Pending EUA, U.S. will receive doses starting in 2021 and throughout 2022 as part of contract agreement with Pfizer
As part of its ongoing efforts to curb the pandemic, reduce hospitalizations, and save lives, the Biden Administration has secured 10 million treatment courses of Pfizer’s promising COVID-19 oral antiviral drug, contingent on emergency use authorization (EUA) or approval from the U.S. Food and Drug Administration (FDA).
The investigational drug, Paxlovid, is being developed to treat non-hospitalized, symptomatic adults diagnosed with COVID-19 who are at increased risk of progressing to severe illness that could lead to hospitalization or death. The company recently announced the results of a pivotal phase 2/3 clinical trial which found that a treatment course of one dose every 12 hours for five days reduced the rate of hospitalization due to COVID-19 or death by nearly 90 percent in patients treated within three days of symptom onset. Similar results were found when treated within five days of symptom onset.
“This promising treatment could help accelerate our path out of this pandemic by offering another life-saving tool for people who get sick with COVID-19,” said HHS Secretary Xavier Becerra. “With President Biden’s leadership, we are using all resources at our disposal to prepare for any future pandemic needs. Getting vaccinated remains the most important action anyone can take to help protect themselves and others and end this pandemic, but for people who do get sick in the future and are at risk of severe outcomes, having pills they can take to keep them out of the hospital could be a lifesaver. This agreement would help ensure millions of doses of this drug would be available to the American people if it is authorized."
Paxlovid is a protease inhibitor designed to block an enzyme the SARS-CoV-2 virus needs to replicate in human cells. Protease inhibitors are a class of drugs that prevent viruses from replicating within cells in the human body, which renders them unable to multiply and spread within the body. In laboratory studies, Paxlovid blocked not only SARS-CoV-2 replication but also other coronaviruses. If the drug is found to be effective in treating SARS-CoV-2 infections, future clinical trials could test the drug’s efficacy against other coronaviruses.
Ritonavir is expected to help Paxlovid remain in the human body for longer periods of time to allow the drug to maintain higher concentrations to help combat the virus, and previously has been used in combination with other antivirals for that reason.
Through the purchase agreement, the U.S. government will receive 10 million treatment courses for $5.295 billion, with the first courses delivered by the end of 2021, pending EUA. The Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), collaborated with the Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and Army Contracting Command, on the agreement.
The contract with Pfizer is the latest in the Administration’s antiviral efforts to reduce hospitalizations from COVID-19 and save lives. HHS announced in June it was investing $3 billion from the American Rescue Plan to accelerate the discovery, development and manufacturing of antiviral medicines as part of the Biden Administration’s whole-of-government strategy to develop the next generation of COVID-19 treatments. HHS and DOD also collaborated on an agreement with Merck in June for an antiviral drug to treat non-hospitalized patients who are at high risk for severe illness.
About HHS, ASPR, and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 61 FDA approvals, licensures or clearances. To learn more about BARDA's COVID-19 Portfolio and BARDA’s COVID-19 Response, visit www.medicalcountermeasures.gov.
About the JPEO-CBRND:
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.