The Food and Drug Administration does not recommend the new shots, Dr. Vinay Prasad said.
The Food and Drug Administration (FDA) approved a new COVID-19 vaccine but is not recommending 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 the 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 65 and older, and those 12 to 64 with at least one condition 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 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.
