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.

In another sign of growing scrutiny over Covid-19 vaccines, the Food and Drug Administration has asked the two makers of mRNA ...

The mRNA vaccines were developed using novel technology that was approved for the first time for public use during the COVID-19 pandemic.

An FDA advisory committee unanimously recommended Thursday that the next COVID vaccine should be a monovalent one in the JN.1 ...

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

The FDA has told vaccine manufacturers to expand the warning labels on their COVID-19 shots with more information about the ...

The US Food and Drug Administration has ordered Pfizer and Moderna to expand their warning labels on COVID-19 vaccines.

Advisers to the Food and Drug Administration met Thursday to help decide which variant of the virus that causes COVID should ...

FDA now requires Pfizer and Moderna COVID-19 vaccines to carry expanded warning labels about risks of myocarditis and pericarditis ...

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels ...

Elaine Chen covers biotech, co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud.

It began in 2020 with a coordinated push to generate public backlash to lockdowns. The ultimate aim was restoring normalcy, ending a politically and economically inconvenient crisis. Over time, ...