CAHAN Disease Notification - CDPH Health Alert - Authorization of Paxlovid
On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms).
The federal government will be allocating Paxlovid to states, and the California Department of Public Health (CDPH) will allocate Paxlovid to jurisdictions based on new COVID-19 cases and an equity measure. Given the limited amount of Paxlovid available, product scarcity is expected. The attached Health Alert outlines suggested prioritization of patients for Paxlovid and ethical considerations in settings of limited availability.
On December 23, 2021, the FDA issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate COVID-19 in adults. More information about the allocation of molnupiravir is coming soon.
For clinical questions, please contact Arnie Spanjers, MD, at arnie.spanjers@acgov.org
For allocation questions, please contact Cynthia Frankel, RN, MN at cynthia.frankel@acgov.org