FDA Sets New Guidelines For Approving COVID-19 Booster Shots In Healthy Individuals: Moderna, Novavax Stocks Rise

The U.S. Food and Drug Administration (FDA ) leaders said on Tuesday they would adopt a new COVID-19 vaccination regulatory framework, requiring new clinical trials to approve annual vaccine booster shots in healthy individuals under 65.

FDA Commissioner Marty Makary and U.S. vaccines regulator Vinay Prasad said in a piece published in the New England Journal of Medicine that different standards of evidence for vaccine approvals would be required based on the risk of getting severely sick from a COVID-19 infection.

The FDA will accept immunogenicity data for adults 65 and older and for individuals above the age of six months with risk factors putting them at high risk for severe infections. Immunogenicity refers to a vaccine's ability to trigger an immune response in the body.

However, for healthy persons with no risk factors for severe COVID-19 infection and between the ages of six months and 64 years, the agency plans to demand stronger evidence of efficacy, such as randomized, controlled trial data evaluating clinical outcomes such as severe COVID-19, hospitalization, and death, before approval is granted.

The leaders also said they would encourage vaccine manufacturers to conduct randomized, controlled trials in healthy adults as part of a postmarketing commitment after approving the vaccines for high-risk groups.

“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,” the leaders said while adding that the new policy would compel “much-needed” evidence generation.

Makary and Prasad said that some 100 million to 200 million Americans would have access to the annual shots under the new framework.

“The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” they said, adding that all other high-income nations have adopted similar policies based on risk factors.

Multiple COVID-19 vaccines have been approved in the U.S., including shots made by Moderna (MRNA), Pfizer (PFE), and Novavax (NVAX). Novavax's COVID-19 vaccine, Nuvaxovid, was approved last week.

While MRNA shares traded 6% higher on the news, NVAX shares were up 3%, and PFE shares rose 2%.

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