COVID-19Regulatory

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

July 22, 2020 / 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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