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.”
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
any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma. The FDA continues to recommend that the designs of ongoing randomized clinical trials of COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care based on the currently available evidence.
An Expanded Access Program for convalescent plasma was initiated in early April to fill an urgent need to provide patient access to a medical product of possible benefit during a time that the FDA was working with researchers to facilitate the initiation of randomized clinical trials to study convalescent plasma. As the number of single-patient IND requests started to number in the hundreds on a daily basis, the FDA worked collaboratively with industry, academic, and government partners to implement an expanded access protocol to provide convalescent plasma to patients in need across the country via the national expanded access treatment protocol. The program was developed with funding from the HHS’ Biomedical Advanced Research and Development Authority (BARDA), with the Mayo Clinic serving as the lead institution. To date, the program has facilitated the infusion of over 70,000 patients with convalescent plasma.
The EUA remains in effect until the termination of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19. The EUA may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
Former FDA Chief, Scott Gottlieb said in an interview that, “I think that this could be beneficial. It might be weakly beneficial.”
“It doesn’t look like a home run,” he continued. “But right now we’re looking for singles and doubles. There aren’t really going to be any home runs on the horizon until we can get the other therapeutic antibodies on the market and hopefully eventually vaccines and better therapeutics.”
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