The article asserted that key figures in the Department of Health and Human Services — including National Institutes of Health (NIH) Director Dr. Francis S. Collins and National Institutes of Allergy and Infectious Disease (NIAID) Director 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 via a program administered by Mayo under a special authorization known as an Experimental Access Program (EAP). That is a format that limits the use of plasma for hundreds of health systems too small to participate in trials, funneling their use under the oversight of Mayo Clinic.
There are also ten or so smaller clinical trials now 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 no stocks of plasma at the time. The move protected the FDA from having to issue hundreds of approvals for the treatment, while building standardized protocols for the gathering of plasma. It also collected emerging data on safety, patient selection, dosage.
An EUA, like that issued and then revoked for hydroxychloriquine, would expand the availability of plasma to all, allowing health systems across the country to begin using the treatment. The Times article asserted that federal health officials were concerned that early findings from the Mayo program were not strong enough to warrant an EUA, leading them to halt imminent FDA action.
“We have an expanded access protocol which continues,” said Dr. Michael Joyner, Principal Investigator of the MayoClinic Convalescent Plasma Program. “At some point that may transition to an Emergency Use Authorization. We anticipated that happening relatively soon. It’s delayed now, but the FDA delays things for additional data all the time. “
“My read on this is that there is no delay on the EUA,” said Mayo plasma program clinical researcher Dr. Scott Wright. “We have no idea,” Wright said when asked why an HHS official would have described an impending approval. “The EUA hasn’t come out, but they had never given a timeline or a fixed deadline for it,” he said.
Further clouding the waters, the Times article referenced unnamed “senior health officials” who privately expressed concern about the rapid growth of the Mayo program. The piece asserted that “scientists have struggled to recruit patients for randomized trials” given the availability of a Mayo alternative.
The Mayo program has grown exponentially. Since starting in early April with a plan to treat 5,000 enrollees, Mayo’s plasma program has swelled to 8,000 doctors in 3,000 hospitals serving 100,000 enrollees — 70,000 to 80,000 of whom have now been transfused.
“That’s a false dichotomy,” Joyner said of the idea that Mayo’s huge database of plasma recipients is draining the nation of clinical trial subjects.
“All these people are being treated in places where there would never be trial. Places like Laughton, Okla.” Clinical trial studies, Wright added, are now being conducted in large metropolitan hospitals, locations not suffering for participants.
The Mayo study has looked at four-hour, and seven- and 30-day outcomes in relation to increasing level of antibodies. Early findings from these patients has helped regulators understand the logistics of a plasma program, as well as provide early safety assurances.
The Mayo program has also treated a diverse patient population, one not often studied in clinical trials. Its patients are 20% Black, over 35% Hispanic, 10% Asian and 40% women.
Because it does not have a comparitor group, however, the Mayo data cannot provide proof of effectiveness, a critical hurdle in the approval process, and one the Mayo clinicians readily endorsed .
“We were never asked to do a randomized trial,” Joyner said. “We’re trying to get the safety and access issues squared away and see what we can learn about efficacy.”
Wright says Mayo asked the FDA twice if they should transition into a clinical trial, but added that, “they said, ‘we appreciate that, but we don’t think that’s necessary. Let those trials enroll patients and you finish this.'”
Wright and Joyner both expressed a hope that the FDA takes all the time it needs to make a careful decision on plasma.
“Even though this is COVID, this is not unusual,” Joyner said. “The fact that there is discussion amongst the various senior scientists inside the department of Health and Human Services is not unusual. We’re just doing our duty trying to get the best data we can under the circumstances of the pandemic.”
Minnesota on Thursday, Aug. 20, reported another 698 cases and seven deaths from COVID-19.
Outstate LeSeur and Stearns counties both posted 21 cases for the day, while suburban metro Dakota County posted another daily spike with 68 cases. The laboratory-confirmed case total for the state is now 67,308.
The cumulative death count sits at 1,745.
The deaths reported Thursday included one resident of Crow Wing County, two residents of Ramsey County — including one in their 40s — and four residents of Hennepin County. Two of the seven deaths were among residents of long-term care.
The state reported an additional 13,810 tests on Thursday. The state’s health systems have now tested more than 1 million Minnesotans, or 18.4% of the population.
Hospitals are currently treating 309 residents for COVID-19, and 149 of those in an ICU setting.
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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.