Health officials in the U.S. have issued an emergency use authorization for convalescent plasma — the blood of recovered coronavirus patients — as a treatment for hospitalized individuals fighting COVID-19, the disease the virus causes.
The U.S. Food and Drug Administration announced Sunday that the “known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product,” after reviewing data from clinical trials over the past several months.
The move, touted by President Donald Trump as a “powerful therapy,” will make it easier for hospitalized patients fighting a severe case of COVID-19 to receive the antibody-rich blood from recovered donors.
Health officials say the emergency authorization could save lives in a time when there are no other “adequate, approved and available alternative treatments,” according to the FDA.
But some experts think the country is moving too fast, citing a lack of data on the treatment’s efficacy.
“Today, I’m pleased to make a truly historic announcement in our battle against the China virus that will save countless lives. The FDA has issued an emergency use authorization… for a treatment known as convalescent plasma,” Trump said during a Sunday press briefing. “It’s had an incredible rate of success. Today’s action will dramatically expand access to this treatment.”
“To deliver treatments and vaccines to save lives, we’re removing unnecessary barriers and delays not by cutting corners, but by marshaling the full power of the federal government,” Trump added.
What one major study has revealed about blood plasma
So far, over 70,000 patients have been treated with convalescent plasma to help them recover from COVID-19 through clinical trials beginning in April. The FDA said “it is reasonable to believe” that the plasma can lessen the severity of the disease and/or shorten the length of illness for some hospitalized individuals.
Secretary of Health and Human Services Alex Azar cited a study of 35,000 coronavirus patients during the Sunday press briefing that showed a 35% lower risk of dying for people who received plasma with the highest levels of antibodies compared to those treated with weaker plasma.
“I just want to emphasize this point because I don’t want you to gloss over this — this number. We dream, in drug development, of something like a 35% mortality reduction,” Azar said during the briefing. “This is a major advance in the treatment of patients.”
The non-peer reviewed study also found that 8.7% of patients given plasma within three days of testing positive for COVID-19 died, while about 12% of patients treated four or more days after their diagnosis passed away.
Some experts think there’s a lack of data on the treatment
Unlike Azar, others aren’t so convinced. That’s because the gold standard in science is randomized controlled trials: studies that aim to reduce bias by randomly assigning patients a treatment or placebo, then comparing their health outcomes with a control group that did not receive any treatment.
“While the data to date show some positive signals that convalescent plasma can be helpful in treating individuals with COVID-19, especially if given early in the trajectory of disease, we lack the randomized controlled trial data we need to better understand its utility in COVID-19 treatment,” Dr. Thomas File, president of the Infectious Diseases Society of America, said in a statement.
He added that more research is needed before “authorizing its wider use” in coronavirus patients.
Director of the Vaccine Education Center at Children’s Hospital of Philadelphia Dr. Paul Offit told CNN he believes the White House pressured the FDA to approve the emergency use authorization.
“I think what’s happening here is you’re seeing bullying, at least at the highest level of the FDA, and I’m sure that there are people at the FDA right now who are the workers there that are as upset about this as I am,” Offit told the outlet.
The FDA says the emergency use authorization “is not intended to replace randomized clinical trials,” which it deems important for determining the safety and efficacy of the treatment.