FDA to Unveil New COVID-19 Vaccine Policy

The agency said it is taking ‘an evidence based approach’ to COVID-19 vaccination.

FDA Commissioner Dr. Marty Makary in Washington on April 22, 2025. Andrew Harnik/Getty Images

Update: The policy was unveiled on May 20.

Original story below.

The Food and Drug Administration (FDA) is going to provide an update on COVID-19 policy this week.

Dr. Marty Makary, the FDA’s commissioner, and Dr. Vinay Prasad, who heads the FDA center that regulates vaccines, are slated to hold a discussion on May 20 about “an evidence based approach to COVID vaccination.”

The FDA has been directing requests for comment to its parent agency, the Department of Health and Human Services (HHS), which did not respond to a request for more details.

The event is dubbed a town hall and scheduled to start at 1 p.m.

Prasad said during a video released by the FDA on May 8 that vaccines save lives “when given at the right time and the right moment to the right person.” He also said that it is important for vaccines to be backed by “solid evidence.”

Makary told an event later in May that the FDA would be releasing a new framework for vaccines in the near future.

“We want to be very transparent, and we want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry,” Makary said at the Food and Drug Law Institute conference, news outlets reported.

Makary and Prasad, before joining the FDA, had criticized the government’s clearance and promotion of COVID-19 vaccine boosters, particularly for young people.

“The FDA is now trying to get the public to accept the idea of an annual mRNA Covid vaccine, with no good data,” Makary wrote on social media in January 2023, referring to vaccines from Pfizer and Moderna that utilize messenger ribonucleic acid technology.

“FDA must demand good RCTs for fall of 2025 and companies can go to hell if they don’t like it,” Prasad added in February, using an acronym for randomized, controlled trials.

HHS said in April that Health Secretary Robert F. Kennedy Jr. was going to require all new vaccines to be tested against placebos before receiving licenses. The FDA on May 16 licensed Novavax’s COVID-19 vaccine, which had previously been available under emergency authorization, without a new trial. An earlier version of the shot was tested in a randomized, controlled trial in 2021.

While all individuals aged 65 and older can receive the Novavax vaccine, the FDA said people aged 12 to 64 can only receive the shot if they have at least one underlying health issue that places them at high risk for severe outcomes from COVID-19.

The agency is slated to meet on May 22 with a panel of outside advisers to consider advice for the next round of COVID-19 vaccines.