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

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

The FDA may limit annual COVID-19 boosters to high-risk groups unless clinical trials prove benefits for healthy adults under ...

Some members of the Vaccines and Related Biologics Products Advisory Committee worried that a strain change would require new ...

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

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

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 about heart inflammation.