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.

The FDA will encourage new clinical trials on the widely used vaccines before approving them for children and healthy adults.

The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory ...

Frank DeStefano, MD, MPH, was there when the CDC's Vaccine Safety Datalink (VSD) first came online in 1990, when the agency ...

The updated warnings highlight a rare risk of heart inflammation in teen boys and young men, CBS News reported. The warning ...

The FDA is forcing Pfizer and Moderna to expand warning labels about the risks of two forms of heart damage, myocarditis and ...

Despite an explanation of the new strategy published Tuesday from FDA Commissioner Marty Makary and Vinay Prasad, who ...

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

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 FDA has updated COVID-19 vaccine regulations. Only people aged 65 and up, along with certain groups, will be eligible to ...

Advisers to the FDA will debate if the virus has mutated enough since last winter to require a tweak to the formula.