Trump announces plasma treatment authorized for COVID-19
WASHINGTON— President Donald Trump announced Sunday the emergency authorization of convalescent plasma for COVID- 1 9 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 comes 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 announced the authorization — which 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 COVID19. Additional data will be forthcoming from other analyses and ongoing, wellcontrolled clinical trials in the coming months.”
The White House had grown agitated with t he pace of the plasma approval, but t he accusations of a slowdown, which were presented without evidence, were just the latest assault from Trump's team on the “deep state” bureaucracy. White House chief of staff Mark Meadows did not deal in specifics, but said that “we've looked at a number of people that are not being as diligent as they should be in terms of getting to the bottom of it.”
“This president is about cutting red tape,” Meadows said in an interview 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.”
The push on Sunday came a day after Trump tweeted sharp criticism on the process to treat the virus, which has killed more than 175,000 Americans and imperiled his reelection chances. The White House has sunk vast resources into an expedited process to develop a vaccine, and Trump aides have been banking on it being an “October surprise” that could help t he president make up ground in the polls.
“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump tweeted. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
Earlier this month, Mayo Clinic researchers reported a strong hint that blood plasma from C OVID1 9 survivors helps other infected patients recover. But it wasn't considered proof.
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.
There's no solid evidence yet that it fights the coronavirus and, if so, how best to use it.
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.