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Pfizer First: Oral Antiviral Paxlovid Wins EUA As Merck’s COVID Pill Languishes At US FDA

 
• By Sue Sutter

Authorized for mild-to-moderate COVID-19 in patients 12 and older at high risk for severe disease, Paxlovid (nirmatrelvir/ritonavir) jumped ahead of Merck & Co./Ridgeback’s molnupiravir in the EUA queue for oral antivirals, with the latter possibly hung up by efficacy and safety concerns.

Crossing finish line
Pfizer beat Merck & Co./Ridgeback to the EUA finish line for COVID-19 oral antiviral treatments. • Source: Alamy

The speed with which the US Food and Drug Administration reviewed and authorized Pfizer Inc.’s COVID-19 treatment Paxlovid may say as much about the agency’s confidence in the antiviral as it does about concerns with Merck & Co., Inc.’s oral antiviral molnupiravir, which was submitted weeks earlier and appears to still be under review.

On 22 December, the FDA granted emergency use authorization to Paxlovid for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and

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