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.

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,

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.

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many others may not be able to get the shots.

Frank DeStefano, MD, MPH, was there when the CDC's Vaccine Safety Datalink (VSD) first came online in 1990, when the agency convinced four health maintenance organizations (HMOs) to contribute data to assess vaccine safety.