US FDA announces emergency authorization for convalescent plasma to treat Covid-19



The FDA said more than 70,000 patients had been treated convalescent plasma, made using the blood of people who have recovered from coronavirus infections.  

On Sunday, a source who is close to the White House Coronavirus Task Force told CNN the FDA had reviewed additional data to inform its impending EUA decision. This official has not personally reviewed the data. They added the FDA is under no obligation to consult anyone outside the agency about its decision.  (they are the buck stops here agency for pharmaceuticals, and their protocols are rigid and sacrosanct) More about that later in one of my next blogs.

Researchers hope this old-fashioned treatment will work for coronavirus.  Convalescent plasma is taken from the blood of people who have recovered from Covid-19. At the end of March, the FDA set up a pathway for scientists to try convalescent plasma with patients and study its impact. It has already been used to treat more than 60,000 Covid-19 patients. However, like blood, convalescent plasma is in limited supply and must come from donors. And while there are promising signals from some studies, there is not yet randomized clinical trial data on convalescent plasma to treat Covid-19. Some of those trials are underway.




Impact of an EUA

The New York Times reported last week an FDA emergency use authorization for blood plasma to treat Covid-19 was on hold after NIH officials intervened. The hold came after a group of federal health officials -- including National Institutes of Health Director Dr. Francis Collins, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci and Dr. H. Clifford Lane, NIAID deputy director -- stepped in to argue the emerging data on the treatment was too weak, the Times reported Wednesday, citing two senior administration sources.

n response to CNN, Dr. Anand Shah, FDA's deputy commissioner for medical and scientific affairs, said he couldn't comment but suggested the NIH was out of line.
"In general, NIH is not involved in the decision-making process at the FDA and does not have the entirety of confidential data the FDA uses to make these regulatory decisions," Shah said in a statement sent to CNN.
"We take seriously our mandate to follow the data and science on the review of medical products to prevent or treat COVID-19 based on the agency's established legal and regulatory standards," Shah added, saying the FDA appreciated the work of NIH and would collaborate with its sister agency.
A senior administration official told CNN's Jim Acosta on Sunday the expected emergency use authorization announcement is an important development.

Comment:  It is surprising. that FDA would make a decision without statistics from the CDC and Anthony Fauci M.D. who heads up the  Coronavirus task force. The reporting is most likely inaccurate.