Trump advances fight against COVID with two historic orders. Experts still come up short
President Trump is pushing through a quick decision for AstraZeneca’s vaccine against severe COVID-19 infection on the basis of a 10,000-person trial taking place in the U.K. that could make the vaccine available before the U.S. election.
“The mooted plan is to allow AstraZeneca to gain emergency use authorization (EUA) on the basis of a 10,000-subject U.K. clinical trial,” says FierceBiotech.
Generally, the FDA wants to see efficacy results from 30,000 subjects with a variety of health conditions before granting approval to use the vaccine in the U.S.
Trump has accused authorities at the FDA of dragging their feet regarding enrollment of trial subjects in studies to delay the approval of treatments before the election.
Trump announced on Sunday that he has also authorized the use of plasma from recovering COVID patients as a possible treatment in fighting the disease.
“This is what I’ve been looking to do for a long time,” Trump told an unusually brief White House news conference, according to the Reuters. “Today I’m pleased to make a truly historic announcement in our battle against the China virus that will save countless lives.”
The WHO immediately said that the treatment of patients with plasma is “inconclusive” and “experimental.”
“WHO’s chief scientist Dr. Soumya Swaminathan said the treatment is difficult to standardize since people produce different levels of antibodies and the plasma must be collected individually from recovered patient,” reports USA Today.
Trump is likely banking on public disaffection with scientists who alter between doomsday predictions, panic and cautious warnings but seem to have no real answers on how to speed the safety of the American people.
One thing is apparent: After six months of the pandemic, scientists have no answers other than widespread lockdowns of communities. Trump thinks that the lockdowns are unsustainable.
“This is a powerful therapy,” Trump said, saying the treatment is “a very historic breakthrough.”
“Plasma is probably incrementally helpful to Covid patients and meets criteria for an EUA,” says Scott Gottlieb, MD, former head of the FDA. “But we need better evidence generation; and we need to keep FDA decisions with FDA. The FDA professional staff supported this. It’s their decision.”
It’s hoped that plasma from recovering COVID patients will help boost sick patients’ immune systems so as to better fight off the viral infection. Thus far, plasma treatment has been tried with 70,000 patients.
“As an institution that has been engaged in the study of convalescent plasma since April, and to date has treated more than 150 patients across its hospitals, Henry Ford supports the FDA’s decision,” said a statement by one hospital at the forefront of plasma treatment trials.
The hospital was responding at the time to FDA orders four days ago that the they suspend plasma trials.
“Anecdotally, Henry Ford patients have done well with convalescent plasma treatment,” the hospital added. “Nevertheless, there are many variables involved before determining whether the treatment is effective.”
It’s likely that the suspension is what decided Trump on this weekend’s order allowing widespread use of plasma treatment.
PHOTO: Official White House Photo by Shealah Craighead
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