FDA outlines stricter Covid vaccine approval standards

The Food and Drug Administration on Tuesday outlined new regulatory guidance for future Covid-19 vaccine boosters, setting stricter approval standards for healthy Americans. 

The agency said it wants to see new clinical trials showing Covid shots are still safe and effective before approving them for healthy adults and children, a costly new requirement for pharmaceutical companies that could limit who gets new jabs each year. Previously, the FDA typically approved updated Covid shots for all Americans each year based on simple tests that show they trigger a strong enough antibody response.

“The truth is that for most of that, for many Americans, we simply do not know the answer to whether or not they should be getting the seven or eight or nine or ten, as the current policy would have us” do, said Vinay Prasad, an outspoken critic of the pharmaceutical industry who was appointed to lead the agency’s division that oversees vaccines, during a town hall on Tuesday.

The FDA recommended different standards of evidence for approval based on patients’ risk of getting severely sick from Covid, according to a paper published Tuesday in the New England Journal of Medicine. The paper’s authors are FDA Commissioner Marty Makary and Prasad.

“The FDA’s new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science,” the agency said in the paper. “The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.

Covid vaccine makers such as Pfizer, its partner BioNTech and Moderna may see slightly lower revenue if the new guidelines are implemented broadly, BMO Capital Markets analyst Evan Seigerman said in a note on Tuesday. But overall, Seigerman said he views the guidelines as “fair and considerate” of the benefits and risks healthy people may gain from additional vaccinations.

“We appreciate new appointees do not appear to be overreaching in their generalizations on Covid-19 vaccine efficacy,” he said.

Jefferies analyst Michael Yee, who covers Moderna, said the new regulatory guidelines “seem OK for now.” The framework is “generally expected” and in line with commentary from advisors to the Centers Disease Control and Prevention leaning toward risk-based vaccine recommendations rather than a universal one.

“So in the big picture this actually eases some investor concern for 2025 guidance to some extent,” Yee said.

But Yee said it’s unclear if the clinical trials requirement will apply for next-generation Covid shots or combination vaccines targeting Covid and other viruses, such as the flu.

The new guidance comes as Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic, overhauls the nation’s health agencies and U.S. immunization…