The U.S. Food and Drug Administration (FDA) has authorized the use of convalescent blood plasma in the treatment of COVID-19 patients.
The FDA’s emergency use authorization (EUA) comes amid ongoing pressure from President Trump for organizations to speed up drug development and testing to fight COVID-19. Trump praised the agency’s decision at a White House press conference on Sunday, August 23.
Different from a vaccine, convalescent plasma is one of a number of treatments that are being tested in clinical trials. The method extracts antibody-rich plasma from people who have recovered from COVID-19 and transfers it to a patient with the condition. In successful cases, the plasma will boost the patient’s immune system, giving them the strength to fight the virus until their body is able to make its own antibodies.
In a statement posted online on Sunday, the FDA said “it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients,” adding, “The known and potential benefits of the product outweigh the known and potential risks of the product.”
However, the FDA cautioned that convalescent plasma “does not yet represent a new standard of care based on the current available evidence,” and so it therefore “continues to recommend that the designs of ongoing randomized clinical trials of COVID-19 convalescent plasma and other therapeutic agents remain unaltered.”
In a tweet posted by Trump on Saturday — the day before the FDA issued the convalescent plasma EUA — the president wrote: “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!” He also tagged in Stephen Hahn, the agency’s commissioner.
At Sunday’s press conference, with Hahn standing close by, Trump described the FDA’s move as “a truly historic announcement,” adding, “This is what I’ve been looking to do for a long time.”
The FDA said convalescent plasma has so far been used to treat more than 70,000 patients in the U.S. According to a New York Times report citing two senior administration officials, the FDA was planning to issue the EUA several weeks ago, but top federal health officials — including Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases — advised caution, claiming that available data on the treatment was too weak. But now the FDA now says that convalescent plasma may be effective in helping to improve the condition of some patients hospitalized with COVID-19.
With November’s presidential election fast approaching and his administration taking a battering from critics over its handling of the crisis, Trump is pinning his hopes on achieving a major breakthrough in the nation’s fight against the virus.
- FDA gives special authorization to speedy COVID-19 test
- Fauci says things might not go back to normal until the end of 2021
- Bill Gates doesn’t expect a coronavirus vaccine by the end of the year
- FDA approves saliva coronavirus test: Here’s what you need to know
- A smartphone app for diagnosing autism could soon win FDA approval