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US FDA announces emergency

authorization for convalescent plasma to
treat Covid-19
By Dr. Sanjay Gupta, Jamie Gumbrecht and Maggie Fox, CNN
Updated 0240 GMT (1040 HKT) August 24, 2020

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(CNN)The US Food and Drug Administration 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."

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.

Researchers hope this old-fashioned treatment will work for coronavirus

"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."
Last week, Trump accused some health officials of playing politics regarding an EUA for
convalescent plasma. When asked about the FDA not having granted an EUA, Trump said
the reason was political.
On Sunday, a source who is close to the White House Coronavirus Task Force told CNN
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 have recovered from Covid-19.
At the end of March, the FDA set up a pathway for scientists to try convalescent plasma
with patients and study its impact. It has already been used to treat more than 60,000
Covid-19 patients.
However, like blood, convalescent plasma is in limited supply and must come from donors.
And while there are promising signals from some studies, there is not yet randomized
clinical trial data on convalescent plasma to treat Covid-19. Some of those trials are
underway.

Experts say more data is needed

US Health and Human Services Secretary Alex Azar said studies involving 70,000
volunteers justified the EUA.
"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," Azar told the White House briefing.

Trump claims 'political reasons' held up convalescent plasma emergency authorization

"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."
Azar appeared to be referring to a national study of 35,000 patients treated with
convalescent plasma. The study, 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%.
Those 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 how 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.

Trump, without evidence, accuses FDA of delaying coronavirus vaccine trials and pressures
agency chief
"The problem is, we don't really have enough data to really understand how effective
convalescent plasma is," Dr. Jonathan Reiner, a professor of medicine at George
Washington University and a CNN medical analyst, said Sunday.
"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.
Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of
Philadelphia, said he thought it likely the White House pressured the FDA into pushing
through the EUA.
"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 CNN's Wolf Blitzer.
According to a knowledgeable source, Dr. Francis Collins, head of the National Institutes of
Health; Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases
and Dr. H. Clifford Lane, who works under Fauci at NIAID, were among government health
officials who had previously been skeptical there was enough data to justify emergency
authorization of plasma for Covid-19.

'Great demand from patients and doctors'

President Trump said there might have been a holdup on the EUA, "but we broke the
logjam over the last week to be honest," Trump said at the briefing. He said he believed
there were officials at the FDA and in the Department of Health and Human Services "that
can see things being held up and wouldn't mind so much."
"It's my opinion, very strong opinion, and that's for political reasons," Trump said.

FDA emergency authorization of blood plasma for Covid-19 on hold, according to the New
York Times
Hahn denied the decision was made for any other than legitimate medical reasons.
"I took an oath as a doctor 35 years ago to do no harm. I abide by that every day," Hahn
said in a statement to CNN's Jim Acosta.
"I've never been asked to make any decision at the FDA based on politics. The decisions
the scientists at the FDA are making are done on data only."
Hahn said during the briefing the agency decided the treatment was safe, and looked
potentially effective enough to justify the EUA, which is not the same as full approval.
"So we have ongoing clinical trials that are randomized between a placebo, or an inactive
substance, and the convalescent plasma. While that was going on we knew there was great
demand from patients and doctors," Hahn said.
While an EUA can open the treatment to more patients, it could also have the effect of
limiting enrollment in clinical trials that determine whether it's effective.
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CNN Health team.
On Thursday, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and
Research, said that doctors have treated so many Covid-19 patients with convalescent
plasma, it has been difficult to figure out if the treatment works.
 "The problem with convalescent plasma is the great enthusiasm about it," Woodcock said in
an online conversation about the latest science behind monoclonal antibody treatments and
convalescent plasma. "It exceeded anyone's expectation as far as the demand."
Bioethics expert Art Caplan said he's worried about whether there's a large enough supply
of convalescent plasma. With an EUA, doctors will be more likely to give convalescent
plasma without tracking data, so it will then be difficult to determine which donors have the
most effective plasma, and which patients are the best candidates to receive it.
"We're going to get a gold rush towards plasma, with patients demanding it and doctors
demanding it for their patients," said Caplan, the founding head of the Division of Medical
Ethics at NYU School of Medicine.
CNN's Jake Tapper, Jim Acosta, Elizabeth Cohen, Naomi Thomas, Jen Christensen and
John Bonifield contributed to this report.

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