Trump Administration Toughens Requirements for Covid Vaccine Approval

The Trump administration released a more stringent set of guidelines for approving Covid-19 vaccines, requiring more evidence for new shots for healthy adults and children.

Any new Covid vaccines for many children and adults will be required to undergo randomized, controlled trials before receiving Food and Drug Administration approval, FDA Commissioner Dr. Marty Makary and the agency’s new vaccines chief, Dr. Vinay Prasad, wrote Tuesday in the New England Journal of Medicine. The agency expects it will be able to approve the shots for adults older than 64 and high-risk groups based on antibody testing but will encourage drugmakers to conduct more randomized trials for those shots too.