The Food and Drug Administration (FDA) approved a new COVID-19 vaccine, but it is not recommending that people receive it, the agency’s top vaccine officials said on June 4.
“There’s another misconception I want to clarify, which is, people have said, ‘You at FDA are recommending the shots to high-risk people and older people.’ I want to be very clear, the FDA is not your doctor. We are not; we don’t recommend shots to people,” Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, said in a video released by the agency.
“What we do is we make them available for patients to have a conversation with their doctor. But I can understand a 66-year-old who goes to see their doctor, and they may decide to do it or not do it; that’s their medical decision. FDA is granting a marketing authorization for that, but we are not in the business of making recommendations.”
Dr. Marty Makary, the FDA commissioner, said on social media platform X that the FDA’s job “is to review data and decide whether products are safe and effective.”
Officials with the Center for Biologics Evaluation and Research on May 31 approved a new COVID-19 vaccine from Moderna.
The FDA cleared the shot for two groups who have previously received a COVID-19 vaccine: people ages 65 and older, and those ages 12 to 64 with at least one condition that the Centers for Disease Control and Prevention says increases their risk of severe COVID-19.
The CDC recently stopped recommending COVID-19 vaccines for healthy children and pregnant women.
The FDA typically authorizes and approves vaccines, while the CDC issues vaccine recommendations. Prasad’s predecessor at the FDA, Dr. Peter Marks, who resigned earlier this year, repeatedly recommended COVID-19 vaccination during the COVID-19 pandemic.
“You should get a COVID-19 booster,” Marks said in one video, published on Dec. 21, 2021. He said that a booster, or an additional shot on top of a previous vaccination, “will increase the level of your immunity and will provide strong protection from the serious complications of COVID-19, including hospitalization and death.”
The COVID-19 vaccines were originally marketed as one- or two-dose regimens, with no mention of potential boosting. When evidence emerged showing that the effects of the vaccines waned over time, the FDA cleared boosters.
The agency later authorized or approved updated formulations of the vaccines in a bid to better target newer variants. They relied primarily on animal and immunogenicity data.
Prasad and Makary announced in May that the FDA would not approve COVID-19 vaccines for Americans who are neither elderly nor have one of the risk conditions, such as obesity, as defined by the CDC, unless manufacturers produced trial data showing that the vaccines were effective against clinical endpoints such as symptomatic COVID-19 among the healthy.
“The FDA can only approve products if it concludes, based on scientific evidence, the benefit-to-harm balance is favorable. And we simply need more data to have that confidence for younger individuals at low-risk of severe disease,” Prasad said at the time.
The FDA’s approval of Moderna’s new COVID-19 vaccine was based on data from a trial in which participants received either the new vaccine or Moderna’s already-available COVID-19 shot. The trial showed the new vaccine triggered non-inferior immune responses, according to data that Moderna provided to the FDA.
“We at FDA felt that that was sufficient to allow this product to be available to the vulnerable people, older people and high-risk people,” Prasad said on June 4.
Moderna has committed to running a placebo-controlled trial of the new shot among healthy people ages 50 to 64. The FDA “will scrutinize every aspect of the trial,” Health Secretary Robert F. Kennedy Jr. said on June 3.
“They’re not going to go up against another Moderna product in this study. It’s Moderna vaccine against a saline placebo,” Prasad said. “We’re going to see all the adverse events in this study. We’re going to see whether or not it helps people, and what it does, and whether or not it’s working like we think it might be in 2025.”
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