COVID-19 Latest: U.S.FDA Imposes New Rules And Limits Use of COVID-19 Convalescent Plasma Based On New Clinical Trial Findings
: Last Friday, the U.S. Food and Drug Administration (FDA) issued new revisions to its emergency use authorization (EUA) for COVID-19 convalescent plasma on the basis of the latest clinical trial study findings. https://www.fda.gov/media/141477/download?source=email
The new revision stipulates that only high-titer COVID-19 convalescent plasma can be used and only in hospitalized patients who are early in the COVID-19 disease course and those with impaired humoral immunity who cannot produce an adequate antibody response.
This new revisions stem from new clinical trial data analyzed or reported since the original EUA was issued in August 2020. The original EUA did not have these restrictions.
Dr Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing the revisions, "This and other changes to the EUA represent important updates to the use of convalescent plasma for the treatment of COVID-19 patients."
He further added, "COVID-19 convalescent plasma used according to the revised EUA may have efficacy, and its known and potential benefits outweigh its known and potential risks.”
The American regulatory agency said it revoked use of low-titer COVID-19 convalescent plasma on the basis of new data from clinical trials, including randomized, controlled trials that have failed to demonstrate that low-titer convalescent plasma may be effective in the treatment of hospitalized patients with COVID-19.
The U.S. FDA’s updated fact sheet for healthcare providers on the use of COVID-19 convalescent plasma also notes that transfusion of COVID-19 convalescent plasma late in the disease course, following respiratory failure requiring intubation and mechanical ventilation, hasn't been found to have clinical benefit.
It was also noted that the revised EUA now includes several additional tests that can be used to manufacture COVID-19 convalescent plasma.
Dr Marks added, "With this update, nine tests are now included in the EUA for testing plasma donations for anti-SARS-CoV-2 antibodies as a manufacturing step to determine suitability before release.”
There are other speculations circulating around that the indiscriminate use of convalescent plasma is also indirectly causing the rise in mutations and variants of the SARS-CoV-2 coronavirus that are becoming antibody resistant, hence triggering the U.S. FDA to start curtailing its use.
In fact numerous studies have shown that convalescent plasma is not effective in treating COVID-19, but the American regulatory body-the U.S. FDA which has lost its credibility due to scandals involving hydroxychloroquine, remdesivir and various monoclonal protocols to treat COVID-19 still insisted on granting it EUA status last year.
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