The vaccine advisory committee of the Centers for Disease Control and Prevention is scheduled to meet Dec. 4 and 5. On the agenda: the hepatitis B vaccine, the overall childhood vaccine schedule and vaccine ingredients. We’ll summarize what we’ve written about these topics and what the committee has said about them in recent meetings.
The group, called the Advisory Committee on Immunization Practices, was reconstituted in June by Health and Human Services Secretary Robert F. Kennedy Jr. The committee has since departed from its normal evidence-based procedures and has made changes to its vaccine recommendations amid misleading claims about vaccine safety.
As we have written, the panel previously was scheduled to vote in September on a recommendation to delay the birth dose of the hepatitis B vaccine but tabled the vote at the last minute. The committee presented no clear rationale for why it was considering delaying the birth dose, and one member cited “trust,” and not safety, as the motivator. Since universal hepatitis B vaccination for infants was recommended in 1991, hepatitis B infections in children have fallen by 99%. Babies and young children who are infected with the hepatitis B virus are disproportionately likely to develop chronic infections, which can lead to liver failure and liver cancer.
Also on the bare-bones agenda are items related to the vaccine schedule, vaccine safety monitoring and a presentation titled “Adjuvants and Contaminants.” The committee also typically votes during its fall meeting to approve the next year’s vaccine schedule documents, Jason Schwartz, who studies vaccination policy at the Yale School of Public Health, told us in an email. These documents compile existing recommendations as a resource for health care providers and parents. Such votes are on the design and footnotes of the documents but do not affect “the underlying recommendations” and do not have “immediate consequences for vaccine access or affordability,” he explained.
The committee will meet this week under new leadership. On Dec. 1, HHS announced that biostatistician and epidemiologist Martin Kulldorff’s short tenure as chair of the committee was over and that he had been appointed to a leadership role in the Office of the Assistant Secretary for Planning and Evaluation. The committee’s new chair is pediatric cardiologist Dr. Kirk Milhoan, another Kennedy appointee, who has a history of promoting treatments for COVID-19 that are not evidence-based and making unfounded claims about COVID-19 vaccination.
Milhoan confirmed to the Washington Post that the group would vote on delaying the hepatitis B birth dose, although the extent of the delay is “still being finalized,” he said. He also said that the group would discuss the effects of the childhood vaccine schedule on chronic health conditions.
In October, the CDC staffers tasked with supporting the committee were let go, according to the Guardian.
Meanwhile at the Food and Drug Administration, a leaked Nov. 28 letter from vaccines regulatory division head Dr. Vinay Prasad announced a new, stricter framework for regulating vaccines. He justified this proposal by claiming, with little detail to back it up, that COVID-19 vaccines had killed at least 10 children. FDA senior adviser Dr. Tracy Beth Høeg, a physical medicine and rehabilitation physician, was involved in the investigation into the safety of the COVID-19 vaccines, Prasad wrote. Høeg is an ex officio member of ACIP.
Hepatitis B Birth Dose
Hepatitis B vaccination takes up the majority of the agenda on the meeting’s first day, which includes an anticipated vote on whether to delay the birth dose. Kennedy long has misleadingly claimed that it’s unnecessary to give a dose of the hepatitis B vaccine at birth because the virus is spread via sexual contact and drug use. But an infected mother can transmit the virus to her baby during birth or after, and it also can be spread by other family members or close contacts through minute amounts of blood.
Getting a hepatitis B vaccine at birth provides a safety net for babies, in case an infection in a mother is missed or the baby is later exposed to another infected person. About half of people in the U.S. who have hepatitis B do not know it, according to data presented at the September meeting by a CDC staff scientist.
A Dec. 2 review by the Vaccine Integrity Project, conducted in advance of the anticipated hepatitis B vaccine vote, found “no evidence of any health benefit with delaying the birth dose and identified only risks related to changing current US recommendations for universal hepatitis B vaccination.” The Vaccine Integrity Project is an initiative of the University of Minnesota’s Center for Infectious Disease Research and Policy that provides evidence-based information on vaccination.
Opponents of the universal birth dose of the hepatitis B vaccine have questioned why some countries have different hepatitis B vaccine strategies than the U.S., but the CDC presentation pointed out that many of these countries have a higher rate than the U.S. of successfully screening mothers for hepatitis B before they give birth and also have universal health care systems.
The move toward changing hepatitis B vaccine recommendations was introduced during an ACIP meeting in June, preceding the September meeting in which the group discussed but failed to vote on whether the birth dose should be delayed by one month.
The group did vote to recommend that all women be tested for hepatitis B during pregnancy. However, this is “already standard clinical practice and outside ACIP’s purview,” a review of the meeting by former ACIP members pointed out.
The member who made the motion to table the hepatitis B vaccine vote, Dr. Robert Malone, subsequently said he had done so because the proposed delay was “not sufficient.” Malone has for years spread false and misleading information about vaccines. Later in September, President Donald Trump suggested that the first dose of the hepatitis B vaccine should be delayed until 12 years of age.
The September presentations leading up to the tabled hepatitis B vote offered little detail on topics that would ordinarily be discussed before changing vaccine recommendations, including whether there could be practical ramifications from changing the vaccine schedule. However, the nonprofit Vaccinate Your Family and others have expressed concerns that changing the timing of a child’s first dose of the hepatitis B vaccine could affect subsequent doses, making it more difficult to use certain commonly used combination vaccines. The childhood vaccine schedule recommends three hepatitis B vaccine doses.
“Changes to recommendations for any component within a combination vaccine risk reducing options for families and could disrupt vaccine supply and limit access for years,” the pharmaceutical company Sanofi wrote in a Nov. 25 public comment posted in advance of the ACIP meeting. “These supply challenges would extend beyond combination vaccines to include stand-alone vaccines that prevent diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and polio.” Sanofi makes Vaxelis, a combination vaccine protecting against hepatitis B along with these other listed diseases.
Vaccine Ingredients and the Vaccine Schedule
The second day of the meeting will focus on a wide variety of topics related to vaccine safety, “Adjuvants and Contaminants,” and the vaccine schedule overall, per the agenda. No votes are listed on the agenda for this day.
It is unclear precisely what the presentations will cover, but the topics overlap with interests of a new ACIP work group established under Kennedy. This group will review “the safety and effectiveness” of the childhood and adolescent vaccine schedule, per a document posted in October.
In this document, the work group suggested it would revisit when and in what order vaccines are given and which vaccines should be given together, for example. As we have written previously, new vaccines are studied in the context of the current vaccine schedule and are approved if shown to be safe and effective. A Dec. 2 post on the Substack Unbiased Science explained that the vaccine schedule has been built over time based on multiple considerations, related to ideal timing to get the best protection, established safety of giving immunizations at the same time, and practicality.
ACIP chair Milhoan also told the Washington Post that the committee is beginning a discussion of aluminum adjuvants, an interest also noted in the new work group document.
Adjuvants are substances added to vaccines in small amounts to improve a person’s immune response to the vaccines’ main ingredients. The most commonly used vaccine adjuvants are aluminum salts, which were discovered to work for this purpose nearly 100 years ago.
In recent months, Kennedy has made incorrect and misleading statements about aluminum adjuvants, cherry-picking and misusing data from a July 15 Danish study to claim that aluminum in vaccines has been linked to autism. In fact, this large study found no association between aluminum in vaccines and 50 chronic conditions, including autism.
Kennedy also ordered a Nov. 19 update to a CDC webpage on vaccines and autism, which repeated these claims about the Danish study. The webpage also cited evidence of “a positive association between vaccine-related aluminum exposure and persistent asthma,” based on a 2022 CDC-funded study.
However, the new CDC webpage failed to note that the Danish researchers, who originally set out to replicate the 2022 study, did not find an association between aluminum content in vaccines and asthma. The first author of the 2022 study, pediatrician Dr. Matthew Daley of Kaiser Permanente Colorado’s Institute for Health Research, in July told STAT that the new Danish study was “well done” and “reassuring.”
The ACIP agenda does not specify what “contaminants” will be discussed. At the group’s September meeting, presenters discussed alleged “DNA contamination” in mRNA COVID-19 vaccines. However, claims of higher-than-expected levels of DNA in COVID-19 vaccines are based on flawed analyses that have been contradicted by other assessments. Moreover, as we have written before, the small quantity of DNA left over in vaccines from the manufacturing process is expected and is not considered contamination.
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