US - F.D.A. issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients

[Mary Wilson]

Government health leaders including Dr. Francis S. Collins and Dr. Anthony S. Fauci urged caution last week, citing weak data from the country’s largest plasma study.

By Noah Weiland, Sharon LaFraniere and Sheri Fink

Aug. 19, 2020 Updated 6:33 p.m. ET

WASHINGTON — Last week, just as the Food and Drug Administration was preparing to issue an emergency authorization for blood plasma as a Covid-19 treatment, a group of top federal health officials including Dr. Francis S. Collins and Dr. Anthony S. Fauci intervened, arguing that emerging data on the treatment was too weak, according to two senior administration officials.

The authorization is on hold for now as more data is reviewed, according to H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases. An emergency approval could still be issued in the near future, he said.

... But clinical trials have not proved whether plasma can help people fighting the coronavirus.

Several top health officials — led by Dr. Collins, the director of the National Institutes of Health; Dr. Fauci, the government’s top infectious disease expert; and Dr. Lane — urged their colleagues last week to hold off, citing recent data from the country’s largest plasma study, run by the Mayo Clinic. They thought the study’s data to date was not strong enough to warrant an emergency approval.

https://www.nytimes.com/2020/08/19/us/politics/blood-plasma-covid-19.html

 

[Mary Wilson]

FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic

August 23, 2020

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.

Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.

The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.

https://www.fda.gov/news-events/pre...plasma-potential-promising-covid-19-treatment

 

[Mary Wilson]

97,000 People Got Convalescent Plasma. Who Knows if It Works?

A treatment made from the blood of recovered Covid-19 patients seemed promising in March. Today … well, it’s still just promising.

08.21.2020 07:00 AM

AS OF MONDAY, August 17, a nationwide program to treat Covid-19 patients with a fluid made from the blood of people who’d recovered from the disease—so-called convalescent plasma—had reached 97,319 patients.

That’s a huge number of people, considering that nobody really knows whether convalescent plasma actually works against Covid-19.

A spontaneously generated, self-assembling group of clinicians and cross-disciplinary researchers that built the nationwide program to ensure “expanded access” to convalescent plasma also created protocols for randomized, controlled trials, the gold standard for evidence in science. They hoped to test plasma’s ability to prevent disease after exposure, its capacity to treat Covid-19—and what Michael Joyner, an exercise physiologist at the Mayo Clinic who was instrumental in setting up the expanded-access network, called a “Hail Mary” protocol to try to help people who are severely ill, on ventilators.

The distribution system got approved and built; the trial protocols did not. They never began.

... A preprint from the expanded-access group, not yet peer-reviewed, recounts the outcomes of more than 35,000 of these recipients at hundreds of hospitals. It retroactively splits that population into groups based on when in their illness they got plasma, or how laden the plasma was with the antibodies that actually do the disease-fighting.

But, as the researchers and outside experts both acknowledge, that’s not as good as a clinical trial in which people get randomly assigned to a group that gets a drug (or procedure or surgery or whatever) versus a group that doesn’t, and then someone compares the results.

https://www.wired.com/story/97000-p...-share&utm_brand=wired&utm_social-type=earned

 

[sharon sanders]

Dr. Stephen M. Hahn

@SteveFDA
?
2h
Media coverage of FDA’s decision to issue emergency authorization for convalescent plasma has questioned whether this was a politically motivated decision. The decision was made by FDA career scientists based on data submitted a few weeks ago.
89
126
186
Dr. Stephen M. Hahn

@SteveFDA
?
2h
They had confidence that convalescent plasma has potential to benefit many sick patients and the safety profile is well defined.
6
7
44
Dr. Stephen M. Hahn

@SteveFDA
?
2h
We unfortunately do not have randomized trials for convalescent plasma but must make decisions based on what we do have from the Mayo Clinic expanded access program.
11
15
41
Dr. Stephen M. Hahn

@SteveFDA
?
2h
The decision was based on significant data from the Mayo Clinic and other reliable sources plus a century of experience with convalescent plasma.
7
5
35
Dr. Stephen M. Hahn

@SteveFDA
?
2h
We at FDA do not permit politics to enter into our scientific decisions. This happens to be a political season but FDA will remain data driven. On behalf of FDA‘s 18,000 career employees, I want to reassure the American public about this commitment.
61
46
111
Dr. Stephen M. Hahn

@SteveFDA
?
2h
The convalescent plasma decision was made entirely by FDA scientists.
16
13
45
Dr. Stephen M. Hahn

@SteveFDA
?
2h
The authorization of emergency use of convalescent plasma is not a final approval. FDA will continue to monitor its use and will revoke authorization if needed. We feel broader use of plasma will truly benefit many patients but will require further study.
13
28
85
Dr. Stephen M. Hahn

@SteveFDA
I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.
9:36 PM ? Aug 24, 2020

 

[sharon sanders]

Dr. Sanjay Gupta

@drsanjaygupta
?
11h
Replying to
@drsanjaygupta
Dr. Hahn told me “he should have better explained the data.” Here’s what he (incorrectly) said on Sunday night: Use of convalescent plasma reduced the risk of death by 35% and that meant if 100 people got coronavirus, 35 would survive. (2/11)

Remarks by President Trump in Press Briefing | August 23, 2020 | The White House
James S. Brady Press Briefing Room 5:32 P.M. EDT THE PRESIDENT: Thank you very much. And it’s good to see you all. Hope you had a great weekend at your
whitehouse.gov
37
243
447
Dr. Sanjay Gupta

@drsanjaygupta
?
11h
Last night he aimed to clarify that by telling me and then tweeting: “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.” This is a fundamental difference and important to understand. (3/11)
Quote Tweet

Dr. Stephen M. Hahn
@SteveFDA
? Aug 24
I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.
Show this thread
14
144
439
Dr. Sanjay Gupta

@drsanjaygupta
?
11h
Let me try and explain. According to the Mayo Clinic’s early analysis of over 35,000 hospitalized patients they found that “For patients who received high IgG plasma seven-day mortality was 8.9%... and for recipients of low IgG plasma mortality was 13.7%.” (4/11)
2
56
209
Dr. Sanjay Gupta

@drsanjaygupta
?
11h
That means the relative risk reduction is calculated like this: (13.7-8.9)/13.7 = .35 or 35%. Those treated with plasma containing the highest levels of antibodies had about a 35% lower risk of dying within a week compared to those treated with less-rich plasma. (5/11)

5
103
314
Dr. Sanjay Gupta

@drsanjaygupta
?
11h
But, that doesn’t mean what Dr. Hahn originally said: that 35 more people -- out of 100 -- would survive. What that actually means is that 13.7/100 people died using low level antibody plasma, and that 8.9/100 died using the high level antibody plasma. (6/11)
5
83
290291
Dr. Sanjay Gupta

@drsanjaygupta
?
11h
So in the high antibody group, 4.8 more people survived out of 100, as compared to the low antibody group. (7/11)
5
59
246
Dr. Sanjay Gupta

@drsanjaygupta
?
11h
But, there is another critical point. This was not a randomized controlled trial, the gold standard for clinical trials. Neither group was compared to a placebo, so we still don’t know if the convalescent serum itself offered survival benefit or not. (8/11)
4
86
355
Dr. Sanjay Gupta

@drsanjaygupta
?
11h
In fact, a closer examination of the study showed 49.8% of the participants were also being treated with steroids, 30.1% were treated with Remdesivir. So, was it the other medications offering the benefit or the convalescent plasma? We can’t say for sure. (9/11)
10
241
817
Dr. Sanjay Gupta

@drsanjaygupta
?
11h
The study, upon which this EUA was based, hasn’t been peer reviewed or published in a journal. (10/11) https://medrxiv.org/content/10.1101/2020.08.12