The FDA will encourage new clinical trials on the widely used vaccines before approving them for children and healthy adults. The requirements could cost drugmakers tens of millions of dollars and are likely to leave boosters largely out of reach for hundreds of millions of Americans this fall.

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

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 most commonly reported adverse events with the AZD1222 COVID-19 vaccine are headache and fatigue, a large-scale active surveillance study from the United Kingdom shows.

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

No, this is not true. Vaccines undergo rigorous safety testing and are continuously monitored for adverse events.

FDA FLAGS SEVERE ITCH — Patients who stop using the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) may experience rare but severe itching after longtime use, the FDA has cautioned.

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 included in this year’s Covid-19 vaccines,