The Food and Drug Administration announced that an emergency authorization has been issued for the use of convalescent plasma treatment in COVID-19 patients admitted to hospitals.
On the same night, US President Donald Trump talked up the promise that plasma treatment may bring in COVID-19 therapies during a briefing at the White House. In his statement, Trump called plasma treatment as a "powerful therapy." He also stated that it helps through transfusing antibodies from the blood of those who have recovered to sick patients, claiming that the treatment has seen an incredible success rate.
According to ABC, Dr. Stephen Hahn, FDA Commissioner stated that the giving of emergency authorization to use the treatment is a result of the push from the administration which works to reduce red tape.
The approval on the use of plasma treatment came amid the continuous race for an effective treatment against COVID-19, and also the high pressure from the government. Treating COVID-19 using blood plasma from recovered patients has been viewed with high hopes early in the pandemic. However, despite some data that support it many officials stated that it still lacks clinical data, which are still being collected as of the moment.
The authorization coming from the FDA was given due to the fact that the organization has the ability to give license to promising therapies amid dire situations. This authority, however, only encompasses therapied that have been proven as both promising and safe - two qualities that plasma has achieved so far.
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Medical Researchers Claim that Authorization may Cause Set Back in Clinical Trials
However, despite the FDA's authorization and Trump's touting, several researchers and healthcare frontliners have expressed that the move may cause additional difficulty in their work. They claim that the given authorization may cause set back in the trials that they are doing to study convalescent plasma treatment.
In a report by The Hill, Dr. Hollis O'Neal, a researcher who is currently involved in studies regarding plasma treatment, patients who have received the treatment cannot be enrolled in the clinical trials. She also added that if given patients are enrolled, it would create a selection bias and violate the integrity of the trials.
Moreover, NYU Langone Health's infectious diseases specialist Dr. Celine Gounder stated that the authorization will make it harder to conduct placebo-controlled trials. Experts added that this could affect their sample size especially since they are already struggling to recruit volunteers in their randomized clinical trials.
Meanwhile, the FDA also clarified on Sunday that its decision to authorize the use of the treatment is not meant to hinder the clinical trials. The organization also emphasized the importance of said trials.
On the other hand, President Donald Trump was blasted by the American Society for Biochemistry and Molecular Biology (ASBMB), saying that the president is pushing a treatment that is unproven and could endanger the lives of those who will receive it. The organization also added that Trump is putting his political goals on top of the well-being and health of Americans.
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