The shift was a marked departure from previous FDA guidance, which recommended an annual COVID vaccine for everyone 6 months and older.

FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.

The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

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.

The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over the age of 65 years and for all persons above the age of 6 months with

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.

New guidelines for COVID vaccine. Prior to the new guidelines, it was recommended that everyone who is 6 months and older get at least one vaccine per year, with those in higher-0

The US Food and Drug Administration (FDA) announces new regulatory guidelines for future COVID-19 vaccines and booster shots. Moderna (MRNA) and Pfizer (PFE) shares move higher on this news, while Novavax (NVAX) takes a dip.