(Daily Signal)—The Food and Drug Administration will issue guidelines requiring clinical trials prior to the approval of new COVID-19 boosters, a spokesperson confirmed to The Daily Signal.
The FDA’s new framework for vaccine approvals will prioritize high-risk populations while requiring gold-standard clinical data for individuals under 65 at low risk of COVID-19, Dr. Vinay Prasad, the FDA’s vaccine division chief, and Dr. Martin Makary, the agency’s commissioner, wrote in the New England Journal of Medicine on Tuesday.
“The COVID-19 public health emergency has officially ended, and we are entering a new phase in our response to the virus,” Department of Health and Human Services spokeswoman Emily Hilliard told The Daily Signal. “A rubber-stamping approach to approving COVID boosters in perpetuity without updated clinical trial data under the Biden administration is now over.”
The forthcoming guidance will only apply to future COVID-19 booster approvals. People of all ages will continue being able to access old boosters if they so choose.
Almost 90% of voters agree that companies should be required to conduct clinical trials before a COVID-19 booster is approved, according to a Center for Excellence in Polling survey obtained by The Daily Signal.
The FDA will continue to consider approving booster shots for adults 65 and older and high-risk individuals with a post-marketing commitment to complete a clinical trial. Healthy individuals ages six months to 64 will require randomized, controlled trials for future vaccine approvals.
“The framework published in NEJM provides forward-looking guidance for a risk stratified approach, rooted in the best available science, to inform future vaccine policy,” Hilliard said. “With the COVID pandemic behind us, it is time to adopt a common-sense approach to COVID policy, grounded in gold-standard science, that balances the needs of all populations.”
While most high-income nations limit COVID-19 vaccine recommendations to older adults at higher risk, the U.S. has a “one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of six months,” Vinay and Makary wrote.
The benefit of giving young people multiple doses of the COVID-19 vaccine are unknown, according to the FDA officials.
“For all healthy persons—those with no risk factors for severe COVID-19—between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted,” Vinay and Makary wrote. “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 postmarketing commitment.”
