September 22, 2020

ACR, Others Implore Caution in FDA COVID-19 Vaccine Development

The American College of Radiology® (ACR®) joined nearly 100 healthcare providers, public health experts, patient groups and other advocacy organizations in a letter urging the United States Food and Drug Administration’s (FDA’s) Commissioner to ensure that a COVID-19 vaccine is only authorized or licensed when it meets the FDA’s existing high standards of safety and efficacy.

The letter acknowledged that a COVID-19 vaccine could help end the pandemic, but cautioned that “approving a vaccine that has not been shown through clinical trials to be safe and effective could cause more harm by significantly undermining COVID-19 vaccination efforts and seriously eroding public confidence in all vaccines.”

Specifically, the letter urged full transparency, adherence to regulatory standards, sound safety and efficacy of data reviewed by independent vaccine experts and the FDA, with the experts supporting approval of the vaccine. The letter stressed the importance of the vaccines being studied across the diverse populations for whom they are intended, including populations who face disparities in care, those who have been disproportionately impacted, and those at greatest risk of serious illness and death due to COVID-19.