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Plasma Treatment For COVID-19 Unlikely To Be 'Home Run,' Says Ex-FDA Commissioner

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Plasma Treatment For COVID-19 Unlikely To Be 'Home Run,' Says Ex-FDA Commissioner

The FDA granted emergency authorization of convalescent plasma to treat hospitalized COVID-19 patients on Sunday, and this could be helpful in treating sick people, former FDA  Commissioner Dr. Scott Gottlieb said on CNBC's "Squawk Box."

An Important Distinction: It may be easy to overlook the fact that an emergency authorization designation has a different standard compared to other authorizations, Gottlieb said.

Typically, the FDA would authorize a new therapy only if it is "safe and effective." In contrast, an emergency authorization is reserved only for a public health crisis and needs to satisfy the criteria of "may provide a benefit."

Based on all the data that has been published, it is "reasonable to conclude" that people suffering from COVID-19 could see a benefit from convalescent plasma, he said.

There is no public data to suggest any serious side effects are possible, and the health care system has "a lot of experience" with plasma treatment, the former FDA commissioner said. 

While plasma treatment is unlikely to be a "home run" treatment, it could generate "singles and doubles," Gottlieb said. 

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AstraZeneca's Vaccine Update: The Trump administration is reportedly considering fast-tracking AstraZeneca plc's (NYSE: AZN) coronavirus vaccine for use in the U.S.

AstraZeneca's trial of 10,000 people in the United Kingdom is around 75% enrolled, Gottlieb said, adding that its smaller size compared to other studies implies that it could release findings sooner and receive approval from the relevant U.K. authorities.

The U.S. could feel some pressure to follow the U.K.'s lead and approve the AstraZeneca vaccine based on the results of a foreign study, Gottlieb said.

Related Links:

Ex-FDA Commissioner Analyzes Johnson & Johnson's Mega Vaccine Trial

Novavax's Coronavirus Vaccine Candidate Protects Against Viral Replication In Animal Studies

 

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