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

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 ...

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

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

FDA's new COVID-19 vaccine policy may restrict low-risk individuals' access, pending clinical trials to prove benefits.

The agency told vaccine makers that COVID-19 vaccines used in the United States starting in fall 2025 should be based on JN.1 ...

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

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

A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make ...

Federal health agencies were alerted in February 2021 to “large reports of myocarditis” in young people who received the Pfizer vaccine, but waited until late June to adjust the ...

Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter ...