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Pending approval of the Pfizer and BioNTech mRNA-based vaccine candidate against SARS-COV-2, the companies will supply the US government with an initial 100 million doses.
Pfizer and BioNTech announced an agreement with the United States Department of Health and Human Services (HHS) and the Department of Defense to meet the US government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. In a July 22, 2020 press release, the companies said that under the agreement, the US government will receive 100 million doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from FDA. The US government will pay the companies $1.95 billion upon the receipt of the first 100 million doses, following FDA authorization or approval, and can acquire up to an additional 500 million doses.
“We’ve been committed to making the impossible possible by working tirelessly to develop and produce, in record time, a safe and effective vaccine to help bring an end to this global health crisis,” said Dr. Albert Bourla, Pfizer Chairman and CEO, in the press release. “We made the early decision to begin clinical work and large-scale manufacturing at our own risk to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted. We are honored to be a part of this effort to provide Americans access to protection from this deadly virus.”
“Expanding Operation Warp Speed’s diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” said HHS Secretary Alex Azar, in the press release. “Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of this vaccine to the American people.”
“This agreement is one of many steps towards providing global access to a safe and efficacious vaccines for COVID-19. We are also in advanced discussions with multiple other government bodies, and we hope to announce additional supply agreements soon. Our goal remains to bring a safe and effective COVID-19 vaccine to many people around the world, as quickly as we can,” said Ugur Sahin, MD, CEO and co-founder of BioNTech, in the release.
Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial in July, seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021.
The BNT162 program is based on BioNTech’s proprietary messenger RNA (mRNA) technology and is supported by Pfizer’s global vaccine development and manufacturing capabilities.
The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target antigen.
Two of the companies’ four investigational vaccine candidates (BNT162b1 and BNT162b2) received Fast Track designation from FDA. This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the US and Germany as well as animal immunogenicity studies. Further data from the ongoing Phase 1/2 clinical trials of the four vaccine candidates will enable the selection of a lead candidate and dose level for an anticipated large, global Phase 2b/3 safety and efficacy study that may begin as early as later this month, pending regulatory approval.
If the ongoing studies are successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October 2020. The companies currently expect to manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021, subject to final dose selection from their clinical trial.
Pfizer and BioNTech have also provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations (CEPI); and the World Health Organization (WHO) that aims to provide governments with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by multiple manufacturers across the world.