FDA Will Limit Approvals for Covid-19 Shots. Moderna Stock Soars.
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The Food and Drug Administration will only stick to its existing process for updating Covid-19 shots for older adults and those at a high risk of severe illness, the agency’s head wrote in a medical journal article on Tuesday. In order to get new Covid-19 shots approved for younger, healthy adults, drugmakers will need to run new randomized clinical trials, FDA commissioner Dr. Marty Makary wrote. The question weighing on Moderna and other Covid-19 vaccine stocks in recent weeks has been whether the FDA will require drugmakers to run a new randomized, controlled trial before approving any updates to their Covid-19 vaccines.