The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain approvals.
FDA Commissioner Marty Makary, M.D., and Center for Biologics Evaluation and Research (CBER) head Vinay Prasad, M.D., laid out the agency's “evidence-based approach to COVID-19 vaccination” in an article in The New England Journal of Medicine on Tuesday.
For people under the age of 65 with no risk factors, the FDA will require vaccine makers to gather clinical trial data to warrant future approvals, the officials wrote.
For people 65 and older and those with risk factors for severe outcomes, the agency expects that with data showcasing the production of antibody titers in people, officials will likely be able to "make favorable benefit–risk findings" for COVID vaccines.
The agency's new position for COVID vaccine approvals largely reflects the restrictions imposed in the recent approval for Novavax’s protein-based COVID vaccine. The approval limits the vaccine’s use to those 65 years and older and in people between the ages of 12 and 64 who have at least one underlying health condition that puts them at a high risk for severe COVID outcomes.
In explaining the shift, Makary and Prasad cited poor uptake of yearly COVID boosters and declining public trust in vaccines across the board. The agency leaders contend the new approach can still provide “timely approval to a broad population,” because the range of diseases that qualify as risk factors for severe COVID is “vast.”
“Our policy also balances the need for evidence,” the FDA leaders wrote. “We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose.”
Plainly put, the guidance stipulates that the FDA will clear new vaccines for high-risk people while demanding “robust, gold-standard data” for those at a low risk for severe COVID outcomes, the officials wrote. The new approach points to vaccine recommendations used in other countries, rejecting the U.S.’s prior “one-size-fits-all” regulatory framework.
The guidance represents the clearest explanation of the new administration's approach to COVID vaccines to date, although rumblings of such a position have been percolating for weeks.
Earlier this month, the Department of Health and Human Services alluded to a stricter approach in a statement declaring that “all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure.”
While placebo testing is already standard practice for novel vaccines, yearly updates to flu and COVID shots haven’t been required to showcase new efficacy data. Makary and Prasad clarified in their new framework that the COVID policy is separate from that of flu vaccines due to the differences between the viruses' mutational evolution, which suggests that immunity from COVID vaccines “may not require annual updates," they wrote.
It remains unclear how exactly the new COVID standards will play out with updated vaccines, as the FDA will opt to “let science tell us” instead of continuing with the typical practice of annualized updates, Prasad said at a Tuesday town hall.
“I don’t envision randomized trials every year, but I do think we have an obligation every few years,” the CBER head said.
Meanwhile, the FDA’s vaccine advisory committee is set to meet on May 22 to discuss updated COVID vaccine formulas from Moderna, Pfizer and Novavax for the 2025-26 virus season. In its briefing document, the FDA noted that updating the current vaccines to better match new strains “may provide added benefit” for the anticipated rise in viral spread during the fall and winter.