President Trump on Sunday announced an emergency authorization for convalescent plasma to be used as a coronavirus treatment, dubbing it a “truly historic” declaration.
The designation by the Food and Drug Administration will make it easier for some COVID-19 patients to obtain the treatment — which utilizes the antibody-rich blood plasma of those who have recovered from the virus — as clinical trials and studies continue.
“I’m pleased to make a truly historic announcement in our battle against the China virus that will save countless lives,” Trump said at a press conference with Health and Human Services Secretary Alex Azar and FDA Director Stephen Hahn.
“Today’s action will dramatically expand access to this treatment.”
Sunday’s announcement comes after the FDA last week halted an emergency approval for the approach to allow for more data to be reviewed.
This prompted Trump to accuse the agency of deliberately slow-walking coronavirus treatments and therapeutics before the November election.
Hahn said Sunday that the treatment is “safe and shows promising efficacy.”
It’s not clear whether the FDA has received any additional data from clinical trials in the last week.
The new action is based primarily on preliminary data from a Mayo Clinic-led study that was part of an “expanded-access program” sponsored by the FDA to speed up access to experimental therapy.
More than 70,000 coronavirus patients in the US have been treated with blood plasma. Preliminary data from 35,000 of them found there were fewer deaths among those given the treatment within the first three days of diagnosis and also among those given plasma with the highest levels of virus-fighting antibodies.
“If you donate plasma you could save a life,” Azar said Sunday.
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 COVID-19.”
“Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials in the coming months.”
On Sunday, Hahn said FDA staffers were working day and night to “cut through red tape” when it comes to coronavirus treatments and therapeutics, at the president’s behest.
Just one other drug, remdesivir, so far has been approved for emergency use by the agency.
With Post wires