NEW YORK and MAINZ, Germany—BioNTech SE and Pfizer Inc. have reported an agreement with the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense, wherein the companies will meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021.
Under the agreement, the 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 either approval or emergency use authorization from the U.S. Food and Drug Administration (FDA).
“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 Alex Azar, secretary of HHS. “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.”
The U.S. government will pay the companies $1.95 billion upon the receipt of the first 100 million doses, following FDA authorization or approval. The government will also be able to acquire up to 500 million additional doses. Americans will reportedly receive the vaccine for free, consistent with the government’s stated commitment for free access to COVID-19 vaccines.
“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,” explained Dr. Albert Bourla, chairman and chief executive officer of Pfizer. “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.”
The BNT162 program is based on BioNTech’s proprietary mRNA technology, and supported by Pfizer’s global vaccine development and manufacturing capabilities. BioNTech is the market authorization holder worldwide, and will hold all trademarks for the potential product. Both collaborators say that they are committed to developing these novel vaccines with preclinical and clinical data at the forefront of all decision-making. The BNT162 vaccine candidates are currently undergoing clinical studies.
“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,” noted Ugur Sahin, M.D., chief executive officer and co-founder of BioNTech. “Our goal remains to bring a safe and effective COVID-19 vaccine to many people around the world, as quickly as we can.”
The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines. Each represents a unique combination of mRNA format and target antigen. Two of the companies’ four investigational vaccine candidates (BNT162b1 and BNT162b2) have recently received Fast Track designation from the FDA. This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the U.S. 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 which may begin as early as later this month, pending regulatory approval.
On July 20, BioNTech and Pfizer announced early positive data from their ongoing German Phase 1/2 trial of BNT162b1. The data, including first T cell response, are available on an online preprint server at medRxiv, and are concurrently undergoing scientific peer-review for potential publication. Overall, the new preliminary data from this German study support and expand upon the recently disclosed early results from the corresponding U.S. trial.
“It is encouraging that the data on BNT162b1 from the German study cohort are very much in line with what we have seen in the U.S. study cohort. The preliminary data indicate that our mRNA-based vaccine was able to stimulate antibody as well as T-cell responses at remarkably low dose levels. We believe both may play an important role in achieving effective clearance of a pathogen such as SARS-CoV-2,” added Özlem Türeci, M.D., chief medical officer and co-founder of BioNTech, in a press release.
If the ongoing studies are successful, Pfizer and BioNTech expect to be ready to seek some form of regulatory approval as early as October 2020. The companies currently 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.
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 and the World Health Organization. The COVAX Facility aims to provide governments with early access to a large portfolio of COVID-19 candidate vaccine candidates, using a range of technology platforms and produced by multiple manufacturers across the world.