Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula, targeting the SARS-CoV-2 ...

Government advisers are meeting Thursday to decide if COVID-19 vaccines need updating to improve protection this fall and ...

An FDA committee on Thursday recommended that COVID-19 vaccines for the 2025-2026 respiratory virus season — which, for the ...

The framework the new FDA leaders laid out on Tuesday raised small and big questions about the regulatory process, vaccine ...

In a major and controversial policy shift, the FDA announced in a New England Journal of Medicine article that updated ...

FDA's new COVID-19 vaccine policy may restrict low-risk individuals' access, pending clinical trials to prove benefits.

Infectious disease experts say mRNA vaccines have been studied for decades, they are safe and effective, and were instrumental in saving lives during the COVID pandemic.

On May 22, an FDA advisory committee unanimously recommended COVID-19 vaccine manufacturers target the JN.1 variant in their formulations.  The Vaccines and Related Biological Products Advisory ...

The FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness.

Despite the fact that vaccines against COVID have already undergone strict safety reviews and that people continue to die ...

The vaccine is expected to remain available for anyone who is at least 65 or who has a medical condition, leaving many Americans ineligible. Here's what we know.