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What exactly is going on with the FDA and the "Emergency Use Authorization" of convalescent plasma? This issue has been widely concerning for many experts.
An article in VOX yesterday explains,
"The Food and Drug Administration whipped up a fierce controversy Sunday when it decided to grant an Emergency Use Authorization, or EUA, for convalescent plasma to be used as a treatment for Covid-19. And by Monday night, FDA commissioner Stephen Hahn admitted on Twitter he had overstated the effectiveness of the treatment.
The FDA’s decision came after many experts, including Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, had warned the agency there wasn’t enough evidence to fast-track authorization for the novel treatment.
But Hahn said Sunday in a statement that he was “encouraged by the early promising data that we’ve seen about convalescent plasma,” adding that “plasma from patients who’ve recovered from Covid-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus.”
President Trump, meanwhile, described the treatment as a “breakthrough.”
Convalescent plasma is already being used to treat dire cases of Covid-19 and is being studied by several research groups. But many scientists and doctors immediately responded to the announcement with concerns that there wasn’t yet sufficient data about its effectiveness to warrant an EUA.
“The evidence [the FDA is] drawing on is not ready for primetime,” said Jeremy Faust, an attending physician in the Brigham and Women’s Hospital and an instructor at Harvard Medical School."
Click here to read the full article and stay informed about this issue.