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

A Phoenix doctor weighs in on the potential impact of FDA plans to limit COVID booster access to high-risk groups, raising cost and care concerns.

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

FDA COVID vaccine update is stirring major public attention as a new policy limits fall COVID-19 booster shots to seniors and high-risk individuals. While the FDA met to decide if vaccine formulas should change for fall 2025,

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

An FDA advisory committee unanimously recommended Thursday that the next COVID vaccine should be a monovalent one in the JN.1 lineage, although members disagreed slightly about which specific strain should be included.

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new commissioner described as a “one-size-fits-all regulatory framework.”

The vaccine eligibility change is a threat to the health of Americans, some experts say, adding that the FDA is not being forthcoming about its research.

With new testing requirements, it’s not even clear whether new Covid or flu shots can be made available this fall.

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit future shots to older Americans and people at higher risk of serious Covid-19 infection.