FDA’s emergency approval of a key coronavirus therapy is on hold

[Chris Smith]

• An unexpected coronavirus treatment update comes from the FDA, which has placed the emergency approval of blood plasma for COVID-19 on hold.
• Health experts, including Dr. Anthony Fauci, think the conclusions from a Mayo Clinic study that enrolled thousands of patients aren’t strong enough and need more scrutiny.
• Empirical evidence and some recent studies have shown that plasma therapy works for some COVID-19 patients. But the most recent studies, including the Mayo research, noted that the treatment works as long as the plasma is rich in antibodies, and it’s administered early in the illness. These were not placebo-controlled studies, however.
• Health experts need answers for this type of therapy and fear an emergency approval would diminish the chances of randomized placebo-controlled plasma studies from happening.

When a pathogen like the novel coronavirus threatens the entire world, doctors and public health officials will come up with all sorts of therapies and measures that can prevent the spread of the illness. That’s what we’ve witnessed with COVID-19 so far. Healthcare workers have tried a variety of drugs to prevent complications and reduce deaths, while officials have come up with protocols that can help limit transmission.

One of the critical treatments tried so far involves plasma transfusions for convalescent patients. Reports from a few months ago proved that the old therapy concept for treating infectious diseases worked on some patients, saving lives in the process. Some studies also showed that plasma could the right answer for some patients, assuming some conditions are met — a large study indicated that plasma should be administered within three days from admission and should be rich in antibodies to reduce complications and deaths. But the Food and Drug Administration (FDA) has temporarily halted the emergency authorization for blood plasma as a COVID-19 treatment. A group of top federal officials, including Dr. Anthony Fauci, have intervened in the process, cautioning that the available data was too weak.

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FDA’s emergency approval of a key coronavirus therapy is on hold originally appeared on BGR.com on Wed, 19 Aug 2020 at 18:40:39 EDT. Please see our terms for use of feeds.

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