Many media outlets are reporting that Trump is expected to announce Sunday evening (around 5:30 pm ET) that the FDA will issue an emergency authorization for the use of blood plasma (aka convalescent plasma) from patients who have recovered from Covid-19 as a treatment for the disease. Late Saturday night, White House press secretary Kayleigh McEnany had tweeted that the announcement would involve “a major therapeutic breakthrough on the China virus.”
Convalescent plasma is not a new treatment. It has been used for many infectious diseases over the past century. It is made by taking blood from people who’ve recovered from a disease, extracting antibodies from it, injecting into infected patients. It can also be used as a preventative therapy. It has been used for COVID-19 since the early days of the pandemic.
We first wrote about Convalescent plasma on March 15 in diary “Some Novel Coronavirus Treatments in the Pipeline - Antibody Harvesting and Plant Based Vaccines”
Here is a quick infographic on Convalescent Plasma therapy -
A large Mayo clinic trial earlier this year enlisted over 90,000 participants, but unfortunately the trial was not done with control groups and hence the results are not conclusive about how much Convalescent plasma helps COVID-19 patients recover or in preventing death.
See the story linked below for more details about the trials.
The FDA was planning to not issue the emergency authorization last week after examining results of the Mayo clinic trial and after feedback from Dr. Fauci and Dr. Francis Collins of the NIH.
From www.politico.com/...
The agency held off on the decision last week over concerns from government scientists that evidence for the treatment's effectiveness is thin — prompting Trump to accuse the FDA of slow-walking the therapy to harm his reelection chances without offering any evidence to support his claim. It is not clear whether the FDA has received additional clinical trial data in the last week that would support the therapy's use.
Here is what experts are saying —
In this randomized trial whose results were published in June, 103 patients were recruited, the conclusion was that among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment did not significantly improve the time to clinical improvement within 28 days (although the trial was terminated early and may have been underpowered to detect a clinically important difference.)
Andy Slavitt (ex-Obama health care head) is predicting already that a vaccine will be announced with trumpish fanfare before the election (like Putin did).
This seems to be another political stunt by trump to claim success before the Republican convention and give himself a chance to crow about how he alone can save America from the “China” virus and to blame the “deep state” for all his failures.
Let’s make sure people understand what this is, that trump and his administration have little to do with any drugs, therapies or vaccines that will eventually slow down or stop COVID-19; the drugs and vaccines will succeed not because of trump but in spite of him. After all, most research on vaccines and therapies started long before the administration even acknowledged the problem. And after they did, they have been hawking HCQ, bleach, UV light and flower oil as miracle therapies, while trashing scientists and the WHO.
