The US Food and Drug Administration (FDA) authorised the use of blood plasma from patients who recovered from COVID-19 as a treatment for the disease, a day after President Donald Trump blamed the agency for impeding the rollout of coronavirus vaccines and therapeutics for political reasons.
The announcement on Sunday from the FDA of a so-called “emergency use authorisation” also comes on the eve of the Republican National Convention, where Trump will be nominated to lead his party for four more years.
A day before the FDA’s announcement, Trump tagged the agency’s Commissioner Stephen Hahn in a tweet and said, “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. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
On Sunday, Trump hailed the FDA move as a “breakthrough”.
“Everybody working together, we are years ahead of approvals than we would be if we went by the speed levels of the past administration,” the Republican president said at a White House news briefing.
“You’ll be hearing very soon about treatments and vaccines to save lives. We’re removing unnecessary barriers and delays, not by cutting corners, but by marshaling the full power of the federal government.”
The FDA said early evidence suggests blood plasma can decrease mortality and improve the health of patients when administered in the first three days of their hospitalisation. It was not immediately clear what the immediate effect of the decision would be.
“It appeared that the product is safe and we’re comfortable with that and we continue to see no concerning safety signals,” Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, said on a conference call with reporters.
The agency also said it determined it was a safe approach in an analysis of 20,000 patients who received the treatment. So far, 70,000 patients have been treated using blood plasma, the FDA said.
Patients who benefitted the most from the treatment are those under 80 years old and who were not on a respirator, the agency said. Such patients had a 35 percent better survival rate a month after receiving the treatment.
FDA Director Stephen Hahn said Trump had not spoken to him or the agency and did not play a role in its decision to make the announcement on Sunday.
With no conclusive evidence of the treatment’s benefits, some health experts were sceptical.
Dr Amesh Adalja, a senior scholar at Johns Hopkins Center for Health Security, said the move will hurt the response of the coronavirus treatment in the country.
“The blood plasma treatment has a lot of biological plausibility, but we do not yet know this works because we don’t have randomised control data to show it is definitely beneficial,” he told Al Jazeera.
“What the president’s move does it makes it very unlikely that we’ll get randomised controlled trial results and we may end up not knowing whether or not this worked.”