FDA to mandate trials for COVID boosters for healthy kids and adults

In an article published in The New England Journal of Medicine titled “An Evidence-Based Approach to Covid-19 Vaccination” by Vinay Prasad and Martin Makary, the pair of FDA leaders said: “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 United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months… We reject this view.” The FDA commissioner and leader of the agency’s vaccine division went on to state: “Although the rapid development of multiple Covid-19 vaccines in 2020 represents a major scientific, medical, and regulatory accomplishment, the benefit of repeat dosing – particularly among low-risk persons who may have previously received multiple doses of Covid-19 vaccines, had multiple Covid-19 infections, or both – is uncertain. The American people, along with many health care providers, remain unconvinced… 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. 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.” Makers of COVID-19 vaccines include Moderna (MRNA), Pfizer (PFE), BioNTech (BNTX), Novavax (NVAX) and AstraZeneca (AZN).