(Headline USA) President Donald Trump on Sunday announced emergency authorization to treat COVID-19 patients with convalescent plasma.
Trump called the move “a breakthrough” and one of his top health officials called “promising.”
The announcement came after White House officials complained there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease.
The authorization makes it easier for some patients to obtain the treatment but is not the same as full FDA approval.
The blood plasma, taken from patients who have recovered from the coronavirus and rich in antibodies, may provide benefits to those battling the disease.
In a letter describing the emergency authorization, the chief scientist for the FDA, Denise Hinton, said: “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.”
White House chief of staff Mark Meadows talked about the speed at which the administration has made treatments available for the coronavirus.
“This president is about cutting red tape,” Meadows said in an interview Sunday on “This Week” on ABC. “He had to make sure that they felt the heat. If they don’t see the light, they need to feel the heat because the American people are suffering.”
Trump said he thought there had been a “logjam” at the FDA over granting the emergency authorization.
He said there are people at the FDA “that can see things being held up … and that’s for political reasons.”
Earlier this month, Mayo Clinic researchers reported a strong hint that blood plasma from COVID-19 survivors helps other infected patients recover.
More than 70,000 patients in the U.S. have been given convalescent plasma, a century-old approach to fend off flu and measles before vaccines. It’s a go-to tactic when new diseases come along, and history suggests it works against some, but not all, infections.
The Mayo Clinic reported preliminary data from 35,000 coronavirus patients treated with plasma, and said there were fewer deaths among people given plasma within three days of diagnosis, and also among those given plasma containing the highest levels of virus-fighting antibodies.
But it wasn’t a formal study. The patients were treated in different ways in hospitals around the country as part of an FDA program designed to speed access to the experimental therapy.
That “expanded access” program tracks what happens to the recipients, but it cannot prove the plasma — and not other care they received — was the real reason for improvement.
Adapted from reporting by the Associated Press.
