July 22,2020: 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.
More on the Pfizer vaccine development: https://www.nytimes.com/2020/07/22/us/politics/pfizer-coronavirus-vaccine.html