The US Department of Health and Human Services and the Department of Defense have signed a $1.95 billion agreement with Pfizer Inc and BioNTech SE for 100 million doses of the companies’ COVID-19 vaccine candidate — BNT162 — if and when it receives regulatory approval. The government also has the option to purchase up to 500 million additional doses.
According to Pfizer and BioNTech, the vaccine “remains on track” to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, followed by regulatory review as early as October 2020. They anticipate being able 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.
Americans will receive the vaccine for free consistent with US government’s commitment for free access for COVID-19 vaccines, according to Pfizer.
“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. “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 BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world. BioNTech is the market authorization holder worldwide and will hold all trademarks for the potential product. Both collaborators are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making.
“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. “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.”
“We are pleased to have signed this important agreement with the US government to supply the initial 100 million doses upon approval as part of our commitment to address the global health threat. 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.