FDA approves new COVID shots, with restrictions; Other COVID-19 updates

The FDA on Wednesday (27 August) approved the updated COVID-19 vaccines for the 2025-2026 respiratory disease season, but with limitations not seen in previous years.

In a post on X, HHS Secretary Robert F. Kennedy Jr. announced that the updated shots made by Moderna, Pfizer and Novavax have been approved by the FDA for anyone aged 65 years or older.

Among children and younger adults, the shots are approved only for those who have at least one of dozens of conditions that place them at a higher risk for severe disease. This adheres to new restrictions announced earlier this year by FDA officials, which replaced years of universal recommendations for the shots.

For people in the younger age groups with at least one high-risk condition, the specific vaccine approvals are:

• Moderna: for people aged 6 months or older;
• Pfizer: for people aged 5 years or older (emergency use authorizations previously in place for some vaccines were rescinded, including Pfizer’s EUA for children aged 6 months to 4 years); and
• Novavax: for people aged 12 years or older.

In addition to announcing the new restrictions in May, FDA officials indicated that they would require data from randomized placebo-controlled trials before approving COVID-19 vaccines for people aged 64 years or younger who do not have a risk factor for severe disease.

In his post, Kennedy said the the changes deliver on his promises to end COVID-19 vaccine mandates, keep vaccines available to people who want them, and “end the emergency.”

“The emergency use authorizations for COVID vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” he wrote. “These vaccines are available for all patients who choose them after consulting with their doctors.”

Recommendations for children, once universal and harmonized, have become complicated.

The CDC no longer recommends universal COVID-19 vaccination for children, favoring a shared clinical decision-making model between patients and providers. However, the American Academy of Pediatrics continues to recommend universal vaccination for all infants aged 6 to 23 months, as well as children aged 2 to 18 years in certain risk groups and any child who has never been vaccinated.

The AAP also recommends that pregnant adolescents get vaccinated — another break with the CDC, which Kennedy said would stop recommending COVID-19 shots in pregnancy, although the previous recommendation remains on the CDC website. (The American College of Obstetricians and Gynecologists continues to recommend vaccination in pregnancy.)

“The biggest issue, in my analysis, will be making sure that children under the age of 2 who have no underlying medical issues — yet who are still at high risk for COVID hospitalization — will be able to receive vaccination,” Amesh A. Adalja, MD, senior scholar at Johns Hopkins Center for Health Security, told Healio. “Physicians have to be comfortable prescribing it off-label.”

Paul A. Offit, MD, director of the Vaccine Education Center and attending physician in the division of infectious diseases at The Children’s Hospital of Philadelphia, said CDC data show thousands of children were hospitalized with COVID-19 last year, one in five were admitted to the ICU, and 152 died.

“You’re leaving a population of children who are vulnerable,” he said.

In a new statement, AAP president Susan J. Kressly, MD, FAAP, called the decision to limit access to the vaccines “deeply troubling.”

“As we enter respiratory virus season, any barrier to COVID-19 vaccination creates a dangerous vulnerability for children and their families,” Kressly said. “Respiratory illnesses can be especially risky for infants and toddlers, whose airways and lungs are small and still developing.”

Offit said anyone who wants to get the vaccine should be able to — regardless of underlying conditions or risk factors, or lack thereof.

“This virus will now be with us for the rest of our lives … if we can protect ourselves, we should,” he said.

The CDC’s Advisory Committee on Immunization Practices (ACIP) is expected to meet within the next month to discuss the recommendations, though no date has been set, according to the current ACIP schedule.

Recommendations made by the ACIP are historically passed to the CDC director, whose sign-off is required to make them official. Before the agency’s new director, Susan Monarez, PhD, was confirmed by the U.S. Senate in late July, Kennedy had been reviewing the recommendations.

By Caitlyn Stulpin, Stephen I. Feller

References:

• CDC. COVID-19 vaccination for women who are pregnant or breastfeeding. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html. Published Sept. 10, 2024. Accessed Aug. 27, 2025.
• CDC. Underlying conditions and the higher risk for severe COVID-19. https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.html. Updated Feb. 6, 2025. Accessed Aug. 27, 2025.
• Pfizer and BioNTech’s COMIRNATY receives U.S. FDA approval for adults 65 and older and individuals ages 5 through 64 at increased risk for severe COVID-19. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontechs-comirnatyr-receives-us-fda-approval. Published Aug. 27, 2025. Accessed Aug. 27, 2025.
• Secretary Kennedy (@SecKennedy). Aug. 27, 2025. X.

Other COVID-19 updates:

• Contagion Live: CDC confirms biannual COVID-19 peaks as ACIP shifts to targeted vaccination guidance
• ImmunityBio announces Phase 2 study of ANKTIVA® in patients with long COVID /press release/
• Infectious Disease Advisor: Obeldesivir linked to faster COVID-19 resolution, does not reduce hospitalization
• ScienceDaily: The common cold’s unexpected superpower against COVID