The Food and Drug Administration on Wednesday approved updated COVID-19 vaccines that target a commonly circulating coronavirus strain, but narrowed who in the U.S. can receive them.
In a post on the social media site X, Health and Human Services Secretary Robert F. Kennedy Jr. said the FDA cleared shots from Pfizer, Moderna and Novavax for use in people who are at higher risk for COVID-19.
“These vaccines are available for all patients who choose them after consulting with their doctors,” Kennedy wrote.
He added that the FDA also rescinded previously granted emergency use authorizations that were used to permit COVID vaccination in certain groups.
“I promised 4 things,” Kennedy wrote on X. “1. to end COVID vaccine mandates. 2. to keep vaccines available to people who want them, especially the vulnerable. 3. to demand placebo-controlled trials from companies. 4. to end the emergency.”
In a statement, Pfizer said its updated booster is now approved for people between the ages of 5 and 64 who are at high risk of disease due to at least one underlying condition, while Moderna said its booster is OK’d for similarly high-risk individuals between the ages of 6 months and 64 years.
Novavax’s vaccine, while unlike Pfizer’s and Moderna’s messenger RNA shots is protein-based, is approved in high-risk individuals aged 12 years through 64 years. French drugmaker Sanofi leads marketing of Novavax’s shot, called Nuvaxovid.
All three shots are cleared for broad use in adults 65 years and over.
In May, the FDA recommended updated shots target a specific coronavirus subvariant known as LP.8.1 for the 2025 and 2026 fall and winter seasons. This subvariant is part of a larger viral subgroup known as JN.1.
Booster accessibility, however, might be more limited than it has been in previous seasons, given the FDA’s clearance only applies to most adults if they’re considered to be at higher risk. The agency’s decisions, as relayed by Kennedy, would also leave Moderna’s vaccine as the only option for children between 6 months and 5 years of age.
The Centers for Disease Control and Prevention currently recommends COVID vaccines for most adults 18 and older.
In May, Secretary Robert F. Kennedy Jr. said the CDC had removed COVID shots from the recommended immunization schedule for healthy children and pregnant women. The agency did not entirely withdraw the shots from its schedule, but instead adopted what’s known as a shared clinical decision-making recommendation for healthy children. The CDC recommends pregnant women get vaccinated against COVID, but the website says the page will be updated to reflect the “updated immunization schedule.”
Several medical organizations have pushed back on Kennedy’s efforts to restrict access to COVID shots. The 17 members of a CDC advisory panel who Kennedy fired earlier this year have also called for an alternative to their committee, which is now made up of seven individuals hand-picked by Kennedy, including several who have been critical of vaccines.
At their first meeting, the new committee members sharply questioned the evidence supporting COVID vaccines’ safety and efficacy.
Their actions, and Kennedy’s policies, have driven a wedge between some physician groups and federal health agencies. Last week, the American Academy of Pediatrics released its own updated vaccination guidelines for children, breaking from the CDC. In a statement, AAP said it recommends a COVID vaccine for all children aged 6 through 23 months.
“COVID-19 continues to result in hospitalization and death in the pediatric population,” the organization said in a statement. “Children younger than 2 years old are especially vulnerable to severe COVID-19 and should be prioritized for vaccination unless they have a known allergy to the vaccine or its ingredients.”
Kennedy later accused the medical organization of endorsing “corporate-friendly vaccine recommendations.
The CDC panel is expected to meet sometime in September, and could possibly vote on COVID vaccine recommendations following the FDA’s approval Wednesday. No date or agenda has been set, however.
Pfizer said it will begin shipping its updated vaccine immediately. Moderna said it expects its shot to be available in the coming days.
Editor’s note: This story has been updated to include mention of Novavax’s statement.