• Supply to be provided over the course of 2021
• Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the COVID-19 pandemic
Pfizer Pakistan and BioNTech SE today announced an agreement with the National Disaster Management Authority, Government of Pakistan to supply 13 million doses of their COVID-19 Vaccine (BNT162b2). Deliveries are planned during course of 2021.
“We are deeply honored to work with the Pakistan government and to marshal our scientific and manufacturing resources toward our shared goal of bringing a COVID-19 vaccine to the people of Pakistan as quickly as possible,” said Syed Muhammad Wajeehuddin, Country Manager Pfizer Pakistan. “In the face of this global health crisis, Pfizer’s purpose – breakthroughs that change patients’ lives – has taken on an even greater urgency. Our hope is that our vaccine will help make this happen.”
“I would like to thank the Pakistan government for its support and putting trust in our ability to develop a vaccine that, we believe, has the potential to help address this global pandemic threat. Our goal remains to deliver a global supply of a well-tolerated and effective COVID-19 vaccine for many people around the world, as quickly as we can,” said Sean Marett, Chief Business and Chief Commercial Officer at BioNTech.
Pfizer and BioNTech aim to manufacture more than 3 billion doses of their COVID-19 vaccine globally in total by the end of 2021, assuming updated six-dose labeling, continuous process improvements, expansion at current facilities and contingent upon adding new suppliers and contract manufacturers.
The vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer, and the marketing authorization holder is BioNTech in the United States, Europe, U.K., Canada, and other countries.
About the Study
The Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, began in late July 2020 and completed enrolled in January 2021 at more than 46,000 participants. A breakdown of the diversity of clinical trial participants can be found at https://www.pfizer.com/science/coronavirus/ vaccine from approximately 150 clinical trials sites in the U.S., Germany, Turkey, South Africa, Brazil and Argentina. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
About Pfizer: Breakthroughs That Change Patients’ Lives
Pfizer has been working for the health and wellbeing of patients in Pakistan for more than 60 years. Our business in Pakistan is part of the global Pfizer Inc. operations, first founded in 1849 in New York, USA. Pfizer Pakistan reach for patients is 20 million of 200 million At Pfizer Pakistan, we provide access to safe, innovative and affordable medicines to millions of Pakistanis. Having a portfolio of medicines that prevent, treat and cure diseases across a range of therapeutic areas allows Pfizer Pakistan to enjoy the reputation of being a leading drug maker in the country. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our operations in Pakistan, please visit us at www.pfizer.com.pk.
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.
BioNTech Forward-looking Statements
This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer regarding a COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our Phase 2/3 trial and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on trial data of BNT162b2 in our Phase 2/3 trial; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimate for 2021. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.
For a discussion of these and other risks and uncertainties, see BioNTech’s Quarterly Report for the Three and Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its Current Report on Form 6-K filed with the SEC on November 10, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.