Jahnavi Sarma
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Written By: Jahnavi Sarma | Updated : August 25, 2020 9:37 AM IST
Plasma therapy involves transfusion of plasma from a convalescent coronavirus patient to a critical patient.
Despite experts raising doubts over the plasma therapy to treat COVID-19, the US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for convalescent plasma to treat the deadly respiratory disease. In a statement on Sunday, the FDA said that the known and potential benefits of the product outweigh the known and potential risks of the product. The FDA said more than 70,000 patients had been treated with convalescent plasma. The authorization comes as President Donald Trump faces intense pressure to curb the contagion that has hobbled the world's largest economy and clouded his once-promising prospects for re-election in November.
Plasma is the pale liquid that remains after red and white cells are removed from blood. The convalescent plasma therapy has gained much traction in several countries including India, where several lives have been saved with the therapy. Plasma donated by people who've survived COVID-19 has high levels of powerful antibodies and is considered safe. It can help fight off the disease faster and help protect people from being seriously hurt by it.
At a White House briefing on Sunday, President Donald Trump said 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 authorisation for blood plasma to treat COVID-19. Trump had 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".
US Health and Human Services Secretary Alex Azar, however, said studies involving 70,000 volunteers justified the authorisation. According to him, data 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. There was about a 35 per cent better chance of survival in the patients who benefited most from the treatment, Azar said in the White House briefing. The development comes as the US still accounts for the highest number of coronavirus cases and deaths in the world.
In a report, The New York Times said the FDA's 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.
According to the FDA, the known and potential benefits of the product outweigh the known and potential risks of the product. The FDA already allows convalescent plasma transfusions for coronavirus patients under certain conditions, such as clinical trials and gravely ill people. While the treatment has already been used on patients in the United States and other nations, the extent of its effectiveness is still debated by experts and some have warned that it could carry side effects.
(With inputs from IANS)
