Plasma Therapy for COVID-19 Approved by USFDA

Blood plasma therapy has been approved for treatment by the US Food and Drug Administration. The potential benefits of the plasma therapy outweigh the known and potential risks.

Convalescent plasma therapy, has been approved to treat COVID-19 infection by the US Food and Drug Administration (FDA). Despite concerns of the efficiency of the therapy, the USFDA has issued an authorization (EUA).

Plasma is a straw-colored, pale liquid that remains after red and white cells are removed from blood. Convalescent plasma is donated by people who have survived Covid-19 this plasma has high levels of antibodies and is considered safe.

Coronavirus
Coronaviruses infect animals, humans, and birds. Human coronaviruses, such as SARS, MERS, and 2019-nCoV cause respiratory distress and even death. The S protein is the infectious agent of the virus.

‘Blood plasma therapy improved the survival rate by 35% in patients with severe respiratory infection due to coronavirus infection. The treatment is most effective when commenced within three days of being diagnosed with the infection.’
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In a statement on Sunday, the FDA said that "known and potential benefits of the product outweigh the known and potential risks of the product".

According to a CNN report, the FDA said more than 70,000 patients had been treated with convalescent plasma.

At a White House briefing on Sunday, President Donald Trump said, "Today, I am pleased to make a truly historic announcement in our battle against the 'China virus' that will save countless lives."

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"Today's action will dramatically increase access to this treatment," the President said, adding that he has directed the FDA to approve the EUA for convalescent plasma therapy.

According to media reports last week, the FDA had put on hold the emergency use authorization for blood plasma to treat Covid-19.

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In a report, The New York Times said the FDA approval for plasma therapy was on hold and "more data is under review and the approval could still be issued in the near future, according to H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases".

Top health officials including Anthony Fauci, the country's top infectious disease expert, have cautioned that available data wasn't strong enough to support emergency approval.

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The convalescent plasma therapy has gained much traction in several countries including India, where several lives have been saved with the therapy.

Trump later accused some health officials of playing politics regarding an emergency use authorisation for convalescent plasma.

When asked about the FDA not having granted an EUA, Trump said the "reason was political", the CNN report said.

US Health and Human Services Secretary Alex Azar, however, said studies involving 70,000 volunteers justified the move.

"The data we gathered suggests that patients who were treated early in their disease course, within three days of being diagnosed, with plasma containing high levels of antibodies, benefited the most from treatment.

"We saw about a 35 percent better survival in the patients who benefited most from the treatment," Azar told the White House briefing.

The development comes as the US still accounts for the highest number of coronavirus cases and deaths in the world.

As of Monday morning, the overall number of cases stood at 5,701,557, with 176,797 deaths, according to the Johns Hopkins University.

Source-IANS