FDA authorizes use of blood plasma
The US Food and Drug Administration (FDA) issued an emergency use authorization for the use of convalescent plasma to treat hospitalized Covid-19 patients. US President Donald Trump announced this on Sunday in an evening press briefing. In this announcement, he said, “Today I am pleased to make a truly historic announcement in our battle against the China virus that will save countless lives.” Then he added, the authorization “will dramatically expand access to this treatment.”
An emergency authorization is not the same as traditional FDA approval, rather it is a way to expand the use of experimental therapy. According to the FDA, the convalescent plasma “may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks.”
Around 70,000 Americans who were Covid-19 positive have already received this treatment. In this process, blood plasma is taken from the people who have already recovered from Covid-19 and is used to treat Covid-19 infected patients.
The FDA said early evidence suggests, this treatment is successful in decreasing mortality and improving the condition of patients if administered within the first three days of their hospitalization.
FDA Commissioner Stephen Hahn, who accompanied President Donald Trump during the briefing said, there is a 35% improvement in survival for COVID-19 patients given the plasma. Hand however made it clear that this treatment is still under the experimental stage and needs to go through a randomized clinical trial to determine its effectiveness and safety.
FDA authorizes use of blood plasma
News reports from the last week suggested that some of the health officials were not is an agreement to issue the emergency use authorization as they thought the data was not strong enough for this approval.
However, Trump felt the agency was delaying the authorization for political reasons. On Saturday in his twitter handle, Trump said, “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
Significantly enough the authorization comes one day prior to the start of the Republican National Convention, where the party will formally nominate Mr. Trump to be the leader of the party for four more years.
Many think FDA had been pressured to give this approval on an urgent basis, however, Hahn did not respond to this question in Sunday’s press briefing.
