Groups Call for FDA to Maintain Independent Authority, Transparency in COVID-19 Vaccine Approvals

In a letter to U.S. Food and Drug Administration leaders today, more than 90 organizations representing physicians and other health providers, as well as scientists, patients and medical advocates, urge the agency to ensure that reviews of COVID-19 vaccine candidates meet all regulatory standards prior to authorization or licensure.

A process that is not transparent and thorough, the letter warns, could damage confidence in all vaccines, and undermine vaccination efforts. Noting that communities that have suffered the highest rates of illness and poor outcomes from the virus will be critical to reach with a COVID-19 vaccine, the letter emphasizes that studies of vaccine candidates must include Black, Indigenous, Latinx and other populations, including older people, health care workers and people with chronic conditions.

“Now more than ever, Americans must maintain trust in the independent decision-making authority and scientific rigor of FDA,” the letter concludes.

The letter was led by the Infectious Diseases Society of America, the American College of Physicians, the Council of Medical Specialty Societies, the National Black Nurses Association, Trust for America’s Health and Vaccinate Your Family.