Pharmaceutical Intermediate
Important Paxlovid Updates Apr 29 , 2022

Important Information About Paxlovid

Paxlovid (nirmatrelvir/PF-07321332 and ritonavir) is 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. Paxlovid is an oral antiviral drug that should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. Paxlovid is available for patients by prescription only.

Emergency Use Authorization of Paxlovid

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 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.

Allocation and Distribution of Paxlovid

The U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) is overseeing 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 were made available for shipment to states and territories and arrived 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.

 

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