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.

The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis and pericarditis.

Previously, updated COVID vaccines had been recommended annually by the CDC for everyone over the age of 6 months. The CDC has historically set vaccine recommendations, while the FDA determines which vaccines to authorize or approve after being deemed safe and effective.

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 HHS has removed the COVID shot from the CDC's recommended list of vaccines for these groups. Experts say they're still at risk, and the decision could limit access to the shot.

A new Covid variant that’s gaining momentum globally has landed in the U.S. The World Health Organization announced last week that it was monitoring the variant, NB.1.8.1, following a rise in cases in several parts of the world, including Europe, Southeast Asia and North and South America.