FDA approves updated COVID vaccines with restrictions on their use

Health and Human Services (HHS) Secretary Robert Kennedy Jr. announced on Wednesday that the Emergency Use Authorizations (EUA) for all COVID-19 vaccines have been rescinded, coinciding with the approval of updated versions of the Moderna, Pfizer, and Novavax vaccines for adults over 65 and for those with underlying conditions that increase their risk for severe disease.

“The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” Kennedy wrote in a post on X.

Kennedy said he has now accomplished four of his promises as HHS secretary, including to end COVID-19 vaccine mandates, to keep vaccines available to those that want them, to demand placebo-controlled trials, and to end the COVID-19 emergency.

“In a series of FDA actions today we accomplished all four goals,” he wrote.

“FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+),” he added. “These vaccines are available for all patients who choose them after consulting with their doctors.”

As of publication, neither HHS nor the Food and Drug Administration (FDA) have issued statements regarding the vaccines or the rescission of the EUAs; however, FDA’s webpages for the three vaccines now state that their respective EUAs have been revoked as of 27 August 2025.

Following Kennedy’s announcement, Pfizer and BioNTech issued a press release stating FDA had approved their supplemental biologics license application (sBLA) for their Comirnaty LP.8.1-adapted monovalent mRNA COVID-19 vaccine for adults 65 years and older. FDA had previously amended its EUA for Pfizer’s COVID-19 vaccine to allow children between 6 months and four years to receive the vaccine if they had not previously been vaccinated or those who had received previous doses of the same vaccine. However, by rescinding the EUA, Pfizer notes that it is now only available to people aged 5 to 64 if they have at least one high-risk underlying condition.

In its EUA revocation memo for the Pfizer vaccine, FDA noted that the company raised several concerns about the withdrawal of the EUA, including about the risk of supply constraints for younger children as Moderna would become the sole manufacturer with a licensed COVID-19 for children younger than 5. Pfizer also argued that its vaccine offers an option with a lower dose of mRNA. However, FDA disagreed with Pfizer on all counts that the EUA should remain in place.

Moderna and Novavax also announced that FDA approved their COVID-19 vaccines for 2025-2026. The updated formula for Moderna's Spikevax is now approved for individuals 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. mNEXSPIKE, Moderna's new COVID-19 vaccine, is approved for individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. Similarly, Novavax Nuvaxovid is also approved for patients ages 12 to 64 with an underlying condition and all adults 65 years of age and older. .

Paul Offit, a pediatrician at the division of infectious diseases at Children's Hospital of Philadelphia, said that means that only Moderna’s Spikevax COVID-19 vaccine is available to children six months and older, if they have at least one high-risk underlying condition. He said the decision was unfortunate because research has found that thousands of healthy children have been hospitalized from the disease, and many of them have been admitted to the intensive care unit.

“Many of these children were previously healthy, so I don’t understand why RFK Jr. is limiting the vaccines,” Offit told Focus. “He’s making vaccine use confusing.”

“He says he doesn’t want to take vaccines away from healthy people, but that’s what he’s done,” he added.

The vaccines can still be administered off-label to children and adults without underlying medical conditions. Still, Offit says the question will be whether health insurance companies will cover them and whether pharmacists will be concerned about any liability. He also said it’ll be a concern whether healthy people who live with elderly people or people at high risk for COVID-19 can receive the vaccines.

“This vaccine will enter the pantheon of respiratory viruses that cause hundreds of thousands of hospitalizations and tens of thousands of deaths every year,” said Offit. “When we have vaccines for influenza and respiratory syncytial virus (RSV), why are we limiting this vaccine?”

FDA’s moves are in line with the new framework for licensing COVID-19 vaccine boosters it announced in May. Under the framework, the agency said it will continue to license boosters for those 65 and older and for individuals with underlying health conditions based on prior immunologic endpoints; however, the agency said it will require randomized, placebo-controlled trials to support the licensure of COVID-19 vaccines in healthy children and adults under 65. (RELATED: FDA unveils new COVID-19 framework, restricting shots to elderly and high-risk people, Regulatory Focus 20 May 2025; Marks decries lack of transparency in FDA's revamped COVID vaccine policy, Regulatory Focus 25 June 2025)

FDA approves updated COVID vaccines with restrictions on their use

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