FDA to Meet on COVID-19 Vaccines

The agency will consult its advisers ahead of the next virus season.

A health care worker prepares a COVID-19 vaccine in New York City, in this file photograph. Michael Santiago/Getty Images

Food and Drug Administration (FDA) officials are going to meet soon to consider the next round of COVID-19 vaccines, the agency said on May 7.

The FDA plans to convene its vaccine advisory panel for a virtual meeting on May 22.

The Vaccines and Related Biological Products Advisory Committee “will meet in an open session to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the United States,” Grace Graham, the FDA’s deputy commissioner for policy, legislation, and international affairs, said in a Federal Register notice.

No materials have been made available for the meeting as of yet.

U.S. officials in 2023 pivoted the COVID-19 vaccine regimen to a model that updates vaccine formulations on a yearly basis, copying the influenza vaccine system, in a bid to counter effectiveness that waned and was even estimated at times to turn negative.

The FDA in 2024 cleared updated COVID-19 shots from Pfizer and Moderna that targeted the KP.2 strain, and a Novavax vaccine that targeted the JN.1 variant. Regulators took action despite no clinical data being available because, they said, animal testing and data from previous formulations showed that the benefit of the vaccines outweighed the risks.

Health Secretary Robert F. Kennedy Jr. said during a recent town hall that officials are examining whether to remove COVID-19 vaccines from the Centers for Disease Control and Prevention’s childhood vaccine schedule, in part because the vaccines can cause heart inflammation and other side effects.

The Department of Health and Human Services, which Kennedy heads, includes the CDC and the FDA.

“Most Americans do not believe in the COVID booster shot for young, healthy children at this point,” Dr. Marty Makary, the FDA’s commissioner, said at a separate event in April. “So if he does something with the COVID vaccine in children, I think it’ll be warmly welcomed by a lot of Americans.”

The CDC currently recommends that people aged 6 months of age and up receive at least one dose of the currently available COVID-19 vaccines.

Advisers to the CDC have said they’re considering narrowing that recommendation.

The FDA clears vaccines, while the CDC decides the level of recommendation from three choices: universal; risk-based, or based on risk factors; and shared clinical decision-making, or individually based. The agencies often accept advice from their advisory panels, but are not required to.

The virus season typically runs from the fall through the winter, and vaccine manufacturers have said they require lead time to manufacture vaccines before the season starts.

A Novavax spokesperson told The Epoch Times in an email that it will be participating in the meeting. Pfizer and Moderna did not immediately return requests for comment.

The FDA previously canceled a March 13 meeting that had been slated to go over the next round of influenza vaccines. The agency later issued its own recommendations to vaccine manufacturers after consulting with officials at other agencies.