FDA Gives EUA for Plasma Transfer in Covid Cases
The emergency authorization for the treatment involving infusions of antibody-rich blood plasma follows an earlier conditional approval for patients in life-threatening circumstances. Up to now, the FDA, said 170,000 people had received the antibodies and a review of the outcomes for 20,000 of them had shown the procedure to be safe. The agency acknowledged, however, that more trials are needed to prove the treatment’s effectiveness.
In its analysis, the US health watchdog leaned on a safety report issued by the Mayo Clinic, one of the leading diagnostic centers, in June. Mayo – which reportedly has performed the most plasma treatments in the US – will coordinate the project. This month it published an online preprint of a study said to show that administering convalescent plasma to patients with severe Covid-19 within three days of diagnosis could lower their risk of death.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said that patients under the age of 80 who received plasma containing high levels of antibodies benefited most from the treatment, with a 35% improved survival rate a month after the treatment than those receiving plasma with a low level of antibodies.
“It appeared that the product is safe, and we're comfortable with that and we continue to see no concerning safety signals," Marks commented, while Alex Azar, US Secretary of Health and Human Services, called the success of treating patients with plasma “ a major advance.” Trump, misstating that the plasma treatment had been "proven to reduce mortality by 35%,” called on Americans who had recovered from Covid-10 to donate plasma.
Author: Dede Williams, Freelance Journalist
Scientific community remains skeptical
Days earlier, a number in the US scientific community, including Anthony Fauci, member of the president’s coronavirus task force, had urged the FDA to wait for the results of “more robust studies” before extending emergency authorization beyond the critically ill.
The Infectious Diseases Society of America reacted similarly, saying that while there were "some positive signals” that convalescent plasma can be helpful in treating individuals with Covid-19, the randomized controlled trial data needed to better understand its utility in Covid-19 treatment was lacking.
Less subtly, Jonathan Reiner, professor of medicine at George Washington University, told US media that the EUA was "a political stunt" to promote Trump’s re-election. The decision was unveiled on Aug.21, just prior to the start of the Republican National Convention on Aug. 24.
The US currently has the worst record in dealing with the pandemic, with deaths now exceeding 176,000, but in a recent poll of Republican voters conducted by Forbes magazine 57% said the death toll was not too high.
Trump said he was making a “truly historic announcement in our battle against the China virus that will save countless lives." A day earlier, he had remarked that the “deep state” at the FDA was making it very difficult for drug companies to get people in order to test vaccines and therapeutics. Moreover, the agency was trying to stall until after the election.