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As pharmacies, clinics, and physician offices gear up for the fall and winter respiratory virus season, a cloud of uncertainty hovers over COVID-19 vaccines.

At press time, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr had just announced on X that the FDA was rescinding emergency authorizations for COVID-19 vaccines and that the agency was restricting approval for the new formulations for 2025-26. Kennedy said he would be ending vaccine mandates and demanding placebo-controlled trials, although the FDA had not yet issued an official statement. 

According to Kennedy, the FDA has approved COVID-19 vaccines for 2025-26 for individuals at higher risk for serious outcomes, limiting it to age 6 months or older for the Moderna shot, 5 years and older for the Pfizer-BioNTech shot, and 12 years and older for the Novavax shot.

The CDC’s Advisory Committee on Immunization Practices (ACIP) has yet to meet — as is customary at this time of year — to make recommendations for COVID vaccines for 2025-26. By law, insurers must cover vaccines on the CDC’s child and adult immunization schedules. ACIP’s lack of recommendations raises questions about whether insurers will pay for COVID-19 vaccines, although Americas Health Insurance Plans noted earlier this summer that its members were “committed to ongoing coverage of vaccines.”

“There is a lot of confusion,” said Claire Hannan, MPH, executive director of the Association of Immunization Managers (AIM), a group of leaders of state, local, and territorial immunization programs. Hannan told Medscape Medical News that immunization providers are trying to plan around many potentially different scenarios.

Immunization managers are operating under the assumption that ACIP will not change the current schedule for children, which calls for shared decision making between clinicians and parents on COVID-19 vaccines, she said. AIM had been expecting that the FDA would not approve the Pfizer-BioNTech vaccine for younger children, and that Moderna’s vaccine would only be approved for children who are at higher risk.

Access to COVID-19 vaccines may be an issue this fall and winter, said Hannan. With approvals limited to smaller populations — and if ACIP does not recommend the vaccines — clinics and physicians who participate in the CDC’s Vaccines for Children program, which provides free immunizations, might pass on stocking the shots, she said. 

Previous Authorizations Now Moot

In July, the FDA authorized (but did not fully approve) Moderna’s 2024-25 Spikevax COVID-19 vaccine for children, regardless of underlying conditions or previous vaccination. The agency also approved Moderna’s next-generation MNEXSPIKE vaccine for those age 12-64 at higher risk for adverse outcomes and for all adults age 65 or older. 

The new FDA approval seems to be only for those over age of 6 months who are at risk for more severe outcomes.

Moderna did not respond to requests for comment on when it might ship new vaccine.

Pfizer-BioNTech’s Comirnaty vaccine had been FDA-approved for all individuals aged 12 or older but had only been authorized for children aged 6 months to 11 years. Now it will only be approved for those age 5 years and older who are at risk for more severe disease. 

The manufacturer would not comment on when it might ship vaccine until it had received FDA approval of the updated formula.

The agency approved an earlier formulation of Novavax’s Nuvaxovid protein-based vaccine in May for adults 65 years and older and individuals 12 through 64 who have at least one underlying condition that puts them at high risk for severe outcomes. The new approval for 2025-26 appears to be similar to the approval for last winter’s formulation.

The updated formulations from all manufacturers will be a monovalent JN.1 lineage, using the LP.8.1 strain, as advised by the FDA in May. The CDC’s most-recent update in June showed that the NB1.8.1 variant was the largest circulating strain (about 43% of the total), followed by the LP.8.1 (31% of total).

Pharmacies have also been awaiting FDA approval and ACIP recommendations.

A spokesperson for CVS Health told Medscape that all CVS Pharmacy and MinuteClinic locations are currently offering last winter’s COVID-19 vaccines, but that it could not say when the newest booster would be available “until the updated vaccine is authorized and we are able to review the FDA’s guidelines.”

The spokesperson added that Aetna, the insurer owned by CVS, would continue to cover approved COVID-19 vaccines.

Medical Organizations Filling in for ACIP

While COVID-related emergency department visits are currently low (1.2% of all visits), they are on the rise, reflecting a late-summer increase that has been typical since the start of the pandemic. Last winter 400-1000 or more individuals died from COVID each week. Children under age 4 and adults over age 65 experience the highest number of infections and hospitalizations, according to CDC data. 

In May, Kennedy announced in a post on X that the HHS was recommending shared decision-making for COVID-19 vaccines for children and it was not recommending vaccination for pregnant women.

The American College of Obstetricians and Gynecologists (ACOG) has since come out with its own guidance, urging all pregnant and lactating individuals to get an updated COVID-19 vaccine. Pregnant women are at higher risk for severe disease, adverse pregnancy outcomes, and maternal death from infections, and the vaccines have been proven safe in pregnancy, said ACOG. Vaccination during pregnancy also provides passive immunity to infants, protecting them from COVID-19 in the first few months of life before they are eligible to be vaccinated.

The American Academy of Pediatrics (AAP) also published recommendations for COVID-19 vaccines in infants, children, and adolescents, urging that all children ages 6-23 months and older children in certain risk groups receive a shot.

Kennedy lambasted the AAP guidance in a post on X, urging Americans to “ask whether the AAP’s recommendations reflect public health interest, or are, perhaps, just a pay-to-play scheme to promote commercial ambitions of AAP’s Big Pharma benefactors.”

The secretary also said that doctors who gave shots outside the ACIP recommendations “are not shielded from liability under the 1986 Vaccine Injury Act.”

The American College of Cardiology (ACC) has also issued its own vaccine guidance — which includes COVID-19 vaccines — for adults with heart disease, noting that these patients have a higher risk of infection when exposed to a respiratory virus

and a higher risk of adverse outcomes such as hospitalization and death.

It is the first-ever vaccine-specific guidance from ACC. A spokesperson said that the ACC felt the timing was right for the publication because of the ongoing burden of respiratory viruses among adults with cardiovascular disease and “increasing evidence that vaccination plays a direct role in reducing cardiovascular risk and preventing adverse outcomes.”

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.