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The US Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual Covid-19 boosters for healthy Americans under age 65, effectively limiting them to older adults and those at risk of developing severe illness.
FDA Commissioner Marty Makary and top US vaccines regulator Vinay Prasad wrote in the New England Journal of Medicine that the benefit of repeated annual shots for healthy adults was uncertain after several years of the virus circulating and vaccines being available.
They also said that the US was an outlier among high-income nations in recommending yearly shots for healthy adults.
"At-risk Americans can be reassured that they will be covered by such approvals. At the same time, we want more evidence at the US Food and Drug Administration," Prasad told scientists at the FDA during a livestreamed presentation.
"We want to know more about what these products are doing, especially as we enter the seventh, eighth and ninth dose," he said.
Health Secretary Robert F. Kennedy Jr., a long-time vaccine sceptic whose department oversees the FDA, has been remaking the US health system to align with President Donald Trump's goal of dramatically shrinking the federal government. Some 20,000 people have left the department as part of mass layoffs.
Makary and Prasad have been critical of US Covid vaccine policies and indicated that they were under review.
Jefferies analyst Michael Yee said the new guidance essentially does not change vaccine policy for older and high-risk Americans, putting investors at ease.
Shares of Covid-19 vaccine makers Moderna were up 7.6 % at $28.40, Pfizer rose 1.9 % to $23.45 and US ADRs of Germany's BioNTech rose 4 %. Novavax shares were up 1.5 % at $7.86.
Pfizer said it was evaluating the details shared today and that discussions with the FDA are ongoing. The other companies did not immediately respond to requests for comment.
Makary and Prasad said they expect the FDA will be able to approve the boosters for adults over the age of 65 years based on data from tests that measure immune response in patients.
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