The US Food and Drug Administration plans to require new clinical trials for approval of annual Covid-19 boosters for healthy Americans under 65, effectively limiting their availability this fall to older adults and those with a higher risk of developing severe illness, FDA leaders said yesterday.
FDA Commissioner Marty Makary and top US vaccines regulator Vinay Prasad said based on data from tests that measure immune response in patients, they anticipate that the FDA will be able to approve the boosters for adults over the age of 65 years.
It would also be available for everyone over the age of six months with one or more risk factors that put them at high risk for severe Covid-19 outcomes, they said in a piece published in the New England Journal of Medicine yesterday.
But for healthy people between the ages of six months and 64 years, the FDA expects it would need randomised, controlled trials for drugmakers to get approval for annual shots.
Vaccine makers have argued that because Covid vaccines have been changed annually to match the circulating strain of the virus, new placebo-controlled trials could delay availability of the shots until after their usefulness has passed.
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