Dr. Retsef Levi speaks during a meeting of the Advisory Committee in Immunization Practices. ACIP is changing its recommendation regarding timing of administration of the hepatitis B vaccine (AP Photo/Mike Stewart)
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The Advisory Committee on Immunization Practices voted 8-3 last week to overturn a 30-year-old vaccine policy that has contributed to a substantial decline in cases of hepatitis B. Changes to the hepatitis B vaccine schedule may seem small, but in light of all that has happened since a new ACIP took over in June, top Centers for Disease Control and Prevention officials resigned in August, and the Secretary of Health and Human Services, Robert F. Kennedy Jr., repeated claims of links between vaccines, autism and chronic disease, there appear to be efforts to gradually erode the public’s trust in childhood vaccines. The ACIP is now laying the groundwork for more scrutiny of a wide variety of shots administered to children, which could undermine confidence in vaccines as a whole.
The ACIP panel voted to alter a decades-long policy to vaccinate all newborns against hepatitis B at birth. Rather, the committee is recommending a shared clinical decision-making process for infants born to mothers who test negative for hepatitis B. Under the new guidance, parents and clinicians would decide whether to vaccinate. If the decision is to vaccinate, then the initial dose should be administered no earlier than two months of age. Parents are advised to consult with healthcare providers to evaluate the need for a subsequent hepatitis B vaccine dose in children, potentially testing antibody levels to hepatitis surface antigen.
Panel members ignored evidence showing hepatitis B shots are safe and effective. Rather, they insinuated unsubstantiated risks without offering data.
Before the availability of a vaccine and adequate testing, hepatitis B was one of the world’s top ten killers, leading to an estimated 1-2 million deaths per year from the virus itself and related complications such as liver cancer. The figure is still high at around 820,000, but immunization has helped lower it significantly.
In the United States where hepatitis B is not endemic, the threat to public health isn’t as acute. Nevertheless, analyses suggest that delays in shots or skipping them altogether in the U.S. could result annually in at least 1,400 preventable hepatitis B infections among children, 300 excess cases of liver cancer and 480 deaths. Giving the vaccine immediately following birth has reduced perinatal and childhood infection in the U.S. by 99% since 1991.
The change in recommendation regarding the hepatitis B vaccine can be viewed as a roadmap for future edits to the childhood immunization schedule.
At meetings last week, prominent members of the ACIP panel, Retsef Levi and Robert Malone, urged examination of unknown risks to administering multiple shots at the same time in early childhood. This is standard practice in the U.S. and elsewhere for combination vaccines such as the measles, mumps and rubella immunization, and has no proven negative outcomes. Yet, the acting director of the Centers for Disease Control and Prevention, Jim O’Neill, has called for the MMR shot to be broken up. And in the fall, President Trump also spoke of splitting up the MMR vaccine into three separate shots. No evidence-based reasons to do so were given. Public health experts strongly dispute insinuations that combination jabs may produce adverse events.
The current ACIP panel is also reviewing aluminum adjuvants in vaccines. Adjuvants are compounds that boost immune responses, improving the ability of vaccines to elicit long-lasting immunity against infectious diseases. Such adjuvants are widely used in inoculations against diphtheria, tetanus and hepatitis B, among others.
HHS Secretary Kennedy has long falsely asserted that vaccines containing aluminum salts cause health problems. He has made similar claims regarding vaccines that include thimerosal as a preservative. In June, his hand-picked ACIP panel recommended against the use of thimerosal in influenza vaccines. Unlike thimerosal, which is only used in a small percentage of influenza vaccines, multiple types of vaccines contain aluminum. This implies that a possible decision to curb or ban its use could have far-reaching implications.
Throughout his tenure thus far as HHS Secretary, Kennedy has doubled down on asserting multiple unproven links to autism, from childhood vaccines to Tylenol (acetaminophen) taken by pregnant mothers and given to infant boys after circumcision. Kennedy’s appointee at CDC, O’Neill, signaled this fall that he plans to examine whether childhood vaccinations cause allergies.
Besides questioning childhood vaccines that have been the norm for decades, Kennedy has heavily criticized more newer immunizations, such as the human papilloma virus vaccine that prevents cervical cancer. In 2019, he called it the “worse vaccine ever.”
Most recently, in an email to staff, Vinay Prasad, director of Food and Drug Administration’s Center for Biologics Evaluation and Research, wrote that his team had found a link between the COVID-19 vaccine and the deaths of at least ten children. While the memorandum indicated the deaths were related to myocarditis, it provided no details on the ages of the children, whether they had comorbidities or how the agency established a link, the New York Times reported.
The cases were drawn from the Vaccine Adverse Event Reporting System and Tracy Beth Høeg. who was recently named acting director of the FDA’s Center for Drug Evaluation and Research, led the review. Prasad requested an analysis of 96 deaths between 2021 and 2024, according to the Washington Post.
VAERS is an early warning system that tracks reports from physicians and others of what could be side effects from vaccines. The system’s passive collection of information after vaccination cannot be used to determine whether a vaccine caused a particular event. For causal proof to be established, follow-up work would have to be conducted.
Public health experts have questioned Prasad’s claim and the supposed manner in which the associations were determined. According to Endpoints News, the actual number may be lower and that the causal relationship in some cases is unclear.
All told, the added scrutiny of vaccines given to the pediatric population could sow doubts with respect to the safety and effectiveness of immunizations. In turn, this would likely exacerbate already rising levels of vaccine hesitancy leading to increased preventable morbidity and mortality.