July 23, 2020 -- Pfizer and BioNtech have inked an agreement with the U.S. Department of Health and Human Services and the Department of Defense, as part of the federal government's Operation Warp Speed, to deliver 300 million doses of the BNT162 vaccine candidate in 2021.
Under the agreement, the U.S. government will receive 100 million doses of the vaccine after Pfizer successfully manufactures and obtains approval for an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA).
In exchange, the U.S. government will pay the companies $1.95 billion upon receiving the first 100 million doses, to be provided for free to Americans. The government can then acquire an additional 500 million doses.
BNT162, the messenger RNA (mRNA) SARS-CoV-2 vaccine candidate, has received fast-track designation from the FDA based on ongoing phase I/II clinical trials and phase IIb/III trials are expected to begin later this month.
The companies will seek the EUA or other regulatory approval of the vaccine candidate as early as October 2020, and they expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021.
The companies are also considering supplying the vaccine to the Covax facility, established by Gavi, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization. Covax aims to provide governments with early access to COVID-19 vaccine candidates produced by multiple manufacturers across the world.