New FDA vaccine approval policy limits access to COVID shots to seniors and others at high risk

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New FDA vaccine approval policy limits access to COVID shots to seniors and others at high risk - Fortune

Quick Summary:

The FDA framework, published Tuesday in the New England Journal of Medicine, urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people.

Prasad said the FDA will ask all manufacturers to do new clinical trials in healthy people ages 50 to 64, randomly assigning them to get a vaccine or a placebo and tracking outcomes with special attention to severe disease, hospitalization or death.

But FDA’s new guidance appears to be the end of that approach, according to Prasad and FDA Commissioner Marty Makary, who co-authored the journal paper and joined the FDA webcast.