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FDA Puts Emergency Approval of Coronavirus Blood Plasma Treatment On Hold Over “Weak” Data

FDA Puts Emergency Approval of Coronavirus Blood Plasma Treatment On Hold Over “Weak” Data

The Food and Drug Administration halted its emergency approval for blood plasma as a coronavirus treatment after top health officials intervened, The New York Times reports.

The FDA was set to issue an emergency authorization for medical professionals to use plasma donated by recovered coronavirus patients as a treatment for the virus.

But top officials, including Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and Dr. Francis Collins, the head of the NIH, argued that the data supporting blood plasma as a treatment was “too weak,” according to the report.

An emergency approval may still be issued in the near future.

Data is limited:

Clinical trials have not shown whether plasma can help treat people infected with the coronavirus.

The top health officials, including Fauci and Collins, argued that a recent study by the Mayo Clinic was “not strong enough to warrant an emergency approval.”

“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Dr. H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases, told the Times.

Experts worry about Mayo Clinic program:

Top health officials have expressed concerns over the Mayo Clinic program, warning that it may be growing too fast and rushing to declare the treatment effective.

“We want to make sure that when we say it works, we are confident, with indisputable evidence,” Dr. Mila Ortigoza, an infectious disease specialist at N.Y.U. Langone Health, told the Times. “We’re dealing with patients’ lives here.”

The program has grown more than 30 times larger than expected.

It “ballooned to a degree that, you know, is becoming unmanageable,” Dr. Lane told the Times.

The treatment requires large randomized trials to prove to be effective but an emergency approval could make it difficult for doctors to determine whether it works.

“We will keep going, because we’re in desperate need of a randomized placebo-controlled trial for convalescent plasma,” Ortigoza said. “This is something our country and the world really needs right now.”