New FDA chiefs limit Covid-19 shots to elderly, sick

What happened

The Trump administration's new Food and Drug Administration leaders said Tuesday they plan to limit Covid-19 booster shots to people 65 and older plus younger people with at least one health condition that puts them at high risk for serious infection. Drugmakers will have to test their vaccines again among younger healthy people before approval is expanded, FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad said Tuesday in an article in The New England Journal of Medicine laying out their new policy.

Who said what

Makary and Prasad are among the "outspoken critics of the government's handling of Covid shots" who Health Secretary Robert F. Kennedy Jr. brought in to lead health agencies, The Associated Press said. Their vaccine plan is a "stark break from the previous federal policy recommending an annual Covid shot for all Americans six months and older," and it's unclear if all "people who want a vaccine this fall will be able to get one."

Prasad called the new policy a "reasonable compromise" that preserves Covid boosters for high-risk people and puts the U.S. in line with other developed countries. Dropping the "one-size-fits-all" approach was "welcomed by some independent public health experts," NPR said, but critics said the new limits "bypass the usual input from independent outside advisers" and create unnecessary barriers and misleading messaging "given the overwhelming evidence that Covid vaccines are safe and effective."

This "doesn't preserve people's choice to get vaccinated," University of Iowa's Dr. Denise Jamieson, an adviser to the Centers for Disease Control and Prevention, told The New York Times. Kennedy "had made it clear that he would never take vaccines away from anyone," University of Minnesota infectious disease expert Michael Osterholm told NPR. "This violates that in every way possible."

What next?

The CDC, not the FDA, is "charged with developing recommendations for which populations should get the shots," The Washington Post, and its vaccine advisory committee has a June 25 meeting to develop guidelines for the fall. An independent FDA advisory panel is scheduled to meet tomorrow to discuss the composition of this fall's Covid boosters.