December 22, 2021
The U.S. FDA has granted emergency use authorization (EUA) to Pfizer’s Paxlovid™ (nirmatrelvir/ritonavir) to treat mild-to-moderate COVID-19 in adults and pediatric patients at least 12 years of age and weighing at least 40kg (88 pounds).
- Under the EUA, patients must have positive results of direct SARS-CoV-2 testing and be at high risk of progression to severe COVID-19, including hospitalization or death.
- Paxlovid consists of nirmatrelvir oral tablets packaged with ritonavir oral tablets. Nirmatrelvir inhibits SARS-CoV-2 from replicating, and ritonavir helps the nirmatrelvir remain in the body for longer at a higher concentration.
- Recommended dosing is two tablets of nirmatrelvir and one tablet of ritonavir taken together by mouth twice a day for five days. The EUA fact sheet recommends that treatment be initiated as soon as possible after a COVID-19 diagnosis and within five days of symptom onset.
- The FDA has emphasized that Paxlovid is not authorized to treat patients requiring hospitalization for severe or critical COVID-19 or to provide post- or pre-exposure prevention of COVID-19. The agency has also emphasized that the drug is not a substitute for vaccination to prevent COVID-19.