The FDA vaccine approval road map proposes longer trials and stricter evidence to improve vaccine safety and effectiveness oversight.

The ongoing Phase 3 clinical trial of Pfizer/BioNTech's coronavirus vaccine confirms its protection lasts at least six months after the second dose, the companies said Thursday. The companies can now ...

A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...

The Food and Drug Administration (FDA) is investigating whether the COVID-19 vaccines were associated with any deaths across ...

The FDA is reportedly considering the addition of high-level warning labels to COVID vaccines, a move that some experts say ...

Pregnant people have a higher risk of severe disease and death from COVID, so making it harder for them to get vaccinated ...

Health Secretary Robert F. Kennedy Jr. may have said he won't take vaccines away from anyone, but that's exactly what the anti-vaccine organization he founded asked the Food and Drug Administration to ...

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

WASHINGTON — The FDA on Friday issued emergency approval for a smaller dose version of Pfizer's COVID-19 vaccine for use in children aged 5 to 11. The agency's decision comes just days after the ...

The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with FDA guidance to more closely match circulating strains 1 Shipping of the LP.8.1-adapted vaccine will ...