The US CDC’s vaccine advisory panel recommended that Americans who want a COVID vaccine should consult with a healthcare provider to determine whether the benefit outweighs the risk.

The Advisory Committee on Immunization Practices (ACIP) voted unanimously that shared decision-making was recommended, “with an emphasis that risk-benefit is most favorable for individuals who are at an increased risk for severe disease” and lowest for those not at increased risk.

It’s not clear how the recommendation will play out. Insurers are required to cover vaccines that are recommended by ACIP. The biggest insurer trade group — AHIP — had already indicated that no matter what came out of this meeting, “health plans will continue to cover all ACIP-recommended immunizations that were recommended as of September 1,” including updated COVID-19 and influenza vaccines, with no cost-sharing.

According to the US Department of Health and Human Services, the recommendation means that the COVID vaccines will be covered through all federal programs including the Vaccines for Children (VFC) Program, the Children’s Health Insurance Program, Medicaid, Medicare, and insurance plans through the federal Health Insurance Marketplace.

The shared decision-making recommendation is a departure from the current adult immunization schedule, which recommends one or more doses of the vaccine for 18- to 64-year-olds and two or more doses for those aged 65 years or older. It is similar to the recommendation in the childhood immunization schedule, which suggests shared decision-making for 6-month- to 12-year-olds who are not immunocompromised.

Many ACIP panel members seemed to intend to sow doubt about the safety and effectiveness of the two messenger RNA (mRNA)-based COVID vaccines.

Retsef Levi, PhD, professor of operations management at MIT Sloan School of Management, Cambridge, Massachusetts, who chaired the ACIP work group charged with providing data to the panel, presented a laundry list of ills. Levi said that CDC-issued COVID vaccine information sheets should be updated with information he gathered purportedly showing that the shots could cause vulnerability to future infections and immune system changes, deaths from “symptomatic and subclinical myocarditis,” a postvaccine syndrome similar to long COVID, and maternal deaths.

CDC experts had presented lengthy analyses attesting to the vaccines’ long record of safety and effectiveness, in particular against hospitalization and severe outcomes.

Henry Bernstein, DO, professor of pediatrics at Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, and two colleagues also gave an official presentation to the ACIP, which refuted Levi’s allegations.

“COVID-19 vaccines are highly safe and effective, or if we don’t want to say safe and effective, they work,” Bernstein told the panel. He also cautioned that he believed that “shared clinical decision-making and the need for a provider prescription create unnecessary steps to receiving a vaccine and do not effectively target those that are at high risk.”

The ACIP panel split 6-6 on whether it should give “the sense” that state and local jurisdictions should require a prescription for a COVID vaccine. Panel Chairman Martin Kulldorff, MD, PhD, broke the tie with a no vote.

The vote was essentially moot, given that ACIP does not have the power to regulate the practice of medicine. Even so, panelists who voted no expressed concern that a prescription requirement would severely limit access.

“A prescription is going to become a big barrier to administration of this vaccine,” said Cody Meissner, MD, professor of pediatrics at Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.

Some thought a prescription was necessary. Panelist Robert W. Malone, MD, a vaccinologist, said, “I prefer to err on the side of an actual prescription after a discussion with a licensed healthcare provider that is well qualified to serve in the patient in making an assessment of risks and benefits based on the medical condition of that patient.”

The updated COVID vaccines for 2025-2026 had already been limited by the FDA. Pfizer-BioNTech’s COMIRNATY (mRNA) vaccine was approved only for individuals aged 5-64 years at risk for severe outcomes and for anyone older than 65 years. Moderna’s two mRNA vaccines — Spikevax and mNexspike — were given the same approvals. The agency approved Novavax’s non-mRNA Nuvaxovid (sold by Sanofi in the US) for the same groups in late August.

The ACIP recommendations are not final until approved by the CDC director. Currently, there is no permanent director, so the task will fall to Acting Director Jim O’Neill, an investor who does not have a clinical or science background.

Chaotic Start to Day

The ACIP panel had met the previous day to vote on two recommendations for a combination measles, mumps, rubella, and varicella (MMRV) vaccine (sold as ProQuad by Merck). Many panelists had been confused about what they were voting on, however.

As reported by Medscape Medical News, they split votes by recommending against use of MMRV as the first dose in children younger than 4 years but supporting its use for children eligible for the VFC Program.

At the start of the second day, Kulldorff allowed the committee to retake the vote on the VFC Program. Nine panelists voted that MMRV should not be used in children younger than 4 years who were eligible for the VFC Program. Three abstained.

Kulldorff had also delayed a vote on whether to change the recommendation on hepatitis B vaccination for infants at birth. The vaccine has been given at birth since 1991, resulting in a steep decline of acute hepatitis B infections, said CDC experts.

Still, panelists debated whether it was safe despite the lack of any new data. Malone said that one reason to revisit the timing of the vaccine was because “it’s clear that a significant population of the United States has significant concerns about vaccine policy and about vaccine mandates.”

Meissner, among others, cautioned against creating more doubt. “This is an absolutely safe vaccine,” he said.

Ultimately, Malone suggested that the hepatitis B vote be tabled. “I believe that there’s enough ambiguity here and enough remaining discussion about safety, effectiveness, and timing that I believe that a vote today is premature,” he said.

The rest of the panel agreed.

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.