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

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

Since 2023, federal health officials have recommended an annual COVID-19 shot for most people, and vaccine makers have not ...

The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded ...

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

The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis and pericarditis.

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

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

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

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...

Under a new policy announced Tuesday by the Trump administration, only people age 65 and older and children or young adults ...

New vaccines are often evaluated in trials in which some participants receive a placebo. But not all studies can be designed ...