BLOOD RUSH
Trump hails fast-track COVID treatment
President Trump yesterday announced the emergency authorization for the blood plasma of COVID-19 survivors to be more readily available as a treatment to battle the virus.
President Trump on Sunday announced an emergency authorization for convalescent plasma to be used as a coronavirus treatment, calling it a “truly historic” action.
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.”
The announcement came after the FDA last week halted an emergency approval for the treatment to allow for more data to be reviewed.
Trump then accused the agency of slow-walking coronavirus treatments and therapeutics until after the election.
Hahn said on Sunday that the treatment is “safe and shows promising efficacy.”
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 plasma.
Preliminary data from 35,000 of those patients found fewer deaths among those who were given the treatment within the first three days of diagnosis and also among those who were given plasma with the highest levels of coronavirus-fighting antibodies.
Azar urged recovered coronavirus patients to donate their plasma.
“If you donate plasma, you could save a life,” he said on Sunday.
In a letter describing the emergency authorization, the chief scientist for the FDA, Denise Hinton, cautioned, “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.”
Hahn said FDA staffers were working day and night to “cut through red tape” when it came to coronavirus treatments and therapies, at the president’s behest.
Just one other drug, remdesivir, so far has been approved for emergency use by the agency.