The U.S. Food and Drug Administration (FDA) on Sunday issued an emergency use authorization for convalescent plasma to treat Covid-19, saying the “known and potential benefits of the product outweigh the known and potential risks of the product.”
This authorization comes with a lot of push back because there are reports that this procedure hasn’t fully gone through the clinical trial process and many claim that it’s only being fast-tracked because President Trump pushed it forward.
Plus, this announcement comes right before the Republican National Convention, which brings this whole strategy into question. Some are even claiming this to be a “political stunt.” But the president said it “has nothing to do with politics.”
“Today I am pleased to make a truly historic announcement in our battle against the China virus that will save countless lives,” President Trump said at a White House briefing, referring to the coronavirus that causes Covid-19. “Today’s action will dramatically increase access to this treatment.”
The FDA said more than 70,000 patients had been treated with convalescent plasma, which is made using the blood of people who have recovered from coronavirus infections.
But, Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City, warned in a USA Today interview, that plasma “has not yet been shown to be effective in COVID-19.”
How Is It Supposed to Work?
The hope is that infusions of antibody-rich plasma from recovered patients can aid the immune systems of the sick. In other words, the blood from people who recovered from COVID should help people who currently have COVID.
When people get sick with Covid-19, their immune systems generate antibodies to fight the disease. Those antibody proteins float in their blood plasma — the liquid component of blood that suspends blood cells.
Doctors can harvest the plasma, test it for safety, and then purify it to isolate those antibodies. That “plasma-derived therapy,” or “convalescent plasma,” can be injected into another patient sick with Covid-19, and the antibodies it contains can help fight the virus early in an infection until the patient’s own immune system generates its own antibodies in sufficient quantities to beat back Covid-19.
The FDA determined that 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. The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments.
The FDA goes on to clarify that this Emergency Use Authorization (EUA) is not intended to replace randomized clinical trials and facilitating the enrollment of patients into