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Pfizer says pill to treat COVID-19 could be authorized by end of year or early 2022: 'It is a game changer'
Pfizer has announced that new data confirm its antiviral pill is effective at reducing the risk of hospitalization or death from COVID-19.
The company said Tuesday final trial results confirmed the antiviral pill reduced the risk of hospitalization or death for high-risk COVID-19 patients by 89 percent when given within three days of symptoms developing. This confirmed earlier data from a clinical trial. Pfizer executive Annaliesa Anderson previously told The New York Times that those results were "really beyond our wildest dreams."
Additionally, the company said Tuesday that the pill worked against the new Omicron variant of COVID-19 in lab studies, according to The New York Times.
"This underscores the treatment candidate's potential to save the lives of patients around the world," Pfizer CEO Albert Bourla said.
Pfizer said this new data has been shared with the FDA as part of its Emergency Use Authorization submission, and Bourla told ABC News that the pill could be authorized in the United States by the end of the year or early 2022. "It is a game changer," Bourla also told ABC. "But at the same time, I want to emphasize that no one should use the existence of the pill as an excuse to avoid vaccination."
An FDA advisory panel previously recommended emergency authorization be granted to a COVID-19 pill from Merck. According to CNN, the FDA hasn't yet set a date for when its advisory committee will consider Pfizer's treatment.