FDA Puts Emergency Approval For Blood Plasma As A Treatment For COVID-19 On Hold

The U.S. Food and Drug Administration put emergency approval of blood plasma to treat COVID-19 patients on hold because federal health officials say the initial data is just too weak, The New York Times reported Wednesday.

Federal health officials, including Dr. Francis S. Collins, the director of the National Institutes of Health, and Dr. Anthony S. Fauci, the federal government’s leading infectious disease expert, argued the emerging data from the blood plasma studies was too weak to justify the emergency approval, two senior administration officials told the Times.

The clinical data came from the largest U.S. plasma study, which was conducted by the Mayo Clinic. Blood plasma donated from patients who have survived the coronavirus and is considered a safe treatment, but initial clinical trials have not shown it is beneficial in fighting the coronavirus.

“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,” Lane told the Times.

While plasma has been used to treat disease since the 1890s, the data collected from the Mayo Clinic, which included more than 35,000 COVID-19 patients, suggested mortality rates dropped when the plasma was infused within three days of diagnosis. However, the study reportedly did not include a control group given placebos to compare the results and determine the effectiveness of the procedure.

The emergency authorization from the FDA would have fast-tracked the use of blood plasma as a COVID-19 treatment, easing stringent data collection requirements.

Emergency approval could still be issued in the near future for the blood plasma, H. Clifford Lane, clinical director at the National Institute of Allergy and Infectious Diseases, told the Times.

The U.S. has reported more than 5.4 million positive cases of the coronavirus and more than 171,000 COVID-19 deaths, Johns Hopkins University tracking data indicate.