The U.S. Department of Health and Human Services and the Department of Defense (DoD) today announced an agreement with U.S.-based Pfizer Inc. for large-scale production and nationwide delivery of 100 million doses of a COVID-19 vaccine in the United States following the vaccine’s successful manufacture and approval. The agreement also allows the U.S. government to acquire an additional 500 million doses.
The federal government will own the 100 million doses of vaccine initially produced as a result of this agreement, and Pfizer will deliver the doses in the United States if the product receives Emergency Use Authorization (EUA) or licensure from the U.S. Food and Drug Administration (FDA), as outlined in FDA guidance, after completing demonstration of safety and efficacy in a large Phase 3 clinical trial.
By entering into this agreement now, a safe and effective vaccine can be shipped quickly if FDA grants EUA or licensure. This approach helps meet the U.S. government’s Operation Warp Speed goal to begin delivering 300 million of doses of safe and effective vaccine to the American people by the end of the year.
“Through Operation Warp Speed, we are assembling a portfolio of vaccines to increase the odds that the American people will have at least one safe, effective vaccine as soon as the end of this year,” said HHS Secretary Alex Azar. “Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of vaccine being developed by Pfizer and BioNTech.”
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command, to provide $1.95 billion for the production and nationwide delivery of the first 100 million doses of the vaccine after EUA or licensure, with the ability to acquire up to an additional 500 million doses.
Subject to technical success and EUA or licensure, the company would begin nationwide delivery of these vaccine doses to locations at the U.S. government’s direction beginning in the fourth quarter of 2020. The vaccine would be available to the American people at no cost. As is customary with government-purchased vaccines, healthcare professionals could charge insurers for the cost of administering the vaccine.
Pfizer is collaborating with BioNTech, a German biotechnology company, to develop COVID-19 investigational vaccines without U.S. government financial support. Phase 1/2 clinical trials are underway for the investigational vaccines in the United States and Germany.
About Operation Warp Speed (OWS):
OWS aims to begin delivery of 300 million doses of an FDA authorized, safe and effective vaccine for COVID-19 by the end of the year as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts, including the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH’s Rapid Acceleration of Diagnostics (RADx) initiative, and work by the Biomedical Advanced Research and Development Authority within the HHS Office of the Assistant Secretary for Preparedness and Response.
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, 55 BARDA-supported products have achieved FDA approval, licensure or clearance. To learn more about federal support for the nationwide COVID-19 response, visit coronavirus.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 threats. As an effective DoD acquisition program, the JPEO-CBRND’s vision is a resilient Joint Force enabled to fight and win unencumbered by a CBRN environment; championed by innovative, agile, results-oriented acquisition professionals. The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) facilitates the advanced development and acquisition of medical solutions to combat CBRN and emerging threats. JPM CBRN Medical works with JPEO-CBRND’s Joint Project Lead for Chemical, Biological, Radiological and Nuclear Defense - Enabling Biotechnologies to provide new and improved medical countermeasures to enable a single treatment for many threats, rapid medical countermeasure responses, genomic sequencing and the capability to diagnose CBRN threats before the onset of symptoms. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus .