The FDA will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to green-lighting shots that have been recommended broadly to the public.

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two COVID-19 vaccines.

According to the FDA, people 5 and older are eligible to receive a single dose of the updated vaccines at least two months since their last dose of any Covid-19 shot, regardless of previous ...

A negative result from a COVID test in a medical setting is more accurate than a negative result from an at-home test, ...

The US Food and Drug Administration wants to simplify the Covid-19 vaccine process to look more like what happens with the flu vaccine, according to documents posted online on Monday. That could ...

These Covid vaccines are the first that do not include the original strain of the SARS-CoV-2 virus that emerged in Wuhan, China, in late 2019.

And while even the XBB.1.5 variant is no longer dominant, FDA determined that it’s close enough to coronavirus strains causing most COVID-19 illnesses today to offer good cross-protection.

In the early years of the pandemic, the FDA moved to establish this annual update of COVID-19 vaccines, with boosters rolling out in the fall alongside flu shots ahead of anticipated winter waves.

“The COVID-19 vaccines that the FDA has approved and authorized for emergency use have made a tremendous difference to public health and have saved countless lives in the U.S. and globally ...

A letter from the FDA to Pfizer reads that "the known and potential benefits of Pfizer-BioNTech COVID‑19 vaccine" outweigh its potential risks for people ages 16 and older.