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FDA issued an emergency use authorization for COVID-19 convalescent plasma treatments following a report on NIH concerns about insufficient studies and data.
On Aug. 23, 2020, FDA issued an emergency use authorization (EUA) for investigational COVID-19 convalescent plasma (CCP) for the treatment of COVID-19 in hospitalized patients, noting in a clinical memorandum that “current data for the use of CCP in adult hospitalized patients with COVID-19 supports the conclusion that CCP meets the ‘may be effective’ criterion for issuance of an EUA.”
The author of the FDA memo, whose name was redacted in the released version of the document, concluded, “It is reasonable to conclude that the known and potential benefits of CCP outweigh the known and potential risks of CCP for the proposed EUA. Current data suggest the largest clinical benefit is associated with high-titer units of CCP administered early in the course of disease.”
The memo also stated the need for “adequate and well-controlled randomized trials” to demonstrate CCP efficacy, determine the optimal product attributes, and identify the patient populations suitable for use
In making the EUA decision, FDA analyzed safety and efficacy data from a National Expanded Access Treatment Protocol (EAP) program initiated by the Mayo Clinic in April 2020. More than 70,000 patients have been treated with CCP.
In an Aug. 23, 2020 press conference, FDA reported that, “Based on an evaluation of the EUA criteria and the totality of the available scientific evidence, the FDA’s Center for Biologics Evaluation and Research determined that the statutory criteria for issuing an EUA criteria were met.”
The agency further noted, “it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients.”
The EUA announcement made by President Donald Trump at a White House press event on Aug. 23, 2020 was met with criticism by medical professionals concerned that the about insufficient randomized controlled clinical trials and concern about the politicization of FDA decision making. In an Aug. 19, 2020 article, the New York Times reported the leading government scientists from the National Institutes of Health warned that data from the Mayo Clinic study were not strong enough to merit an emergency authorization. On Aug. 22, the President expressed his displeasure at the lack of action in a Tweet, suggesting the delay was politically motivated.