murky and stormy relationship between the CDC and the president, the vaccine recommendation may be issued by the White House and not the CDC.
For those of us who were practicing medicine during the Swine Flu fiasco of 1976, the pace and the politics surrounding the development of a SARS-CoV-2 vaccine has a discomforting déjà vu quality about it. The fact that like this year 1976 was an election year that infused the development process with a sense of urgency above and beyond any of the concerns about the pandemic that never happened. Although causality was never proven, there was a surge in Guillain-Barré syndrome cases that had been linked temporally to the vaccine.
Of course, our pandemic is real, and it would be imprudent to wait a year or more to watch for long-term vaccine sequelae. However, I am more than a little concerned that fast tracking the development process may result in unfortunate consequences in the short term that could have been avoided with a more measured approach to trialing the vaccines.
The sad reality is that as a nation we tend to be impatient. We are drawn to quick fixes that come in a vial or a capsule. We are learning that simple measures like mask wearing and social distancing can make a difference in slowing the spread of the virus. It would be tragic to rush a vaccine into production that at best turns out to simply be an expensive alternative to the measures that we know work or at worst injures more of us than it saves.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
When the pandemic was just emerging from its infancy and we were just beginning to think about social distancing, I was sitting around enjoying an adult beverage and some gluten free (not my choice) snacks with some friends. A retired nurse who had just celebrated her 80th birthday said, “I can’t wait until they’ve developed a vaccine.” A former electrical engineer sitting just short of 2 meters to her left responded, “Don’t save me a place near the front of the line for something that is being developed in a program called Warp Speed.”
How do you feel about the potential SARS-CoV-2 vaccine? Are you going to roll up your sleeve as soon as the vaccine becomes available in your community? What are you going to suggest to your patients, your children? I suspect many of you will answer, “It depends.”
Will it make any difference to you which biochemical-immune-bending strategy is being used to make the vaccine? All of them will probably be the result of a clever sounding but novel technique, all of them with a track record that is measured in months and not years. Will you be swayed by how large the trials were? Or how long the follow-up lasted? How effective must the vaccine be to convince you that it is worth receiving or recommending? Do you have the tools and experience to make a decision like that? I know I don’t. And should you and I even be put in a position to make that decision?
In the past, you and I may have relied on the Centers for Disease Control and Prevention for advice. But given the somewhat murky and stormy relationship between the CDC and the president, the vaccine recommendation may be issued by the White House and not the CDC.
For those of us who were practicing medicine during the Swine Flu fiasco of 1976, the pace and the politics surrounding the development of a SARS-CoV-2 vaccine has a discomforting déjà vu quality about it. The fact that like this year 1976 was an election year that infused the development process with a sense of urgency above and beyond any of the concerns about the pandemic that never happened. Although causality was never proven, there was a surge in Guillain-Barré syndrome cases that had been linked temporally to the vaccine.
Of course, our pandemic is real, and it would be imprudent to wait a year or more to watch for long-term vaccine sequelae. However, I am more than a little concerned that fast tracking the development process may result in unfortunate consequences in the short term that could have been avoided with a more measured approach to trialing the vaccines.
The sad reality is that as a nation we tend to be impatient. We are drawn to quick fixes that come in a vial or a capsule. We are learning that simple measures like mask wearing and social distancing can make a difference in slowing the spread of the virus. It would be tragic to rush a vaccine into production that at best turns out to simply be an expensive alternative to the measures that we know work or at worst injures more of us than it saves.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
When the pandemic was just emerging from its infancy and we were just beginning to think about social distancing, I was sitting around enjoying an adult beverage and some gluten free (not my choice) snacks with some friends. A retired nurse who had just celebrated her 80th birthday said, “I can’t wait until they’ve developed a vaccine.” A former electrical engineer sitting just short of 2 meters to her left responded, “Don’t save me a place near the front of the line for something that is being developed in a program called Warp Speed.”
How do you feel about the potential SARS-CoV-2 vaccine? Are you going to roll up your sleeve as soon as the vaccine becomes available in your community? What are you going to suggest to your patients, your children? I suspect many of you will answer, “It depends.”
Will it make any difference to you which biochemical-immune-bending strategy is being used to make the vaccine? All of them will probably be the result of a clever sounding but novel technique, all of them with a track record that is measured in months and not years. Will you be swayed by how large the trials were? Or how long the follow-up lasted? How effective must the vaccine be to convince you that it is worth receiving or recommending? Do you have the tools and experience to make a decision like that? I know I don’t. And should you and I even be put in a position to make that decision?
In the past, you and I may have relied on the Centers for Disease Control and Prevention for advice. But given the somewhat murky and stormy relationship between the CDC and the president, the vaccine recommendation may be issued by the White House and not the CDC.
For those of us who were practicing medicine during the Swine Flu fiasco of 1976, the pace and the politics surrounding the development of a SARS-CoV-2 vaccine has a discomforting déjà vu quality about it. The fact that like this year 1976 was an election year that infused the development process with a sense of urgency above and beyond any of the concerns about the pandemic that never happened. Although causality was never proven, there was a surge in Guillain-Barré syndrome cases that had been linked temporally to the vaccine.
Of course, our pandemic is real, and it would be imprudent to wait a year or more to watch for long-term vaccine sequelae. However, I am more than a little concerned that fast tracking the development process may result in unfortunate consequences in the short term that could have been avoided with a more measured approach to trialing the vaccines.
The sad reality is that as a nation we tend to be impatient. We are drawn to quick fixes that come in a vial or a capsule. We are learning that simple measures like mask wearing and social distancing can make a difference in slowing the spread of the virus. It would be tragic to rush a vaccine into production that at best turns out to simply be an expensive alternative to the measures that we know work or at worst injures more of us than it saves.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
Parental refusal of neonatal therapy a growing problem
according to an update at the virtual Pediatric Hospital Medicine virtual. This finding indicates the value of preparing policies and strategies to guide parents to appropriate medical decisions in advance.
“Elimination of nonmedical exceptions to vaccinations and intramuscular vitamin K made it into two of the AAP [American Academy of Pediatrics] top 10 public health resolutions, most likely because refusal rates are going up,” reported Ha N. Nguyen, MD, of the division of pediatric hospital medicine at Stanford (Calif.) University.
Importantly, state laws differ. For example, erythromycin ointment is mandated in neonates for prevention of gonococcal ophthalmia neonatorum in many states, including New York, where it can be administered without consent, according to Dr. Nguyen. Conversely, California does not mandate this preventive therapy even though the law does not offer medico-legal protection to providers if it is not given.
“There is a glaring gap in the way the [California] law was written,” said Dr. Nguyen, who used this as an example of why protocols and strategies to reduce risk of parental refusal of neonatal therapies should be informed by, and consistent with, state laws.
Because of the low levels of vitamin K in infants, the rate of bleeding within the first few months of life is nearly 2%, according to figures cited by Dr. Nguyen. It falls to less than 0.001% with administration of intramuscular vitamin K.
Families who refuse intramuscular vitamin K often state that they understand the risks, but data from a survey Dr. Nguyen cited found this is not necessarily true. In this survey, about two-thirds knew that bleeding was the risk, but less than 20% understood bleeding risks included intracranial hemorrhage, and less than 10% were aware that there was potential for a fatal outcome.
“This is a huge piece of the puzzle for counseling,” Dr. Nguyen said. “The discussion with parents should explicitly involve the explanation that the risks include brain bleeds and death.”
Although most infant bleeds attributed to low vitamin K stores are mucocutaneous or gastrointestinal, intracranial hemorrhage does occur, and these outcomes can be devastating. Up to 25% of infants who experience an intracranial hemorrhage die, while 60% of those who survive have some degree of neurodevelopmental impairment, according to Dr. Nguyen.
Oral vitamin K, which requires multiple doses, is not an appropriate substitute for the recommended single injection of the intramuscular formulation. The one study that compared intramuscular and oral vitamin K did not prove equivalence, and no oral vitamin K products have been approved by the Food and Drug Administration, Dr. Nguyen reported.
“We do know confidently that oral vitamin K does often result in poor adherence,” she said,
In a recent review article of parental vitamin K refusal, one of the most significant predictors of refusal of any recommended neonatal preventive treatment was refusal of another. According to data in that article, summarized by Dr. Nguyen, 68% of the parents who declined intramuscular vitamin K also declined erythromycin ointment, and more than 90% declined hepatitis B vaccine.
“One reason that many parents refuse the hepatitis B vaccine is that they do not think their child is at risk,” explained Kimberly Horstman, MD, from Stanford University and John Muir Medical Center in Walnut Creek, Calif.
Yet hepatitis B virus (HBV) infection, which is asymptomatic, can be acquired from many sources, including nonfamily contacts, according to Dr. Horstman.
“The AAP supports universal hepatitis B vaccine within 24 hours of birth for all infants over 2,000 g at birth,” Dr. Horstman said. In those weighing less, the vaccine is recommended within the first month of life.
The risk of parental refusal for recommended neonatal preventive medicines is higher among those with more education and higher income relative to those with less, Dr. Nguyen said. Other predictors include older maternal age, private insurance, and delivery by a midwife or at a birthing center.
Many parents who refuse preventive neonatal medications do not fully grasp what risks they are accepting by avoiding a recommended medication, according to both Dr. Nguyen and Dr. Horstman. In some cases, the goal is to protect their child from the pain of a needlestick, even when the health consequences might include far more invasive and painful therapies if the child develops the disease the medication would have prevented.
In the case of intramuscular vitamin K, “we encourage a presumptive approach,” Dr. Nguyen said. Concerns can then be addressed only if the parents refuse.
For another strategy, Dr. Nguyen recommended counseling parents about the need and value of preventive therapies during pregnancy. She cited data suggesting that it is more difficult to change the minds of parents after delivery.
Echoing this approach in regard to HBV vaccine, Dr. Horstman suggested encouraging colleagues, including obstetricians and community pediatricians, to raise and address this topic during prenatal counseling. By preparing parents for the recommended medications in the prenatal period, concerns can be addressed in advance.
The health risks posed by parents who refuse recommended medications is recognized by the Centers for Disease Control and Prevention. Both Dr. Horstman and Dr. Nguyen said there are handouts from the CDC and the AAP to inform parents of the purpose and benefit of recommended preventive therapies, as well as to equip caregivers with facts for effective counseling.
according to an update at the virtual Pediatric Hospital Medicine virtual. This finding indicates the value of preparing policies and strategies to guide parents to appropriate medical decisions in advance.
“Elimination of nonmedical exceptions to vaccinations and intramuscular vitamin K made it into two of the AAP [American Academy of Pediatrics] top 10 public health resolutions, most likely because refusal rates are going up,” reported Ha N. Nguyen, MD, of the division of pediatric hospital medicine at Stanford (Calif.) University.
Importantly, state laws differ. For example, erythromycin ointment is mandated in neonates for prevention of gonococcal ophthalmia neonatorum in many states, including New York, where it can be administered without consent, according to Dr. Nguyen. Conversely, California does not mandate this preventive therapy even though the law does not offer medico-legal protection to providers if it is not given.
“There is a glaring gap in the way the [California] law was written,” said Dr. Nguyen, who used this as an example of why protocols and strategies to reduce risk of parental refusal of neonatal therapies should be informed by, and consistent with, state laws.
Because of the low levels of vitamin K in infants, the rate of bleeding within the first few months of life is nearly 2%, according to figures cited by Dr. Nguyen. It falls to less than 0.001% with administration of intramuscular vitamin K.
Families who refuse intramuscular vitamin K often state that they understand the risks, but data from a survey Dr. Nguyen cited found this is not necessarily true. In this survey, about two-thirds knew that bleeding was the risk, but less than 20% understood bleeding risks included intracranial hemorrhage, and less than 10% were aware that there was potential for a fatal outcome.
“This is a huge piece of the puzzle for counseling,” Dr. Nguyen said. “The discussion with parents should explicitly involve the explanation that the risks include brain bleeds and death.”
Although most infant bleeds attributed to low vitamin K stores are mucocutaneous or gastrointestinal, intracranial hemorrhage does occur, and these outcomes can be devastating. Up to 25% of infants who experience an intracranial hemorrhage die, while 60% of those who survive have some degree of neurodevelopmental impairment, according to Dr. Nguyen.
Oral vitamin K, which requires multiple doses, is not an appropriate substitute for the recommended single injection of the intramuscular formulation. The one study that compared intramuscular and oral vitamin K did not prove equivalence, and no oral vitamin K products have been approved by the Food and Drug Administration, Dr. Nguyen reported.
“We do know confidently that oral vitamin K does often result in poor adherence,” she said,
In a recent review article of parental vitamin K refusal, one of the most significant predictors of refusal of any recommended neonatal preventive treatment was refusal of another. According to data in that article, summarized by Dr. Nguyen, 68% of the parents who declined intramuscular vitamin K also declined erythromycin ointment, and more than 90% declined hepatitis B vaccine.
“One reason that many parents refuse the hepatitis B vaccine is that they do not think their child is at risk,” explained Kimberly Horstman, MD, from Stanford University and John Muir Medical Center in Walnut Creek, Calif.
Yet hepatitis B virus (HBV) infection, which is asymptomatic, can be acquired from many sources, including nonfamily contacts, according to Dr. Horstman.
“The AAP supports universal hepatitis B vaccine within 24 hours of birth for all infants over 2,000 g at birth,” Dr. Horstman said. In those weighing less, the vaccine is recommended within the first month of life.
The risk of parental refusal for recommended neonatal preventive medicines is higher among those with more education and higher income relative to those with less, Dr. Nguyen said. Other predictors include older maternal age, private insurance, and delivery by a midwife or at a birthing center.
Many parents who refuse preventive neonatal medications do not fully grasp what risks they are accepting by avoiding a recommended medication, according to both Dr. Nguyen and Dr. Horstman. In some cases, the goal is to protect their child from the pain of a needlestick, even when the health consequences might include far more invasive and painful therapies if the child develops the disease the medication would have prevented.
In the case of intramuscular vitamin K, “we encourage a presumptive approach,” Dr. Nguyen said. Concerns can then be addressed only if the parents refuse.
For another strategy, Dr. Nguyen recommended counseling parents about the need and value of preventive therapies during pregnancy. She cited data suggesting that it is more difficult to change the minds of parents after delivery.
Echoing this approach in regard to HBV vaccine, Dr. Horstman suggested encouraging colleagues, including obstetricians and community pediatricians, to raise and address this topic during prenatal counseling. By preparing parents for the recommended medications in the prenatal period, concerns can be addressed in advance.
The health risks posed by parents who refuse recommended medications is recognized by the Centers for Disease Control and Prevention. Both Dr. Horstman and Dr. Nguyen said there are handouts from the CDC and the AAP to inform parents of the purpose and benefit of recommended preventive therapies, as well as to equip caregivers with facts for effective counseling.
according to an update at the virtual Pediatric Hospital Medicine virtual. This finding indicates the value of preparing policies and strategies to guide parents to appropriate medical decisions in advance.
“Elimination of nonmedical exceptions to vaccinations and intramuscular vitamin K made it into two of the AAP [American Academy of Pediatrics] top 10 public health resolutions, most likely because refusal rates are going up,” reported Ha N. Nguyen, MD, of the division of pediatric hospital medicine at Stanford (Calif.) University.
Importantly, state laws differ. For example, erythromycin ointment is mandated in neonates for prevention of gonococcal ophthalmia neonatorum in many states, including New York, where it can be administered without consent, according to Dr. Nguyen. Conversely, California does not mandate this preventive therapy even though the law does not offer medico-legal protection to providers if it is not given.
“There is a glaring gap in the way the [California] law was written,” said Dr. Nguyen, who used this as an example of why protocols and strategies to reduce risk of parental refusal of neonatal therapies should be informed by, and consistent with, state laws.
Because of the low levels of vitamin K in infants, the rate of bleeding within the first few months of life is nearly 2%, according to figures cited by Dr. Nguyen. It falls to less than 0.001% with administration of intramuscular vitamin K.
Families who refuse intramuscular vitamin K often state that they understand the risks, but data from a survey Dr. Nguyen cited found this is not necessarily true. In this survey, about two-thirds knew that bleeding was the risk, but less than 20% understood bleeding risks included intracranial hemorrhage, and less than 10% were aware that there was potential for a fatal outcome.
“This is a huge piece of the puzzle for counseling,” Dr. Nguyen said. “The discussion with parents should explicitly involve the explanation that the risks include brain bleeds and death.”
Although most infant bleeds attributed to low vitamin K stores are mucocutaneous or gastrointestinal, intracranial hemorrhage does occur, and these outcomes can be devastating. Up to 25% of infants who experience an intracranial hemorrhage die, while 60% of those who survive have some degree of neurodevelopmental impairment, according to Dr. Nguyen.
Oral vitamin K, which requires multiple doses, is not an appropriate substitute for the recommended single injection of the intramuscular formulation. The one study that compared intramuscular and oral vitamin K did not prove equivalence, and no oral vitamin K products have been approved by the Food and Drug Administration, Dr. Nguyen reported.
“We do know confidently that oral vitamin K does often result in poor adherence,” she said,
In a recent review article of parental vitamin K refusal, one of the most significant predictors of refusal of any recommended neonatal preventive treatment was refusal of another. According to data in that article, summarized by Dr. Nguyen, 68% of the parents who declined intramuscular vitamin K also declined erythromycin ointment, and more than 90% declined hepatitis B vaccine.
“One reason that many parents refuse the hepatitis B vaccine is that they do not think their child is at risk,” explained Kimberly Horstman, MD, from Stanford University and John Muir Medical Center in Walnut Creek, Calif.
Yet hepatitis B virus (HBV) infection, which is asymptomatic, can be acquired from many sources, including nonfamily contacts, according to Dr. Horstman.
“The AAP supports universal hepatitis B vaccine within 24 hours of birth for all infants over 2,000 g at birth,” Dr. Horstman said. In those weighing less, the vaccine is recommended within the first month of life.
The risk of parental refusal for recommended neonatal preventive medicines is higher among those with more education and higher income relative to those with less, Dr. Nguyen said. Other predictors include older maternal age, private insurance, and delivery by a midwife or at a birthing center.
Many parents who refuse preventive neonatal medications do not fully grasp what risks they are accepting by avoiding a recommended medication, according to both Dr. Nguyen and Dr. Horstman. In some cases, the goal is to protect their child from the pain of a needlestick, even when the health consequences might include far more invasive and painful therapies if the child develops the disease the medication would have prevented.
In the case of intramuscular vitamin K, “we encourage a presumptive approach,” Dr. Nguyen said. Concerns can then be addressed only if the parents refuse.
For another strategy, Dr. Nguyen recommended counseling parents about the need and value of preventive therapies during pregnancy. She cited data suggesting that it is more difficult to change the minds of parents after delivery.
Echoing this approach in regard to HBV vaccine, Dr. Horstman suggested encouraging colleagues, including obstetricians and community pediatricians, to raise and address this topic during prenatal counseling. By preparing parents for the recommended medications in the prenatal period, concerns can be addressed in advance.
The health risks posed by parents who refuse recommended medications is recognized by the Centers for Disease Control and Prevention. Both Dr. Horstman and Dr. Nguyen said there are handouts from the CDC and the AAP to inform parents of the purpose and benefit of recommended preventive therapies, as well as to equip caregivers with facts for effective counseling.
FROM PHM 2020
Oxford coronavirus vaccine ‘triggers immune response’
The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.
Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.
In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.
The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.
However, there were no serious adverse events from the vaccine, the researchers said.
‘Still a long way to go’
Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.
“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.
“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”
The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.
A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.
ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.
On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
Expert reaction to the findings
The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.
“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”
Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.
“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”
He said it was also vital that people older than 55 were included in later trials.
Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.
“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”
This article first appeared on Medscape.com.
The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.
Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.
In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.
The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.
However, there were no serious adverse events from the vaccine, the researchers said.
‘Still a long way to go’
Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.
“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.
“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”
The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.
A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.
ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.
On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
Expert reaction to the findings
The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.
“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”
Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.
“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”
He said it was also vital that people older than 55 were included in later trials.
Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.
“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”
This article first appeared on Medscape.com.
The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.
Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.
In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.
The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.
However, there were no serious adverse events from the vaccine, the researchers said.
‘Still a long way to go’
Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.
“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.
“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”
The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.
A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.
ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.
On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
Expert reaction to the findings
The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.
“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”
Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.
“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”
He said it was also vital that people older than 55 were included in later trials.
Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.
“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”
This article first appeared on Medscape.com.
COVID vaccine tested in people shows early promise
the company says in a news release.
Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.
The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.
A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.
The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.
The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.
In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.
Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.
The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older
Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.
This article first appeared on WebMD.com.
the company says in a news release.
Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.
The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.
A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.
The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.
The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.
In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.
Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.
The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older
Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.
This article first appeared on WebMD.com.
the company says in a news release.
Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.
The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.
A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.
The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.
The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.
In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.
Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.
The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older
Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.
This article first appeared on WebMD.com.
Taking steps to slow the upswing in oral and pharyngeal cancers
A recent report by the Centers for Disease Control and Prevention (CDC) documents the trends in oral and pharyngeal cancers (OPC) in the United States over a 10-year period, 2007-2016.1 The rate of OPC began to increase in 1999 and has been increasing ever since. The age-adjusted rate in 2007 was 10.89/100,000 compared with 11.7/100,000 in 2016 (TABLE 11). This is an annual relative increase of about 6% per year. In absolute numbers, there were 35,076 cases in 2007 and 44,419 in 2016.1 The trends in incidence of OPC vary by anatomical site, with some increasing and others declining.
There are 3 known causal factors related to OPC: tobacco use, alcohol use, and human papillomavirus (HPV) infection. The CDC estimates that, overall, 70% of OPCs are caused by HPV.2 However, while cancers at some oropharyngeal sites are likely related to HPV infection, cancers at other sites are not. The rising overall incidence of OPC is being driven by increases in HPV-related cancers at an average rate of 2.1% per year, while the rates at non-HPV-associated sites have been declining by 0.4% per year.1 It is also important to appreciate that HPV causes cancer at other anatomical sites (TABLE 22) and is responsible for an estimated 35,000 cancers per year.2
Other trends of note in all OPCs combined are increasing rates among non-Hispanic whites and Asian-Pacific Islanders; decreasing rates among Hispanics and African Americans; increasing rates among males with no real change in rates among females; increasing rates in those 50 to 79 years of age; decreasing rates among those 40 to 49 years of age; and unchanged rates in other age groups.1
The role of the family physician
Preventing OPC and all HPV-related cancers begins by encouraging patients to reduce alcohol and tobacco use and by emphasizing the importance of HPV vaccination. Educate teens and parents/guardians about HPV vaccine and its safety. Screen for tobacco and alcohol use, and offer brief clinical interventions as needed to decrease usage.
Recommendations by the US Preventive Services Task Force regarding screening for, and reducing use of, tobacco and alcohol, as well as screening for cervical cancer, are listed in TABLE 3.3-6 Remember that cervical cancer screening is both a primary and secondary intervention: It can reduce mortality by preventing cervical cancer (via treatment of precancerous lesions) and by detecting cervical cancer early at more treatable stages.
HPV vaccination essentials. CDC recommendations for the use of HPV vaccine and the vaccine dosing schedule appear in TABLE 4.7 While it is true that the best evidence for HPV vaccine’s prevention of cancer comes from the study of cervical and anal cancers, it is reasonable to expect that it will also be proven over time to prevent other HPV-caused cancers as the rate of HPV infections declines.
HPV vaccine is underused. In a 2018 survey, only 68.1% of adolescents had received 1 or more doses of HPV vaccine, and only 51.1% were up to date.8 In contrast, 86.6% had received 1 or more doses of quadrivalent meningococcal vaccine; 88.9% had received 1 or more doses of tetanus, diphtheria & acellular pertussis vaccine; 91.9% were up to date with 2 or more doses of measles, mumps & rubella vaccine; and 92.1% were up to date with hepatitis B vaccine, with 3 or more doses.8
Continue to: Address parental concerns, including these 5 false beliefs
Address parental concerns, including these 5 false beliefs
One study found 5 major false beliefs parents hold about HPV vaccine9:
- Vaccination is not effective at preventing cancer.
- Pap smears are sufficient to prevent cervical cancer.
- HPV vaccination is not safe.
- HPV vaccination is not needed since most infections are naturally cleared by the immune system.
- Eleven to 12 years of age is too young to vaccinate.
There is some evidence that if clinicians actively engage with parents about these concerns and address them head on, same-day vaccination rates can improve.10
We can expect to see HPV-associated OPC decline in the coming years due to the delayed effects on cancer incidence by the HPV vaccine. These anticipated declines will be more dramatic if we can increase the uptake of the HPV vaccine.
1. Ellington TD, Henley SJ, Senkomago V, et al. Trends in the incidence of cancers of the oral cavity and pharynx—United States 2007-2016. MMWR Morb Mortal Wkly Rep. 2020;69:433-438.
2. CDC. HPV and cancer. 2019. https://www.cdc.gov/cancer/hpv/statistics/cases.htm. Accessed June 29, 2020.
3. USPSTF. Unhealthy alcohol use in adolescents and adults: screening and behavioral counseling interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/unhealthy-alcohol-use-in-adolescents-and-adults-screening-and-behavioral-counseling-interventions. Accessed June 29, 2020.
4. USPSTF. Prevention and cessation of tobacco use in children and adolescents: primary care interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions. Accessed June 29, 2020.
5. USPSTF. Tobacco smoking cessation in adults, including pregnant women: behavioral and pharmacotherapy interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions. Accessed June 29, 2020.
6. USPSTF. Cervical cancer: screening. www.uspreventiveservicestaskforce.org/uspstf/recommendation/cervical-cancer-screening. Accessed June 29, 2020.
7. CDC. Vaccines and preventable diseases. HPV vaccine recommendations. 2020. www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html. Accessed June 29, 2020.
8. Walker TY, Elam-Evans LD, Yankey D, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years-United States, 2018. MMWR Morb Mortal Wkly Rep. 2019:68:718-723.
9. Bednarczyk RA. Addressing HPV vaccine myths: practical information for healthcare providers. Hum Vaccin Immunother. 2019;15:1628-1638.
10. Shay LA, Baldwin AS, Betts AC, et al. Parent-provider communication of HPV vaccine hesitancy. Pediatrics 2018;141:e20172312.
A recent report by the Centers for Disease Control and Prevention (CDC) documents the trends in oral and pharyngeal cancers (OPC) in the United States over a 10-year period, 2007-2016.1 The rate of OPC began to increase in 1999 and has been increasing ever since. The age-adjusted rate in 2007 was 10.89/100,000 compared with 11.7/100,000 in 2016 (TABLE 11). This is an annual relative increase of about 6% per year. In absolute numbers, there were 35,076 cases in 2007 and 44,419 in 2016.1 The trends in incidence of OPC vary by anatomical site, with some increasing and others declining.
There are 3 known causal factors related to OPC: tobacco use, alcohol use, and human papillomavirus (HPV) infection. The CDC estimates that, overall, 70% of OPCs are caused by HPV.2 However, while cancers at some oropharyngeal sites are likely related to HPV infection, cancers at other sites are not. The rising overall incidence of OPC is being driven by increases in HPV-related cancers at an average rate of 2.1% per year, while the rates at non-HPV-associated sites have been declining by 0.4% per year.1 It is also important to appreciate that HPV causes cancer at other anatomical sites (TABLE 22) and is responsible for an estimated 35,000 cancers per year.2
Other trends of note in all OPCs combined are increasing rates among non-Hispanic whites and Asian-Pacific Islanders; decreasing rates among Hispanics and African Americans; increasing rates among males with no real change in rates among females; increasing rates in those 50 to 79 years of age; decreasing rates among those 40 to 49 years of age; and unchanged rates in other age groups.1
The role of the family physician
Preventing OPC and all HPV-related cancers begins by encouraging patients to reduce alcohol and tobacco use and by emphasizing the importance of HPV vaccination. Educate teens and parents/guardians about HPV vaccine and its safety. Screen for tobacco and alcohol use, and offer brief clinical interventions as needed to decrease usage.
Recommendations by the US Preventive Services Task Force regarding screening for, and reducing use of, tobacco and alcohol, as well as screening for cervical cancer, are listed in TABLE 3.3-6 Remember that cervical cancer screening is both a primary and secondary intervention: It can reduce mortality by preventing cervical cancer (via treatment of precancerous lesions) and by detecting cervical cancer early at more treatable stages.
HPV vaccination essentials. CDC recommendations for the use of HPV vaccine and the vaccine dosing schedule appear in TABLE 4.7 While it is true that the best evidence for HPV vaccine’s prevention of cancer comes from the study of cervical and anal cancers, it is reasonable to expect that it will also be proven over time to prevent other HPV-caused cancers as the rate of HPV infections declines.
HPV vaccine is underused. In a 2018 survey, only 68.1% of adolescents had received 1 or more doses of HPV vaccine, and only 51.1% were up to date.8 In contrast, 86.6% had received 1 or more doses of quadrivalent meningococcal vaccine; 88.9% had received 1 or more doses of tetanus, diphtheria & acellular pertussis vaccine; 91.9% were up to date with 2 or more doses of measles, mumps & rubella vaccine; and 92.1% were up to date with hepatitis B vaccine, with 3 or more doses.8
Continue to: Address parental concerns, including these 5 false beliefs
Address parental concerns, including these 5 false beliefs
One study found 5 major false beliefs parents hold about HPV vaccine9:
- Vaccination is not effective at preventing cancer.
- Pap smears are sufficient to prevent cervical cancer.
- HPV vaccination is not safe.
- HPV vaccination is not needed since most infections are naturally cleared by the immune system.
- Eleven to 12 years of age is too young to vaccinate.
There is some evidence that if clinicians actively engage with parents about these concerns and address them head on, same-day vaccination rates can improve.10
We can expect to see HPV-associated OPC decline in the coming years due to the delayed effects on cancer incidence by the HPV vaccine. These anticipated declines will be more dramatic if we can increase the uptake of the HPV vaccine.
A recent report by the Centers for Disease Control and Prevention (CDC) documents the trends in oral and pharyngeal cancers (OPC) in the United States over a 10-year period, 2007-2016.1 The rate of OPC began to increase in 1999 and has been increasing ever since. The age-adjusted rate in 2007 was 10.89/100,000 compared with 11.7/100,000 in 2016 (TABLE 11). This is an annual relative increase of about 6% per year. In absolute numbers, there were 35,076 cases in 2007 and 44,419 in 2016.1 The trends in incidence of OPC vary by anatomical site, with some increasing and others declining.
There are 3 known causal factors related to OPC: tobacco use, alcohol use, and human papillomavirus (HPV) infection. The CDC estimates that, overall, 70% of OPCs are caused by HPV.2 However, while cancers at some oropharyngeal sites are likely related to HPV infection, cancers at other sites are not. The rising overall incidence of OPC is being driven by increases in HPV-related cancers at an average rate of 2.1% per year, while the rates at non-HPV-associated sites have been declining by 0.4% per year.1 It is also important to appreciate that HPV causes cancer at other anatomical sites (TABLE 22) and is responsible for an estimated 35,000 cancers per year.2
Other trends of note in all OPCs combined are increasing rates among non-Hispanic whites and Asian-Pacific Islanders; decreasing rates among Hispanics and African Americans; increasing rates among males with no real change in rates among females; increasing rates in those 50 to 79 years of age; decreasing rates among those 40 to 49 years of age; and unchanged rates in other age groups.1
The role of the family physician
Preventing OPC and all HPV-related cancers begins by encouraging patients to reduce alcohol and tobacco use and by emphasizing the importance of HPV vaccination. Educate teens and parents/guardians about HPV vaccine and its safety. Screen for tobacco and alcohol use, and offer brief clinical interventions as needed to decrease usage.
Recommendations by the US Preventive Services Task Force regarding screening for, and reducing use of, tobacco and alcohol, as well as screening for cervical cancer, are listed in TABLE 3.3-6 Remember that cervical cancer screening is both a primary and secondary intervention: It can reduce mortality by preventing cervical cancer (via treatment of precancerous lesions) and by detecting cervical cancer early at more treatable stages.
HPV vaccination essentials. CDC recommendations for the use of HPV vaccine and the vaccine dosing schedule appear in TABLE 4.7 While it is true that the best evidence for HPV vaccine’s prevention of cancer comes from the study of cervical and anal cancers, it is reasonable to expect that it will also be proven over time to prevent other HPV-caused cancers as the rate of HPV infections declines.
HPV vaccine is underused. In a 2018 survey, only 68.1% of adolescents had received 1 or more doses of HPV vaccine, and only 51.1% were up to date.8 In contrast, 86.6% had received 1 or more doses of quadrivalent meningococcal vaccine; 88.9% had received 1 or more doses of tetanus, diphtheria & acellular pertussis vaccine; 91.9% were up to date with 2 or more doses of measles, mumps & rubella vaccine; and 92.1% were up to date with hepatitis B vaccine, with 3 or more doses.8
Continue to: Address parental concerns, including these 5 false beliefs
Address parental concerns, including these 5 false beliefs
One study found 5 major false beliefs parents hold about HPV vaccine9:
- Vaccination is not effective at preventing cancer.
- Pap smears are sufficient to prevent cervical cancer.
- HPV vaccination is not safe.
- HPV vaccination is not needed since most infections are naturally cleared by the immune system.
- Eleven to 12 years of age is too young to vaccinate.
There is some evidence that if clinicians actively engage with parents about these concerns and address them head on, same-day vaccination rates can improve.10
We can expect to see HPV-associated OPC decline in the coming years due to the delayed effects on cancer incidence by the HPV vaccine. These anticipated declines will be more dramatic if we can increase the uptake of the HPV vaccine.
1. Ellington TD, Henley SJ, Senkomago V, et al. Trends in the incidence of cancers of the oral cavity and pharynx—United States 2007-2016. MMWR Morb Mortal Wkly Rep. 2020;69:433-438.
2. CDC. HPV and cancer. 2019. https://www.cdc.gov/cancer/hpv/statistics/cases.htm. Accessed June 29, 2020.
3. USPSTF. Unhealthy alcohol use in adolescents and adults: screening and behavioral counseling interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/unhealthy-alcohol-use-in-adolescents-and-adults-screening-and-behavioral-counseling-interventions. Accessed June 29, 2020.
4. USPSTF. Prevention and cessation of tobacco use in children and adolescents: primary care interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions. Accessed June 29, 2020.
5. USPSTF. Tobacco smoking cessation in adults, including pregnant women: behavioral and pharmacotherapy interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions. Accessed June 29, 2020.
6. USPSTF. Cervical cancer: screening. www.uspreventiveservicestaskforce.org/uspstf/recommendation/cervical-cancer-screening. Accessed June 29, 2020.
7. CDC. Vaccines and preventable diseases. HPV vaccine recommendations. 2020. www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html. Accessed June 29, 2020.
8. Walker TY, Elam-Evans LD, Yankey D, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years-United States, 2018. MMWR Morb Mortal Wkly Rep. 2019:68:718-723.
9. Bednarczyk RA. Addressing HPV vaccine myths: practical information for healthcare providers. Hum Vaccin Immunother. 2019;15:1628-1638.
10. Shay LA, Baldwin AS, Betts AC, et al. Parent-provider communication of HPV vaccine hesitancy. Pediatrics 2018;141:e20172312.
1. Ellington TD, Henley SJ, Senkomago V, et al. Trends in the incidence of cancers of the oral cavity and pharynx—United States 2007-2016. MMWR Morb Mortal Wkly Rep. 2020;69:433-438.
2. CDC. HPV and cancer. 2019. https://www.cdc.gov/cancer/hpv/statistics/cases.htm. Accessed June 29, 2020.
3. USPSTF. Unhealthy alcohol use in adolescents and adults: screening and behavioral counseling interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/unhealthy-alcohol-use-in-adolescents-and-adults-screening-and-behavioral-counseling-interventions. Accessed June 29, 2020.
4. USPSTF. Prevention and cessation of tobacco use in children and adolescents: primary care interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions. Accessed June 29, 2020.
5. USPSTF. Tobacco smoking cessation in adults, including pregnant women: behavioral and pharmacotherapy interventions. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions. Accessed June 29, 2020.
6. USPSTF. Cervical cancer: screening. www.uspreventiveservicestaskforce.org/uspstf/recommendation/cervical-cancer-screening. Accessed June 29, 2020.
7. CDC. Vaccines and preventable diseases. HPV vaccine recommendations. 2020. www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html. Accessed June 29, 2020.
8. Walker TY, Elam-Evans LD, Yankey D, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years-United States, 2018. MMWR Morb Mortal Wkly Rep. 2019:68:718-723.
9. Bednarczyk RA. Addressing HPV vaccine myths: practical information for healthcare providers. Hum Vaccin Immunother. 2019;15:1628-1638.
10. Shay LA, Baldwin AS, Betts AC, et al. Parent-provider communication of HPV vaccine hesitancy. Pediatrics 2018;141:e20172312.
About one-third of older Americans receive shingles vaccine
The number of Americans aged 60 years and older who report receiving shingles vaccination had risen steadily since 2008 and has leveled off during the past few years, new data from the Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics reveal.
The proportion of people in this age group who were vaccinated rose from 6.7% in 2008 to 34.5% in 2018, for example.
Emily Terlizzi, MPH, told Medscape Medical News.
The report was published online July 9 in NCHS Data Brief.
Similar rates for men and women
Rates of people who reported receiving at least one vaccination with Zostavax (Merck) or Shingrix (GlaxoSmithKline) varied by factors that included Hispanic origin, education, and family income. An unexpected finding was that rates did not vary significantly between men and women.
“One finding that I would say surprised me was that, although the percentage who had ever received a shingles vaccine among women aged 60 and over was higher than that among men in this age group, this difference was not statistically significant,” said Ms. Terlizzi, a health statistician in the Data Analysis and Quality Assurance Branch, Division of Health Interview Statistics, the CDC National Center for Health Statistics. In 2018, for example, 35.4% of women and 33.5% of men reported ever receiving a shingles vaccine.
The similarity of rates was less of a surprise to Len Horovitz, MD, a pulmonary specialist at Lenox Hill Hospital in New York, who was not affiliated with the report. “In my anecdotal experience, I don’t see a preponderance of one sex getting shingles more than another. It’s pretty evenly distributed,” he said in an interview.
Ms. Terlizzi and coauthor Lindsey I. Black, MPH, say their findings align with prior research. However, they noted: “Our report uses more recent data from a large, nationally representative data source to update these estimates and describe these disparities.” Data come from results of the annual National Health Interview Survey of households nationwide.
Multiple factors explain vaccination differences
Non-Hispanic White adults were more likely to report receiving the vaccine than were Hispanic and non-Hispanic Black survey respondents. Non-Hispanic White adults were about twice as likely to report vaccination – 38.6% – compared with 19.5% of Hispanic adults and 18.8% of non-Hispanic Black adults.
The disparity in vaccination by race was “disappointing news,” Kenneth E. Schmader, MD, said in an interview.
“The health disparity with regard to lower vaccination rates in Hispanic and non-Hispanic Black populations is reported with other vaccines as well and points to the need for better efforts to vaccinate Hispanic and non-Hispanic Black populations,” added Dr. Schmader, a professor of medicine at Duke University in Durham, N.C.
On a positive note, “It was good to see increasing use of shingles vaccination over time, given how devastating zoster can be in older adults and the fact that the vaccines are effective,” said Dr. Schmader, who also serves on the working groups for the Herpes Zoster, Influenza and General Adult Immunization Guidelines for the CDC Advisory Committee on Immunization Practices (ACIP).
Self-reports of receiving vaccination increased in association with higher education and family income levels. For example, 39.9% of respondents who had more than a high school diploma or GED (General Educational Development) reported receiving the shingles vaccine. In contrast, only 21.2% of people with lower educational attainment reported receiving a vaccine.
In terms of income, 20.4% of poor adults reported being vaccinated, compared with 38.4% of adults who were not poor.
The investigators also evaluated the data by geographic region. They found that rates of vaccinations varied from 26.3% in the East South Central part of the United States (which includes Tennessee, Kentucky, and Alabama) to 42.8% in the West North Central region (which includes the Dakotas, Minnesota, and Nebraska).
Clinical and research considerations
For most of the decade evaluated in the study, ACIP recommended vaccination against shingles for Americans aged 60 years and older. The current findings, therefore, do not account for ACIP’s expanding its recommendations in 2017 to include adults aged 50 years and older.
Zostavax is expected to be discontinued this year. It was the only shingles vaccine available before the approval of Shingrix in 2018. The shift to a single product could alter vaccination patterns further.
Ms. Terlizzi plans to continue monitoring trends to “see what changes occur in the next few years,” she said.
Compliance a concern
Data on vaccination rates for shingles are important given the large proportion of the population at risk, Dr. Horovitz said. “People over age 50 who have had chickenpox have a one third chance over their lifetimes to get shingles. That is a lot of people.”
Multiple factors could be contributing to the fact that vaccination rates have hovered around 34% in recent years, he said. “Whenever you see variations in vaccination rates, you have to think about cultural differences and questions about differences in access, accessibility, and attitudes. Attitudes toward vaccines vary widely – from people who don’t believe in vaccination to people who are eager to take vaccinations.
“I don’t know how to dissect all that out of these data,” he added.
Compliance with recommendations also contributes to vaccination rates, Dr. Horovitz said. The fact that in about 10% of people, a flulike syndrome develops the day after being vaccinated with Shingrix can cause some to postpone or rethink immunization, he added. In addition, Shingrix requires two shots. “People have to come back, and that always sets up an issue with recalling someone.”
Marketplace shortages of the Shingrix vaccine could also contribute to lower vaccination rates. However, Dr. Horovitz said that, in his practice, availability was only a problem during the first year after approval in 2017.
On a related note, manufacturer GlaxoSmithKline announced that a decrease in vaccination demand during the COVID-19 pandemic has allowed the supply to catch up. Shingrix no longer qualifies for the CDC’s shortages list, according to a July 9 report.
Ms. Terlizzi, Dr. Horovitz, and Dr. Schmader have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The number of Americans aged 60 years and older who report receiving shingles vaccination had risen steadily since 2008 and has leveled off during the past few years, new data from the Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics reveal.
The proportion of people in this age group who were vaccinated rose from 6.7% in 2008 to 34.5% in 2018, for example.
Emily Terlizzi, MPH, told Medscape Medical News.
The report was published online July 9 in NCHS Data Brief.
Similar rates for men and women
Rates of people who reported receiving at least one vaccination with Zostavax (Merck) or Shingrix (GlaxoSmithKline) varied by factors that included Hispanic origin, education, and family income. An unexpected finding was that rates did not vary significantly between men and women.
“One finding that I would say surprised me was that, although the percentage who had ever received a shingles vaccine among women aged 60 and over was higher than that among men in this age group, this difference was not statistically significant,” said Ms. Terlizzi, a health statistician in the Data Analysis and Quality Assurance Branch, Division of Health Interview Statistics, the CDC National Center for Health Statistics. In 2018, for example, 35.4% of women and 33.5% of men reported ever receiving a shingles vaccine.
The similarity of rates was less of a surprise to Len Horovitz, MD, a pulmonary specialist at Lenox Hill Hospital in New York, who was not affiliated with the report. “In my anecdotal experience, I don’t see a preponderance of one sex getting shingles more than another. It’s pretty evenly distributed,” he said in an interview.
Ms. Terlizzi and coauthor Lindsey I. Black, MPH, say their findings align with prior research. However, they noted: “Our report uses more recent data from a large, nationally representative data source to update these estimates and describe these disparities.” Data come from results of the annual National Health Interview Survey of households nationwide.
Multiple factors explain vaccination differences
Non-Hispanic White adults were more likely to report receiving the vaccine than were Hispanic and non-Hispanic Black survey respondents. Non-Hispanic White adults were about twice as likely to report vaccination – 38.6% – compared with 19.5% of Hispanic adults and 18.8% of non-Hispanic Black adults.
The disparity in vaccination by race was “disappointing news,” Kenneth E. Schmader, MD, said in an interview.
“The health disparity with regard to lower vaccination rates in Hispanic and non-Hispanic Black populations is reported with other vaccines as well and points to the need for better efforts to vaccinate Hispanic and non-Hispanic Black populations,” added Dr. Schmader, a professor of medicine at Duke University in Durham, N.C.
On a positive note, “It was good to see increasing use of shingles vaccination over time, given how devastating zoster can be in older adults and the fact that the vaccines are effective,” said Dr. Schmader, who also serves on the working groups for the Herpes Zoster, Influenza and General Adult Immunization Guidelines for the CDC Advisory Committee on Immunization Practices (ACIP).
Self-reports of receiving vaccination increased in association with higher education and family income levels. For example, 39.9% of respondents who had more than a high school diploma or GED (General Educational Development) reported receiving the shingles vaccine. In contrast, only 21.2% of people with lower educational attainment reported receiving a vaccine.
In terms of income, 20.4% of poor adults reported being vaccinated, compared with 38.4% of adults who were not poor.
The investigators also evaluated the data by geographic region. They found that rates of vaccinations varied from 26.3% in the East South Central part of the United States (which includes Tennessee, Kentucky, and Alabama) to 42.8% in the West North Central region (which includes the Dakotas, Minnesota, and Nebraska).
Clinical and research considerations
For most of the decade evaluated in the study, ACIP recommended vaccination against shingles for Americans aged 60 years and older. The current findings, therefore, do not account for ACIP’s expanding its recommendations in 2017 to include adults aged 50 years and older.
Zostavax is expected to be discontinued this year. It was the only shingles vaccine available before the approval of Shingrix in 2018. The shift to a single product could alter vaccination patterns further.
Ms. Terlizzi plans to continue monitoring trends to “see what changes occur in the next few years,” she said.
Compliance a concern
Data on vaccination rates for shingles are important given the large proportion of the population at risk, Dr. Horovitz said. “People over age 50 who have had chickenpox have a one third chance over their lifetimes to get shingles. That is a lot of people.”
Multiple factors could be contributing to the fact that vaccination rates have hovered around 34% in recent years, he said. “Whenever you see variations in vaccination rates, you have to think about cultural differences and questions about differences in access, accessibility, and attitudes. Attitudes toward vaccines vary widely – from people who don’t believe in vaccination to people who are eager to take vaccinations.
“I don’t know how to dissect all that out of these data,” he added.
Compliance with recommendations also contributes to vaccination rates, Dr. Horovitz said. The fact that in about 10% of people, a flulike syndrome develops the day after being vaccinated with Shingrix can cause some to postpone or rethink immunization, he added. In addition, Shingrix requires two shots. “People have to come back, and that always sets up an issue with recalling someone.”
Marketplace shortages of the Shingrix vaccine could also contribute to lower vaccination rates. However, Dr. Horovitz said that, in his practice, availability was only a problem during the first year after approval in 2017.
On a related note, manufacturer GlaxoSmithKline announced that a decrease in vaccination demand during the COVID-19 pandemic has allowed the supply to catch up. Shingrix no longer qualifies for the CDC’s shortages list, according to a July 9 report.
Ms. Terlizzi, Dr. Horovitz, and Dr. Schmader have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The number of Americans aged 60 years and older who report receiving shingles vaccination had risen steadily since 2008 and has leveled off during the past few years, new data from the Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics reveal.
The proportion of people in this age group who were vaccinated rose from 6.7% in 2008 to 34.5% in 2018, for example.
Emily Terlizzi, MPH, told Medscape Medical News.
The report was published online July 9 in NCHS Data Brief.
Similar rates for men and women
Rates of people who reported receiving at least one vaccination with Zostavax (Merck) or Shingrix (GlaxoSmithKline) varied by factors that included Hispanic origin, education, and family income. An unexpected finding was that rates did not vary significantly between men and women.
“One finding that I would say surprised me was that, although the percentage who had ever received a shingles vaccine among women aged 60 and over was higher than that among men in this age group, this difference was not statistically significant,” said Ms. Terlizzi, a health statistician in the Data Analysis and Quality Assurance Branch, Division of Health Interview Statistics, the CDC National Center for Health Statistics. In 2018, for example, 35.4% of women and 33.5% of men reported ever receiving a shingles vaccine.
The similarity of rates was less of a surprise to Len Horovitz, MD, a pulmonary specialist at Lenox Hill Hospital in New York, who was not affiliated with the report. “In my anecdotal experience, I don’t see a preponderance of one sex getting shingles more than another. It’s pretty evenly distributed,” he said in an interview.
Ms. Terlizzi and coauthor Lindsey I. Black, MPH, say their findings align with prior research. However, they noted: “Our report uses more recent data from a large, nationally representative data source to update these estimates and describe these disparities.” Data come from results of the annual National Health Interview Survey of households nationwide.
Multiple factors explain vaccination differences
Non-Hispanic White adults were more likely to report receiving the vaccine than were Hispanic and non-Hispanic Black survey respondents. Non-Hispanic White adults were about twice as likely to report vaccination – 38.6% – compared with 19.5% of Hispanic adults and 18.8% of non-Hispanic Black adults.
The disparity in vaccination by race was “disappointing news,” Kenneth E. Schmader, MD, said in an interview.
“The health disparity with regard to lower vaccination rates in Hispanic and non-Hispanic Black populations is reported with other vaccines as well and points to the need for better efforts to vaccinate Hispanic and non-Hispanic Black populations,” added Dr. Schmader, a professor of medicine at Duke University in Durham, N.C.
On a positive note, “It was good to see increasing use of shingles vaccination over time, given how devastating zoster can be in older adults and the fact that the vaccines are effective,” said Dr. Schmader, who also serves on the working groups for the Herpes Zoster, Influenza and General Adult Immunization Guidelines for the CDC Advisory Committee on Immunization Practices (ACIP).
Self-reports of receiving vaccination increased in association with higher education and family income levels. For example, 39.9% of respondents who had more than a high school diploma or GED (General Educational Development) reported receiving the shingles vaccine. In contrast, only 21.2% of people with lower educational attainment reported receiving a vaccine.
In terms of income, 20.4% of poor adults reported being vaccinated, compared with 38.4% of adults who were not poor.
The investigators also evaluated the data by geographic region. They found that rates of vaccinations varied from 26.3% in the East South Central part of the United States (which includes Tennessee, Kentucky, and Alabama) to 42.8% in the West North Central region (which includes the Dakotas, Minnesota, and Nebraska).
Clinical and research considerations
For most of the decade evaluated in the study, ACIP recommended vaccination against shingles for Americans aged 60 years and older. The current findings, therefore, do not account for ACIP’s expanding its recommendations in 2017 to include adults aged 50 years and older.
Zostavax is expected to be discontinued this year. It was the only shingles vaccine available before the approval of Shingrix in 2018. The shift to a single product could alter vaccination patterns further.
Ms. Terlizzi plans to continue monitoring trends to “see what changes occur in the next few years,” she said.
Compliance a concern
Data on vaccination rates for shingles are important given the large proportion of the population at risk, Dr. Horovitz said. “People over age 50 who have had chickenpox have a one third chance over their lifetimes to get shingles. That is a lot of people.”
Multiple factors could be contributing to the fact that vaccination rates have hovered around 34% in recent years, he said. “Whenever you see variations in vaccination rates, you have to think about cultural differences and questions about differences in access, accessibility, and attitudes. Attitudes toward vaccines vary widely – from people who don’t believe in vaccination to people who are eager to take vaccinations.
“I don’t know how to dissect all that out of these data,” he added.
Compliance with recommendations also contributes to vaccination rates, Dr. Horovitz said. The fact that in about 10% of people, a flulike syndrome develops the day after being vaccinated with Shingrix can cause some to postpone or rethink immunization, he added. In addition, Shingrix requires two shots. “People have to come back, and that always sets up an issue with recalling someone.”
Marketplace shortages of the Shingrix vaccine could also contribute to lower vaccination rates. However, Dr. Horovitz said that, in his practice, availability was only a problem during the first year after approval in 2017.
On a related note, manufacturer GlaxoSmithKline announced that a decrease in vaccination demand during the COVID-19 pandemic has allowed the supply to catch up. Shingrix no longer qualifies for the CDC’s shortages list, according to a July 9 report.
Ms. Terlizzi, Dr. Horovitz, and Dr. Schmader have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Influenza vaccine efficacy called undiminished in MS
, Jackie Nguyen reported at the virtual annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC). She presented a systematic review and meta-analysis of nine published cohort studies including 417 MS patients and more than 500 healthy controls, all of whom received inactivated seasonal influenza vaccine.
The impetus for this project was a recognition that the great majority of the research on the impact of influenza vaccine in patients with MS has focused on safety and MS relapse rates. In contrast, the nine studies included in the meta-analysis contained data on influenza vaccine efficacy as reflected in the ability to mount an adequate immune response. This was defined in standard fashion either by seroconversion, which required at least a fourfold increase in antibody titers following vaccination, or seroprotection, with a postvaccination antihemagglutination immunoglobulin G titer of at least 40. The analysis included patients with MS irrespective of disease duration or severity or treatment regimen, noted Ms. Nguyen, a third-year medical student at Nova Southeastern University College of Allopathic Medicine in Davie, Fla.
The researchers found that there was no significant difference between patients with MS and healthy controls in the rates of an adequate immune response for influenza H1N1, H3N2, or influenza B virus. “The vaccine should thus continue to be recommended for MS patients, as the data shows it to be efficacious,” she said.
Her conclusion is consistent with guidance provided in the American Academy of Neurology’s 2019 practice guideline update on immunization in MS, highlighted elsewhere at CMSC 2020 in a presentation by Marijean Buhse, PhD, of Stony Brook University in New York.
The guideline, updated for the first time in 17 years, states that all MS patients should be advised to receive influenza vaccine annually: “With known risks of exacerbation and other morbidity with influenza infection and no identified risks of exacerbation with influenza vaccines, benefits of influenza vaccination outweigh the risks in most scenarios. The exception involves the relatively few MS patients having a specific contraindication to the influenza vaccine, such as a previous severe reaction, noted Dr. Buhse, who wasn’t involved in developing the evidence-based guidelines.
The available evidence indicates that some but not all disease-modifying therapies for MS reduce the effectiveness of vaccination against influenza.
According to the guideline, “it is possible” that persons with MS being treated with glatiramer acetate have a reduced likelihood of seroprotection from influenza vaccine, a conclusion the guidelines committee drew with “low confidence in the evidence.” Further, the guideline states that “it is probable” MS patients on fingolimod have a lower likelihood of obtaining seroprotection from influenza vaccine than patients not on the drug, with moderate confidence in the evidence. Also, it is deemed probable that patients with MS who are taking mitoxantrone have a reduced likelihood of response to influenza vaccination, compared with healthy controls. But it is probable that patients with MS who are receiving interferon-beta have no diminution in the likelihood of seroprotection. According to the guideline, there is insufficient evidence to say whether patients with MS who are on natalizumab, teriflunomide, or methotrexate have a diminished response to influenza vaccination.
Dr. Buhse noted that rituximab is off-label therapy for MS, so there are no data available regarding the likelihood of seroprotection in response to influenza vaccination in that setting. However, rituximab profoundly decreases the immunogenicity of influenza and pneumococcal vaccines in rheumatoid arthritis patients. It is therefore recommended that inactivated influenza vaccine be given to patients with MS at least 2 weeks prior to starting rituximab or 6 months after the last dose in order to optimize the humoral results. Ms. Nguyen reported having no financial conflicts regarding her presentation. Dr. Buhse reported having received honoraria from Genzyme and Biogen.
, Jackie Nguyen reported at the virtual annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC). She presented a systematic review and meta-analysis of nine published cohort studies including 417 MS patients and more than 500 healthy controls, all of whom received inactivated seasonal influenza vaccine.
The impetus for this project was a recognition that the great majority of the research on the impact of influenza vaccine in patients with MS has focused on safety and MS relapse rates. In contrast, the nine studies included in the meta-analysis contained data on influenza vaccine efficacy as reflected in the ability to mount an adequate immune response. This was defined in standard fashion either by seroconversion, which required at least a fourfold increase in antibody titers following vaccination, or seroprotection, with a postvaccination antihemagglutination immunoglobulin G titer of at least 40. The analysis included patients with MS irrespective of disease duration or severity or treatment regimen, noted Ms. Nguyen, a third-year medical student at Nova Southeastern University College of Allopathic Medicine in Davie, Fla.
The researchers found that there was no significant difference between patients with MS and healthy controls in the rates of an adequate immune response for influenza H1N1, H3N2, or influenza B virus. “The vaccine should thus continue to be recommended for MS patients, as the data shows it to be efficacious,” she said.
Her conclusion is consistent with guidance provided in the American Academy of Neurology’s 2019 practice guideline update on immunization in MS, highlighted elsewhere at CMSC 2020 in a presentation by Marijean Buhse, PhD, of Stony Brook University in New York.
The guideline, updated for the first time in 17 years, states that all MS patients should be advised to receive influenza vaccine annually: “With known risks of exacerbation and other morbidity with influenza infection and no identified risks of exacerbation with influenza vaccines, benefits of influenza vaccination outweigh the risks in most scenarios. The exception involves the relatively few MS patients having a specific contraindication to the influenza vaccine, such as a previous severe reaction, noted Dr. Buhse, who wasn’t involved in developing the evidence-based guidelines.
The available evidence indicates that some but not all disease-modifying therapies for MS reduce the effectiveness of vaccination against influenza.
According to the guideline, “it is possible” that persons with MS being treated with glatiramer acetate have a reduced likelihood of seroprotection from influenza vaccine, a conclusion the guidelines committee drew with “low confidence in the evidence.” Further, the guideline states that “it is probable” MS patients on fingolimod have a lower likelihood of obtaining seroprotection from influenza vaccine than patients not on the drug, with moderate confidence in the evidence. Also, it is deemed probable that patients with MS who are taking mitoxantrone have a reduced likelihood of response to influenza vaccination, compared with healthy controls. But it is probable that patients with MS who are receiving interferon-beta have no diminution in the likelihood of seroprotection. According to the guideline, there is insufficient evidence to say whether patients with MS who are on natalizumab, teriflunomide, or methotrexate have a diminished response to influenza vaccination.
Dr. Buhse noted that rituximab is off-label therapy for MS, so there are no data available regarding the likelihood of seroprotection in response to influenza vaccination in that setting. However, rituximab profoundly decreases the immunogenicity of influenza and pneumococcal vaccines in rheumatoid arthritis patients. It is therefore recommended that inactivated influenza vaccine be given to patients with MS at least 2 weeks prior to starting rituximab or 6 months after the last dose in order to optimize the humoral results. Ms. Nguyen reported having no financial conflicts regarding her presentation. Dr. Buhse reported having received honoraria from Genzyme and Biogen.
, Jackie Nguyen reported at the virtual annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC). She presented a systematic review and meta-analysis of nine published cohort studies including 417 MS patients and more than 500 healthy controls, all of whom received inactivated seasonal influenza vaccine.
The impetus for this project was a recognition that the great majority of the research on the impact of influenza vaccine in patients with MS has focused on safety and MS relapse rates. In contrast, the nine studies included in the meta-analysis contained data on influenza vaccine efficacy as reflected in the ability to mount an adequate immune response. This was defined in standard fashion either by seroconversion, which required at least a fourfold increase in antibody titers following vaccination, or seroprotection, with a postvaccination antihemagglutination immunoglobulin G titer of at least 40. The analysis included patients with MS irrespective of disease duration or severity or treatment regimen, noted Ms. Nguyen, a third-year medical student at Nova Southeastern University College of Allopathic Medicine in Davie, Fla.
The researchers found that there was no significant difference between patients with MS and healthy controls in the rates of an adequate immune response for influenza H1N1, H3N2, or influenza B virus. “The vaccine should thus continue to be recommended for MS patients, as the data shows it to be efficacious,” she said.
Her conclusion is consistent with guidance provided in the American Academy of Neurology’s 2019 practice guideline update on immunization in MS, highlighted elsewhere at CMSC 2020 in a presentation by Marijean Buhse, PhD, of Stony Brook University in New York.
The guideline, updated for the first time in 17 years, states that all MS patients should be advised to receive influenza vaccine annually: “With known risks of exacerbation and other morbidity with influenza infection and no identified risks of exacerbation with influenza vaccines, benefits of influenza vaccination outweigh the risks in most scenarios. The exception involves the relatively few MS patients having a specific contraindication to the influenza vaccine, such as a previous severe reaction, noted Dr. Buhse, who wasn’t involved in developing the evidence-based guidelines.
The available evidence indicates that some but not all disease-modifying therapies for MS reduce the effectiveness of vaccination against influenza.
According to the guideline, “it is possible” that persons with MS being treated with glatiramer acetate have a reduced likelihood of seroprotection from influenza vaccine, a conclusion the guidelines committee drew with “low confidence in the evidence.” Further, the guideline states that “it is probable” MS patients on fingolimod have a lower likelihood of obtaining seroprotection from influenza vaccine than patients not on the drug, with moderate confidence in the evidence. Also, it is deemed probable that patients with MS who are taking mitoxantrone have a reduced likelihood of response to influenza vaccination, compared with healthy controls. But it is probable that patients with MS who are receiving interferon-beta have no diminution in the likelihood of seroprotection. According to the guideline, there is insufficient evidence to say whether patients with MS who are on natalizumab, teriflunomide, or methotrexate have a diminished response to influenza vaccination.
Dr. Buhse noted that rituximab is off-label therapy for MS, so there are no data available regarding the likelihood of seroprotection in response to influenza vaccination in that setting. However, rituximab profoundly decreases the immunogenicity of influenza and pneumococcal vaccines in rheumatoid arthritis patients. It is therefore recommended that inactivated influenza vaccine be given to patients with MS at least 2 weeks prior to starting rituximab or 6 months after the last dose in order to optimize the humoral results. Ms. Nguyen reported having no financial conflicts regarding her presentation. Dr. Buhse reported having received honoraria from Genzyme and Biogen.
REPORTING FROM CMSC 2020
Phase 3 COVID-19 vaccine trials launching in July, expert says
The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.
According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”
Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”
Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”
Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”
Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”
“Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”
The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”
A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”
Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”
Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”
Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”
The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.
According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”
Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”
Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”
Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”
Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”
“Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”
The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”
A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”
Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”
Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”
Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”
The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.
According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”
Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”
Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”
Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”
Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”
“Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”
The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”
A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”
Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”
Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”
Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”
FROM PEDIATRIC DERMATOLOGY 2020