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

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

Trump administration to restrict COVID vaccines to seniors and high-risk groups, pending more data for everyone else.

The FDA’s new policy limits COVID-19 vaccine eligibility to older adults and high-risk groups, excluding millions from ...

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

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 ...

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.

The revised version of the vaccine, marketed as Spikevax, follows FDA guidance recommending that this year’s shots target ...

At the outset of the meeting, the FDA's new top vaccine regulator, Vinay Prasad, said he and FDA leaders wanted to "give people a little more time to digest the policy." He said that the FDA is still ...

The FDA is implementing stricter guidance for the approval of COVID-19 vaccines, according to a paper published in The New England Journal of Medicine.

The US FDA may limit Covid-19 boosters to high-risk groups only, citing lack of efficacy in healthy individuals. Meanwhile, ...

Dr. Peter McCullough testified Thursday at a Senate hearing on "The Corruption of Science and Federal Health Agencies: How Health Officials Downplayed and Hid Myocarditis and Other Adverse Events ...