The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the virus, and those older than age 65.

If coronavirus vaccines are restricted to seniors and those at high risk, parents of young children and relatives of medically vulnerable people face a higher bar for shots.

A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make a broad recommendation about which lineage of the coronavirus should be included in this year’s Covid-19 vaccines,

This vaccine did previously have emergency approval by the FDA for use but can now be marketed in the U.S. for use, the letter said.

Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active

The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.

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