FDA puts on hold plasma therapy to treat COVID-19

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In the absence of a specific treatment or vaccine for COVID-19, doctors and researchers around the world are trying a variety of existing drugs and therapies to prevent complications and reduce deaths. One of the most touted treatments so far is convalescent plasma therapy. It involves transfusion of antibody-rich plasma from the blood of recovered COVID-19 patients into those who are moderately or critically-ill. There were many reports claiming that antibody therapy worked on some patients, saving lives in the process. But the U.S. Food and Drug Administration (FDA) has put emergency approval of blood plasma to treat severely ill COVID-19 patients on hold stating that the available data is too weak. Also Read – Top COVID-19 testing myths debunked: Stop believing them

Federal health officials, including Dr. Anthony S. Fauci, the US government’s leading infectious disease expert, argued the emerging data from the blood plasma studies was too weak to justify the emergency approval – a leading US daily reported on Wednesday. The health officials said that the nation’s largest plasma study, run by the Mayo Clinic, did not provide strong enough conclusions to warrant an emergency approval. Dr. Clifford Lane, the clinical director of the National Institute of Allergy and Infectious Diseases, told the paper that the authorization is on hold while the data is reviewed. Also Read – This breathalyzer test can detect COVID-19 in seconds

The FDA could still approve plasma’s use as a COVID-19 therapy within the next few months if new data shows it is safe and effective, Dr. Lane added. Also Read – COVID-19 Live Updates: Cases in India surge to 29,05,823 as death toll reaches 54,849

What Indian health experts say about blood plasma therapy

Health experts in India, however, support blood plasma therapy to treat critical Covid-19 patients. So far, the treatment has shown encouraging results in the country.

Rahul Bhargava, Director and Head, Haematology at Fortis Memorial Research Institute in Gurugram, told IANS that convalescent plasma therapy should not be abandoned until we have a vaccine or any other option to treat sick patients. “We should follow the policy of let’s do no harm,” he was quoted as saying.

Speaking to the news agency, Dr Satya Prakash Yadav, Head of Pediatric Hematology, Medanta Hospital in Gurugram, also noted that multiple studies have proved that the use of convalescent plasma to treat Covid-19 patients had no unexpected or serious adverse effects.

While many patients improved clinically and cleared the virus, it is still unclear whether it was due to the plasma treatment as these patients also received at least one additional therapy, including antivirals, antibiotics or antifungals and corticosteroids, he said. Therefore, he also agrees that more randomised controlled trials are needed to confirm the benefit of plasma therapy for severe Covid-19 patients.

Mention may be made that the Indian Council of Medical Research (ICMR) had in April sought participation in a randomised controlled study to assess the safety and efficacy of plasma therapy. The results of the study have not been released yet.

Union Minister of State for Defence and AYUSH Shripad Naik was recently been administered plasma therapy for the treatment of COVID-19. The 67-year-old minister was tested positive for COVID-19 on August 12 after which he was admitted to a private hospital in Goa. The first dose of convalescent plasma was administered to him on Monday. “He is responding well to the plasma therapy,” a Goa health department official told PTI.

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