US President Mr. Donald Trump announced, calling a ‘break-through’, an emergency authorization to treat Covid-19 patients with convalescent plasma. The convalescent plasma is thought to help patients battling the disease but the evidence so far has not been conclusive. The treatment involves transferring antibodies from recovered Covid-19 patients to patients suffering from the disease.
With the Food and Drug Administration’s (FDA) approval secured, the US will expand access to the treatment, which is already being used. One of Mr Trump’s top health officials called the measure “promising” and other health experts said it needed more study before being celebrated.
The announcement on Sunday came after White House officials complained there were politically motivated delays by the FDA in approving vaccine and therapeutics for the disease that has reversed Mr Trump’s re-election chances.
On the eve of the Republican National Convention, Mr Trump put himself at the centre of the FDA’s announcement of the authorization at a news conference on Sunday evening. 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 corona
virus and rich in antibodies, may provide benefits to those battling 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, 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.”
But Mr Trump had made clear to aides that he was eager to show good news in the battle against the virus, and the timing allowed him to head into his convention with momentum. He and aides billed it as a “major” development and used the White House briefing room to make the announcement.
Mr Trump also displayed some rare discipline in the evening news conference, sticking to his talking points, deferring to the head of the FDA, Stephen Hahn, and only taking three questions from reporters.
The White House had grown agitated with the pace of the plasma approval. The accusations of an FDA slowdown, which were presented without evidence, were just the latest assault from Mr Trump’s team on what he refers to as 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”.
On Saturday, Mr Trump criticized the process to treat the virus, which has killed more than 180,000 Americans and endangered his re-election chances.
The White House has sunk vast resources into an expedited process to develop a vaccine and his aides have been banking on it being an “October surprise” that could help him to 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 said in Twitter. “Obviously, they are hoping to delay the answer until after November 3. Must focus on speed and saving lives”, Mr. Trump added.