According to the FDA, the product may be effective in treating the virus and its known and potential benefits outweigh the known and potential risks, based on available scientific evidence.
The announcement came amid pressure put on the FDA by President Donald Trump, who has made claims that a hold on clearance for plasma was a politically-driven move with eyes on the November election. The president also criticized the FDA on Twitter, claiming that the “deep state, or whoever, over at the FDA” was making it difficult for companies to speed up the testing of their vaccine and therapeutic candidates, again citing a delay with the election in mind.
EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by healthcare providers in treating suspected or laboratory-confirmed COVID-19 in hospitalized patients.
The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of illness caused by the virus in some hospitalized patients. Additionally, the known and potential benefits not only outweigh risks, but stack up against the lack of adequate and approved alternative treatments, the FDA said.
According to a news release, the FDA continues to recommend that designs for randomized clinical trials for COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as it does not represent a standard of care, based on available evidence.
“I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives,” FDA Commissioner Dr. Stephen Hahn said in the release. “We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus.
“At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”
Dr. Scott Gottlieb, who served as FDA Commissioner from 2017 to 2019, took to Twitter to share his thoughts on the EUA for convalescent plasma, agreeing that it met the required standards, but tempering any potential expectations that the treatment could be some sort of definitive cure right now.
Speaking on CNBC’s “Squawk Box,” Gottlieb noted that convalescent plasma treatment “doesn’t look like a home run, but right now we are looking for singles and doubles.”
“Plasma may provide a benefit, and it could be meaningful for certain patients, but we need more evidence to prove it,” Gottlieb Tweeted. “The data FDA had supports an authorization for emergency use, where the standard is “may be effective” but we need better studies to confirm preliminary findings.”