The United States government has reached into an agreement worth $1.95 billion with US-based vaccine maker Pfizer and German biotechnology company BioNTech to produce and deliver 100 million doses of their COVID-19 vaccine candidate.
The arrangement also provides the U.S with the rights to procure an additional 500 million doses if required. Americans are expected to receive the vaccine for free subject to at least an emergency approval by the Food and Drug Administration (FDA).
Pfizer will present the doses if the product gains Emergency Use Authorization or licensure from the U.S. FDA, after completing the demonstration of safety and efficacy in a large Phase 3 clinical trial.
Large-scale safety and efficacy trials are expected to begin this month, with an administrative examination of results to be conducted as early as October.
The US health secretary Alex M. Azar II said “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.”
Unlike other competitors such as AstraZeneca, Johnson & Johnson and Moderna, Pfizer has did not get a contract for its initial research and development efforts but only for producing and distributing the doses.
John Young, Pfizer’s chief business officer added, “We didn’t accept the federal government funding solely for the reason that we wanted to be able to move as quickly as possible with our vaccine candidate into the clinic.”