FDA authorizes COVID-19 pills from Pfizer and Merck

The treatment has been cleared for anyone 12 years old and older who is at high risk for severe COVID-19, including hospitalization and death.

December 23, 2021 / Jeff Lagasse, Associate Editor

The U.S. Food and Drug Administration has issued emergency use authorizations for Pfizer and Merck’s antiviral COVID-19 pills.

The FDA gave emergency use authorization to Pfizer’s pill on Wednesday and announced the Merck approval today.

The FDA issued an emergency use authorization (EUA) for Pfizer’s Paxlovid for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients, the agency announced this week.

The treatment has been cleared for anyone 12 years old and older who weigh at least 88 lbs., and for anyone, child or adult, who is at high risk for progression to severe COVID-19, including hospitalization or death.

Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19, and within five days of symptom onset.

Importantly, the drug is not authorized for the prevention of COVID-19, or for treating those already requiring hospitalization due to severe or critical COVID-19. It’s also not a substitute for vaccination in those for whom the shot and a booster dose are recommended.

At the same time, the FDA has also approved an antiviral COVID-19 treatment developed by Merck, which the FDA’s Antimicrobial Drugs Advisory Committee voted 13-10 to authorize earlier this month. 


Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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