Pfizer and BioNTech announced an agreement with the Ministry of Health, Labour and Welfare (MHLW) in Japan to supply 120 million doses of BNT162 mRNA-based vaccine candidate against SARS-CoV2, subject to clinical success and regulatory approval, beginning in 2021.
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 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 (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 the US Food and Drug Administration (FDA). 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 (CBER) 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-neutralising antibodies. In the late-stage trial, the companies will study a 30 µg dose level in a two-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 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021,” informed the companies through a statement.