An emergency use authorization (EUA) was issued by the US Food and Drug Administration on Sunday for convalescent plasma to treat Covid-19 saying the known and potential risks of the product are outweighed by the known and potential benefits of the product.
More than 70,000 patients had been treated with convalescent plasma made from the blood of COVID-19 recovered patients, said the FDA. Scientists expect this old fashioned treatment to work for SARS-CoV-2 infection.
President Trump, at a White House briefing, was pleased to make the historic announcement that could save countless lives from the virus. Trump had accused the health officials last week for playing politics regarding a EUA for convalescent plasma. He said the reason was political when asked about FDA not having granted a EUA.
Convalescent plasma is obtained from the blood of patients who have recovered from the SARS-CoV-2 infection. FDA established a pathway for scientists at the end of March to try convalescent plasma with coronavirus patients and study its impact. More than 60,000 COVID-19 patients have already been treated using this.
However, convalescent plasma is very limited and should come from donors, and the clinical trial data on convalescent plasma is not yet randomized even though there are promising signals from some studies. Some of the clinical trials are still underway, and more data is needed.
The data gathered by the scientists show that plasma containing high levels of antibodies benefited the patients who were treated early in their course most, probably within three days of being diagnosed. The patients who benefited from the treatment had a 35% better survival rate.
US Health and Human Services Secretary Alex Azar said they are hoping to develop something that can reduce the mortality rate by 35%. A national study of 35,000 patients treated with convalescent plasma released in a pre-print on August 12 showed that about 12% of patients who were treated four days or more after their diagnosis died while only 8.7% of patients who were treated within three days of diagnosis died which is like 37% difference. A 35% lower risk of dying was found in patients treated with plasma containing the highest levels of antibodies compared to those treated with less-rich plasma.
But this is not how clinical trials are done. The study should be a placebo-controlled clinical trial conducted in randomly selected people to tell whether its the treatment affecting survival or something else. The results from treated patients should be compared with that of untreated.
Dr. Jonathan Reiner, a professor of medicine at George Washington University, said Sunday that they don’t have enough data to really understand how effective the convalescent plasma is to treat COVID-19.
It is likely that the White House pressured the FDA into pushing through the EUA, said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
Author: Namitha
