FDA outlines stricter ‘evidence-based approach’ to COVID vaccinations
The U.S. Food and Drug Administration (FDA) is tightening guidelines for the approval of future COVID-19 vaccines and booster shots, bucking the agency’s trend since 2020 of loosening restrictions on approvals, per the emergency rules of the pandemic.
Updated boosters have been accelerated for approval, especially for adults—but in new guidance revealed Tuesday in the New England Journal of Medicine, it appears that’s about to change. In a paper authored by FDA Commissioner Martin Makary, MD, and hematologist-oncologist and health researcher Vinay Prasad, MD, the duo rejected the current policy and outlined a new framework for the approval of future COVID-19 vaccines, putting them more on par with standard approvals.
Prasad, who was appointed as the FDA’s top immunization official, has been a vocal critic of FDA policy, which he believes is heavily motivated by commercial interests. He and Makary called the push for COVID boosters in the U.S. the “most aggressive” policy in the world, when compared to what Europe is doing.
“While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe COVID-19, the U.S has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,” they wrote. “The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations.”
“We reject this view,” they emphasized.
For people over 65, as well as anyone over six months of age who is deemed at high risk for complications from the virus, as described by the Centers for Disease Control and Prevention (CDC), immunogenicity is sufficient for approval and recommendation by the FDA. Meaning, if there’s “proof that a vaccine can generate antibody titers” in those populations more susceptible to severe COVID infection, that’s enough for a green light.
However, for healthy people under 65, the agency now expects manufacturers to provide “randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted.”
Further, while not setting a firm policy, Makary and Prasad would like drug developers to also apply this standard even for high-risk individuals, as it aligns more closely with the rigorous standards applied to most pharmaceuticals.
“Insofar as possible, when approving a COVID-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their post-marketing commitment,” they added.
Ending flu shot comparisons
As it stood before this policy shift, COVID boosters were treated more like annual flu shots. However, Prasad and Makary are skeptical the data justifying those common seasonal inoculations apply to COVID-19.
“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,” they argued, adding that more data is needed to come to a firm conclusion.
“COVID-19 is distinct from influenza in several ways. First, the SARS-CoV-2 virus has undergone a mutational evolution different from that of influenza; COVID vaccine–induced immunity may not require annual updates for the most clinically meaningful health outcomes but may perhaps be triggered by significant antigenic shift,” Makary and Prasad said.
“Second, COVID-19 has summer transmission that can facilitate the conduct of randomized studies that continue to apply in future time periods. Third, natural immunity from COVID-19 against severe disease appears robust,” they concluded.
The duo added that the new philosophy of the FDA aims to balance “regulatory flexibility” with a “commitment to gold-standard science,” Makary and Prasad wrote, emphasizing that post-marketing studies and additional clinical data will help ensure agency policy is best aligned with the facts surrounding the efficacy of ongoing COVID vaccinations.
“These new trials will provide information that is desperately craved by healthcare providers and the American people,” they said.
The FDA plans to submit its proposal to the CDC, which will vote on the new framework in June. The CDC will continue to have the authority to develop recommendations for how the public should approach any vaccine approved by the FDA, including those for COVID-19.
Makary and Prasad’s full letter in the New England Journal of Medicine can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.