The US Food and Drug Administration (FDA) has granted emergency authorization on Sunday to use convalescent plasma treatment for coronavirus patients.
The method uses antibody-rich plasma from the people who have successfully recovered from the virus, and 70,000 have already been treated by it.
According to the FDA, the early trials indicate that the method is safe but more research is needed to prove its effectiveness.
The recently authorized convalescent plasma treatment for coronavirus patients uses blood from people, who were coronavirus patients and have recovered from the virus and have also built antibodies against the coronavirus, and infuses it into coronavirus patients to prevent the disease to get more severe, according to the Mayo Clinic. However, convalescent plasma is short in supply, like blood, and must come from donors.
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Alex Azar, the US Health and Human Services Secretary said that the studies that involved 70,000 volunteers justify the emergency use authorization (EUA). He said that the data gathered suggests that the patients who were treated within 3 days of being diagnosed benefitted the most from the treatment. A 35% better survival rate was observed in the patients who benefitted most from the treatment.
Azar was referring to a national study of the convalescent plasma treatment which involved almost 35,000 patients. The study, which had not been peer-reviewed, showed that only 8.7% of the patents died who were treated within 3 days of contracting the virus, in comparison, among those who were treated after 4 days or more of being coronavirus positive 12% of the patients died, the difference is nearly 37%. The study also showed that patients who were treated with plasma which contained the highest levels of antibodies had a 35% chance of surviving than those who were treated with plasma containing fewer antibodies.
Several health experts including Director of National Institute of Health Dr.
Francis Collins and Director of National Institute of Allergy and Infectious Diseases (NIAID) Dr. Anthony Fauci have raised concerns about the convalescent plasma treatment for coronavirus patients saying that not enough data is available about whether the treatment will be effective in reducing the death rate from coronavirus.
Professor of Medicine at George Washington University Dr. Jonathan Reiner said on Sunday that the problem with the treatment is there’s not enough data to really understand how effective the convalescent plasma treatment is. While the data show some positive signs that the convalescent plasma can be used for treating covid19 patients, especially if given early but we lack the controlled trial data that is needed to better understand its utility in the treatment for coronavirus patients, said President of the Infectious Disease Society of America, Dr. Thomas File.
Director of the Vaccine Education Center at Children’s Hospital of Philadelphia Dr. Paul Offit believes that the White House pressured the FDA into granting the emergency use authorization and described it as the bullying at the highest level.
Sick Coronavirus patients whose immune system is not strong enough to fight against the coronavirus can certainly do with the transfusion of plasma full of antibodies from someone who has already recovered from the virus. The treatment has been used before to treat some other diseases like Ebola. It is generally tolerable but unwanted effects can occur, that’s why the experts are skeptical about the treatment before clinical trials prove its effectiveness.