The American College of Radiology (ACR) is one of almost 100 health organizations urging the U.S. Food and Drug Administration (FDA) to proceed with caution when authorizing and licensing COVID-19 vaccines.
In a letter addressed to Dr. Stephen Hahn and Dr. Peter Mark, PhD, FDA commissioner and director of biologics evaluation and research, respectively, the organizations requested that the FDA ensure vaccines meet the administration's high safety and efficacy standards. The letter was signed by more than 90 health-focused organizations and universities, including the ACR, American College of Physicians, and Harvard Medical School.
"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," the organizations wrote.
The ACR and other signees called for the FDA to ensure the approval process is transparent and doesn't skirt regulatory standards, including allowing independent vaccine experts to review trial data. The organizations added that recent research shows that only about half of Americans plan to get vaccinated against COVID-19, making it especially important to conduct a transparent approval process.
"Thorough and transparent FDA review of data supporting a vaccine's approval is the essential foundation upon which we can strengthen public confidence in a COVID-19 vaccine," they wrote.
In addition, the organizations noted that vaccines must be studied in populations that often face disparities in accessing care and who have been disproportionately affected by the COVID-19 pandemic, including Black, indigenous, and Hispanic populations, as well as older adults and people with chronic conditions. The vaccines should also be researched in populations who might have different reactions, including pregnant women and children.
