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The article claimed that key figures from the Department of Health and Human Services – including the director of the National Institutes of Health (NIH), Dr Francis S. Collins and the director of the National Institutes of Allergy and Infectious Disease (NIAID ), Dr Anthony S. Fauci – intervened last week to persuade the FDA to delay an Emergency Use Authorization (EUA) for the treatment.
Currently, convalescent plasma is offered through a program administered by Mayo under special authorization known as the Experimental Access Program (EAP). It’s a format that limits the use of plasma for hundreds of healthcare systems too small to participate in trials, channeling their use under the supervision of the Mayo Clinic.
About ten smaller clinical trials are also underway to study plasma with a placebo comparison.
The Mayo EAP was designed to make the experimental treatment widely available early in the pandemic despite the lack of plasma stocks at the time. The move shielded the FDA from having to issue hundreds of drug approvals, while developing standardized protocols for plasma collection. It also collected emerging data on safety, patient selection and dosage.
An EUA, like the one issued and then revoked for hydroxychloriquin, would expand the availability of plasma to everyone, allowing health systems across the country to begin using the treatment. The Times article claimed that federal health officials feared the Mayo program’s initial findings were not strong enough to warrant an EUA, leading them to halt imminent FDA action.
“We have an expanded access protocol that continues,” said Dr. Michael Joyner, principal investigator of the MayoClinic Convalescent Plasma program. “At some point, it could move to emergency use authorization. We expected this to happen relatively soon. It’s delayed now, but the FDA is delaying things for additional data all the time. . “
“In my opinion, there is no lag on the EUA,” said Dr Scott Wright, clinical researcher for the Mayo Plasma Program. “We have no idea,” Wright said when asked why an HHS official would describe an imminent approval. “The EUA has not come out, but they never gave a timeline or deadline for it,” he said.
Darkening the waters further, the Times article referred to unnamed “senior health officials” who privately expressed concern about the rapid growth of the Mayo program. The article claimed that “scientists have had trouble recruiting patients for randomized trials” given the availability of a Mayo alternative.
The Mayo program has grown exponentially. Since launching in early April with a treatment plan for 5,000 enrolled, Mayo’s plasma program has grown to 8,000 physicians in 3,000 hospitals serving 100,000 enrolled – of which 70,000 to 80,000 have now been transfused.
“It’s a false dichotomy,” Joyner said of the idea that Mayo’s huge database of plasma recipients is emptying the country of clinical trial subjects.
“All of these people are being treated in places where there would never be a trial. Places like Laughton, Okla.” Clinical trial studies, Wright added, are currently being conducted in large metropolitan hospitals, places that do not suffer for participants.
The Mayo study looked at the results of four hours, seven and 30 days in relation to the increase in the level of antibodies. Early results from these patients have helped regulators understand the logistics of a plasma program, as well as provide early guarantees of safety.
The Mayo program also treated a diverse patient population, rarely studied in clinical trials. His patients are 20% black, over 35% Hispanic, 10% Asian, and 40% female.
Because it does not have a comparison group, however, the Mayo data cannot provide evidence of efficacy, a critical hurdle in the approval process, and Mayo clinicians gladly approved it.
“We were never asked to do a randomized trial,” Joyner said. “We’re trying to solve the security and access issues and see what we can learn about efficiency.”
Wright says Mayo has twice asked the FDA if it should transition to a clinical trial, but added that, “They said, ‘we appreciate this, but we don’t think it’s necessary. Leave these trials recruit patients and you finish that. ‘”
Wright and Joyner have both expressed hope that the FDA will take all the time necessary to make a prudent decision on plasma.
“Even though this is COVID, it’s not unusual,” Joyner said. “The fact that there are discussions between the various senior scientists within the Department of Health and Human Services is not unusual. We are simply doing our duty in trying to get the best data possible under the circumstances of the pandemic. “
Minnesota, Thursday, August 20, reported an additional 698 cases and seven deaths from COVID-19.
Outstate LeSeur and Stearns counties both recorded 21 cases for the day, while suburban Dakota County posted another daily peak with 68 cases. The total laboratory-confirmed cases for the state are now 67,308.
The cumulative number of deaths is 1,745.
The deaths reported Thursday included a Crow Wing County resident, two Ramsey County residents – one in his 40s – and four Hennepin County residents. Two of the seven deaths were in long-term care residents.
The state reported 13,810 additional tests on Thursday. The state’s health systems have now tested over 1 million Minnesotans, or 18.4% of the population.
Hospitals are currently treating 309 residents for COVID-19, and 149 of those in an intensive care facility.
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- Minnesota Department of Health COVID-19 Hotline: 651-201-3920.
- COVID-19 Discrimination Hotline: 833-454-0148
- Minnesota Department of Health COVID-19 website: Coronavirus disease (COVID-19) website.
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