The Department of Health and Human Services and the Department of Defense announced an agreement 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 pay Pfizer $1.95 billion to own the first 100 million doses of vaccine initially produced as a result of this agreement. Pfizer will deliver the doses if its vaccine receives at least Emergency Use Authorization or licensure from the Food and Drug Administration after completing the 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 the FDA grants EUA or licensure. This approach helps meet the U.S. government’s Operation Warp Speed goal to begin delivering 300 million doses of a 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 the vaccine being developed by Pfizer and BioNTech.”
Pending approval, Pfizer would begin nationwide delivery of the vaccine doses to locations in 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 United States and Germany.