Recent weeks have brought good news about vaccines: studies show that flu vaccination reduces heart diseasethe shingles vaccine may prevent or slow dementia, and one human papillomavirus shot protects girl from cervical cancer for the rest of her life.
But in the topsy-turvy world of Health and Human Services Secretary Robert F. Kennedy Jr., vaccines are on the brink. The Vaccine Committee, dominated by the skeptics it selected to serve on the panel, voted 8-3 on Friday to overturn a 34-year-old recommendation that newborns be vaccinated against hepatitis B, a practice that has helped reduce the number of cases of the virus among children by 99%, from about 16,000 in 1991 to just seven in 2023.
While the committee was engaged in its deliberations, the dangers of refusing vaccines were clear. The nation's worst year since 1992 for measles, a vaccine-preventable disease, continued with outbreaks in Utah, Arizona and South Carolina. A two-year outbreak of whooping cough, which can also be stopped by vaccines, has caused about 60,000 reported cases, including at least six child deaths.
But none of these diseases were discussed on the first day of the meeting by members of the Advisory Committee on Immunization Practices. The commission's primary purpose is to set vaccination policies to counter such risks, but under Kennedy it has focused on responding to hesitancy from vaccine skeptics and anti-vaxxers.
Like previous meetings of the committee, which was chosen by Kennedy after he fired the panel's 17 sitting experts in June, this meeting chaotically contradicted past Centers for Disease Control and Prevention practices. Kennedy called the agency a “cesspool of corruption.”
The committee's chairman, epidemiologist Martin Kulldorf, left his post three days before the meeting and was appointed to the top position in the Ministry of Health. His successor, Kirk Milhoan, is a pediatric cardiologist who stated that mRNA technology used to make Covid vaccines poses the “biggest threat to humanity” was discussed for much of the meeting on the plane or in Asia, leaving the reins to Vice Chairman Robert Malone. Malone opposes vaccine mandates and became a darling of the anti-vaccine movement when he told podcast host Joe Rogan in 2021 that Americans had been “essentially hypnotized” into taking the Covid vaccine.
Typically, panel meeting slides and details are posted on the CDC website several days in advance. This time they were not published at all.
The committee's working group that studied hepatitis B vaccines did not include recognized hepatitis experts. When several panel members expressed doubts during the ACIP meeting, CDC hepatitis specialist Adam Langer was brought in to answer questions. He did not approve of the proposed changes.
Unexpected choice of experts
At 8 a.m. on December 4, the Centers for Disease Control and Prevention (CDC) finally listed the names of the meeting's presenters. Aaron Seery, one of Kennedy's former lawyers and an outspoken anti-vaxxer, was expected to lead Friday's discussion of the childhood vaccination schedule.
Senator Bill Cassidy, a Republican from Louisiana and a physician who cast the tie-breaking vote for Kennedy to be confirmed, said on social media platform X: “Aaron Seery is a trial lawyer who makes a living suing vaccine manufacturers. He acts like an expert on childhood vaccines. ACIP is completely discredited. They don't protect children.”
In responses to his post, some people demanded to know what Cassidy plans to do about it. Although he has publicly criticized some of Kennedy's moves on vaccines, the senator has made no apparent effort to reverse them.
At the start of the meeting, Malone announced that Vicki Pebsworth, a senior fellow at the National Vaccine Information Center, which has been a cornerstone of vaccine skepticism for four decades, is leading a committee that is reviewing the entire childhood vaccination schedule. It is a repository of ACIP recommendations that protect American children from measles, whooping cough, influenza, tetanus, chickenpox, meningitis and a variety of other diseases.
Typically, experienced CDC and FDA vaccine and infectious disease experts present data on a disease and its prevention options before ACIP votes on a policy. Instead, Pebsworth, a climate scientist who is skeptical of vaccines Cynthia Nevisonand businessman Mark Blacksill, who helped lead another anti-vaxxer group, presented a case – negative – for the hepatitis B vaccine on December 4th.
Sports medicine doctor Tracy Beth Hoegh, who spent a year working with UCSF epidemiologist Vinay Prasad, now the FDA's vaccine chief, in a leadership role at the agency, frequently chimed in on the conversation. Nevison and Blacksill were co-authors of a 2021 study on autism that was retracted due to data misrepresentation and other problems.
Not surprisingly, the picture they painted on December 4 suggested that a dose of hepatitis B at birth was unnecessary and could be dangerous, despite years of scientific consensus to the contrary.
The presentations stunned Cody Meissner, an infectious disease specialist and one of the few vaccinologists on the CDC panel. “There were so many statements that I disagreed with that it’s hard to be concise,” he said.
Yvonne Maldonado, an infectious disease specialist at Stanford University and one of the former ACIP members ousted in June, said she was intimidated by watching untested presentations by non-medical laypeople.
“Almost every statement made by this committee has been misinformation, disinformation or outright lies,” she said. “They cherry-pick data, pull marginal articles, misunderstand good articles. They are not the right people to make decisions.”
Pebsworth said the committee took up the birth dose issue because of “pressure from interest groups,” presumably including Kennedy and his allies. In her erroneous view, the United States is an “outsider” in its universal recommendations.
In fact, the birth dose of hepatitis B vaccine is administered in 115 countries and is recommended by the World Health Organization. However, many Western European countries limit the birth dose to target groups.
Arguments for birth dose
Nevison said targeted efforts to stop the virus in the 1980s, including promoting safer sex, increased blood screening and vaccinating children of mothers infected with hepatitis B, have accounted for most of the drop in cases since then. But most experts say birth dose played a key role. And the virus remains a threat because about 640,000 carriers in the USA
The birth dose “is insurance,” Meissner said. “This is really for chronically infected mothers who, for one reason or another, are not getting tested.”
“Where is the evidence of harm?” asked another panelist, psychiatrist Joseph Hibbeln.
In the years since the birth dose of hepatitis B vaccine was recommended, it has caused vanishingly few documented serious side effects.
Blacksill, who 25 years ago helped promote the debunked theory that traces of mercury in vaccines are causing the autism epidemic, said hepatitis B vaccines have not been studied enough. He pointed to a study that showed high fevers in some children after vaccination, which he said indicates inflammation of the brain.
Maldonado said that was wrong. “I have seen thousands of children with fever,” she said. “It's not the same as encephalitis.”
Nevison said a small number of vaccine court decisions have proven at least some harm from hepatitis B shots. Reed Grimes, director of the office of injury compensation programs at the Health Resources and Services Administration, explained that an award does not necessarily mean proof of injury, but rather that the government has decided not to fight the claim.
Speculation flourished. Panelist Evelyn Griffin, an obstetrician, suggested that the rise in inflammatory bowel disease cases could be linked to the brewer's yeast used in the production of the hepatitis B vaccine. She did not identify the source of the idea.
Children born with hepatitis B infection have a 90% chance of developing chronic liver infection later in life, and 25% of children with chronic infection die prematurely due to chronic liver disease.
Panel members who favor ending the universal birth dose argued that blood tests on pregnant women should show who needs the vaccine. But only 35% of women who test positive receive all the recommended aftercare, and the virus can easily spread through common contacts such as a toothbrush or bath towel. According to a recent study, stopping dosing at birth could lead to almost 500 deaths per year.
The meeting was preceded by an intensive round of briefings for journalists and “preliminary” papers from recognized medical experts who view the new ACIP as a bastion of anti-vaccine views – “inflating speculative risks while downplaying the well-established benefits of vaccines,” as three recent CDC officials wrote.
They noted that a dose of hepatitis B at birth is no longer necessary, although doctors strongly recommend it. But recommending that it be a blanket decision based on individual choice, as ACIP voted on Dec. 5, could add paperwork for doctors and sow doubt in the minds of parents.
ACIP recommendations are not mandatory but have been used in the past by health insurers to make coverage decisions. Federal agencies and private insurers will in most cases continue to pay for hepatitis B vaccinations if parents choose, said Andrew Johnson, who represented the Centers for Medicare and Medicaid Services during the meeting. But studies have shown that ambiguous advice leads to lower vaccination rates, says Katherine Edwards, a vaccinologist at Vanderbilt University.
Anti-vaccine activists have long targeted the birth dose of hepatitis B. At one time they claimed, without evidence, that it caused sudden infant death syndrome.
But in the decade since universal dosing was introduced, SIDS rates have dropped. dropped by almost half. This was thanks to the HHS-American Academy of Pediatrics' “back to sleep” campaign, which urged parents to avoid the risk of suffocation by not allowing their babies to sleep on their stomachs.
