NEW YORK, Dec 5 (Reuters) – A group of vaccine advisers to U.S. Health Secretary Robert F. Kennedy Jr. on Friday voted to remove the broad recommendation that all newborns in the U.S. receive a hepatitis B vaccine, in one of the most sweeping changes to vaccine policy under Kennedy’s leadership so far. The Advisory Committee on Immunization Practices (ACIP) advises the U.S. Centers for Disease Control and Prevention on which public health recommendations to adopt.
Here are some reactions to the decision:
PHARMACEUTICAL COMPANY MERCK, IN A STATEMENT: “We are deeply concerned by ACIP’s vote to modify the longstanding hepatitis B birth dose recommendation. This decision disregards decades of safety and effectiveness data that unequivocally support the hepatitis B birth dose; its removal risks reversing this progress and puts infants at unnecessary risk of chronic infection, liver cancer and even death. There is no evidence that delaying it provides any benefit and in fact, the universal hepatitis B birth dose has contributed to a 99% decline in reported acute hepatitis B cases among children, adolescents and young adults in the U.S.
“The CDC has reported that one in two people are unaware that they are infected. Transmission can occur not only from an infected mother, but also from close contact with someone who may not know they have hepatitis B – such as caregivers, friends and even strangers.”
DR. DEMETRE DASKALAKIS, WHO RESIGNED FROM THE CDC IN AUGUST AS DIRECTOR OF THE NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES: “This will signal to clinicians that there is something wrong with the vaccine – there is not – and that there are liability risks.” As for the vote to recommend antibody testing before infants receive the second or third dose of the three dose series, it is “a slap in the face of science and clinical pediatrics,” noting that it takes three doses to establish lifelong immunity. Testing before the full series is completed “adds cost and complexity, risks missed follow-up, and can widen gaps in protection—contrary to public health goals of universal, durable immunity.”
DR. MICHAEL OSTERHOLM, DIRECTOR OF THE UNIVERSITY OF MINNESOTA’S CENTER FOR INFECTIOUS DISEASE RESEARCH AND POLICY. “Today is a defining moment for our country. We can no longer trust federal health authorities when it comes to vaccines.
“In voting to eliminate the universal birth dose of the hepatitis B vaccine, ACIP ignored decades of evidence confirming its strong safety profile and effectiveness. Its decision will result in more hepatitis B infections and more people with chronic liver disease. If ACIP chooses to ignore evidence, when it comes to vaccines, parents and clinicians must ignore ACIP and look to those who continue to offer data-based guidance, especially our medical societies.” “Today is a defining moment for our country. We can no longer trust federal health authorities when it comes to vaccines.”
AMERICAN PHARMACISTS ASSOCIATION (APHA): “We remain steadfast in our commitment to protecting patients across their lifespan. The science is clear: the hepatitis B birth dose saves lives, and there is no new evidence to justify delaying or removing this critical protection. We are deeply disappointed by today’s vote by the CDC’s Advisory Committee on Immunization Practices (ACIP) to remove the universal recommendation for administering the hepatitis B vaccine birth dose for infants born in the United States. This reversal rolls back a highly effective, evidence-based public health measure that has been in place since 1991.”
FORMER CDC DIRECTOR DR. THOMAS FRIEDEN AND CEO OF RESOLVE TO SAVE LIVES ADVOCACY GROUP, IN A STATEMENT: “The ACIP recommendation to end the universal birth dose of the hepatitis B vaccine puts millions of American children at greater risk of liver damage, cancer and early death. Now obstetricians, pediatricians, insurers, state health departments and others should stand up for fact-based care, protect our children, and not mess with success — not accept this misguided and dangerous recommendation.”
FORMER CDC OFFICIAL DEBRA HOURY: “The December ACIP meeting this week hit an all-time low. The three presenters on the hepatitis B vaccine were not vaccine scientists, and two had authored a retracted paper about autism. Added to this, the Secretary’s ally, an anti-vaccine trial lawyer named Aaron Siri who previously petitioned the FDA to revoke approval of the polio vaccine, was given a platform to present on the childhood vaccine schedule…. What we have witnessed at the CDC is not reform. It is the hollowing out of an institution Americans rely on in every emergency.”
DR. MOLLY O’SHEA, PEDIATRICIAN AT THE BIRMINGHAM PEDIATRICS & WELLNESS CENTER: “I have been communicating with pediatric colleagues across the country today. We are all distressed and disheartened by these decisions. Restricting the recommended birth dose of Hepatitis B vaccine to only those babies whose mothers test positive for Hep B puts tens of thousands of babies at risk. Up to 18% of people have not been screened for Hepatitis B at the time of delivery, and those babies will fall through the gaps. Because those parents are likely to have had less consistent prenatal care, more likely to face adverse circumstances, they are at greater risk of carrying the virus without knowing it and passing it along to their infants.”
DR. RICHARD RUPP, PROFESSOR OF PEDIATRICS AT THE UNIVERSITY OF TEXAS MEDICAL BRANCH: “The decision to roll back the blanket recommendation that all infants receive the hepatitis B vaccine at birth is very concerning and unnecessarily puts children at risk. The vaccine is not harmful, and even children whose mothers do not have hepatitis B could contract the virus through another means of exposure if not immunized. The vaccine is incredibly safe and has had a historic positive impact on public health since its inception. Rolling back the initiative to protect all children will almost certainly lead to an increase in hepatitis B cases nationwide.”
AMERICAN PUBLIC HEALTH ASSOCIATION EXECUTIVE DIRECTOR GEORGES C. BENJAMIN: “The Advisory Committee on Immunization Practices’ decision to change the universal Hepatitis B vaccine guidance increases the risk of infection for babies. This recommendation will leave children vulnerable to unnecessary exposure and preventable illness. ACIP members failed to provide scientific evidence to show the long-term health benefits of delaying vaccination. As a committee tasked with giving guidance to practitioners on the front lines of improving the health of all communities, this decision creates confusion instead of the needed evidence-based roadmap for families to make informed decisions about their child’s health.”
DR. JON TEMTE, UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH, FORMER ACIP CHAIR AND CURRENT CHAIR OF THE WISCONSIN COUNCIL ON IMMUNIZATION PRACTICES: “This was once the world’s preeminent advisory committee. Now nothing is working like it should, it’s just a clown show. We as physicians are left with nothing coming from this committee. We no longer have a unified, trusted source. We are having to turn to our professional organizations and our states for guidance. People will not trust ACIP anymore.”
RAVI JHAVER, MD, FPIDS, OF LURIE CHILDREN’S HOSPITAL IN CHICAGO: “This is an incredibly disappointing result. In the face of decades of evidence supporting the number of cases of liver cancer and cirrhosis prevented by this vaccine with no specific data concerning the safety, the current ACIP voted to remove the birth dose recommendation. Despite the promise of “gold standard science”, this decision reflects an unscientific approach. Parents and families should be reassured that organizations like the American Academy of Pediatrics will not be changing the recommendation for the timing of the birth dose HepB vaccine. The Pediatric Infectious Diseases Society 100% supports the recommendation for birth dose administration because it prevents an infection that is lifelong, has no cure and could lead to liver cancer. The public overwhelmingly votes with their feet everyday to receive vaccines because they recognize the benefits for their children and family members.
MARY HOLLAND, ESQ., PRESIDENT AND CEO, CHILDREN’S HEALTH DEFENSE: “I welcome the ACIP Committee’s decision to end the ill-conceived universal recommendation for the Hep B birth-dose vaccine. The evidence backing that recommendation was flawed and was based on insufficient clinical trials. Undoubtedly, hundreds of babies have died because of it. While I question whether any infant should receive a vaccine for such a rare disease as Hep B, I am pleased that this is now a decision for parents and their healthcare providers, not a government mandate driven by a federal pharma-backed recommendation. Although the ACIP debate on this topic was sometimes tedious and heated, it is a very positive development that genuine discussions about childhood vaccines are now happening in government forums with real impact. This reflects the pro-science approach and transparency that Secretary Kennedy promised.”
HOUSE ENERGY & COMMERCE HEALTH SUBCOMMITTEE RANKING MEMBER DIANA DEGETTE, IN A STATEMENT: “This administration’s anti-science agenda is going to get kids killed. The vote by members of ACIP to end the universal Hepatitis B vaccine birth dose recommendation for newborns is not supported by science and is incredibly reckless. Donald Trump and RFK Jr. have eroded Americans’ confidence in public health and diminished our capacity to protect the public, from hawking unproven treatments to ousting trusted medical experts across the federal government. Now, because of an ACIP stacked with vaccine conspiracy theorists, children will be more likely to get preventable diseases and die.”
MICHAEL KRIEGER, CREATOR AND EDITOR OF LIBERTY BLITZKRIEG, SAID IN A POST ON X: “Hep B vaccine at birth was an obvious scam to anyone who did 5 seconds of research. Fortunately for us, we did that research before having kids and were able to distrust the experts and dodge this pointless shot. When a system is as transparently corrupt as ours is you cannot simply “trust” the system. You and only you are responsible for your family, you must take that job seriously.”
SENATOR RON WYDEN, THE SENIOR DEMOCRAT ON THE SENATE FINANCE COMMITTEE, ONE OF THE PANELS THAT HAS OVERSIGHT OF HEALTHCARE POLICY: “There is blood on the hands of Donald Trump, Robert Kennedy, and every Republican who has allowed this sham to go on for far too long. When kids die unnecessarily and once-eradicated diseases darken the doors of terrified families and pediatricians, Americans will know who is responsible. There’s still time to disarm the radical anti-vaccine activists who are wrenching American public health backwards by a generation, but time is running out.”
DR. OLIVER BROOKS, FORMER MEMBER OF CDC’S ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES AND A PEDIATRICIAN IN LOS ANGELES: “This vaccine recommendation has been in place for 34 years, and there have been no issues. It’s not like we found a lot of side effects from the vaccine being given. There have been millions and millions of doses given. If there was some safety signal, we’d know about it, and there isn’t. Their goal is to sow mistrust, hesitancy and skepticism regarding vaccines. They want to make the utilization of vaccines diminish by whatever means, by regulation, by administrative changes, but more fundamentally, philosophically.”
ACIP MEMBER RETSEF LEVI, PROFESSOR OF OPERATIONS MANAGEMENT AT MIT, WHO VOTED YES: “If you’re a baby that was born to a mother that was tested negative to hep B, you need to realize as a parent that your risk of infection throughout your early stage of life, and probably throughout most of your childhood, is extremely low… As a parent, we encourage you, in consultation with your physician, to think very carefully. Do you want to expose your child, your baby, to an intervention that could have some potential harms when the risk is so low?”
AMERICAN ACADEMY OF PEDIATRICS PRESIDENT DR. SUSAN KRESSLY: ““This irresponsible and purposely misleading guidance will lead to more hepatitis B infections in infants and children. I want to reassure parents and clinicians that there is no new or concerning information about the hepatitis B vaccine that is prompting this change, nor has children’s risk of contracting hepatitis B changed. Instead, this is the result of a deliberate strategy to sow fear and distrust among families.”
DR. PAUL OFFIT, DIRECTOR OF THE VACCINE EDUCATION CENTER AT THE CHILDREN’S HOSPITAL OF PHILADELPHIA: “I think that this vote will condemn probably hundreds of children to a shorter life.”
Offit said in 1991, there were 30,000 hepatitis B infections among children under age 10. Of those, 15,000 got it from their mothers. “The other 15,000 got it from relatively casual contact with one of the millions of people in this country who have chronic hepatitis B virus and don’t know it. This virus is 50 to 100 times more contagious than AIDS, and I don’t think they understand that.”
SENATE HELP COMMITTEE CHAIRMAN BILL CASSIDY, REPUBLICAN OF LOUISIANA, ON X: “As a liver doctor who has treated patients with hepatitis B for decades, this change to the vaccine schedule is a mistake. The hepatitis B vaccine is safe and effective. The birth dose is a recommendation, NOT a mandate. Before the birth dose was recommended, 20,000 newborns a year were infected with hepatitis B. Now, it’s fewer than 20. Ending the recommendation for newborns makes it more likely the number of cases will begin to increase again. This makes America sicker. Acting CDC Director O’Neill should not sign these new recommendations and instead retain the current, evidence-based approach.”
DORIT REISS, A VACCINE LAW EXPERT AT UC LAW SAN FRANCISCO: “The committee did not have good data, has no one with hepatitis B expertise among its members, and the actual experts recommended against this. Overturning a decision by actual experts with no change in data is inappropriate, and this will put babies at risk. The vote language has been changed multiple times and not announced in advance. The misleading information presented would confuse people. At least they left it as shared clinical decision making, so insurance will still cover it.”
DR. CODY MEISSNER, COMMITTEE MEMBER AND PROFESSOR OF PEDIATRICS AT DARTMOUTH: “We have heard ‘do no harm’ is a moral imperative. We are doing harm by changing this wording. And I vote no.”
JOSEPH HIBBELN, COMMITTEE MEMBER AND FORMER CHIEF OF SECTION ON NUTRITIONAL NEUROSCIENCES AT THE NATIONAL INSTITUTES OF HEALTH: “We have still not had any information or science presented or discussed with regard to this issue of before or after two months of age. This is unconscionable. How can we go forward when this is a specific issue that was supposed to be identified?”
DR. WILLIAM SCHAFFNER, PREVENTIVE MEDICINE AND INFECTIOUS DISEASES SPECIALIST AT VANDERBILT UNIVERSITY MEDICAL CENTER AND FORMER ACIP MEMBER: “I’m very disappointed. I think that if we look many years down the road, we will see that there are children who have acquired hepatitis B infection during the birth process and have subsequently developed active hepatitis and the consequences of cirrhosis and perhaps even liver cancer.
“They’ve turned back the clock to pre-1991. There’s no science behind either of these recommendations. That’s the painful part. Just there’s profound misunderstanding on the part of many of the committee members of the science.”
DR. FLOR MUNOZ, INFECTIOUS DISEASES SPECIALIST AT TEXAS CHILDREN’S HOSPITAL: Shared decision-making by parents and doctors “is already existing practice. There is no reason why this has to be a new policy, or that there would be a change in how physicians and parents make decisions on vaccines. All vaccines in the schedule are recommended vaccines. None is mandated.”
NOEL BREWER, FORMER ACIP MEMBER AND PROFESSOR IN PUBLIC HEALTH AT UNC: “ACIP continues to take away parents’ choices and make it harder to protect their children through vaccination. The vote to eliminate universal hepatitis B vaccination will increase harm to children, increasing their risk of cancer and being a lifelong carrier of a deadly pathogen.”
“We’ve gone from smart health policy by doctors who love and care for children to chaotic utterances by your nutty uncle.”
(Reporting by Reuters health team staf)
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