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The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.
Pfizer and BioNTech have announced separate agreements with Japan and Canada to supply their investigational messenger RNA (mRNA)-based COVID-19 vaccine, BNT162, to those countries, pending clinical success and regulatory approvals.
The companies’ agreement with the Ministry of Health, Labor and Welfare (MHLW) in Japan involves supplying 120 million doses of BNT162 mRNA-based vaccine candidate beginning in 2021, Pfizer and BioNTech announced in a July 31, 2020 press release. Financial terms of the agreement were not disclosed, but the terms were based on the timing of delivery and the volume of doses.
“We are deeply honored to work with the Japanese government and to marshal our scientific and manufacturing resources toward our shared goal of bringing millions of doses of a potential COVID-19 vaccine to the Japanese people as quickly as possible,” said Albert Bourla, chairman and CEO, Pfizer, in the company press release.
The agreement with the government of Canada entails supplying the vaccine, also pending clinical success and regulatory approval by Health Canada. As with the Japan agreement, financial details were not disclosed, but the terms were based on the timing of delivery and the volume of doses. As requested by the government of Canada, deliveries of the vaccine candidate are planned for over the course of 2021, the companies stated in an Aug. 5, 2020 press release.
"We continue to be committed to partnering with the Canadian government to help fight this pandemic and are pleased with their collaborative approach to addressing a national COVID-19 immunization strategy with public health officials," said Cole C. Pinnow, president, Pfizer Canada in the press release.
"As the development of effective COVID-19 vaccines continues around the world, we commend the work of Pfizer and BioNTech , which will provide Canadians access to a vaccine candidate for the virus. This agreement is another critical step in our government's efforts to keep Canadians safe and healthy as the pandemic continues to evolve," said The Honorable Anita Anand, minister of Public Services and Procurement, Government of Canada, in the press release.
"This agreement is part of our commitment to address the pandemic by supporting global supply of our vaccine candidate. Our teams are working diligently to advance the lead product candidate through clinical development in order to seek regulatory review as early as October. At the same time, Pfizer and BioNTech continue to scale up manufacturing capacities to be able to produce up to 100 (million) doses in 2020 and more than one billion doses in 2021," said Sean Marett, chief business and chief commercial officer at BioNTech, in the press release.
The BNT162 vaccine development program is based on BioNTech’s proprietary mRNA technology and is supported by Pfizer’s global vaccine development and manufacturing capabilities. The program is evaluating at least four experimental vaccine candidates, each of which represents a unique combination of mRNA format and target antigen. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world.
Recently, two of the companies’ four investigational vaccine candidates—BNT162b1 and BNT162b2—received fast track designation from FDA. Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
In addition to engagements with governments, Pfizer and BioNTech have 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 World Health Organization that aims to provide governments, including those in the emerging markets, 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.