Public Health Emergency - Leading a Nation Prepared
December 22, 2021 - U.S. Food and Drug Administration 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 coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 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. Learn More >>
On Dec. 22, 2021, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization 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.
The U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) will oversee the fair and equitable allocation of Paxlovid to state and territorial health departments, and select Health Resources & Services Administration (HRSA) funded health clinics.
The federal government has purchased a total of 10 million courses of Paxlovid. Product will be limited at first and ramp up significantly in the coming months. An initial 65,000 courses of Paxlovid will be made available for shipment to states and territories and will begin arriving at dispensing sites by the end of December. Initial allocations of Paxlovid were determined on a pro rata basis and will be provided to state and territorial health departments for free.
State and territorial health departments will allocate product to dispensing sites across their jurisdictions, and the distributor will ship product directly to receiving sites, which include pharmacies, doctors’ offices, clinics, hospitals, urgent care centers, and local health departments.
Courses of product will continue to be made available to states and territories as supply increases, with shipments occurring every two weeks. An additional 200,000 courses are expected in January, ramping up steadily in the months ahead.
Equity is a top priority in our national COVID-19 response. As part of our commitment to equitable access, the U.S. Department of Health and Human Services will identify a subset of 200 Health Resources and Services Administration (HRSA)- funded health centers across all 50 states to receive an allotment of oral antiviral products during each distribution cycle. This allocation will equal 15% of total product available to the federal government in a given distribution period and will be separate from the pool of product allocated to states and territories. Health departments will have insight into selected HRSA-funded health centers and their product allocations and reporting. This effort will complement the focus you already place on equity by helping ensure these products are accessible to some of the most vulnerable communities and hard-hit populations around the country.
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