First antiviral treatments for COVID-19 authorized by Food and Drug Administration

This week, the Food and Drug Administration (FDA) authorized two oral antiviral treatments for COVID-19 disease:

  • Pfizer’s drug Paxlovid for treatment of mild-to-moderate COVID-19 for adults as well as children age 12 and older weighing at least 40 kg (88 pounds) who are at high risk of severe COVID-19 because of age or underlying medical conditions.
  • Merck’s drug Molnupiravir for treatment of mild-to-moderate COVID-19 in adults age 18 and older who are at high risk of severe COVID-19 and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.

Different antiviral treatments work in different ways.

Paxlovid is an oral antiviral that inhibits the replication of SARS-CoV-2 virus in the body by binding to an enzyme crucial to the virus’ function and reproduction.

Molnupiravir is an oral antiviral that disrupts replication of the virus’s genetic material.

In clinical trials, Paxlovid reduced hospitalization and death in people with COVID-19 by 88% when received within five days of symptom onset. Molnupiravir was found to reduce risk of hospitalization and death by about 30%

Both products are authorized for use in vaccinated and unvaccinated people. Treatment should begin as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. Neither is authorized for people with severe COVID-19 who require hospitalization. Molnupiravir is not recommended for use by pregnant people or children.

Supply of these antiviral products is limited nationwide. The federal government will distribute these medicines to states during the first week in January 2022. Shipments are expected to occur every two weeks and increase as supply increases.

The Oregon Health Authority’s distribution plan is centered on equity to ensure those disproportionately affected by the pandemic have access to appropriate treatment. The products will be distributed on request, with priority given to Tribal clinics, federally qualified health centers, local public health and hospitals.

While treatments are beginning to emerge, vaccination, boosters, physical distancing and use of face covers remain the most effective ways to guard against severe disease caused by COVID-19.

People should talk with their healthcare provider about whether these medicines may be right for them.