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BioNTech SE (Nasdaq: BNTX) has initiated a first-in-human Phase 1 clinical study for BNT163, a herpes simplex virus (HSV) vaccine aimed at preventing genital lesions caused by HSV-2 and potentially HSV-1. This study is part of a collaboration with the University of Pennsylvania, addressing a significant unmet medical need as no vaccine for HSV-related conditions is currently available. The trial will recruit about 100 healthy volunteers aged 18-55 to evaluate the safety, tolerability, and immunogenicity of BNT163, which encodes three HSV-2 glycoproteins.

Pfizer and BioNTech Announce FDA Fast Track Designation

On December 9, 2022, Pfizer Inc. and BioNTech SE received Fast Track Designation from the FDA for their mRNA combination vaccine candidate targeting influenza and COVID-19. This designation aims to expedite the development of vaccines addressing serious health conditions. Their Phase 1 trial will assess the vaccine's safety and immunogenicity in healthy adults. This combined vaccine could simplify immunization strategies against evolving respiratory diseases, which pose significant public health challenges.

Pfizer and BioNTech announce the FDA's Emergency Use Authorization (EUA) for their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a third 3-µg dose in the primary vaccination series for children aged 6 months to 4 years. Given the urgent need due to rising COVID-19 cases and respiratory illnesses in young children, vaccine doses will ship immediately upon CDC recommendation. The EUA is supported by clinical data and aims to enhance protection against severe illness in this age group.

BioNTech (Nasdaq: BNTX) and Pfizer announced the FDA's Emergency Use Authorization for their Omicron BA.4/BA.5-adapted bivalent vaccine as a third 3-µg dose for children aged 6 months to 4 years. This addition allows a three-dose primary series, enhancing protection in a vulnerable age group amid increasing COVID-19 and respiratory illness rates across the U.S. Vaccine shipments will commence upon CDC recommendation. The companies aim to broaden access to variant-adapted vaccines for children as they continue combating COVID-19.

BioNTech and Ryvu Therapeutics have initiated a significant collaboration focused on developing small molecule immunotherapies for cancer treatment. BioNTech will acquire an exclusive global license for Ryvu's STING agonist portfolio, receiving a €20 million upfront payment and an additional €20 million equity investment. The collaboration also includes research funding and the potential for further milestone payments and royalties. BioNTech aims to enhance its immunotherapy pipeline utilizing novel immune signaling pathways.

Pfizer and BioNTech announced significant findings regarding their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. One month post a 30-µg booster, neutralizing antibody titers against newer Omicron sublineages increased 3.2- to 4.8-fold compared to the original vaccine. Specifically, antibody levels rose 4.8- to 11.1-fold for sublineages BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1. The bivalent vaccine has been authorized for emergency use in the U.S. and marketed in the EU for individuals 5 years and older, potentially offering improved protection against COVID-19 variants.

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.