WASHINGTON (New York Times) — 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. Francis S. Collins and 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.
The FDA's emergency authorization for blood plasma as a COVID-19 treatment has been put on hold after top federal health officials warned that evidence for the effectiveness of the treatment was too weak, according to a reporthttps://t.co/32VpUZS9dV— The Daily Beast (@thedailybeast) August 19, 2020
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. Collins, the director of the National Institutes of Health; 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.
Important message from FDA and NIH. Covid-19 Is Creating a Wave of Heart Disease https://t.co/VWSrvpf7KG— Robert M Califf (@califf001) August 19, 2020
“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.