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Pfizer and BioNTech announced the initiation of a Phase 1 study for their next-generation COVID-19 vaccine candidate BNT162b4. This candidate aims to enhance T cell responses and broaden protection against SARS-CoV-2. The study will enroll around 180 healthy individuals aged 18-55 who have received at least three mRNA vaccine doses. The trial will evaluate various doses of BNT162b4 alongside the bivalent bivalent COVID-19 vaccine targeting Omicron variants. This initiative is part of their long-term strategy for robust and enduring immune responses against COVID-19.

BioNTech announced the acquisition of a GMP-certified manufacturing facility in Singapore from Novartis for establishing its first mRNA manufacturing hub in the Asia Pacific region. This facility aims to support BioNTech's growing pipeline of mRNA-based vaccines and therapeutics, with operations expected to begin in late 2023. The site will create over 100 jobs and is projected to manufacture several hundred million doses of mRNA vaccines annually upon full operational capacity.

BioNTech and Pfizer have received a significant recommendation from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, COMIRNATY, aimed at children aged 5 to 11 years. This follows existing authorization for those aged 12 and above. Clinical trials indicated a strong immune response and a favorable safety profile. The final decision from the European Commission is anticipated soon, which could expand vaccination options for younger populations amidst ongoing COVID-19 challenges.

BioNTech announced financial results for the nine months ending September 30, 2022, reporting revenues of €13.0 billion, slightly down from €13.4 billion in 2021. Net profit increased to €7.2 billion, up from €7.1 billion, with diluted EPS at €27.70. The company raised its 2022 COVID-19 vaccine revenue guidance to €16-17 billion, reflecting the successful launch of its Omicron-adapted bivalent vaccines. BioNTech also expanded its oncology pipeline, starting three new clinical trials, and continues to lead in COVID-19 vaccine distribution, with approximately 300 million doses invoiced by mid-October 2022.

BioNTech and Pfizer announced promising results from a Phase 2/3 trial of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (BNTX). The study revealed that, one month post a 30-µg booster, antibody levels increased 13.2-fold in individuals older than 55 and 9.5-fold in adults aged 18-55, significantly outpacing the original vaccine's 2.9-fold increase. The safety profile remained favorable, resembling that of the original vaccine. The companies plan to share findings with regulatory bodies and continue examining the vaccine’s performance against emerging variants.

Pfizer and BioNTech announced robust results from a Phase 2/3 clinical trial for their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. A 30-µg booster significantly increased neutralizing antibody titers—13.2-fold in adults over 55 and 9.5-fold for those aged 18 to 55 compared to the original vaccine. The safety profile remains favorable, similar to the original vaccine. These findings suggest enhanced protection against Omicron variants and support ongoing evaluations of the vaccine's effectiveness against emerging strains.

BioNTech SE (Nasdaq: BNTX) announced it will release its third quarter 2022 financial results on November 7, 2022. The company invites investors and the public to a conference call and webcast on the same day at 8:00 AM EDT (2:00 PM CEST) to discuss the results and provide a corporate update. Registration for the call is required, and the presentation will be accessible on BioNTech's Investor Relations website. A replay will be available post-call for 30 days.

Pfizer and BioNTech announced on October 19, 2022, that the European Medicines Agency's (EMA) CHMP recommended marketing authorization for a 3-µg dose of COMIRNATY (COVID-19 vaccine) for children aged 6 months to under 5 years. The decision is based on a Phase 2/3 trial with 4,526 participants where the vaccine showed a 73.2% efficacy against COVID-19 with a safety profile similar to placebo. The European Commission is expected to review this recommendation soon. Ongoing discussions regarding potential authorization of an adapted bivalent vaccine for younger children are also in progress.

Pfizer and BioNTech announced early results from a Phase 2/3 clinical trial of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, showing substantial increases in neutralizing antibody responses. Participants receiving a 30-µg booster demonstrated significantly improved immunity against Omicron variants. The vaccine showed a favorable safety profile similar to the original vaccine. Further data on responses one month post-administration are expected soon, aiding potential full licensure and global registration efforts.