More than 90 organizations representing scientists, physicians, health providers, as well as patients and medical advocates are urging the U.S. Food and Drug Administration to ensure that reviews of COVID-19 vaccine candidates meet all regulatory standards prior to authorization.
“While we are encouraged by the rapid development of the COVID-19 vaccine, the process must be fully transparent and not circumvent regulatory standards. Sound safety and efficacy data reviewed by FDA and independent vaccine experts must support the authorization or licensure of a COVID-19 vaccine. COVID-19 vaccines should be studied in the populations for whom they are intended, including, but not limited to, Black, Indigenous, Hispanic, Latinx, Asian American, Native Hawaiian, Pacific Islanders, and other populations that face disparities in care and who have been disproportionately impacted by the pandemic, as well as older individuals, health care workers, and people with chronic conditions who are at greatest risk of serious illness and death due to COVID-19,” the organizations stated in a letter to FDA Commissioner Stephen Hahn and Peter Marks, the director of the Center for Biologics Evaluation and Research.
Among the groups who sent the letter include 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, among others.
They said a process that is not transparent and thorough could damage confidence and undermine vaccination efforts.
“Now more than ever, Americans must maintain trust in the independent decision-making authority and scientific rigor of FDA,” the letter concludes.