Pfizer to Provide U.S. Government with an Additional 10 Million Treatment Courses of its Oral Therapy to Help Combat COVID-19
Pfizer Inc. (NYSE: PFE) announced that the U.S. government has committed to purchasing an additional 10 million treatment courses of its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets). This commitment will supplement the 10 million treatment courses previously contracted by the U.S. Government, bringing the total amount of treatment courses to 20 million. Collectively, approximately 10 million PAXLOVID treatment courses have been accelerated for delivery by the end of June, with the remaining 10 million to follow by the end of September.
“With the Omicron variant surging, the availability of and accessibility to treatment options is of utmost importance, as millions of people are being diagnosed with COVID-19 each and every day,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “With data showing significant reductions in hospitalizations and deaths, along with the potential for PAXLOVID to maintain robust antiviral activity against Omicron, we believe this therapy will be an important tool in the fight against COVID-19. We are pleased to be working with the U.S. government to help broaden patient access to this potentially game changing therapy.”
PAXLOVID includes nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer’s laboratories, which was specifically designed to block the activity of the SARS-CoV-2 Mpro, an enzyme that the coronavirus needs to replicate. The U.S. Food and Drug Administration (FDA) recently authorized the emergency use of PAXLOVID for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
PAXLOVID is also currently authorized for conditional or emergency use in several countries across the globe. Pfizer has submitted applications for regulatory approval or authorization to multiple regulatory agencies and anticipates further regulatory decisions to follow.
Please see Full Emergency Use Authorization (EUA) Prescribing Information available at www.fda.gov and www.COVID19oralRx.com. Under the EUA, the U.S. Government and State Governments decide how PAXLOVID is distributed among pharmacies, hospitals, urgent cares, and other entities. Healthcare providers and healthcare facilities should contact their state health department to determine how to access product. Additional information about how the U.S. Department of Health and Human Services will supply PAXLOVID can be found at www.PHE.gov and https://www.hhs.gov/coronavirus/covid-19-treatments-therapeutics/index.html. Locations of publicly available COVID-19 Therapeutics can be found at COVID-19 Public Therapeutic Locator | HealthData.gov.