Pfizer Paxlovid Updates
On December 22, 2021 the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Pfizer for its oral antiviral drug Paxlovid to treat COVID-19. Paxlovid (nirmatrelvir/PF-07321332 and ritonavir) is now authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adult and pediatric patients age 12 years and older weighing at least 40 kg, with positive SARS-CoV-2 test, who are at high risk for progressing to severe COVID-19, including hospitalization or death.
In a clinical trial of mild to moderately ill outpatients at high-risk for disease progression, Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88% compared to placebo among patients treated within five days of symptom onset.
For additional clinical information on Paxlovid, please see the FDA's FAQ (PDF).
Merck Molnupiravir Updates
On December 23, 2021, the FDA granted Emergency Use Authorization to Merck for it's oral antiviral drug Molnupiravir (MD-4482) to treat COVID-19. Molnupiravir is now authorized for the treatment of mild to moderate COVID-19 in adults age 18 years and older, who are at high risk for progressing to severe COVID-19 and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate.
For additional clinical information on Mulnupiravir, please see the FDA's FAQ (PDF).
Antiviral product is anticipated to begin arriving at the end of December. Initially supply will be very scarce and use will need to be prioritized to patients at highest risk of hospitalization or death.
To find COVID-19 antiviral distributors near you, please visit the U.S. Department of Health and Human Services’ Therapeutics Locator. A prescription from a health care provider is required to receive these medications.
Originally published on December 28, 2021