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.

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.

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.

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

The US Food and Drug Administration has fully approved a new COVID vaccine option specifically targeting high-risk individuals, including seniors. The protein-based Nuvaxovid vaccine, produced by Novavax,

Late-stage trial data suggest that a new COVID-flu vaccine offers good protection against both infections, but experts expect the shot's approval may be delayed.

Since the COVID-19 pandemic, there has been a decline in U.S. vaccine uptake, while widespread misinformation and distrust make it challenging to craft effective public health responses.