Daily US Times: On Sunday, the US Food and Drug Administration 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.”
More than 70,000 patients had been treated with convalescent plasma, the FDA says. The plasma is made using the blood of people who have recovered from coronavirus infections.
President Trump said at a White House briefing: “Today I am pleased to make a truly historic announcement in our battle against the China virus that will save countless lives. Today’s action will dramatically increase access to this treatment.”
Last week, the US president accused some health officials of playing politics regarding an EUA for convalescent plasma. Being asked about the FDA not having granted an EUA, Trump replied that the reason was political.
A source who is close to the White House Coronavirus Task Force told CNN on Sunday that the FDA had reviewed additional data to inform its EUA decision. This official has not personally reviewed the data. They added the FDA is under no obligation to consult anyone outside the agency about its decision.
Convalescent plasma is taken from the blood of people who already survived from Covid-19. The FDA set up a pathway for scientists at the end of March to try convalescent plasma with patients and study its impact. The treatment has already been used to treat more than 60,000 Covid-19 patients.
However, like blood, convalescent plasma must come from donors and is in limited supply. There are promising signals from some studies, there is not yet randomized clinical trial data on convalescent plasma to treat Covid-19 patient. Some of those trials are currently underway.
Experts say more data is needed
Alex Azar, US Health and Human Services Secretary, said studies involving 70,000 volunteers justified the EUA.
Azar told the White House briefing: “The data we gathered suggests that patients who were treated early in their disease course, within three days of being diagnosed, with plasma containing high levels of antibodies, benefited the most from treatment. We saw about a 35% better survival in the patients who benefited most from the treatment.”
“We dream in drug development of something like a 35% mortality reduction. This is a major advance in the treatment of patients. A major advance,” he said.
Azar appeared to be referring to a national study of 35,000 Covid-19 patients treated with convalescent plasma. The study was released August 12 in a pre-print, meaning it had not yet been peer-reviewed, showed that 8.7% of patients who were treated within three days of diagnosis died, compared to about 12% of patients who were treated four days or more after their diagnosis. That’s about a difference of about 37%.
Covid19 patients who treated with plasma containing the highest levels of antibodies had a 35% lower risk of dying within a week compared to those treated with less-rich plasma.
But this is not the process doctors usually measure the benefit of a treatment. The gold standard is a randomized, placebo-controlled clinical trial that means that doctors randomly choose who gets the treatment and who doesn’t, so they can truly tell whether it’s the treatment affecting survival and not something else. And the comparison is usually treated patients compared to untreated patients — not patients treated earlier compared to those treated later.
Dr. Jonathan Reiner, a professor of medicine at George Washington University said Sunday: “The problem is, we don’t really have enough data to really understand how effective convalescent plasma is.”
President of the Infectious Diseases Society of America, Dr. Thomas File, said in a statement: “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.”
‘Great demand from patients and doctors’
President Donald Trump said as the briefing that there might have been a holdup on the EUA, “but we broke the logjam over the last week to be honest.”
He said he believed there were officials in the Department of Health and Human Services and at the FDA “that can see things being held up and wouldn’t mind so much.”
Trump said: “It’s my opinion, very strong opinion, and that’s for political reasons.”
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