FDA authorizes Pfizer pill to treat COVID-19

In clinical trials, Pfizer's antiviral drug reduced the risk of hospitalization or death by 89%.

Paxlovid consists of two types of pills -- nirmatrelvir tablets and ritonavir tablets, co-packaged -- to treat COVID-19.
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Pfizer COVID-19 pills have now been authorized by the US Food and Drug Administration to treat COVID-19 patients. The FDA made the decision to give emergency use authorization to Paxlovid on Wednesday.

"Today's authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic," said Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, in a release.

Pfizer asked for FDA approval for its therapeutic pill a month ago, saying it reduces the risk of hospitalization or death by 89% if given to COVID-19 patients within three days of symptoms appearing, and 88% if administered within five days.

Paxlovid, which is available by prescription only, has been authorized to treat "mild-to-moderate coronavirus disease" in adults and pediatric patients 12 and older who have tested positive for COVID-19, said the FDA. Paxlovid consists of three tablets that are taken together twice daily for five days, for a total of 30 tablets. 

The FDA noted that Paxlovid isn't a substitute for getting vaccinated against COVID-19 and isn't authorized for pre- or post-exposure prevention. 

The Pfizer authorization follows an FDA advisory panel narrowly voting to support Merck's antiviral COVID-19 drug at the end of November, though Merck's has only 30% effectiveness in preventing hospitalization and death.

Both Pfizer and Merck have agreed to share their pill formulas with lower-income countries that have limited access to COVID-19 vaccines, in an effort to stem the tide of serious illness and death.

Pfizer's is the only vaccine that has full approval from the FDA, rather than the emergency use authorization that the Moderna and Johnson & Johnson vaccines have.

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