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The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Convalescent Plasma for the Treatment of COVID-19
Last Updated: September 01, 2020
On August 23, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA)* for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19.1,2 The COVID-19 Treatment Guidelines Panel (the Panel) reviewed the available evidence from published and unpublished data on convalescent plasma for the treatment for COVID-19, including the FDA analyses that supported the EUA.
There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19. The FDA analysis of data on a subset of hospitalized patients from the Mayo Clinic’s Expanded Access Program (EAP) compared outcomes in patients who received convalescent plasma with high titers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibodies to outcomes in patients who received plasma with low titers and found no difference in 7-day survival overall. Among patients who were not intubated, 11% of those who received convalescent plasma with high antibody titers died within 7 days of transfusion compared with 14% of those who received convalescent plasma with low antibody titers. Among those who were intubated, there was no difference in 7-day survival. Although these data suggest that convalescent plasma with high antibody titers may be beneficial in nonintubated patients, uncertainty remains about the efficacy and safety of convalescent plasma due to the lack of a randomized control group and possible confounding in the Mayo Clinic’s EAP. Additionally, antibody levels in currently available COVID-19 convalescent plasma are highly variable, and assays to determine the effective antibody titers remain limited.3
Based on the available evidence, the Panel has determined the following:
- There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19.
- Available data suggest that serious adverse reactions following the administration of COVID-19 convalescent plasma are infrequent and consistent with the risks associated with plasma infusions for other indications. The long-term risks of treatment with COVID-19 convalescent plasma and whether its use attenuates the immune response to SARS-CoV-2, making patients more susceptible to reinfection, have not been evaluated.
- Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19.
- Prospective, well-controlled, adequately powered randomized trials are needed to determine whether convalescent plasma is effective and safe for the treatment of COVID-19. Members of the public and health care providers are encouraged to participate in these prospective clinical trials.
- The Panel will continue to evaluate emerging clinical data on the use of convalescent plasma for the treatment of COVID-19 and will update the Convalescent Plasma section of the Guidelines in the near future.
* The criteria for issuance of an EUA are not the same as the standards for FDA approval.4 There are currently no FDA-approved therapies for the treatment of COVID-19.
References
- Food and Drug Administration. Coronavirus disease 2019 (COVID-19) EUA information. 2020. Available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covid19euas. Accessed August 31, 2020.
- Food and Drug Administration. Convalescent plasma letter of authorization. 2020. Available at: https://www.fda.gov/media/141477/download. Accessed August 31, 2020.
- Food and Drug Administration. EUA 26382: Emergency Use Authorization (EUA) Request. 2020. Available at: https://www.fda.gov/media/141480/download. Accessed August 31, 2020.
- Food and Drug Administration. Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders. January 2017; Available at: https://www.fda.gov/media/97321/download. Accessed August 31, 2020.
https://www.covid19treatmentguidelines.nih.gov/statement-on-convalescent-plasma-eua/
13 comments:
The Agudah Fressers need to start dressing up Eddie Betesh as their token SY Fresser again
A group of local doctors from the Syrian Jewish community, which is concentrated in Midwood and Deal, New Jersey, released a letter last week noting over 100 new infections in Deal last week.
“Because of the decrease in number and severity of cases, many of us have stopped keeping the precautions that caused the infections to decrease since the spring, believing that the threat is gone,” they wrote. “But as we continue to monitor the number of positive cases in our community, we have a dramatic increase in infections over the last two weeks; there have been over 100 new infections in Deal, NJ this week alone.”
Those cases could seed new ones in Midwood as Brooklyn residents with summer homes in Deal return home for the school year.
Don't feed the behayma gassa, convicted felon Tischler threatening to smack Cuomo on the tuchess
https://twitter.com/JustEnoughHeshy/status/1302731029732626441
In a video taken at a wedding Sunday where unmasked guests appeared in the background, Borough Park activist and radio host Heshy Tischler vowed to attend a wedding every night no matter what restrictions Gov. Andrew Cuomo and New York City Mayor Bill de Blasio impose.
“Go drop dead, Cuomo, go drop dead, Mayor de Blasio,” said Tischler, who this summer cut the chains off local playgrounds alongside local Orthodox politicians in defiance of the mayor’s orders to keep playgrounds shut. “You’re not coming into my neighborhood, we’re going to do whatever we want.”
The mayor in Beitar Illit, a large West Bank settlement, said it would not comply with the rules, accusing the government of discriminating against ultra-Orthodox cities like his own by applying sweeping curfews rather than singling out specific neighborhoods.
Meir Porush, of the Agudah-United Torah Judaism party, similarly complained about how the curfew measures were being applied.
“It is absurd and riling"
Earlier plans for local round-the-clock lockdowns were shelved after heavy pressure on Prime Minister Benjamin Netanyahu from the ultra-Orthodox community.
Four Haredi mayors published an unprecedented open letter Sunday accusing the prime minister of “trampling” their communities and “turning us into disease vectors and enemies of the people.”
The curfews will be in effect every day between 7 p.m. and 5 a.m. through September 15. During the curfew, residents must keep within 500 meters of their homes and non-essential businesses will be closed. Schools will be closed at all times, except for special needs programs.
Aryeh Deri, who leads the ultra-Orthodox Shas party, voted against even the watered down measure.
Twelve students at a religious seminary for women in Israel have tested positive for the coronavirus, in an outbreak that strikes at fears that the country’s residential learning programs could be a tinderbox for the disease.
Some 125 of 200 students in the Talmud & "semicha" programs at Midreshet Lindenbaum in Jerusalem have gone into isolation
The Agudah can add "snake oil" salesmen to their long list of failures. First they get their tipshim sick with their phony, dumb, murderous psakim, now they rally around a cure that could be dangerous.
These guys should be put out of business and misery once and for all!
Two behaviors popping up at yeshivos who are following Fresser protocols
Despite public claims of these yeshivos that (while jammed together like sardines with improper ventilation) the kids are wearing masks, the kids are actually being told by their instructors that's it's avadda too shver to wear a mask a gantz tog, so fuhgeddaboudit.
The SURGING OUTBREAKS of infection that they sanitize as "upticks" are being blamed on chassunos instead of the much more dangerous mediums of community spread: yeshivos & shuls. No mention either of the jam packed supermarkets. Therefore, guided by Agudah-TU, the mosdos are implementing takonnos against chassunos that are a farce. But the takonnos are not an exercise in futility. They are cover to fool the oylem goylem into believing that it is "safe" to keep the yeshivos open instead of closing them. Meanwhile the mosdos are also illegally hiding infections from State authorities.
All this Fresser misbehavior in the yeshivos has a moshol.
Special Agent Fox Mulder in the X-Files asked Assistant FBI Director Skinner with hishtomemus how the shadow group in the government was able to act with such impunity when violating every law in the book.
Cuomo is only acting on select examples, and even then it's only because he is currently angry at the Fressers for publicly insulting him.
Murphy is letting the Fressers get away with murder. And he's revamped everything in Trenton to delist all the direct phone extensions in departments. For all practical purposes they don't even have an active main switchboard. Even if you manage to catch a lazy bureaucrat in person, they want you to identify yourself. The Fressers have enough of their people on the inside in NJ govt., that it would be suicide to leave a complaint with your name & contact info.
As of last Thurs, 112 infected & 713 in quarantine
https://news.yahoo.com/west-virginia-university-suspending-person-215200800.html
West Virginia University suspending in-person undergrad classes amid COVID-19 spike
SUNY Oneonta up to 700 infections now.
I think Cuomo knew this was coming but decided to take a break from all the lawsuits nogaya everything he keeps closed.
The latest propaganda broadcast from Agudah Fresser channels to yeshivos is that the virus has "mutated" and is "no longer dangerous".
Roshei yeshiva & Menahelim who are otherwise very on the ball & do not back Agudah if it requires speaking sheker, have been duped into repeating it.
This fraudulent sound byte is also being typed into letters sent to all yeshiva families.
Try telling this garbage to the nunter of all the heimishe Yidden recently rushed to hospital Emerg's & ICUs.
One rosh yeshiva inquired to a mumche who informed him the Agudah Fressers are peddling falshkeit that makes people dangerously lower their guard.
To be completely accurate the exact words intended to downplay the choimer are: "reduction in the severity"
There's a major shvantz by the hillbilly yehupitz who grew up modern ortho, son of a YU rabbi. He was chasing shiksas for years, publicly promoting it with childish antics. He landed one that went through phony convert motions under the slob with the personality disorder, "Hershel Goldwasser". One or both of them lecture at WVU. I don't think he even pretends to be frum anymore. Saw him online hanging out with a chomo Reformer rabbiner.
How many yeshivos & Bais Yaakovs who refuse to provide video hookup and who subscribe to the Agudah Fresser achzoriyus to davka make everything difficult as a way to force kids back into infection prone classes, are not even providing audio hookup, or at least one that any human can hear the rebbi/morah talking?
I know of 4 places already.
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