An additional 500 million doses can be acquired, and U.S. citizens would receive the vaccine for free, according to the agreement.
A Phase 2b/3 trial of the vaccine, with human subjects, is scheduled to start later this month and will be subject to regulatory review as early as October 2020. If successful, 100 million doses would be manufactured by the end of this year and possibly more than 1.3 billion would be produced in 2021.
“Adding a vaccine from Pfizer and BioNTech” to the government’s Operation Warp Speed inoculation-development program “increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” Health and Human Services Secretary Alex Azar said in a statement.
Operation Warp Speed aims to deliver 300 million doses of a safe and effective COVID-19 vaccine by January 2021. The initiative accelerates the development, production and distribution of tests, treatments and vaccines for the disease, which has reached pandemic proportions worldwide, infecting more than 3 million people in the U.S. and killing 142,000.
Pfizer and BioNTech are currently evaluating four possible COVID-19 vaccines, two of which have received Fast Track designation by the FDA, allowing for an expedited development process.