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September 22, 2025 Agency Capture Health Conditions News

Policy

Key Takeaways From Last Week’s Meeting of New CDC Vaccine Advisers

A contentious two-day meeting of the Centers for Disease Control and Prevention’s vaccine advisory committee ended Friday with new recommendations for the COVID-19 and combined measles, mumps, rubella and chicken pox vaccines — but no vote on new recommendations for the Hep B vaccine.

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A contentious two-day meeting of the Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee ended Friday with new recommendations for the COVID-19 and MMRV vaccines — but no vote on new recommendations for the hepatitis B (Hep B) vaccine.

Here are the three key changes recommended last week by members of the CDC’s Advisory Committee on Immunization Practices (ACIP):

1. COVID-19 vaccines: ACIP changed its recommendation for the COVID-19 vaccine, shifting from a universal recommendation that everyone ages 6 months and up get the vaccine to an individualized approach in which people assess the risks and benefits in consultation with their healthcare provider.

In May, Kennedy announced changes to the COVID-19 vaccination recommendations for children, recommending “shared clinical decision-making” between parents and providers for healthy children ages 6 months to 17 years.

The new ACIP recommendations extend a similar recommendation to everyone.

The COVID-19 vaccines remain available to everyone ages 6 months and up, and the decision still allows for the vaccines to be covered by insurance, ACIP Chair Martin Kulldorff, said during the meeting.

2. MMR/MMRV vaccines: On Thursday, ACIP voted to recommend limiting the MMRV (measles, mumps, rubella and varicella) vaccine to children ages 4 and older, due to concerns about adverse events related to the vaccine in younger children.

The committee recommended that children under 4 still get the MMR (measles, mumps, rubella) and varicella (chicken pox) vaccines, but separately — not in one combined shot.

Post-marketing data presented in the meeting showed that children who received the MMRV shot experienced post-vaccination febrile seizures at nearly twice the rate of children who took the shots separately.

Febrile seizures are convulsions most often caused by fevers brought on by infections such as those related to common childhood illnesses.

On Thursday, the committee voted that the CDC’s Vaccines for Children (VFC) Program, which funds routine childhood vaccines for uninsured and underinsured children, should continue to cover the cost of the combined shot for children who want to receive it.

However, on Friday, they clarified the motion and voted that the program’s funding should align with the panel’s recommendations — therefore, the program would not cover the cost of the combined shot for children under age 4.

3. Hep B vaccine: ACIP postponed its expected vote to change the Hep B vaccine recommendation, currently given to infants on the day they are born.

The committee considered whether to delay the first Hep B shot until infants are at least 1 month old, but its members said they wanted more time to consider the evidence.

ACIP’s new COVID-19 workgroup presented data on vaccine-related risks that, while available publicly, had not previously been discussed openly by health agencies.

The workgroup’s presentations addressed the low quality of data supporting continued COVID-19 booster shots, safety concerns related to vaccine contamination, and the widespread and well-documented problem of vaccine injury, including death, that some committee members alleged health agencies have ignored.

Mary Holland, CEO of Children’s Health Defense (CHD), said the meeting’s results were mixed:

“I was encouraged to see real debate among the ACIP members. Historically, this committee has been a rubber stamp for every vaccine and has been rife with conflicts of interest.

“I am pleased that COVID-19 shots are now subject to ‘individual decision-making’ and that MMRV is no longer recommended or covered by the Vaccines for Children Program for children under 4, but I am disappointed that the group did not vote on the birth dose of the Hep B vaccine.

“CHD is looking for a faster pace towards change. With over half of all children afflicted with chronic disease, and with vaccines an almost universal potential contributor, it is imperative that this newly constituted ACIP move forward with a sense of purpose as quickly as possible.”

ACIP makes recommendations to the CDC director, who typically adopts them as agency policy. Healthcare providers and public and private insurance providers use the CDC recommendations to determine vaccine practices and coverage.

Jim O’Neill is acting director of the CDC, following the firing last month of Susan Monarez, Ph.D., after she clashed with U.S. Health Secretary Robert F. Kennedy Jr.

What do changes to COVID vaccine recommendations mean?

ACIP voted on four questions relating to COVID-19 vaccine recommendations.

1. The committee unanimously voted to update pediatric and adult immunization schedules for people ages 6 months and older to recommend that vaccination be based on “individual-based decision making.”

For those under 65, providers should advise patients that the risk-benefit of vaccination is most favorable for those at increased risk for severe disease.

Kulldorff confirmed this recommendation would allow for insurance coverage for COVID-19 vaccines for all people ages 6 months and up.

2. ACIP also unanimously voted to recommend that healthcare providers discuss the risks and benefits of COVID-19 vaccines with individual patients before vaccination as part of the informed consent process.

3. In an 11-1 vote, ACIP recommended that the CDC promote “more consistent and comprehensive informed consent processes.” This would involve creating clearer, more accessible language to describe the six risks and uncertainties ACIP identified regarding the COVID-19 vaccines.

Retsef Levi, Ph.D., tapped last month to lead a new ACIP workgroup tasked with examining COVID-19 vaccine safety and efficacy, said this proposal was meant to send a strong message that informed consent should be obtained before vaccination.

4. ACIP defeated a motion recommending that state and local jurisdictions require a prescription for people to receive a COVID-19 vaccine. Following an extensive debate, the vote ended in a 6-6 tie. As ACIP chair, Kulldorff’s “no” vote broke the tie.

This vote came amid growing discrepancies over which segments of the population qualify for a COVID-19 vaccine.

Following previous changes to the CDC’s COVID-19 vaccination guidelines, some states require a prescription to administer a COVID-19 shot. Some states are currently working to change state-level policies and recommendations to eliminate this requirement.

New COVID vaccine workgroup reports on safety issues

Levi formally introduced the new COVID-19 workgroup and its 15 new members, and outlined the key takeaways from the group, before the committee voted on COVID-19 vaccine recommendations.

He said the assessment of the protection levels provided by COVID-19 vaccines, and particularly the boosters, against severe outcomes is based on “very low-quality data and analysis.”

Levi also said vaccine injuries are “demonstrably not recognized by current pharmacovigilance systems, leaving vaccine-injured individuals abandoned and without appropriate care.” He said ACIP plans to follow up on the issue.

Levi said there is substantial evidence suggesting “serious safety uncertainties and concerns” with the COVID-19 vaccines, including vaccine contamination, that is not being sufficiently addressed.

The workgroup recommended enhancing efforts to better diagnose and care for vaccine-injured people and developing better national safety surveillance systems.

During one presentation, John Su, M.D., Ph.D., of the CDC’s Immunization Safety Office, told ACIP that a safety signal for ischemic stroke — a blood clot in the brain — was identified for the 2022-2023 and 2023-2024 formulations of the COVID-19 vaccines.

Other speakers presented evidence of an increased risk of birth defects found during clinical trials for the Pfizer shot, as well as evidence that mRNA crosses the blood-brain barrier. Evidence also showed that DNA contaminants, which spread throughout the body, have been detected in breast milk.

Representatives of vaccine manufacturers who attended the meeting dodged questions about birth defects and DNA contamination in their COVID-19 vaccines.

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Absence of Hep B safety data doesn’t prove shot is safe

ACIP unanimously voted to recommend that all pregnant women be tested for hepatitis B, but postponed a vote to change the Hep B vaccine recommendation that all infants receive the shot on the day of their birth.

The postponed vote would have delayed the first dose of the three-shot Hep B series for babies born to mothers who test negative for hepatitis B until age 1 month.

Since 2005, the CDC has recommended the shot for all newborns. Kulldorff said only about one-half of 1% of babies have a hepatitis B-positive mother and need the vaccine.

Additionally, pregnant women can be tested for the disease. Some committee members argued that mothers can be tested when they give birth, and receive immediate results indicating whether a baby needs the shot.

Critics have long raised concerns about the safety and necessity of giving the vaccine to newborns not at risk for the disease. Today, the Hep B vaccine contains at least 250 micrograms of aluminum. Aluminum exposure has been linked to autism.

For infants who contract hepatitis B from their mother, the long-term effects can be serious. The CDC reports that up to 90% of those infants develop chronic hepatitis B.

Committee members questioned the need to vaccinate healthy babies with a shot that can cause a range of mild-to-serious adverse reactions. Up to one-third of babies experience a reaction to the shot.

Levi cited data from the workgroup showing that rates of hepatitis B among babies dropped significantly when the vaccine was first introduced, but recommending that all newborns receive the shot did significantly affect the numbers.

ACIP member Dr. Robert W. Malone said the lack of studies assessing whether the Hep B vaccine causes harm shouldn’t be interpreted as confirmation that the vaccine is safe.

“To interpret that the absence of data implies safety is, I think, a perversion,” Malone said. “The burden is to generate safety, not to generate the statistics to demonstrate the converse, non-safety.”

Some medical organizations boycotted the meeting

ACIP has become a flashpoint in the debate over vaccine safety under Kennedy since he fired all 17 sitting members in June, citing conflicts of interest. He initially replaced them with seven new members, who were joined at last week’s meeting by five additional members.

The conflict over ACIP heated up last month, when representatives from several medical associations, including the American Academy of Pediatrics (AAP) and the American Medical Association, were removed from the ACIP working groups because they are funded by the vaccine manufacturers.

Medical associations typically send liaison representatives who are given space to share their opinions at ACIP meetings. The AAP did not attend the meeting, but representatives from several other medical organizations were present.

In July, the AAP and five other medical organizations sued Kennedy and several public health officials and agencies over changes to COVID-19 vaccine recommendations for children and pregnant women. Last month, the AAP issued its own “evidence-based” COVID-19 vaccination recommendations.

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