Vaccines

Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.

If the request is approved, the broader use of Pfizer boosters would be a step toward President Biden’s goal of boosters for all adults. He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.

This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.

However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.

The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.

The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.

The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
 

A version of this article first appeared on WebMD.com.

Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.

If the request is approved, the broader use of Pfizer boosters would be a step toward President Biden’s goal of boosters for all adults. He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.

This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.

However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.

The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.

The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.

The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
 

A version of this article first appeared on WebMD.com.

Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.

If the request is approved, the broader use of Pfizer boosters would be a step toward President Biden’s goal of boosters for all adults. He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.

This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.

However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.

The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.

The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.

The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
 

A version of this article first appeared on WebMD.com.

The United States of America are not united. Politics have polarized the competing monologues and the policy making around vaccines, masks, children returning to school, what children are taught in school, and whether the federal government (or the National Football League) can or should create universal mandates enforcing one extreme of any of those policy disputes. Public health and health care have become so entangled in polarized politics that the role of science has often been pushed aside.

Polarization is not a novel event in the history of governments. The partition of India in 1947 divided most of its Hindu and Muslim inhabitants into separate countries, but that hasn’t stopped the recent resurgence of Hindu nationalism in India. The Thirty Years’ War in Europe sought to decide whether Catholics or Protestants would dominate Western Christianity. Those two sides decided in 1648 that coexistence was wiser than continuing into the abyss of mutual annihilation. Current conflicts between Israelis and Palestinians, between Shia and Sunni Arab states, between China and the Uyghurs, and within Sudan and Ethiopia together demonstrate that polarization to the point of genocide can occur regardless of religion, race, and nationality.

Abraham Lincoln, a lawyer in Illinois with a habit of losing elections, was nominated in 1858 to be the Republican nominee in the U.S. Senate race. His speech accepting the nomination spoke a truth that resonated across the nation and across time. It is known as the House Divided speech. He said: “A house divided against itself cannot stand. I believe this government cannot endure, permanently half slave and half free. I do not expect the Union to be dissolved – I do not expect the house to fall – but I do expect it will cease to be divided. It will become all one thing or all the other.”

The Republican Lincoln, supported by antislavery groups, lost that election to the Democrat Stephen A. Douglas, whose party espoused popular sovereignty and local decision-making about slavery. Lincoln’s acceptance speech propelled him 2 years later to be nominated for and elected President of the United States. Lincoln’s first inaugural address as the President of the United States on March 4, 1861, focused on the issue of division and secession. This time, Lincoln placed much more emphasis on preserving the Union. He specifically renounced any federal efforts to use force to abolish slavery in the states that permitted it. He declared: “I have no purpose, directly or indirectly, to interfere with the institution of slavery in the States where it exists. I believe I have no lawful right to do so, and I have no inclination to do so.”

President Lincoln’s approach might not meet muster in today’s cancel culture. He was facing a precariously divided nation not unlike the current day, so his speech contains insights and wisdom important for today. Lincoln saw government as “a majority held in restraint by constitutional checks and limitations.” I am loath to further quote out of context or paraphrase his masterful words. Go read the original, in its balanced entirety.

I have written previous columns about the importance of taking time to reflect on one’s life and one’s career. Reflection is both a wellness check and a moral compass check. Some call it mindfulness. I lean toward calling it thankfulness and gratitude. Hence, November is a convenient time for pediatricians if flu and respiratory syncytial virus seasons haven’t started.

The Gettysburg Address extols the virtue of dedication. Lincoln’s second inaugural address promotes mercy and forgiveness. His Farewell Address to Springfield in 1861 in a single paragraph captures grief, faith, and hope. Those speeches are my perennial favorites. But this year it is the two aforementioned addresses that must be mined for wisdom.

I advocate vaccine and mask mandates, but I am not enamored with the idea of President Biden using the unchecked power of the executive branch to promulgate a single federal regulation that overreaches into every moderate-size business nationwide. The 1861 inaugural address concurs. Lincoln’s prophecy that division will be solved when one side ultimately wins is not the model I seek. It hasn’t worked for gun control. It hasn’t worked for abortion as we approach the 50th anniversary of Roe v. Wade. The present 50+1 vote majority in the U.S. Senate does not have a mandate to overhaul society, especially when those majorities are transient. One should have the courage to seek change, but beware of creating large divisions with small majorities.

Facebook profits when you meditate in the echo chambers of large, outraged groups. Avoid that. Hebrew tradition has some reflection occurring in groups of two or three, rather than solo. Truth is revealed in community. Voltaire said: “Cherish those who seek the truth but beware of those who find it.” As a scientist, my experience is that humility, skepticism, and a dedication to finding truth have served me well for a lifetime.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

The United States of America are not united. Politics have polarized the competing monologues and the policy making around vaccines, masks, children returning to school, what children are taught in school, and whether the federal government (or the National Football League) can or should create universal mandates enforcing one extreme of any of those policy disputes. Public health and health care have become so entangled in polarized politics that the role of science has often been pushed aside.

Polarization is not a novel event in the history of governments. The partition of India in 1947 divided most of its Hindu and Muslim inhabitants into separate countries, but that hasn’t stopped the recent resurgence of Hindu nationalism in India. The Thirty Years’ War in Europe sought to decide whether Catholics or Protestants would dominate Western Christianity. Those two sides decided in 1648 that coexistence was wiser than continuing into the abyss of mutual annihilation. Current conflicts between Israelis and Palestinians, between Shia and Sunni Arab states, between China and the Uyghurs, and within Sudan and Ethiopia together demonstrate that polarization to the point of genocide can occur regardless of religion, race, and nationality.

Abraham Lincoln, a lawyer in Illinois with a habit of losing elections, was nominated in 1858 to be the Republican nominee in the U.S. Senate race. His speech accepting the nomination spoke a truth that resonated across the nation and across time. It is known as the House Divided speech. He said: “A house divided against itself cannot stand. I believe this government cannot endure, permanently half slave and half free. I do not expect the Union to be dissolved – I do not expect the house to fall – but I do expect it will cease to be divided. It will become all one thing or all the other.”

The Republican Lincoln, supported by antislavery groups, lost that election to the Democrat Stephen A. Douglas, whose party espoused popular sovereignty and local decision-making about slavery. Lincoln’s acceptance speech propelled him 2 years later to be nominated for and elected President of the United States. Lincoln’s first inaugural address as the President of the United States on March 4, 1861, focused on the issue of division and secession. This time, Lincoln placed much more emphasis on preserving the Union. He specifically renounced any federal efforts to use force to abolish slavery in the states that permitted it. He declared: “I have no purpose, directly or indirectly, to interfere with the institution of slavery in the States where it exists. I believe I have no lawful right to do so, and I have no inclination to do so.”

President Lincoln’s approach might not meet muster in today’s cancel culture. He was facing a precariously divided nation not unlike the current day, so his speech contains insights and wisdom important for today. Lincoln saw government as “a majority held in restraint by constitutional checks and limitations.” I am loath to further quote out of context or paraphrase his masterful words. Go read the original, in its balanced entirety.

I have written previous columns about the importance of taking time to reflect on one’s life and one’s career. Reflection is both a wellness check and a moral compass check. Some call it mindfulness. I lean toward calling it thankfulness and gratitude. Hence, November is a convenient time for pediatricians if flu and respiratory syncytial virus seasons haven’t started.

The Gettysburg Address extols the virtue of dedication. Lincoln’s second inaugural address promotes mercy and forgiveness. His Farewell Address to Springfield in 1861 in a single paragraph captures grief, faith, and hope. Those speeches are my perennial favorites. But this year it is the two aforementioned addresses that must be mined for wisdom.

I advocate vaccine and mask mandates, but I am not enamored with the idea of President Biden using the unchecked power of the executive branch to promulgate a single federal regulation that overreaches into every moderate-size business nationwide. The 1861 inaugural address concurs. Lincoln’s prophecy that division will be solved when one side ultimately wins is not the model I seek. It hasn’t worked for gun control. It hasn’t worked for abortion as we approach the 50th anniversary of Roe v. Wade. The present 50+1 vote majority in the U.S. Senate does not have a mandate to overhaul society, especially when those majorities are transient. One should have the courage to seek change, but beware of creating large divisions with small majorities.

Facebook profits when you meditate in the echo chambers of large, outraged groups. Avoid that. Hebrew tradition has some reflection occurring in groups of two or three, rather than solo. Truth is revealed in community. Voltaire said: “Cherish those who seek the truth but beware of those who find it.” As a scientist, my experience is that humility, skepticism, and a dedication to finding truth have served me well for a lifetime.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

The United States of America are not united. Politics have polarized the competing monologues and the policy making around vaccines, masks, children returning to school, what children are taught in school, and whether the federal government (or the National Football League) can or should create universal mandates enforcing one extreme of any of those policy disputes. Public health and health care have become so entangled in polarized politics that the role of science has often been pushed aside.

Polarization is not a novel event in the history of governments. The partition of India in 1947 divided most of its Hindu and Muslim inhabitants into separate countries, but that hasn’t stopped the recent resurgence of Hindu nationalism in India. The Thirty Years’ War in Europe sought to decide whether Catholics or Protestants would dominate Western Christianity. Those two sides decided in 1648 that coexistence was wiser than continuing into the abyss of mutual annihilation. Current conflicts between Israelis and Palestinians, between Shia and Sunni Arab states, between China and the Uyghurs, and within Sudan and Ethiopia together demonstrate that polarization to the point of genocide can occur regardless of religion, race, and nationality.

Abraham Lincoln, a lawyer in Illinois with a habit of losing elections, was nominated in 1858 to be the Republican nominee in the U.S. Senate race. His speech accepting the nomination spoke a truth that resonated across the nation and across time. It is known as the House Divided speech. He said: “A house divided against itself cannot stand. I believe this government cannot endure, permanently half slave and half free. I do not expect the Union to be dissolved – I do not expect the house to fall – but I do expect it will cease to be divided. It will become all one thing or all the other.”

The Republican Lincoln, supported by antislavery groups, lost that election to the Democrat Stephen A. Douglas, whose party espoused popular sovereignty and local decision-making about slavery. Lincoln’s acceptance speech propelled him 2 years later to be nominated for and elected President of the United States. Lincoln’s first inaugural address as the President of the United States on March 4, 1861, focused on the issue of division and secession. This time, Lincoln placed much more emphasis on preserving the Union. He specifically renounced any federal efforts to use force to abolish slavery in the states that permitted it. He declared: “I have no purpose, directly or indirectly, to interfere with the institution of slavery in the States where it exists. I believe I have no lawful right to do so, and I have no inclination to do so.”

President Lincoln’s approach might not meet muster in today’s cancel culture. He was facing a precariously divided nation not unlike the current day, so his speech contains insights and wisdom important for today. Lincoln saw government as “a majority held in restraint by constitutional checks and limitations.” I am loath to further quote out of context or paraphrase his masterful words. Go read the original, in its balanced entirety.

I have written previous columns about the importance of taking time to reflect on one’s life and one’s career. Reflection is both a wellness check and a moral compass check. Some call it mindfulness. I lean toward calling it thankfulness and gratitude. Hence, November is a convenient time for pediatricians if flu and respiratory syncytial virus seasons haven’t started.

The Gettysburg Address extols the virtue of dedication. Lincoln’s second inaugural address promotes mercy and forgiveness. His Farewell Address to Springfield in 1861 in a single paragraph captures grief, faith, and hope. Those speeches are my perennial favorites. But this year it is the two aforementioned addresses that must be mined for wisdom.

I advocate vaccine and mask mandates, but I am not enamored with the idea of President Biden using the unchecked power of the executive branch to promulgate a single federal regulation that overreaches into every moderate-size business nationwide. The 1861 inaugural address concurs. Lincoln’s prophecy that division will be solved when one side ultimately wins is not the model I seek. It hasn’t worked for gun control. It hasn’t worked for abortion as we approach the 50th anniversary of Roe v. Wade. The present 50+1 vote majority in the U.S. Senate does not have a mandate to overhaul society, especially when those majorities are transient. One should have the courage to seek change, but beware of creating large divisions with small majorities.

Facebook profits when you meditate in the echo chambers of large, outraged groups. Avoid that. Hebrew tradition has some reflection occurring in groups of two or three, rather than solo. Truth is revealed in community. Voltaire said: “Cherish those who seek the truth but beware of those who find it.” As a scientist, my experience is that humility, skepticism, and a dedication to finding truth have served me well for a lifetime.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

The effectiveness of COVID-19 vaccines produced by Pfizer/BioNTech, Moderna, and Johnson & Johnson dropped dramatically as the Delta variant swept the United States, a study of almost 800,000 veterans found.

The study, published in the journal Science ., says the three vaccines offered about the same protection against the virus in March, when the Delta variant was first detected in the United States, but that changed 6 months later.

The Moderna two-dose vaccine went from being 89% effective in March to 58% effective in September, according to a story about the study in theLos Angeles Times.

Meanwhile, the Pfizer/BioNTech vaccine went from being 87% effective to 45% effective over the same time period.

The Johnson & Johnson vaccine showed the biggest drop -- from 86% effectiveness to 13% over those 6 months.

“In summary, although vaccination remains protective against SARS-CoV-2 infection, protection waned as the Delta variant emerged in the U.S., and this decline did not differ by age,” the study said.

The three vaccines also lost effectiveness in the ability to protect against death in veterans 65 and over after only 3 months, the Los Angeles Times reported.

Compared to unvaccinated veterans in that age group, veterans who got the Moderna vaccine and had a breakthrough case were 76% less likely to die of COVID-19 by July.

The protection was 70% for Pfizer/BioNTech vaccine recipients and 52% for J&J vaccine recipients for the same age group, compared to unvaccinated veterans, according to the newspaper.

For veterans under 65, the protectiveness against a fatal case of COVID was 84% for Pfizer/BioNTech recipients, 82% for Moderna recipients, and 73% for J&J recipients, compared to unvaccinated veterans in that age group.

The study confirms the need for booster vaccines and protective measures such as vaccine passports, vaccine mandates, masking, hand-washing, and social distancing, the researchers said.

Of the veterans studied, about 500,000 were vaccinated and 300,000 were not. Researchers noted that the study population had 6 times as many men as women. About 48% of the study group was 65 or older, 29% was 50-64, while 24% was under 50.

Researchers from the Public Health Institute in Oakland, the Veterans Affairs Medical Center in San Francisco, and the University of Texas Health Science Center conducted the study.

A version of this article first appeared on WebMD.com.

The effectiveness of COVID-19 vaccines produced by Pfizer/BioNTech, Moderna, and Johnson & Johnson dropped dramatically as the Delta variant swept the United States, a study of almost 800,000 veterans found.

The study, published in the journal Science ., says the three vaccines offered about the same protection against the virus in March, when the Delta variant was first detected in the United States, but that changed 6 months later.

The Moderna two-dose vaccine went from being 89% effective in March to 58% effective in September, according to a story about the study in theLos Angeles Times.

Meanwhile, the Pfizer/BioNTech vaccine went from being 87% effective to 45% effective over the same time period.

The Johnson & Johnson vaccine showed the biggest drop -- from 86% effectiveness to 13% over those 6 months.

“In summary, although vaccination remains protective against SARS-CoV-2 infection, protection waned as the Delta variant emerged in the U.S., and this decline did not differ by age,” the study said.

The three vaccines also lost effectiveness in the ability to protect against death in veterans 65 and over after only 3 months, the Los Angeles Times reported.

Compared to unvaccinated veterans in that age group, veterans who got the Moderna vaccine and had a breakthrough case were 76% less likely to die of COVID-19 by July.

The protection was 70% for Pfizer/BioNTech vaccine recipients and 52% for J&J vaccine recipients for the same age group, compared to unvaccinated veterans, according to the newspaper.

For veterans under 65, the protectiveness against a fatal case of COVID was 84% for Pfizer/BioNTech recipients, 82% for Moderna recipients, and 73% for J&J recipients, compared to unvaccinated veterans in that age group.

The study confirms the need for booster vaccines and protective measures such as vaccine passports, vaccine mandates, masking, hand-washing, and social distancing, the researchers said.

Of the veterans studied, about 500,000 were vaccinated and 300,000 were not. Researchers noted that the study population had 6 times as many men as women. About 48% of the study group was 65 or older, 29% was 50-64, while 24% was under 50.

Researchers from the Public Health Institute in Oakland, the Veterans Affairs Medical Center in San Francisco, and the University of Texas Health Science Center conducted the study.

A version of this article first appeared on WebMD.com.

The effectiveness of COVID-19 vaccines produced by Pfizer/BioNTech, Moderna, and Johnson & Johnson dropped dramatically as the Delta variant swept the United States, a study of almost 800,000 veterans found.

The study, published in the journal Science ., says the three vaccines offered about the same protection against the virus in March, when the Delta variant was first detected in the United States, but that changed 6 months later.

The Moderna two-dose vaccine went from being 89% effective in March to 58% effective in September, according to a story about the study in theLos Angeles Times.

Meanwhile, the Pfizer/BioNTech vaccine went from being 87% effective to 45% effective over the same time period.

The Johnson & Johnson vaccine showed the biggest drop -- from 86% effectiveness to 13% over those 6 months.

“In summary, although vaccination remains protective against SARS-CoV-2 infection, protection waned as the Delta variant emerged in the U.S., and this decline did not differ by age,” the study said.

The three vaccines also lost effectiveness in the ability to protect against death in veterans 65 and over after only 3 months, the Los Angeles Times reported.

Compared to unvaccinated veterans in that age group, veterans who got the Moderna vaccine and had a breakthrough case were 76% less likely to die of COVID-19 by July.

The protection was 70% for Pfizer/BioNTech vaccine recipients and 52% for J&J vaccine recipients for the same age group, compared to unvaccinated veterans, according to the newspaper.

For veterans under 65, the protectiveness against a fatal case of COVID was 84% for Pfizer/BioNTech recipients, 82% for Moderna recipients, and 73% for J&J recipients, compared to unvaccinated veterans in that age group.

The study confirms the need for booster vaccines and protective measures such as vaccine passports, vaccine mandates, masking, hand-washing, and social distancing, the researchers said.

Of the veterans studied, about 500,000 were vaccinated and 300,000 were not. Researchers noted that the study population had 6 times as many men as women. About 48% of the study group was 65 or older, 29% was 50-64, while 24% was under 50.

Researchers from the Public Health Institute in Oakland, the Veterans Affairs Medical Center in San Francisco, and the University of Texas Health Science Center conducted the study.

A version of this article first appeared on WebMD.com.

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention has unanimously voted to recommend universal hepatitis B (HBV) immunization in all unvaccinated adults aged 59 years or younger. The group also voted to expand recommendations for vaccinating people at risk for occupational exposure to Ebola and to recommend Jynneos, a smallpox and monkeypox vaccine, for at-risk populations.

The recommendations were approved Nov. 3.

Previously, ACIP recommended HBV vaccination for unvaccinated adults at increased risk for infection because of sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, HIV infection, and travel to areas with high to intermediate levels of HBV infection. But experts agreed a new strategy was needed, as previously falling rates of HBV have plateaued. “The past decade has illustrated that risk-based screening has got us as far as it can take us,” Mark Weng, MD, a lieutenant commander in the U.S. Public Health Service and lead of the ACIP Hepatitis Vaccine Working Group, said during the meeting.

There are 1.9 million people living with chronic HBV in the United States, with over 20,000 new acute infections every year. Rates are highest among those in their 40s and 50s, Dr. Weng noted.

The group debated whether to apply the universal recommendation to all ages, but in a close vote (eight yes, seven no), ACIP included an age cutoff of 59. The majority argued that adults 60 and older are at lower risk for infection and vaccination efforts targeting younger adults would be more effective. Those 60 and older would continue to follow the risk-based guidelines, but anyone, regardless of age, can receive the vaccine if they wish to be protected, the group added.

The CDC director as well as several professional societies need to approve the recommendation before it becomes public policy.

ACIP also voted to recommend the following:

• Adding updated recommendations to the 2022 immunization schedules for children, adolescents, and adults, including dengue vaccination for children aged 9-16 years in endemic areas and in adults over 65 and those aged 19-64 with certain chronic conditions.
• The use of Jynneos, a smallpox and monkeypox vaccine, as an alternative to ACAM2000 for those at risk for occupational exposure.
• Pre-exposure vaccination of health care personnel involved in the transport and treatment of suspected Ebola patients at special treatment centers, or lab and support staff working with or handling specimens that may contain the Ebola virus.

A version of this article first appeared on Medscape.com.

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention has unanimously voted to recommend universal hepatitis B (HBV) immunization in all unvaccinated adults aged 59 years or younger. The group also voted to expand recommendations for vaccinating people at risk for occupational exposure to Ebola and to recommend Jynneos, a smallpox and monkeypox vaccine, for at-risk populations.

The recommendations were approved Nov. 3.

Previously, ACIP recommended HBV vaccination for unvaccinated adults at increased risk for infection because of sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, HIV infection, and travel to areas with high to intermediate levels of HBV infection. But experts agreed a new strategy was needed, as previously falling rates of HBV have plateaued. “The past decade has illustrated that risk-based screening has got us as far as it can take us,” Mark Weng, MD, a lieutenant commander in the U.S. Public Health Service and lead of the ACIP Hepatitis Vaccine Working Group, said during the meeting.

There are 1.9 million people living with chronic HBV in the United States, with over 20,000 new acute infections every year. Rates are highest among those in their 40s and 50s, Dr. Weng noted.

The group debated whether to apply the universal recommendation to all ages, but in a close vote (eight yes, seven no), ACIP included an age cutoff of 59. The majority argued that adults 60 and older are at lower risk for infection and vaccination efforts targeting younger adults would be more effective. Those 60 and older would continue to follow the risk-based guidelines, but anyone, regardless of age, can receive the vaccine if they wish to be protected, the group added.

The CDC director as well as several professional societies need to approve the recommendation before it becomes public policy.

ACIP also voted to recommend the following:

• Adding updated recommendations to the 2022 immunization schedules for children, adolescents, and adults, including dengue vaccination for children aged 9-16 years in endemic areas and in adults over 65 and those aged 19-64 with certain chronic conditions.
• The use of Jynneos, a smallpox and monkeypox vaccine, as an alternative to ACAM2000 for those at risk for occupational exposure.
• Pre-exposure vaccination of health care personnel involved in the transport and treatment of suspected Ebola patients at special treatment centers, or lab and support staff working with or handling specimens that may contain the Ebola virus.

A version of this article first appeared on Medscape.com.

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention has unanimously voted to recommend universal hepatitis B (HBV) immunization in all unvaccinated adults aged 59 years or younger. The group also voted to expand recommendations for vaccinating people at risk for occupational exposure to Ebola and to recommend Jynneos, a smallpox and monkeypox vaccine, for at-risk populations.

The recommendations were approved Nov. 3.

Previously, ACIP recommended HBV vaccination for unvaccinated adults at increased risk for infection because of sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, HIV infection, and travel to areas with high to intermediate levels of HBV infection. But experts agreed a new strategy was needed, as previously falling rates of HBV have plateaued. “The past decade has illustrated that risk-based screening has got us as far as it can take us,” Mark Weng, MD, a lieutenant commander in the U.S. Public Health Service and lead of the ACIP Hepatitis Vaccine Working Group, said during the meeting.

There are 1.9 million people living with chronic HBV in the United States, with over 20,000 new acute infections every year. Rates are highest among those in their 40s and 50s, Dr. Weng noted.

The group debated whether to apply the universal recommendation to all ages, but in a close vote (eight yes, seven no), ACIP included an age cutoff of 59. The majority argued that adults 60 and older are at lower risk for infection and vaccination efforts targeting younger adults would be more effective. Those 60 and older would continue to follow the risk-based guidelines, but anyone, regardless of age, can receive the vaccine if they wish to be protected, the group added.

The CDC director as well as several professional societies need to approve the recommendation before it becomes public policy.

ACIP also voted to recommend the following:

• Adding updated recommendations to the 2022 immunization schedules for children, adolescents, and adults, including dengue vaccination for children aged 9-16 years in endemic areas and in adults over 65 and those aged 19-64 with certain chronic conditions.
• The use of Jynneos, a smallpox and monkeypox vaccine, as an alternative to ACAM2000 for those at risk for occupational exposure.
• Pre-exposure vaccination of health care personnel involved in the transport and treatment of suspected Ebola patients at special treatment centers, or lab and support staff working with or handling specimens that may contain the Ebola virus.

A version of this article first appeared on Medscape.com.

New data from England show the success of the national program for vaccinating girls against human papillomavirus (HPV) to prevent cervical cancer.

Among young women who received the HPV vaccine when they were 12-13 years old (before their sexual debut), cervical cancer rates are 87% lower than among previous nonvaccinated generations.

“It’s been incredible to see the impact of HPV vaccination, and now we can prove it prevented hundreds of women from developing cancer in England,” senior author Peter Sasieni, MD, King’s College London, said in a statement. “To see the real-life impact of the vaccine has been truly rewarding.”

“This study provides the first direct evidence of the impact of the UK HPV vaccination campaign on cervical cancer incidence, showing a large reduction in cervical cancer rates in vaccinated cohorts,” Kate Soldan, MD, U.K. Health Security Agency, London, commented in a statement.

Vanessa Saliba, MD, a consultant epidemiologist for the U.K. Health Security Agency, agreed, saying that “these remarkable findings confirm that the HPV vaccine saves lives by dramatically reducing cervical cancer rates among women.

“This reminds us that vaccines are one of the most important tools we have to help us live longer, healthier lives,” she added.

The study was published online Nov. 3, 2021, in The Lancet.

Approached for comment on the new study, Maurice Markman, MD, president, Medicine and Science Cancer Treatment Centers of America, noted that the results of the English study are very similar to those of a Swedish study of the quadrivalent vaccine alone.

“You can put any superlatives you want in here, but these are stunningly positive results,” Dr. Markman said in an interview. He said that, as an oncologist who has been treating cervical cancer for 40 years, particularly patients with advanced cervical cancer, “I can tell you this is one of the most devastating diseases to women, and the ability to eliminate this cancer with something as simple as a vaccine is the goal of cancer therapy, and it’s been remarkably successful.

“I can only emphasize the critical importance of all parents to see that their children who are eligible for the vaccine receive it. This is a cancer prevention strategy that is unbelievably, remarkably effective and safe,” Dr. Markman added.
 

National vaccination program

The national HPV vaccination program in England began in 2008. Initially, the bivalent Cervarix vaccine against HPV 16 and 18 was used. HPV 16 and 18 are responsible for 70% to 80% of all cervical cancers in England, the researchers note in their article.

In 2012, the program switched to the quadrivalent HPV vaccine (Gardasil), which is effective against two additional HPV types, HPV 6 and 11. Those strains cause genital warts.

The prevention program originally recommended a three-dose regimen in which both HPV vaccines were used. Currently, two doses are given to girls younger than 15 years. In addition, a single dose of the HPV vaccine provides good protection against persistent infection. The efficacy rate of a single dose is similar to that of three doses, the authors comment.
 

Population-based registry

The new data come from a population-based cancer registry that shows the incidence of cervical cancer and noninvasive cervical carcinoma (CIN3) in England between January 2006 and June 2019.

The study included seven cohorts of women who were aged 20-64 years at the end of 2019. Three of these cohorts composed the vaccinated population.

The team reports that overall, from January 2006 to June 2019, there were 27,946 cases of cervical cancer and 318,058 cases of CIN3.

In the three vaccinated cohorts, there were around 450 fewer cases of cervical cancer and 17,200 fewer cases of CIN3 than would be expected in a nonvaccinated population.

The three vaccinated cohorts had been eligible to receive Cervarix when they were aged 12-13 years. A catch-up scheme aimed at 14- to 16-year-olds and 16- to 18-year-olds. Most of these persons were vaccinated through a school vaccination program.

The team analyzed the data for each of these cohorts.

Among the cohort eligible for vaccination at 12-13 years of age, 89% received at least one dose of the HPV vaccine; 85% received three shots and were fully vaccinated. Among these persons, the rate of cervical cancer was 87% lower than expected in a nonvaccinated population, and the rate of CIN3 was 97% lower than expected.

For the cohort that was eligible to be vaccinated between the ages of 14 and 16 years, the corresponding reductions were 62% for cervical cancer and 75% for CIN3.

For the cohort eligible for vaccination between the ages of 16 and 18 years (of whom 60% had received at least one dose and 45% were fully vaccinated), the corresponding reduction were 34% for cervical cancer and 39% for CIN3.

The authors acknowledge some limitations with the study, principally that cervical cancer is rare in young women, and these vaccinated populations are still young. The youngest would have been vaccinated at age 12 in 2008 and so would be only 23 years old in 2019, when the follow-up in this current study ended. The authors emphasize that because the vaccinated populations are still young, it is too early to assess the full impact of HPV vaccination on cervical cancer rates.
 

Editorial commentary

“The relative reductions in cervical cancer, expected as a result of the HPV vaccination program, support the anticipated vaccine effectiveness,” commented two authors of an accompanying editorial, Maggie Cruickshank, MD, University of Aberdeen (Scotland), and Mihaela Grigore, MD, University of Medicine and Pharmacy, Lasi, Romania.

“The scale of the HPV vaccination effect reported by this study should also stimulate vaccination programs in low-income and middle-income countries where the problem of cervical cancer is a far greater public health issue than in those with well established systems of vaccination and screening,” they comment.

“The most important issue, besides the availability of the vaccine ... is the education of the population to accept the vaccination because a high rate of immunization is a key element of success,” they emphasize. “Even in a wealthy country, such as England with free access to HPV immunization, uptake has not reached the 90% vaccination target of girls aged 15 years set by WHO [World Health Organization].”

The authors and editorialists disclosed no relevant financial relationships. Dr. Markman is a regular contributor to Medscape Oncology. He has received income of $250 or more from Genentech, AstraZeneca, Celgene, Clovis, and Amgen.

A version of this article first appeared on Medscape.com.

New data from England show the success of the national program for vaccinating girls against human papillomavirus (HPV) to prevent cervical cancer.

Among young women who received the HPV vaccine when they were 12-13 years old (before their sexual debut), cervical cancer rates are 87% lower than among previous nonvaccinated generations.

“It’s been incredible to see the impact of HPV vaccination, and now we can prove it prevented hundreds of women from developing cancer in England,” senior author Peter Sasieni, MD, King’s College London, said in a statement. “To see the real-life impact of the vaccine has been truly rewarding.”

“This study provides the first direct evidence of the impact of the UK HPV vaccination campaign on cervical cancer incidence, showing a large reduction in cervical cancer rates in vaccinated cohorts,” Kate Soldan, MD, U.K. Health Security Agency, London, commented in a statement.

Vanessa Saliba, MD, a consultant epidemiologist for the U.K. Health Security Agency, agreed, saying that “these remarkable findings confirm that the HPV vaccine saves lives by dramatically reducing cervical cancer rates among women.

“This reminds us that vaccines are one of the most important tools we have to help us live longer, healthier lives,” she added.

The study was published online Nov. 3, 2021, in The Lancet.

Approached for comment on the new study, Maurice Markman, MD, president, Medicine and Science Cancer Treatment Centers of America, noted that the results of the English study are very similar to those of a Swedish study of the quadrivalent vaccine alone.

“You can put any superlatives you want in here, but these are stunningly positive results,” Dr. Markman said in an interview. He said that, as an oncologist who has been treating cervical cancer for 40 years, particularly patients with advanced cervical cancer, “I can tell you this is one of the most devastating diseases to women, and the ability to eliminate this cancer with something as simple as a vaccine is the goal of cancer therapy, and it’s been remarkably successful.

“I can only emphasize the critical importance of all parents to see that their children who are eligible for the vaccine receive it. This is a cancer prevention strategy that is unbelievably, remarkably effective and safe,” Dr. Markman added.
 

National vaccination program

The national HPV vaccination program in England began in 2008. Initially, the bivalent Cervarix vaccine against HPV 16 and 18 was used. HPV 16 and 18 are responsible for 70% to 80% of all cervical cancers in England, the researchers note in their article.

In 2012, the program switched to the quadrivalent HPV vaccine (Gardasil), which is effective against two additional HPV types, HPV 6 and 11. Those strains cause genital warts.

The prevention program originally recommended a three-dose regimen in which both HPV vaccines were used. Currently, two doses are given to girls younger than 15 years. In addition, a single dose of the HPV vaccine provides good protection against persistent infection. The efficacy rate of a single dose is similar to that of three doses, the authors comment.
 

Population-based registry

The new data come from a population-based cancer registry that shows the incidence of cervical cancer and noninvasive cervical carcinoma (CIN3) in England between January 2006 and June 2019.

The study included seven cohorts of women who were aged 20-64 years at the end of 2019. Three of these cohorts composed the vaccinated population.

The team reports that overall, from January 2006 to June 2019, there were 27,946 cases of cervical cancer and 318,058 cases of CIN3.

In the three vaccinated cohorts, there were around 450 fewer cases of cervical cancer and 17,200 fewer cases of CIN3 than would be expected in a nonvaccinated population.

The three vaccinated cohorts had been eligible to receive Cervarix when they were aged 12-13 years. A catch-up scheme aimed at 14- to 16-year-olds and 16- to 18-year-olds. Most of these persons were vaccinated through a school vaccination program.

The team analyzed the data for each of these cohorts.

Among the cohort eligible for vaccination at 12-13 years of age, 89% received at least one dose of the HPV vaccine; 85% received three shots and were fully vaccinated. Among these persons, the rate of cervical cancer was 87% lower than expected in a nonvaccinated population, and the rate of CIN3 was 97% lower than expected.

For the cohort that was eligible to be vaccinated between the ages of 14 and 16 years, the corresponding reductions were 62% for cervical cancer and 75% for CIN3.

For the cohort eligible for vaccination between the ages of 16 and 18 years (of whom 60% had received at least one dose and 45% were fully vaccinated), the corresponding reduction were 34% for cervical cancer and 39% for CIN3.

The authors acknowledge some limitations with the study, principally that cervical cancer is rare in young women, and these vaccinated populations are still young. The youngest would have been vaccinated at age 12 in 2008 and so would be only 23 years old in 2019, when the follow-up in this current study ended. The authors emphasize that because the vaccinated populations are still young, it is too early to assess the full impact of HPV vaccination on cervical cancer rates.
 

Editorial commentary

“The relative reductions in cervical cancer, expected as a result of the HPV vaccination program, support the anticipated vaccine effectiveness,” commented two authors of an accompanying editorial, Maggie Cruickshank, MD, University of Aberdeen (Scotland), and Mihaela Grigore, MD, University of Medicine and Pharmacy, Lasi, Romania.

“The scale of the HPV vaccination effect reported by this study should also stimulate vaccination programs in low-income and middle-income countries where the problem of cervical cancer is a far greater public health issue than in those with well established systems of vaccination and screening,” they comment.

“The most important issue, besides the availability of the vaccine ... is the education of the population to accept the vaccination because a high rate of immunization is a key element of success,” they emphasize. “Even in a wealthy country, such as England with free access to HPV immunization, uptake has not reached the 90% vaccination target of girls aged 15 years set by WHO [World Health Organization].”

The authors and editorialists disclosed no relevant financial relationships. Dr. Markman is a regular contributor to Medscape Oncology. He has received income of $250 or more from Genentech, AstraZeneca, Celgene, Clovis, and Amgen.

A version of this article first appeared on Medscape.com.

New data from England show the success of the national program for vaccinating girls against human papillomavirus (HPV) to prevent cervical cancer.

Among young women who received the HPV vaccine when they were 12-13 years old (before their sexual debut), cervical cancer rates are 87% lower than among previous nonvaccinated generations.

“It’s been incredible to see the impact of HPV vaccination, and now we can prove it prevented hundreds of women from developing cancer in England,” senior author Peter Sasieni, MD, King’s College London, said in a statement. “To see the real-life impact of the vaccine has been truly rewarding.”

“This study provides the first direct evidence of the impact of the UK HPV vaccination campaign on cervical cancer incidence, showing a large reduction in cervical cancer rates in vaccinated cohorts,” Kate Soldan, MD, U.K. Health Security Agency, London, commented in a statement.

Vanessa Saliba, MD, a consultant epidemiologist for the U.K. Health Security Agency, agreed, saying that “these remarkable findings confirm that the HPV vaccine saves lives by dramatically reducing cervical cancer rates among women.

“This reminds us that vaccines are one of the most important tools we have to help us live longer, healthier lives,” she added.

The study was published online Nov. 3, 2021, in The Lancet.

Approached for comment on the new study, Maurice Markman, MD, president, Medicine and Science Cancer Treatment Centers of America, noted that the results of the English study are very similar to those of a Swedish study of the quadrivalent vaccine alone.

“You can put any superlatives you want in here, but these are stunningly positive results,” Dr. Markman said in an interview. He said that, as an oncologist who has been treating cervical cancer for 40 years, particularly patients with advanced cervical cancer, “I can tell you this is one of the most devastating diseases to women, and the ability to eliminate this cancer with something as simple as a vaccine is the goal of cancer therapy, and it’s been remarkably successful.

“I can only emphasize the critical importance of all parents to see that their children who are eligible for the vaccine receive it. This is a cancer prevention strategy that is unbelievably, remarkably effective and safe,” Dr. Markman added.
 

National vaccination program

The national HPV vaccination program in England began in 2008. Initially, the bivalent Cervarix vaccine against HPV 16 and 18 was used. HPV 16 and 18 are responsible for 70% to 80% of all cervical cancers in England, the researchers note in their article.

In 2012, the program switched to the quadrivalent HPV vaccine (Gardasil), which is effective against two additional HPV types, HPV 6 and 11. Those strains cause genital warts.

The prevention program originally recommended a three-dose regimen in which both HPV vaccines were used. Currently, two doses are given to girls younger than 15 years. In addition, a single dose of the HPV vaccine provides good protection against persistent infection. The efficacy rate of a single dose is similar to that of three doses, the authors comment.
 

Population-based registry

The new data come from a population-based cancer registry that shows the incidence of cervical cancer and noninvasive cervical carcinoma (CIN3) in England between January 2006 and June 2019.

The study included seven cohorts of women who were aged 20-64 years at the end of 2019. Three of these cohorts composed the vaccinated population.

The team reports that overall, from January 2006 to June 2019, there were 27,946 cases of cervical cancer and 318,058 cases of CIN3.

In the three vaccinated cohorts, there were around 450 fewer cases of cervical cancer and 17,200 fewer cases of CIN3 than would be expected in a nonvaccinated population.

The three vaccinated cohorts had been eligible to receive Cervarix when they were aged 12-13 years. A catch-up scheme aimed at 14- to 16-year-olds and 16- to 18-year-olds. Most of these persons were vaccinated through a school vaccination program.

The team analyzed the data for each of these cohorts.

Among the cohort eligible for vaccination at 12-13 years of age, 89% received at least one dose of the HPV vaccine; 85% received three shots and were fully vaccinated. Among these persons, the rate of cervical cancer was 87% lower than expected in a nonvaccinated population, and the rate of CIN3 was 97% lower than expected.

For the cohort that was eligible to be vaccinated between the ages of 14 and 16 years, the corresponding reductions were 62% for cervical cancer and 75% for CIN3.

For the cohort eligible for vaccination between the ages of 16 and 18 years (of whom 60% had received at least one dose and 45% were fully vaccinated), the corresponding reduction were 34% for cervical cancer and 39% for CIN3.

The authors acknowledge some limitations with the study, principally that cervical cancer is rare in young women, and these vaccinated populations are still young. The youngest would have been vaccinated at age 12 in 2008 and so would be only 23 years old in 2019, when the follow-up in this current study ended. The authors emphasize that because the vaccinated populations are still young, it is too early to assess the full impact of HPV vaccination on cervical cancer rates.
 

Editorial commentary

“The relative reductions in cervical cancer, expected as a result of the HPV vaccination program, support the anticipated vaccine effectiveness,” commented two authors of an accompanying editorial, Maggie Cruickshank, MD, University of Aberdeen (Scotland), and Mihaela Grigore, MD, University of Medicine and Pharmacy, Lasi, Romania.

“The scale of the HPV vaccination effect reported by this study should also stimulate vaccination programs in low-income and middle-income countries where the problem of cervical cancer is a far greater public health issue than in those with well established systems of vaccination and screening,” they comment.

“The most important issue, besides the availability of the vaccine ... is the education of the population to accept the vaccination because a high rate of immunization is a key element of success,” they emphasize. “Even in a wealthy country, such as England with free access to HPV immunization, uptake has not reached the 90% vaccination target of girls aged 15 years set by WHO [World Health Organization].”

The authors and editorialists disclosed no relevant financial relationships. Dr. Markman is a regular contributor to Medscape Oncology. He has received income of $250 or more from Genentech, AstraZeneca, Celgene, Clovis, and Amgen.

A version of this article first appeared on Medscape.com.

On Nov. 2, the Centers for Disease Control and Prevention endorsed vaccination with the Pfizer/BioNTech COVID-19 vaccine for children aged 5-11 years. What are some best practices for meeting the challenges of immunizing this younger age group?

This news organization spoke to several pediatric experts to get answers.

More than 6 million children and adolescents (up to age 18 years) in the United States have been infected with SARS-CoV-2. Children represent about 17% of all cases, and an estimated 0.1%-2% of infected children end up hospitalized, according to Oct. 28 data from the American Academy of Pediatrics.

Physicians and other health care practitioners are gearing up for what could be an influx of patients. “Pediatricians are standing by to talk with families about the vaccine and to administer the vaccine to children as soon as possible,” Lee Savio Beers, MD, FAAP, president of the AAP, said in a statement.

In this Q&A, this news organization asked for additional advice from Sara “Sally” Goza, MD, a pediatrician in Fayetteville, Georgia, and immediate past president of the AAP; Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine and codirector of the Texas Children’s Hospital Center for Vaccine Development, both in Houston; and Danielle M. Zerr, MD, professor and chief of the division of pediatric infectious disease at the University of Washington, Seattle, and medical director of infection prevention at Seattle Children’s Hospital.
 

Q: How are smaller pediatric practices and solo practitioners going to handle the additional vaccinations?

Dr. Goza: It’s a scheduling challenge with this rollout and all the people who want it and want it right now. They’re going to want it this week.

I’ve actually had some children asking their moms: “When can I get it? When can I get it?” It’s been very interesting – they are chomping at the bit.

If I give the vaccine to a patient this week, in 3 weeks the second dose will be right around Thanksgiving. No one in my office is going to want to be here to give the shot on Thanksgiving, and no patient is going to want to come in on Thanksgiving weekend. So I’m trying to delay those parents – saying, let’s do it next week. That way we’re not messing up a holiday.

Children are going to need two doses, and they won’t be fully protected until 2 weeks after their second dose. So they won’t get full protection for Thanksgiving, but they will have full protection for Christmas.

I know there are a lot of pediatricians who have preordered the vaccine. I know in our office they sent us an email ... to let us know our vaccines are being shipped. So I think a lot of pediatricians are going to have the vaccine.
 

Q: How should pediatricians counsel parents who are fearful or hesitant?

Dr. Hotez: It’s important to emphasize the severity of the 2021 summer Delta epidemic in children. We need to get beyond this false narrative that COVID only produces a mild disease in children. It’s caused thousands of pediatric hospitalizations, not to mention long COVID.

Dr. Zerr: It is key to find out what concerns parents have and then focus on answering their specific questions. It is helpful to emphasize the safety and efficacy of the vaccine and to explain the rigorous processes that the vaccine went through to receive Food and Drug Administration approval.
 

Q: How should pediatricians counter any misinformation/disinformation out there about the COVID-19 vaccines?

Dr. Goza: The most important thing is not to discount what they are saying. Don’t say: “That’s crazy” or “That’s not true.” Don’t roll your eyes and say: “Really, you’re going to believe all that?”

Instead, have a conversation with them about why we think that is not true, or why we know that’s not true. We really have to have that relationship and ask: “Well, what are your concerns?” And then really counter (any misinformation) with facts, with science, and based on your experience.
 

Q: Do the data presented to the FDA and the CDC about the safety and effectiveness of the COVID-19 vaccine for 5- to 11-year-olds seem robust to you?

Dr. Zerr: Yes, and data collection will be ongoing.

Dr. Hotez: I’ve only seen what’s publicly available so far, and it seems to support moving forward with emergency use authorization. The only shortfall is the size, roughly 2,200 children, which would not be of sufficient size to detect a rare safety signal.
 

Q: Do previous controversies around pediatric vaccines (for example, the MMR vaccine and autism) give pediatricians some background and experience so they can address any pushback on the COVID-19 vaccines?

Dr. Goza: Pediatricians have been dealing with vaccine hesitancy for a while now, ever since the MMR and autism controversy started. Even before then, there were certain groups of people who didn’t want vaccines.

We’ve really worked hard at helping teach pediatricians how to deal with the misinformation, how to counter it, and how to help parents understand the vaccines are safe and effective – and that they save lives.

That (experience) will help us in some ways. Unfortunately, there is more misinformation out there – there is almost a concerted effort on misinformation. It’s big.

Pediatricians will do everything we can, but we need help countering it. We need the misinformation to quit getting spread on social media. We can talk one on one with patients and families, but if all they are hearing on social media is the misinformation, it’s really hard.
 

Q: Are pediatricians, especially solo practitioners or pediatricians at smaller practices, going to face challenges with multidose vials and not wasting vaccine product?

Dr. Goza: I’m at a small practice. We have 3.5 FTEs (full-time equivalents) of MDs and three FTEs of nurse practitioners. So we’re not that big – about six providers.

You know, it is a challenge. We’re not going to buy the super-duper freezer, and we’re not going to be able to store these vaccines for a long period of time.

So when we order, we need smaller amounts. For the 12- to 18-year-olds, [maximum storage] was 45 days. Now for the 5- to 11-year-olds, we’re going to be able to store the vaccine in the refrigerator for 10 weeks, which gives us more leeway there.

We try to do all of vaccinations on 1 day, so we know how many people are coming in, and we are not going to waste too many doses.

Our Department of Public Health in Georgia has said: “We want these vaccines in the arms of kids, and if you have to waste some doses, don’t worry about it.” But it’s a 10-dose vial. It’s going to be hard for me to open it up for one child. I just don’t like wasting anything like this.

Our main goal is to get this vaccine in to the arms of children whose parents want it.
 

Q: What are some additional sources of information for pediatricians?

Dr. Zerr: There are a lot of great resources on vaccine hesitancy from reputable sources, including these from the CDC and from the National Academies of Sciences, Engineering, and Medicine:

• Building Confidence With OVID-19 Vaccines
• How to Talk With Parents About COVID-19 Vaccination
• Strategies for Building Confidence in the COVID-19 Vaccines
• Communication Strategies for Building Confidence in COVID-19 Vaccines: Addressing Variants and Childhood Vaccinations

A version of this article first appeared on Medscape.com.

On Nov. 2, the Centers for Disease Control and Prevention endorsed vaccination with the Pfizer/BioNTech COVID-19 vaccine for children aged 5-11 years. What are some best practices for meeting the challenges of immunizing this younger age group?

This news organization spoke to several pediatric experts to get answers.

More than 6 million children and adolescents (up to age 18 years) in the United States have been infected with SARS-CoV-2. Children represent about 17% of all cases, and an estimated 0.1%-2% of infected children end up hospitalized, according to Oct. 28 data from the American Academy of Pediatrics.

Physicians and other health care practitioners are gearing up for what could be an influx of patients. “Pediatricians are standing by to talk with families about the vaccine and to administer the vaccine to children as soon as possible,” Lee Savio Beers, MD, FAAP, president of the AAP, said in a statement.

In this Q&A, this news organization asked for additional advice from Sara “Sally” Goza, MD, a pediatrician in Fayetteville, Georgia, and immediate past president of the AAP; Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine and codirector of the Texas Children’s Hospital Center for Vaccine Development, both in Houston; and Danielle M. Zerr, MD, professor and chief of the division of pediatric infectious disease at the University of Washington, Seattle, and medical director of infection prevention at Seattle Children’s Hospital.
 

Q: How are smaller pediatric practices and solo practitioners going to handle the additional vaccinations?

Dr. Goza: It’s a scheduling challenge with this rollout and all the people who want it and want it right now. They’re going to want it this week.

I’ve actually had some children asking their moms: “When can I get it? When can I get it?” It’s been very interesting – they are chomping at the bit.

If I give the vaccine to a patient this week, in 3 weeks the second dose will be right around Thanksgiving. No one in my office is going to want to be here to give the shot on Thanksgiving, and no patient is going to want to come in on Thanksgiving weekend. So I’m trying to delay those parents – saying, let’s do it next week. That way we’re not messing up a holiday.

Children are going to need two doses, and they won’t be fully protected until 2 weeks after their second dose. So they won’t get full protection for Thanksgiving, but they will have full protection for Christmas.

I know there are a lot of pediatricians who have preordered the vaccine. I know in our office they sent us an email ... to let us know our vaccines are being shipped. So I think a lot of pediatricians are going to have the vaccine.
 

Q: How should pediatricians counsel parents who are fearful or hesitant?

Dr. Hotez: It’s important to emphasize the severity of the 2021 summer Delta epidemic in children. We need to get beyond this false narrative that COVID only produces a mild disease in children. It’s caused thousands of pediatric hospitalizations, not to mention long COVID.

Dr. Zerr: It is key to find out what concerns parents have and then focus on answering their specific questions. It is helpful to emphasize the safety and efficacy of the vaccine and to explain the rigorous processes that the vaccine went through to receive Food and Drug Administration approval.
 

Q: How should pediatricians counter any misinformation/disinformation out there about the COVID-19 vaccines?

Dr. Goza: The most important thing is not to discount what they are saying. Don’t say: “That’s crazy” or “That’s not true.” Don’t roll your eyes and say: “Really, you’re going to believe all that?”

Instead, have a conversation with them about why we think that is not true, or why we know that’s not true. We really have to have that relationship and ask: “Well, what are your concerns?” And then really counter (any misinformation) with facts, with science, and based on your experience.
 

Q: Do the data presented to the FDA and the CDC about the safety and effectiveness of the COVID-19 vaccine for 5- to 11-year-olds seem robust to you?

Dr. Zerr: Yes, and data collection will be ongoing.

Dr. Hotez: I’ve only seen what’s publicly available so far, and it seems to support moving forward with emergency use authorization. The only shortfall is the size, roughly 2,200 children, which would not be of sufficient size to detect a rare safety signal.
 

Q: Do previous controversies around pediatric vaccines (for example, the MMR vaccine and autism) give pediatricians some background and experience so they can address any pushback on the COVID-19 vaccines?

Dr. Goza: Pediatricians have been dealing with vaccine hesitancy for a while now, ever since the MMR and autism controversy started. Even before then, there were certain groups of people who didn’t want vaccines.

We’ve really worked hard at helping teach pediatricians how to deal with the misinformation, how to counter it, and how to help parents understand the vaccines are safe and effective – and that they save lives.

That (experience) will help us in some ways. Unfortunately, there is more misinformation out there – there is almost a concerted effort on misinformation. It’s big.

Pediatricians will do everything we can, but we need help countering it. We need the misinformation to quit getting spread on social media. We can talk one on one with patients and families, but if all they are hearing on social media is the misinformation, it’s really hard.
 

Q: Are pediatricians, especially solo practitioners or pediatricians at smaller practices, going to face challenges with multidose vials and not wasting vaccine product?

Dr. Goza: I’m at a small practice. We have 3.5 FTEs (full-time equivalents) of MDs and three FTEs of nurse practitioners. So we’re not that big – about six providers.

You know, it is a challenge. We’re not going to buy the super-duper freezer, and we’re not going to be able to store these vaccines for a long period of time.

So when we order, we need smaller amounts. For the 12- to 18-year-olds, [maximum storage] was 45 days. Now for the 5- to 11-year-olds, we’re going to be able to store the vaccine in the refrigerator for 10 weeks, which gives us more leeway there.

We try to do all of vaccinations on 1 day, so we know how many people are coming in, and we are not going to waste too many doses.

Our Department of Public Health in Georgia has said: “We want these vaccines in the arms of kids, and if you have to waste some doses, don’t worry about it.” But it’s a 10-dose vial. It’s going to be hard for me to open it up for one child. I just don’t like wasting anything like this.

Our main goal is to get this vaccine in to the arms of children whose parents want it.
 

Q: What are some additional sources of information for pediatricians?

Dr. Zerr: There are a lot of great resources on vaccine hesitancy from reputable sources, including these from the CDC and from the National Academies of Sciences, Engineering, and Medicine:

• Building Confidence With OVID-19 Vaccines
• How to Talk With Parents About COVID-19 Vaccination
• Strategies for Building Confidence in the COVID-19 Vaccines
• Communication Strategies for Building Confidence in COVID-19 Vaccines: Addressing Variants and Childhood Vaccinations

A version of this article first appeared on Medscape.com.

On Nov. 2, the Centers for Disease Control and Prevention endorsed vaccination with the Pfizer/BioNTech COVID-19 vaccine for children aged 5-11 years. What are some best practices for meeting the challenges of immunizing this younger age group?

This news organization spoke to several pediatric experts to get answers.

More than 6 million children and adolescents (up to age 18 years) in the United States have been infected with SARS-CoV-2. Children represent about 17% of all cases, and an estimated 0.1%-2% of infected children end up hospitalized, according to Oct. 28 data from the American Academy of Pediatrics.

Physicians and other health care practitioners are gearing up for what could be an influx of patients. “Pediatricians are standing by to talk with families about the vaccine and to administer the vaccine to children as soon as possible,” Lee Savio Beers, MD, FAAP, president of the AAP, said in a statement.

In this Q&A, this news organization asked for additional advice from Sara “Sally” Goza, MD, a pediatrician in Fayetteville, Georgia, and immediate past president of the AAP; Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine and codirector of the Texas Children’s Hospital Center for Vaccine Development, both in Houston; and Danielle M. Zerr, MD, professor and chief of the division of pediatric infectious disease at the University of Washington, Seattle, and medical director of infection prevention at Seattle Children’s Hospital.
 

Q: How are smaller pediatric practices and solo practitioners going to handle the additional vaccinations?

Dr. Goza: It’s a scheduling challenge with this rollout and all the people who want it and want it right now. They’re going to want it this week.

I’ve actually had some children asking their moms: “When can I get it? When can I get it?” It’s been very interesting – they are chomping at the bit.

If I give the vaccine to a patient this week, in 3 weeks the second dose will be right around Thanksgiving. No one in my office is going to want to be here to give the shot on Thanksgiving, and no patient is going to want to come in on Thanksgiving weekend. So I’m trying to delay those parents – saying, let’s do it next week. That way we’re not messing up a holiday.

Children are going to need two doses, and they won’t be fully protected until 2 weeks after their second dose. So they won’t get full protection for Thanksgiving, but they will have full protection for Christmas.

I know there are a lot of pediatricians who have preordered the vaccine. I know in our office they sent us an email ... to let us know our vaccines are being shipped. So I think a lot of pediatricians are going to have the vaccine.
 

Q: How should pediatricians counsel parents who are fearful or hesitant?

Dr. Hotez: It’s important to emphasize the severity of the 2021 summer Delta epidemic in children. We need to get beyond this false narrative that COVID only produces a mild disease in children. It’s caused thousands of pediatric hospitalizations, not to mention long COVID.

Dr. Zerr: It is key to find out what concerns parents have and then focus on answering their specific questions. It is helpful to emphasize the safety and efficacy of the vaccine and to explain the rigorous processes that the vaccine went through to receive Food and Drug Administration approval.
 

Q: How should pediatricians counter any misinformation/disinformation out there about the COVID-19 vaccines?

Dr. Goza: The most important thing is not to discount what they are saying. Don’t say: “That’s crazy” or “That’s not true.” Don’t roll your eyes and say: “Really, you’re going to believe all that?”

Instead, have a conversation with them about why we think that is not true, or why we know that’s not true. We really have to have that relationship and ask: “Well, what are your concerns?” And then really counter (any misinformation) with facts, with science, and based on your experience.
 

Q: Do the data presented to the FDA and the CDC about the safety and effectiveness of the COVID-19 vaccine for 5- to 11-year-olds seem robust to you?

Dr. Zerr: Yes, and data collection will be ongoing.

Dr. Hotez: I’ve only seen what’s publicly available so far, and it seems to support moving forward with emergency use authorization. The only shortfall is the size, roughly 2,200 children, which would not be of sufficient size to detect a rare safety signal.
 

Q: Do previous controversies around pediatric vaccines (for example, the MMR vaccine and autism) give pediatricians some background and experience so they can address any pushback on the COVID-19 vaccines?

Dr. Goza: Pediatricians have been dealing with vaccine hesitancy for a while now, ever since the MMR and autism controversy started. Even before then, there were certain groups of people who didn’t want vaccines.

We’ve really worked hard at helping teach pediatricians how to deal with the misinformation, how to counter it, and how to help parents understand the vaccines are safe and effective – and that they save lives.

That (experience) will help us in some ways. Unfortunately, there is more misinformation out there – there is almost a concerted effort on misinformation. It’s big.

Pediatricians will do everything we can, but we need help countering it. We need the misinformation to quit getting spread on social media. We can talk one on one with patients and families, but if all they are hearing on social media is the misinformation, it’s really hard.
 

Q: Are pediatricians, especially solo practitioners or pediatricians at smaller practices, going to face challenges with multidose vials and not wasting vaccine product?

Dr. Goza: I’m at a small practice. We have 3.5 FTEs (full-time equivalents) of MDs and three FTEs of nurse practitioners. So we’re not that big – about six providers.

You know, it is a challenge. We’re not going to buy the super-duper freezer, and we’re not going to be able to store these vaccines for a long period of time.

So when we order, we need smaller amounts. For the 12- to 18-year-olds, [maximum storage] was 45 days. Now for the 5- to 11-year-olds, we’re going to be able to store the vaccine in the refrigerator for 10 weeks, which gives us more leeway there.

We try to do all of vaccinations on 1 day, so we know how many people are coming in, and we are not going to waste too many doses.

Our Department of Public Health in Georgia has said: “We want these vaccines in the arms of kids, and if you have to waste some doses, don’t worry about it.” But it’s a 10-dose vial. It’s going to be hard for me to open it up for one child. I just don’t like wasting anything like this.

Our main goal is to get this vaccine in to the arms of children whose parents want it.
 

Q: What are some additional sources of information for pediatricians?

Dr. Zerr: There are a lot of great resources on vaccine hesitancy from reputable sources, including these from the CDC and from the National Academies of Sciences, Engineering, and Medicine:

• Building Confidence With OVID-19 Vaccines
• How to Talk With Parents About COVID-19 Vaccination
• Strategies for Building Confidence in the COVID-19 Vaccines
• Communication Strategies for Building Confidence in COVID-19 Vaccines: Addressing Variants and Childhood Vaccinations

A version of this article first appeared on Medscape.com.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has endorsed a two-dose regimen of Pfizer’s lower-dose mRNA vaccine for children ages 5 through 11 years-old – meaning the shots are now available for immediate use.

The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.

President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.

The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.

“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.

“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.

Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.

“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.

She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.

“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.

The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.

To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.

The CDC also addressed the question of kids who are close to age 12 when they get their first dose.

In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.

For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.

COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.

In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.

Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.

Weighing benefits and risks

In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.

These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.

No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.

Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.

Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.

Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.

Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.

Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.

The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.

What about benefits?

Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.

The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.

For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.

CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.

The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.

CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.

This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has endorsed a two-dose regimen of Pfizer’s lower-dose mRNA vaccine for children ages 5 through 11 years-old – meaning the shots are now available for immediate use.

The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.

President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.

The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.

“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.

“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.

Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.

“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.

She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.

“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.

The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.

To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.

The CDC also addressed the question of kids who are close to age 12 when they get their first dose.

In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.

For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.

COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.

In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.

Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.

Weighing benefits and risks

In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.

These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.

No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.

Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.

Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.

Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.

Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.

Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.

The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.

What about benefits?

Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.

The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.

For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.

CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.

The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.

CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.

This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has endorsed a two-dose regimen of Pfizer’s lower-dose mRNA vaccine for children ages 5 through 11 years-old – meaning the shots are now available for immediate use.

The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.

President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.

The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.

“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.

“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.

Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.

“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.

She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.

“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.

The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.

To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.

The CDC also addressed the question of kids who are close to age 12 when they get their first dose.

In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.

For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.

COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.

In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.

Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.

Weighing benefits and risks

In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.

These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.

No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.

Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.

Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.

Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.

Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.

Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.

The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.

What about benefits?

Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.

The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.

For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.

CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.

The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.

CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.

This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.

The Food and Drug Administration has authorized Pfizer’s COVID-19 vaccine for children ages 5 to 11, which means vaccines could be available to school-aged children starting next week.

The move brings families with young children a step closer to resuming their normal activities, and it should help further slow transmission of the coronavirus virus in the United States.

States have already placed their orders for initial doses of the vaccines. The Oct. 29 FDA authorization triggers the shipment of millions of doses to pediatricians, family practice doctors, children’s hospitals, community health centers, and pharmacies.

Next, a panel of experts known as the Advisory Committee on Immunization Practices, or ACIP, will meet Nov. 2 to vote on recommendations for use of the vaccine.

As soon as the Centers for Disease Control and Prevention’s director signs off on those recommendations, children can get the shots, perhaps as early as Nov. 3.

Pfizer’s vaccine for children is 10 micrograms, or one-third of the dose given to teens and adults. Kids get two doses of the vaccine 3 weeks apart. In clinical trials, the most common side effects were pain at the injection site, fatigue, and headache. These side effects were mild and disappeared quickly. There were no serious adverse events detected in the studies, which included about 3,100 children. In one study, the vaccine was 90% effective at preventing COVID-19 infections with symptoms in younger children.

There are about 28 million children in the United States between the ages of 5 and 12.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock, MD, said in an FDA news release.

“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” she said.

A version of this article first appeared on WebMD.com.

The Food and Drug Administration has authorized Pfizer’s COVID-19 vaccine for children ages 5 to 11, which means vaccines could be available to school-aged children starting next week.

The move brings families with young children a step closer to resuming their normal activities, and it should help further slow transmission of the coronavirus virus in the United States.

States have already placed their orders for initial doses of the vaccines. The Oct. 29 FDA authorization triggers the shipment of millions of doses to pediatricians, family practice doctors, children’s hospitals, community health centers, and pharmacies.

Next, a panel of experts known as the Advisory Committee on Immunization Practices, or ACIP, will meet Nov. 2 to vote on recommendations for use of the vaccine.

As soon as the Centers for Disease Control and Prevention’s director signs off on those recommendations, children can get the shots, perhaps as early as Nov. 3.

Pfizer’s vaccine for children is 10 micrograms, or one-third of the dose given to teens and adults. Kids get two doses of the vaccine 3 weeks apart. In clinical trials, the most common side effects were pain at the injection site, fatigue, and headache. These side effects were mild and disappeared quickly. There were no serious adverse events detected in the studies, which included about 3,100 children. In one study, the vaccine was 90% effective at preventing COVID-19 infections with symptoms in younger children.

There are about 28 million children in the United States between the ages of 5 and 12.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock, MD, said in an FDA news release.

“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” she said.

A version of this article first appeared on WebMD.com.

The Food and Drug Administration has authorized Pfizer’s COVID-19 vaccine for children ages 5 to 11, which means vaccines could be available to school-aged children starting next week.

The move brings families with young children a step closer to resuming their normal activities, and it should help further slow transmission of the coronavirus virus in the United States.

States have already placed their orders for initial doses of the vaccines. The Oct. 29 FDA authorization triggers the shipment of millions of doses to pediatricians, family practice doctors, children’s hospitals, community health centers, and pharmacies.

Next, a panel of experts known as the Advisory Committee on Immunization Practices, or ACIP, will meet Nov. 2 to vote on recommendations for use of the vaccine.

As soon as the Centers for Disease Control and Prevention’s director signs off on those recommendations, children can get the shots, perhaps as early as Nov. 3.

Pfizer’s vaccine for children is 10 micrograms, or one-third of the dose given to teens and adults. Kids get two doses of the vaccine 3 weeks apart. In clinical trials, the most common side effects were pain at the injection site, fatigue, and headache. These side effects were mild and disappeared quickly. There were no serious adverse events detected in the studies, which included about 3,100 children. In one study, the vaccine was 90% effective at preventing COVID-19 infections with symptoms in younger children.

There are about 28 million children in the United States between the ages of 5 and 12.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock, MD, said in an FDA news release.

“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” she said.

A version of this article first appeared on WebMD.com.

The CDC is urging parents and guardians to vaccinate children ages 5-11 against COVID-19 once the shot is fully approved, despite questions from FDA advisers about the urgency given falling national case rates.

On Oct. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee voted to recommend a 10-microgram shot for children. Though 17 of the 18 panelists voted in favor of it, some members said it was a hard decision and questioned the need for it now that cases and hospitalizations are down.

“There’s urgency because we’re seeing disease in children, we’ve seen deaths in children, we’ve seen long COVID,” CDC Director Rochelle Walensky, MD, said at a White House briefing on Oct. 27. “Certainly we’ve seen cases come down before, and the way to prevent surges again is to get more and more people vaccinated.”

CDC data presented at an Oct. 26 advisory committee meeting show that among children 5-11, COVID-19 was one of top 10 causes of death over last year, Dr. Walensky said. There have been more than 8,300 hospitalizations and 745 deaths in children under 18.

As of yesterday, the 7-day average of daily COVID-19 cases was 65,900, a 16% decrease from the prior week. Hospitalizations are down 54% from the week of Aug. 28, Dr. Walensky said.

“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” James Hildreth, MD, president and CEO at Meharry Medical College in Nashville, said at the advisory committee meeting on Oct. 26.

But according to one CDC study, hospitalization rates for adolescents were 10 times higher in those who were unvaccinated. Another study found that COVID-related emergency room visits and hospital admissions among children were more than 3 times as high in states with the lowest vaccination rates.

“We are down from our peak in early September, and we are now heading in the right direction, but with cases still high, we must remain vigilant heading into the colder, drier winter months,” Dr. Walensky said, noting that the 7-day average of daily deaths still exceeds 1,000.

Meanwhile, the booster program is off to a “very strong start,” said White House COVID-19 Response Coordinator Jeff Zients.

In the 5 days since authorizations, about 15 million people have received an additional dose of the Pfizer, Moderna, and Johnson & Johnson vaccines.

A version of this article first appeared on WebMD.com.

The CDC is urging parents and guardians to vaccinate children ages 5-11 against COVID-19 once the shot is fully approved, despite questions from FDA advisers about the urgency given falling national case rates.

On Oct. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee voted to recommend a 10-microgram shot for children. Though 17 of the 18 panelists voted in favor of it, some members said it was a hard decision and questioned the need for it now that cases and hospitalizations are down.

“There’s urgency because we’re seeing disease in children, we’ve seen deaths in children, we’ve seen long COVID,” CDC Director Rochelle Walensky, MD, said at a White House briefing on Oct. 27. “Certainly we’ve seen cases come down before, and the way to prevent surges again is to get more and more people vaccinated.”

CDC data presented at an Oct. 26 advisory committee meeting show that among children 5-11, COVID-19 was one of top 10 causes of death over last year, Dr. Walensky said. There have been more than 8,300 hospitalizations and 745 deaths in children under 18.

As of yesterday, the 7-day average of daily COVID-19 cases was 65,900, a 16% decrease from the prior week. Hospitalizations are down 54% from the week of Aug. 28, Dr. Walensky said.

“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” James Hildreth, MD, president and CEO at Meharry Medical College in Nashville, said at the advisory committee meeting on Oct. 26.

But according to one CDC study, hospitalization rates for adolescents were 10 times higher in those who were unvaccinated. Another study found that COVID-related emergency room visits and hospital admissions among children were more than 3 times as high in states with the lowest vaccination rates.

“We are down from our peak in early September, and we are now heading in the right direction, but with cases still high, we must remain vigilant heading into the colder, drier winter months,” Dr. Walensky said, noting that the 7-day average of daily deaths still exceeds 1,000.

Meanwhile, the booster program is off to a “very strong start,” said White House COVID-19 Response Coordinator Jeff Zients.

In the 5 days since authorizations, about 15 million people have received an additional dose of the Pfizer, Moderna, and Johnson & Johnson vaccines.

A version of this article first appeared on WebMD.com.

The CDC is urging parents and guardians to vaccinate children ages 5-11 against COVID-19 once the shot is fully approved, despite questions from FDA advisers about the urgency given falling national case rates.

On Oct. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee voted to recommend a 10-microgram shot for children. Though 17 of the 18 panelists voted in favor of it, some members said it was a hard decision and questioned the need for it now that cases and hospitalizations are down.

“There’s urgency because we’re seeing disease in children, we’ve seen deaths in children, we’ve seen long COVID,” CDC Director Rochelle Walensky, MD, said at a White House briefing on Oct. 27. “Certainly we’ve seen cases come down before, and the way to prevent surges again is to get more and more people vaccinated.”

CDC data presented at an Oct. 26 advisory committee meeting show that among children 5-11, COVID-19 was one of top 10 causes of death over last year, Dr. Walensky said. There have been more than 8,300 hospitalizations and 745 deaths in children under 18.

As of yesterday, the 7-day average of daily COVID-19 cases was 65,900, a 16% decrease from the prior week. Hospitalizations are down 54% from the week of Aug. 28, Dr. Walensky said.

“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” James Hildreth, MD, president and CEO at Meharry Medical College in Nashville, said at the advisory committee meeting on Oct. 26.

But according to one CDC study, hospitalization rates for adolescents were 10 times higher in those who were unvaccinated. Another study found that COVID-related emergency room visits and hospital admissions among children were more than 3 times as high in states with the lowest vaccination rates.

“We are down from our peak in early September, and we are now heading in the right direction, but with cases still high, we must remain vigilant heading into the colder, drier winter months,” Dr. Walensky said, noting that the 7-day average of daily deaths still exceeds 1,000.

Meanwhile, the booster program is off to a “very strong start,” said White House COVID-19 Response Coordinator Jeff Zients.

In the 5 days since authorizations, about 15 million people have received an additional dose of the Pfizer, Moderna, and Johnson & Johnson vaccines.

A version of this article first appeared on WebMD.com.

Approximately 12,000 new cases of cervical cancer are diagnosed in women in the United States each year, based on data from the Centers for Disease Control and Prevention, said B.J. Rimel, MD, of Cedars-Sinai Medical Center, Los Angeles, in a presentation at the virtual Advancing NIH Research on the Health of Women conference sponsored by the National Institutes of Health.

Despite increased cervical cancer prevention and screening efforts, the incidence of, and mortality from, cervical cancer has remained stable for the past 2 decades, said Dr. Rimel.

Cervical cancer is the only cancer that can be prevented by vaccination, Dr. Rimel noted. It is essential to identify the women who are dying from cervical cancer, as well as who gets screened, who gets vaccinated, and who ends up in clinical trials, she said.

Novel agents for treating cervical cancer suggest that improvement in stagnant mortality rates is possible, said Dr. Rimel. She noted recent studies of cemiplimab, tisotumab vedotin, and a combination therapy involving pembrolizumab and platinum/paclitaxel, with and without bevacizumab.

Dr. Rimel suggested several opportunities to improve the identification and treatment of cervical cancer: Treat it like a rare disease; address structural racism through clinical trials; create opportunities for low–socioeconomic status patients to be involved in research; and develop solutions according to location (urban vs. rural), she said.

Compared with other cancers, cervical cancer is relatively rare in the United States, Dr. Rimel said. However, “It is important that those with cervical cancer can get treated and get healed from the disease,” she said. To better identify the women with cervical cancer who need treatment and to get them into clinical trials, she suggested using strategies employed by rare disease groups, such as seeking out patient support groups and registries.

Significant racial and ethnic disparities persist in cervical cancer, Dr. Rimel emphasized. Data from the CDC show that Black and Hispanic women in the United States are diagnosed with cervical cancer more frequently than women of other races and ethnicities and are less likely to survive.

“Reimagine cervical cancer as a disease of patients who are historically underrepresented due to race, language, poverty, and location,” she said.

Improving equity in cervical cancer care involves structural and trial-specific issues, said Dr. Rimel. Structural issues start with addressing how women enter into the health care system, she said. Consider where women receive care, and whether women have the opportunity to be vaccinated, and later screened, she said. Consider barriers to cervical cancer trials in centers with larger underserved populations, not only cost or insurance, but also issues of language and trust between patients and health care providers, she noted.

To improve the equity of cervical cancer clinical trials, consider potential barriers to enrollment, she added.

“Low English fluency is a barrier to trial enrollment,” said Dr. Rimel. In-person translation is essential for consent to participate in a trial, and “clinical trial budgets must reflect this requirement,” she added. Patient-reported outcomes need to be in the patient’s preferred language, “this includes online content,” Dr. Rimel said.

Dr. Rimel presented other strategies for clinical trial designs to improve equity.

“Compensate patients for their travel, or provide them with tech to allow for off-site monitoring,” she proposed. Patients of lower socioeconomic status in rural and urban areas have different barriers to enrollment, but virtual visits might be an option for those able to access the Internet when given a device. For others, smaller trial sites closer to home, combined with compensation for travel or missed work, might create more opportunities to participate, Dr. Rimel said. Finally, researchers should consider potential roles for smaller or broader studies that involve less travel and testing that would be feasible for more patients who might not otherwise participate in a clinical trial, she concluded.

Dr. Rimel had no financial conflicts to disclose.

Approximately 12,000 new cases of cervical cancer are diagnosed in women in the United States each year, based on data from the Centers for Disease Control and Prevention, said B.J. Rimel, MD, of Cedars-Sinai Medical Center, Los Angeles, in a presentation at the virtual Advancing NIH Research on the Health of Women conference sponsored by the National Institutes of Health.

Despite increased cervical cancer prevention and screening efforts, the incidence of, and mortality from, cervical cancer has remained stable for the past 2 decades, said Dr. Rimel.

Cervical cancer is the only cancer that can be prevented by vaccination, Dr. Rimel noted. It is essential to identify the women who are dying from cervical cancer, as well as who gets screened, who gets vaccinated, and who ends up in clinical trials, she said.

Novel agents for treating cervical cancer suggest that improvement in stagnant mortality rates is possible, said Dr. Rimel. She noted recent studies of cemiplimab, tisotumab vedotin, and a combination therapy involving pembrolizumab and platinum/paclitaxel, with and without bevacizumab.

Dr. Rimel suggested several opportunities to improve the identification and treatment of cervical cancer: Treat it like a rare disease; address structural racism through clinical trials; create opportunities for low–socioeconomic status patients to be involved in research; and develop solutions according to location (urban vs. rural), she said.

Compared with other cancers, cervical cancer is relatively rare in the United States, Dr. Rimel said. However, “It is important that those with cervical cancer can get treated and get healed from the disease,” she said. To better identify the women with cervical cancer who need treatment and to get them into clinical trials, she suggested using strategies employed by rare disease groups, such as seeking out patient support groups and registries.

Significant racial and ethnic disparities persist in cervical cancer, Dr. Rimel emphasized. Data from the CDC show that Black and Hispanic women in the United States are diagnosed with cervical cancer more frequently than women of other races and ethnicities and are less likely to survive.

“Reimagine cervical cancer as a disease of patients who are historically underrepresented due to race, language, poverty, and location,” she said.

Improving equity in cervical cancer care involves structural and trial-specific issues, said Dr. Rimel. Structural issues start with addressing how women enter into the health care system, she said. Consider where women receive care, and whether women have the opportunity to be vaccinated, and later screened, she said. Consider barriers to cervical cancer trials in centers with larger underserved populations, not only cost or insurance, but also issues of language and trust between patients and health care providers, she noted.

To improve the equity of cervical cancer clinical trials, consider potential barriers to enrollment, she added.

“Low English fluency is a barrier to trial enrollment,” said Dr. Rimel. In-person translation is essential for consent to participate in a trial, and “clinical trial budgets must reflect this requirement,” she added. Patient-reported outcomes need to be in the patient’s preferred language, “this includes online content,” Dr. Rimel said.

Dr. Rimel presented other strategies for clinical trial designs to improve equity.

“Compensate patients for their travel, or provide them with tech to allow for off-site monitoring,” she proposed. Patients of lower socioeconomic status in rural and urban areas have different barriers to enrollment, but virtual visits might be an option for those able to access the Internet when given a device. For others, smaller trial sites closer to home, combined with compensation for travel or missed work, might create more opportunities to participate, Dr. Rimel said. Finally, researchers should consider potential roles for smaller or broader studies that involve less travel and testing that would be feasible for more patients who might not otherwise participate in a clinical trial, she concluded.

Dr. Rimel had no financial conflicts to disclose.

Approximately 12,000 new cases of cervical cancer are diagnosed in women in the United States each year, based on data from the Centers for Disease Control and Prevention, said B.J. Rimel, MD, of Cedars-Sinai Medical Center, Los Angeles, in a presentation at the virtual Advancing NIH Research on the Health of Women conference sponsored by the National Institutes of Health.

Despite increased cervical cancer prevention and screening efforts, the incidence of, and mortality from, cervical cancer has remained stable for the past 2 decades, said Dr. Rimel.

Cervical cancer is the only cancer that can be prevented by vaccination, Dr. Rimel noted. It is essential to identify the women who are dying from cervical cancer, as well as who gets screened, who gets vaccinated, and who ends up in clinical trials, she said.

Novel agents for treating cervical cancer suggest that improvement in stagnant mortality rates is possible, said Dr. Rimel. She noted recent studies of cemiplimab, tisotumab vedotin, and a combination therapy involving pembrolizumab and platinum/paclitaxel, with and without bevacizumab.

Dr. Rimel suggested several opportunities to improve the identification and treatment of cervical cancer: Treat it like a rare disease; address structural racism through clinical trials; create opportunities for low–socioeconomic status patients to be involved in research; and develop solutions according to location (urban vs. rural), she said.

Compared with other cancers, cervical cancer is relatively rare in the United States, Dr. Rimel said. However, “It is important that those with cervical cancer can get treated and get healed from the disease,” she said. To better identify the women with cervical cancer who need treatment and to get them into clinical trials, she suggested using strategies employed by rare disease groups, such as seeking out patient support groups and registries.

Significant racial and ethnic disparities persist in cervical cancer, Dr. Rimel emphasized. Data from the CDC show that Black and Hispanic women in the United States are diagnosed with cervical cancer more frequently than women of other races and ethnicities and are less likely to survive.

“Reimagine cervical cancer as a disease of patients who are historically underrepresented due to race, language, poverty, and location,” she said.

Improving equity in cervical cancer care involves structural and trial-specific issues, said Dr. Rimel. Structural issues start with addressing how women enter into the health care system, she said. Consider where women receive care, and whether women have the opportunity to be vaccinated, and later screened, she said. Consider barriers to cervical cancer trials in centers with larger underserved populations, not only cost or insurance, but also issues of language and trust between patients and health care providers, she noted.

To improve the equity of cervical cancer clinical trials, consider potential barriers to enrollment, she added.

“Low English fluency is a barrier to trial enrollment,” said Dr. Rimel. In-person translation is essential for consent to participate in a trial, and “clinical trial budgets must reflect this requirement,” she added. Patient-reported outcomes need to be in the patient’s preferred language, “this includes online content,” Dr. Rimel said.

Dr. Rimel presented other strategies for clinical trial designs to improve equity.

“Compensate patients for their travel, or provide them with tech to allow for off-site monitoring,” she proposed. Patients of lower socioeconomic status in rural and urban areas have different barriers to enrollment, but virtual visits might be an option for those able to access the Internet when given a device. For others, smaller trial sites closer to home, combined with compensation for travel or missed work, might create more opportunities to participate, Dr. Rimel said. Finally, researchers should consider potential roles for smaller or broader studies that involve less travel and testing that would be feasible for more patients who might not otherwise participate in a clinical trial, she concluded.

Dr. Rimel had no financial conflicts to disclose.