{UAH} AN EMERGENCY AUTHORIZATION OF PLASMA TREATMENT

Trump announces emergency authorization of plasma treatment for COVID-19

By Tamar Lapin

August 23, 2020 | 4:01pm

Chip Somodevilla/Getty Images

 

President Trump on Sunday announced that the Food and Drug Administration had issued an emergency authorization for convalescent plasma as a coronavirus treatment.

The designation will make it easier for some COVID-19 patients to obtain the treatment, as clinical trials and studies continue.

“Today’s action will dramatically expand access to this treatment,” Trump said at a press conference with Health and Human Services Secretary Alex Azar and the director of the Food and Drug Administration, Stephen Hahn.

Blood plasma from people who have recovered from COVID-19 is rich in antibodies and may help those battling the disease.

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 to hurt his 2020 reelection chances.

It’s not clear whether the FDA has received any additional data from clinical trials in the last week.

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.”

The 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 declared Sunday.

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.

EM         -> { Trump for 2020 }

On the 49^th Parallel          

                 Thé Mulindwas Communication Group
"With Yoweri Museveni, Ssabassajja and Dr. Kiiza Besigye, Uganda is in anarchy"
                    Kuungana Mulindwa Mawasiliano Kikundi
"Pamoja na Yoweri Museveni, Ssabassajja na Dk. Kiiza Besigye, Uganda ni katika machafuko"