US President Donald Trump has announced the emergency authorisation of convalescent plasma for Covid-19 patients, after expressing frustration at the slow pace of approval for coronavirus treatments.
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 Mr Trump’s re-election chances.
On the eve of the Republican National Convention, Mr Trump issued the emergency order, which would make it easier for some patients to obtain the treatment, in a news conference on Sunday, according to White House officials.
The blood plasma, taken from patients who have recovered from coronavirus and rich in antibodies, may provide benefits to those with the disease.
But the evidence has been inconclusive as to how it works or how best to administer it.
Many scientists and physicians believe that convalescent plasma might provide some benefit, but it is far from a breakthrough.
It is rich in antibodies that could be helpful in fighting coronavirus, 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 authorisation, 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.”
The White House had grown agitated with the pace of the plasma approval, but the accusations of a slowdown, which were presented without evidence, were just the latest assault from Mr 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”.
The push on Sunday came a day after Mr Trump tweeted sharp criticism on the process to treat the virus, which has killed more than 175,000 Americans and imperilled his re-election 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 the 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,” Mr 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 Covid-19 survivors helps other infected patients recover. But it was not considered proof.
Today, we issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of hospitalized COVID-19 patients as part of the agency’s ongoing efforts to fight #COVID19. https://t.co/sxWrblWsxr pic.twitter.com/DnTrJaDTX1— U.S. FDA (@US_FDA) August 23, 2020
More than 70,000 patients in the US have been given convalescent plasma, a century-old approach to fend off flu and measles before vaccines. It is a go-to tactic when new diseases come along, and history suggests it works against some, but not all, infections.
There is no solid evidence yet that it fights coronavirus and, if so, how best to use it.