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.

The shift indicates that critics' efforts to build support by releasing data on the harmful effects of the COVID-19 vaccines ...

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

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

The new vaccine is indicated for individuals who have been previously vaccinated with any COVID-19 vaccine and are 65 years or older, or 12 to 64 years of age with at least 1 underlying condition that ...

Panel members had questions about whether a new FDA proposal to require randomized trials for vaccines in healthy adults ...

The Food and Drug Administration has approved Moderna's new COVID-19 vaccine, days after the federal government tightened ...

In the wake of recent warnings from the Food and Drug Administration (FDA), about half of Americans think vaccines against ...

The FDA is also expanding its warning that some vaccines are linked to a risk of heart inflammation in young men.

Federal health officials have pulled back a key recommendation that pregnant women get the COVID-19 vaccine -- causing sharp ...

The FDA is proposing to limit annual COVID-19 boosters to older adults and high-risk individuals. Pfizer and Moderna are requested to update vaccine labels with a warning about potential heart ...

The U.S. Food and Drug Administration will now require COVID-19 vaccines from Pfizer and Moderna to come with new warning labels. The shots already come with a warning about heart inflammation called ...