FDA issues emergency authorization for coronavirus convalescent plasma treatment

FDA issues emergency authorization for coronavirus convalescent plasma treatment

The Food and Drug Administration has just issued an emergency use authorization for convalescent plasma to treat coronavirus.

Convalescent plasma treatment utilizes the antibody-reach blood plasma of those who recovered from a infection with the Wuhan Coronavirus, as those antibodies are still capable of destroying more virus. Doctor harvest the plasma and purify it to isolate those antibodies, which are then injected into another patient sick with Covid-19.

Shortly the FDA authorization was issued, President Donald Trump announced the developments and the bacground associated with this move during a Sunday afternoon news conference.

The authorization allows convalescent plasma, which is used in an experimental treatment involving blood plasma transfusions from people who have developed antibodies to the new coronavirus, to be distributed by healthcare providers to treat people with COVID-19. Blood plasma has been used to treat other infectious diseases.

“This is a powerful therapy that transfuses very, very strong antibodies form the blood of recovered patients to help treat patients battling a current infection,” Trump said.

Trump cited a $48 million Mayo Clinic study that demonstrated the case fatality rate dropped by 35% for patients, and was more effective for those under 80 years old who were not on a ventilator.

The patients were treated in different ways in hospitals around the country as part of an FDA program designed to speed access to the experimental therapy. That so-called “expanded access” program tracks what happens to the recipients, but it cannot prove the plasma — and not other care they received — was the real reason for improvement.

Administration officials, in a call with reporters Sunday, discussed a benefit for patients who were within three days of admission to a hospital and were not on a respirator, and were given ‘high-titer’ convalescent plasma containing higher concentrations of antibodies. They were then compared to similar patients who were given lower-titer plasma. The findings suggest deaths were 35% lower in the high-titer group.

Trump was joined in the press conference by United States Secretary of Health and Human Services Alex Azar and FDA Commissioner Stephen M. Hahn, M.D.

Azar notes that 100,000 American entrolled in the expanded access program, and 70,000 participated to provide the data used in the assessment. There was a request that those interested in donating go to coronavirus.gov and check the section on Plasma Donation.

During the press conference, Trump address a question as to whether he was placing pressure on the FDA to make the move for political reasons.

https://twitter.com/realDonaldTrump/status/1297138862108663808?ref_src=twsrc%5Etfw

It appears that Trump wasn’t the only one worried about the speed of the FDA’s response, either.

According to two sources in the Monday meeting, Peter Navarro had aggressively confronted FDA officials, saying, "You are all Deep State and you need to get on Trump Time." Navarro declined to comment.
https://t.co/3eop6Q7FUa

— Jonathan Swan (@jonathanvswan) August 23, 2020

In response the the reporter’s query, Trump noted that a “log jam broke last week”. He inidacted that it was his opinion the authorization was being held-up for political reasons, highlighting “Every day is lives”.

Additionally, Trump hinted at his low opinion of most media.

.@realDonaldTrump to the media:

"It's good to see you all. I hope you had a great weekend at your convention."

???https://t.co/aqqRQjhyk4

— The First (@TheFirstonTV) August 23, 2020

That assessment was shown to be warranted, given that the last question from one of the “reporters” was a nit-picking question as to whether over the difference between “siginificant development” and “promising effectiveness”.

Trump clearly intends to continue “Operation Warp Speed” at its current pace, as the administration is considering fast tracking an experimental vaccine developed in the U.K. for use in this country.

One option being explored to speed up the availability of a vaccine would involve the US Food and Drug Administration awarding “emergency use authorisation” (EUA) in October to a vaccine being developed in a partnership between AstraZeneca and Oxford university, based on the results from a relatively small UK study if it is successful, the people said.

The AstraZeneca study has enrolled 10,000 volunteers, whereas the US government’s scientific agencies have said that a vaccine would need to be studied in 30,000 people to pass the threshold for authorisation. AstraZeneca is also conducting a larger study with 30,000 volunteers, although the results from that will come after the smaller trial.

Donations tax deductible
to the full extent allowed by law.