The FDA announced Sunday it will grant an emergency use authorization (EUA) of convalescent plasma as a treatment for the coronavirus, one day after President Trump accused the agency of slow-walking the development of vaccines and therapeutics to hurt him politically.
The state of play: The authorization for plasma, which is safe but not yet proven to work on COVID-19, had been on hold after federal health officials intervened with the FDA last week and argued that the current data on the effectiveness of the treatment was too weak, the New York Times reported.
- Former FDA commissioner Scott Gottlieb said on Sunday that plasma is "probably weakly beneficial," but that health officials "wanted to see more rigorous data to ground this decision."
- It's unlikely to be the major "breakthrough" that White House press secretary Kayleigh McEnany touted in a tweet previewing the announcement on Saturday, according to Gottlieb and other health experts.
What they're saying: "The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients," the FDA said in a news release....
- "The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments."
- "The EUA is not intended to replace randomized clinical trials and facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety