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

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

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

This week, mRNA vaccines are set to face intense scrutiny from critics in Congress. Here's an explainer of how we know they ...

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.

Here’s how COVID-19 vaccine guidance is changing in the U.S. For people at high risk of severe COVID-19. The process of ...

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

A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make a broad recommendation about which lineage of the coronavirus should be ...

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

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