Fall Covid vaccine rollout for healthy kids, adults is likely not going to happen

The FDA is planning major changes for how Covid vaccines are going to be rolled out and who will be able to get the updated shots this fall.

The Food and Drug Administration plans major changes for how Covid vaccines are rolled out and who will be able to get the updated shots this fall.

In a paper published Tuesday in the New England Journal of Medicine, the FDA commissioner, Dr. Marty Makary, and Dr. Vinay Prasad, the FDA’s new vaccine chief, wrote that any new Covid vaccine now must undergo placebo-controlled clinical trials — meaning some people would get the actual vaccine while others would get an inactive substance like a saline shot, to compare results.

At a planned FDA vaccine panel meeting Thursday, agency advisers are expected to advise the vaccine makers about which strains to target for new shots. The new clinical trial requirement isn't expected to affect the fall rollout for older adults and other people at high risk for severe illness because drugmakers are exempt from additional testing for those groups.

Makary and Prasad said in a question-and-answer session later Tuesday that annual shots for healthy children and adults would no longer be routinely approved. They also suggested that the vaccines may not be updated every year.

“Instead of having a Covid strategy that’s year to year, why don’t we let the science tell us when we should change?” Prasad said. “The virus doesn’t have a calendar.”