U.S. drugmaker Pfizer said final analysis of its oral antiviral COVID-19 pill showed near 90% efficacy in preventing hospitalizations and deaths in high-risk patients
on Tuesday said final analysis of its antiviral COVID-19 pill still showed near 90% efficacy in preventing hospitalizations and deaths in high-risk patients, and recent lab data suggests the drug retains its effectiveness against the fast spreading Omicron variant of the coronavirus.
Pfizer also released early data from a second clinical trial suggesting that the treatment reduced hospitalizations by around 70% in a smaller trial of standard-risk adults, including some higher-risk vaccinated people. The results were not statistically significant, but Pfizer said they showed a "positive data trend for reduction in risk." The trial did not show that the drug alleviated symptoms of COVID-19 in the same population.
"We're in very advanced regulatory dialogues with both Europe and the UK, and we have dialogues with most of the major regulatory agencies globally," Dolsten said. The FDA's decision could come within a matter of weeks, if not days, said Zarina Saidova, an analyst at Moscow-based Finam Holdings, as the new data confirms what the company previously disclosed and submitted to the regulator.
Some scientists have also raised safety concerns about the potential for birth defects from the Merck drug, as well as worries that it could cause the virus to mutate.
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