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Pfizer said it submitted a New Drug Application for Paxlovid to
the Food and Drug Administration for the treatment of COVID-19
in vaccinated and unvaccinated people at high risk for
progression to severe illness.
That is basically consistent with the drug's current EUA, which
Pfizer said covers 50% to 60% of the U.S. population, citing
estimates from the U.S. Centers for Disease Control and
Prevention.
The two-drug treatment taken for five days beginning shortly
after onset of COVID symptoms reduced the risk of
hospitalization or death by 88% in non-hospitalized, high-risk
adult patients in Pfizer's clinical trial, which did not
included vaccinated people.
Data from a study in Israel earlier this month showed Paxlovid
reduced COVID-19 hospitalization and death rates in vaccinated
and unvaccinated patients 65 years and older, but was not found
to prevent severe illness among younger adults.
More than 1.6 million courses of Paxlovid have been administered
in the United States, according to data from the Department of
Health and Human Services.
(Reporting by Michael Erman; Editing by Bill Berkrot)
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