FDA Authorizes Two Oral Antiviral Treatments for COVID-19

Two oral antiviral treatments for COVID-19 recently received emergency use authorization by the U.S. Food & Drug Administration (FDA): Pfizer’s Paxlovid tablets and Merck's molnupiravir capsules.

Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) is for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older, weighing at least 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are 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. It is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19. Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.

Molnupiravir is for the treatment of mild-to-moderate COVID-19 in adults at high risk of severe illness. High risk people include adults aged 65 and over and people with certain medical conditions. Molnupiravir 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. It is not authorized for use in patients younger than 18 years of age, because molnupiravir may affect bone and cartilage growth. It is also not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19, because benefit of treatment has not been observed in people when treatment started after hospitalization due to COVID-19. The FDA also states that molnupiravir should only be used when other COVID-19 treatments are unavailable.