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Sunday, March 7th, 2021

Infectious diseases society cautions FDA commissioner on COVID-19 vaccines

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The Infectious Diseases Society of America (IDSA) and the HIV Medicine Association (HIVMA) are urging the Food and Drug Administration to make sure that rigorous safety and efficacy data support the approval of a COVID-19 vaccine.

Full licensure of a vaccine is preferable to an Emergency Use Authorization, the leaders of the two organizations wrote in a letter to FDA Commissioner Stephen Hahn and Center for Biologics Evaluation and Research Director Peter Marks.

If an EUA is the route to market for a vaccine, IDSA and HIVMA stress that supporting data must first be scrutinized by internal and independent experts. At a minimum, a Phase 3 trial should be completed before FDA approval, they said.

“While we believe that meeting the requirements for full approval is the surest route to maximum public trust and vaccine uptake, if a COVID-19 vaccine is made available via EUA, some specific actions may be necessary to shore up public confidence,” IDSA and HIVMA officials wrote in the letter. “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 the fact that only about half of Americans are committed to receiving a COVID-19 vaccine when it becomes available.

“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.”