The U.S. Dept. of Health and Human Services, along with the U.S. Defense Dept., agreed to the large-scale production and U.S. delivery deal once Pfizer’s vaccine is successfully manufactured and approved. In addition to the 100 million doses initially agreed upon. the U.S. government will be able to acquire an additional 500 million doses.
Pfizer will deliver the initial 100 million doses if the vaccine candidate receives FDA emergency use authorization (EUA) or licensure once a Phase 3 clinical trial is complete, demonstrating safety and efficacy in the fight against COVID-19. The timing of the agreement is designed to allow quick shipment once approval is garnered in an effort to meet the U.S. government’s “Operation Warp Speed” goal of delivering 300 vaccine doses by the end of 2020.
The Biomedical Advanced Research and Development Authority (BARDA), part of HHS, collaborated with the DoD to provide $1.95 billion for the production and nationwide delivery of the vaccine. Subject to success and approval, Pfizer is set to begin delivery at the beginning of the fourth quarter of 2020 at no cost to the American people, according to a news release.
“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,” HHS Secretary Alex Azar said in the release. “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.”
Pfizer’s collaboration with BioNTech (NSDQ:BNTX) is currently in the Phase I/II clinical trial stage as they investigate the vaccine candidate in the U.S. and Germany. Earlier this week, the companies said early trial results suggested safety and T cell responses in the vaccine, while a separate vaccine candidate from AstraZeneca (NYSE:AZN) and Oxford University is also showing promise.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease