Policy & Regulation
Pfizer and BioNTech to Supply Japan with 120 m Doses of their BNT162 mRNA-based Vaccine Candidate
31 July 2020 - - US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) and Germany-based BioNTech SE (NASDAQ: BNTX) have inked an agreement with the Ministry of Health, Labour and Welfare in Japan to supply 120 m doses of BNT162 mRNA-based vaccine candidate against SARS-CoV2, subject to clinical success and regulatory approval, beginning in 2021, the companies said.

Financial details of the agreement were not disclosed, but the terms were based on the timing of delivery and the volume of doses.

As requested by the government of Japan, deliveries of the vaccine candidate are planned for the first half of 2021.

The BNT162 program is based on BioNTech's proprietary mRNA technology and supported by Pfizer's global vaccine development and manufacturing capabilities.

The vaccine development program is evaluating at least four experimental vaccine candidates, each of which represents a unique combination of messenger RNA format and target antigen. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world.

Both collaborators are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making.

Recently, two of the companies' four investigational vaccine candidates BNT162b1 and BNT162b2 received Fast Track designation from the US Food and Drug Administration.

This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies.

On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA's Center for Biologics Evaluation and Research and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study.

BNT162b2 encodes an optimised SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralizing antibodies.

In the late-stage trial, the companies will study a 30 µg dose level in a 2 dose regimen among up to 30,000 participants aged 18 85 years.

It is expected to include approximately 120 sites globally including in regions with significant expected SARS-CoV-2 transmission.

Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorisation or approval is obtained, plan to supply up to 100 m doses worldwide by the end of 2020 and approximately 1.3 bn 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.

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

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.
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