The FDA’s new approach to boosters could mean that kids will no longer be able to get vaccinated against the disease to begin with.

The truth is that for most of that, for many Americans, we simply do not know the answer to whether or not they should be getting the seven or eight or nine or ten, as the current policy would have us,

Two weeks into his tenure leading the FDA’s biologics center, Vinay Prasad has made his mark with a new framework for approving future Covid-19 vaccines that he feels will counteract existing “dogma.”

The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at higher risk of severe disease, but will require vaccine makers to conduct major new clinical trials before approving them for wider use.

We want to know more about what these products are doing,” said Dr. Vinay Prasad during a recent FDA livestreamed presentation. This statement comes amidst a significant shift in the U.S. Food and Drug Administration’s (FDA) policy on Covid-19 booster shots.

Older adults can continue getting covid boosters, but not everyone who wants them can. You’re reading The Checkup With Dr. Wen, a newsletter on how to navigate medical and public health challenges. Click here to get the full newsletter in your inbox, including answers to reader questions and a summary of new scientific research.

But the framework has perhaps created as much confusion as clarity. Broadly, the FDA said it will limit approval of Covid-19 vaccines to people 65 and older and to those at risk for severe Covid outcomes, and will require vaccine makers to conduct clinical trials investigating whether the shots benefit healthy adults and children.

A previous federal policy recommended an annual COVID shot for all Americans six months and older. Here is what the new proposal would be.

The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination.

Høeg has been skeptical of the safety and value of some vaccines and mandates, raising questions about her approach at the FDA.