MAINZ — Pfizer Japan Inc. and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced conclusion of an agreement between the Japanese government and Pfizer Japan Inc. to supply an additional 10 million doses of the Omicron XBB.1.5-adapted COVID-19 vaccine (COMIRNATY Omicron XBB.1.5) for the special vaccination program in Japan which started this autumn.
The vaccine doses to be supplied based on this agreement will be the monovalent vaccine containing messenger RNA (mRNA) encoding the spike protein of the Omicron XBB.1.5 sublineage of the novel coronavirus (SARS-CoV-2) which was applied for approval to the Ministry of Health, Labour and Welfare of Japan on July 7, 2023, and was approved on September 1, 2023. In July 2023, the Japanese government and Pfizer Japan Inc. agreed to supply 20 million doses and additional supplies as needed.
The COVID-19 vaccines (COMIRNATY®) by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY and its adapted vaccines (COMIRNATY Original/Omicron BA.1; COMIRNATY Original/Omicron BA.4/BA.5; COMIRNATY Omicron XBB.1.5.) in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.