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FDA Grants EUA to 'Controversial' Convalescent Plasma Therapy

Critics of the potential therapy for COVID-19 patients urged FDA to hold off on Emergency Use Authorization.

FDA has granted emergency use authorization for the use of convalescent plasma, a therapy President Trump championed, to treat COVID-19 patients.

The federal agency said the move comes after the extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.

The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by healthcare providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.

The theory behind convalescent plasma is that people who have been afflicted with COVID-19 that have recovered will have antibodies in the blood that helped fight off the infection. The thought is that if people who are sick with the virus are given this plasma they could recover.

Initially, FDA was close to doling out an EUA to the therapy but pulled back citing the need for more data, according to a report from The New York Times.

However, several top health officials including infectious disease expert Dr. Anthony Fauci and National Institutes of Health Director, Dr. Francis S. Collins last week urged FDA to hold off on the EUA, citing data from a plasma study conducted by Mayo Clinic, according to The Times.

During a White House Press Conference last Wednesday, the president indicated that the reason for a potential hold on the EUA for convalescent plasma could be political. He alleged there might be some people in FDA that would want to wait until after the election to grant the EUA.

In a release announcing the EUA, dated Aug. 23, Stephen Hahn, MD, and FDA’s commissioner said “I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus. At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”

 

TAGS: COVID-19
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