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U.S. government engaging Pfizer to produce millions of COVID-19 vaccine doses

Pfizer will deliver the doses in the U.S. if the product receives Emergency Use Authorization or licensure from the FDA.

Jeff Lagasse, Associate Editor

The U.S. Department of Health and Human Services and the Department of Defense announced an agreement today with Pfizer for large-scale production and nationwide delivery of 100 million doses of a COVID-19 vaccine 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 U.S. if the product receives Emergency Use Authorization or licensure from the U.S. Food and Drug Administration, as outlined in FDA guidance, after demonstrating its 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, HHS said. This approach helps meet the U.S. government's Operation Warp Speed goal to begin delivering 300 million of doses of a safe and effective vaccine to the American people by the end of the year.

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WHAT'S THE IMPACT

The Biomedical Advanced Research and Development Authority, 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 and 2 clinical trials are underway for the investigational vaccines in the U.S. and Germany.

THE LARGER TREND

HHS' Operation Warp Speed, an initiative that aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by the peak of the next flu season. It's part of a broader strategy to accelerate the development, manufacture and distribution of coronavirus vaccines, therapeutics and diagnostics – collectively referred to by HHS as "countermeasures."

OWS intends to achieve this goal by investing in and coordinating countermeasure development, in part by partnering with components of HHS, including the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, and the Biomedical Advanced Research and Development Authority,

OWS is also engaging with private firms and other federal agencies, including the Department of Agriculture, the Department of Energy and the Department of Veterans Affairs. It will coordinate 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 BARDA.

Congress has directed almost $10 billion to this effort through supplemental funding, including the CARES Act. Congress has also appropriated other flexible funding. The almost $10 billion specifically directed includes more than $6.5 billion designated for countermeasure development through BARDA and $3 billion for NIH research.

ON THE RECORD

"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."
 

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com