Infectious Diseases Specialists to FDA: Don’t Cut Corners in COVID-19 Vaccine Approval
The Infectious Diseases Society of America and its HIV Medicine Association are urging the Food and Drug Administration to ensure rigorous safety and efficacy data support the approval of a COVID-19 vaccine before its widespread use by the public.
In an Aug. 26 letter to FDA Commissioner Stephen Hahn, M.D., and Center for Biologics Evaluation and Research Director Peter Marks, M.D., PhD, the groups strongly recommend that full licensure of a vaccine is preferable to an Emergency Use Authorization, particularly in light of public distrust of vaccines. If an EUA is the route to market for a vaccine, however, IDSA and HIVMA stress that supporting data must first be scrutinized by internal and independent experts. At a minimum, the groups urge, a Phase 3 trial should be completed before FDA approval.
“While we believe that meeting the requirements for full approval is the surest route to maximum public trust and vaccine uptake,” the letter states, “if a COVID-19 vaccine is made available via EUA, some specific actions may be necessary to shore up public confidence. Clear, consistent public messaging explaining the difference between an EUA and traditional approval will be important. Further, an informed consent process that explains why the vaccine is only available under an EUA will be critical.”
The letter cites recent polls that show only about half of Americans are committed to receiving a COVID-19 vaccine when it becomes available. In addition, the groups point out that the communities hardest hit by the pandemic may be particularly wary of a vaccine.
“… we thank you for your leadership and urge you to maintain FDA’s independent decision-making and scientific rigor, which serve as the foundation for the American public’s confidence in our medical products,” IDSA and HIVMA write. “Cutting corners with respect to the evaluation of safety and effectiveness must not be done.”