WASHINGTON (AP) — President Donald Trump announced Sunday the emergency authorization of convalescent plasma for COVID-19 patients, in a move he called “a breakthrough,” one of his top health officials called “promising,” and other health experts said needs more study before it’s celebrated.
The announcement came after days of White House officials suggesting there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease that has upended Trump’s reelection chances.
On the eve of the Republican National Convention, Trump put himself at the center of the FDA’s announcement of the authorization — it makes it easier for some patients to obtain the treatment — in a news conference Sunday evening.
The blood plasma, taken from patients who have recovered from the coronavirus and rich in antibodies, may provide benefits to those battling with the disease. But the evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed.
In a letter describing the emergency authorization, the chief scientist for the FDA, Denise Hinton, noted: “COVID-19 convalescent plasma should not be considered a new standard of care for the treatment of patients with COVID-19. Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials in the coming months.”
An emergency use authorization is not the same as full FDA approval.
In the authorization letter, FDA officials emphasized convalescent plasma is still under investigation. “COVID-19 convalescent plasma should not be considered a new standard of care for the treatment of patients with COVID-19. Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials in the coming months,” it said.
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Source: Yahoo
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