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Pfizer and BioNTech Receive Health Canada Authorization for XBB.1.5-Adapted Monovalent COVID-19 Vaccine. COMIRNATY Omicron XBB.1.5-adapted monovalent COVID-19 vaccine is now authorized in Canada for individuals 6 months of age and older. New Omicron XBB.1.5-adapted COVID-19 vaccine is administered as a single dose for individuals 5 years of age and older, regardless of COVID-19 vaccination history. In children 6 months through 4 years of age the vaccine is administered as a three-dose series in those without a history of completion of a COVID-19 primary vaccination course, or as a single dose in those with a history of completion of a COVID-19 primary vaccination course. The updated vaccine is expected to be available in Canada in the coming weeks.
Pfizer and BioNTech announce agreement between Pfizer and the Japanese government to provide additional COVID-19 Vaccine Doses for the 2023 Autumn Special Vaccination Program Pfizer Japan Inc. and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today the 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.
BioNTech and CEPI Announce Partnership to Advance mRNA Mpox Vaccine Development and Support CEPI’s 100 Days Mission BioNTech is initiating a Phase 1/2 clinical trial of the mRNA-based mpox vaccine program, BNT166. The Coalition for Epidemic Preparedness Innovations (CEPI) commits funding of up to $90 million for the development of vaccine candidates. Data generated by this partnership will contribute to CEPI’s 100 Days Mission, a global effort to accelerate the development of well-tolerated and effective vaccines against future viral threats with pandemic potential. The partnership is part of BioNTech’s strategy to develop novel prophylactic vaccines for the prevention of high-medical-need infectious diseases, including diseases that disproportionally affect lower-income countries.
Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine This season’s vaccine is tailored to the SARS-CoV-2 XBB.1.5 sublineage and indicated as a single dose for most individuals 5 years of age and older. Pre-clinical data show that the updated COVID-19 vaccine generates improved neutralizing antibody responses against multiple circulating Omicron-related sublineages, including XBB.1.5, BA.2.86 (Pirola) and EG.5.1 (Eris), which currently account for the largest portion of U.S. cases. The companies are working closely with pharmacies, hospitals, and clinics across the country to ensure rapid access to this season’s vaccine.
The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older. Recommendation is based on pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates an improved response against multiple XBB-related sublineages, including XBB.1.5, XBB.1.16, XBB.2.3, and EG.5.1 (Eris), which continue to dominate globally. Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission.