Kamada (KMDA)

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Hold off approving plasma for emergency use, Fauci and others warn the F.D.A.: The data isn’t strong enough yet.


Last week, just as the Food and Drug Administration was preparing to issue an emergency authorization for blood plasma as a Covid-19 treatment, a group of top federal health officials including Dr. Anthony S. Fauci intervened, arguing that emerging data on the treatment was too weak, according to two senior administration officials.

The authorization is on hold for now as more data is reviewed, according to H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases. An emergency approval could still be issued in the near future, he said.

Donated by people who have survived the disease, antibody-rich plasma is considered safe. President Trump has hailed it as a “beautiful ingredient” in the veins of people who have survived Covid-19.

But clinical trials have not proved whether plasma can help people fighting the coronavirus.

Several top health officials — led by Dr. Francis S. Collins, the director of the National Institutes of Health, and including Dr. Fauci, the government’s top infectious disease expert, and Dr. Lane — urged their colleagues last week to hold off, citing recent data from the country’s largest plasma study, run by the Mayo Clinic. They thought the study’s data to date 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. Lane said in an interview on Tuesday.

The drafted emergency authorization leaned on the history of plasma’s use in other disease outbreaks and in animal research and a spate of plasma studies, including the Mayo Clinic’s program, which has infused more than 66,000 people with Covid-19 thanks to financing from the federal government.

An F.D.A. spokeswoman declined to comment.

Plasma, the pale yellow liquid left over after blood is stripped of its red and white cells, has been the subject of months of intense enthusiasm from scientists, celebrities and Mr. Trump, part of the administration’s push for coronavirus treatments as a stopgap while pharmaceutical companies race to complete dozens of clinical trials for vaccines.