FDA halts COVID-19 blood plasma emergency approval

Anthony Fauci speaks at the White House on April 16, 2020
Anthony Fauci, M.D. (C-SPAN)

As the FDA was prepping to allow emergency use of blood plasma donation from recovered COVID-19 patients, government officials have put pay to that.  

The authorization is on hold for now as more data are reviewed, and H. Clifford Lane, M.D., clinical director at the National Institute of Allergy and Infectious Diseases, said an emergency approval could still be issued in the near future, as quoted by The New York Times.

This comes after National Institutes of Health leader Francis Collins, M.D., and COVID-19 response leader Anthony Fauci, M.D., recently questioned how efficacious treatments from it could be.

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It has been touted as a potential treatment by President Donald Trump, but leading scientists want to see more data and robust testing to see whether this is borne out.

The idea is to take blood from those who have had the disease and successfully fought it off; in theory, they should have a high level of antibodies (and the more recent and more ill a patient was appears to be the better for it) that can be used in sick patients struggling to battle the disease.

Essentially, it is using someone else’s antibodies to try to attack the virus in those who haven’t made them, or made enough. But the data on whether this can actually help have been mixed, and studies not always well conducted, leading to questions over how well it can help some of the sickest patients and how well trials into assessing this are being done.

“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,” said Lane in an NYT interview.

The FDA declined to comment on the story.

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