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

The FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness.

Senior Biden Food and Drug Administration (FDA) officials spent weeks casting doubt on reports of cardiac risks associated ...

The FDA will require Moderna and Pfizer to add warnings to their COVID-19 vaccine labels about myocarditis and pericarditis in young men.

The U.S. Food and Drug Administration (FDA) has ordered Pfizer and Moderna to expand their warning labels on COVID-19 vaccines. The updated warnings highlight a rare risk of heart inflammation in ...

The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity in some patients, citing a recent study and new data.

In a significant shift, more Americans now believe COVID-19 vaccines may have caused heart problems in some patients, a sign ...

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.

Trump HHS ends nearly $1 billion in funding to Moderna for mRNA bird flu vaccines, citing safety concerns and lack of ...

The US Food and Drug Administration may limit Covid-19 boosters shots to high-risk groups from 2025; Pfizer reviewing proposal as agency seeks new trials, clearer risk labels for younger males ...

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