BIONTECH - BNTX STOCK NEWS

Pfizer and BioNTech have secured a new vaccine supply agreement with the U.S. government for 105 million doses of COVID-19 vaccines. The deal is worth $3.2 billion, with doses to be delivered by Q4 2022, potentially including Omicron-adapted vaccines pending FDA authorization. The agreement allows for an additional 195 million doses if required. This effort aims to ensure access to vaccines as COVID-19 variants evolve and will continue to provide free vaccinations to eligible U.S. residents.

Pfizer and BioNTech have announced promising results from Phase 2/3 trials of two Omicron-adapted COVID-19 vaccine candidates, both monovalent and bivalent. A booster dose of these vaccines showed significant increases in neutralizing geometric titers against the Omicron BA.1 variant, with 13.5 and 19.6-fold increases for the monovalent and 9.1 and 10.9-fold for the bivalent candidates at 30 µg and 60 µg doses, respectively. Both candidates demonstrated a favorable safety profile. Data is being shared with regulators for potential rapid introduction, targeting current and future COVID-19 variants.

Pfizer and BioNTech announced positive results from their study of two Omicron-adapted COVID-19 vaccine candidates, a monovalent and a bivalent one. These candidates exhibited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1 at 30 µg and 60 µg doses, respectively. The bivalent vaccine demonstrated a 9.1 and 10.9-fold increase against the same variant. Both candidates showed a favorable safety profile, and data will be discussed with regulatory authorities for potential emergency use authorization.

BioNTech has received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for its investigational product candidate BNT211. This designation aims to enhance regulatory support for the clinical development of BNT211 in treating heavily pretreated testicular cancer patients. The decision follows positive interim Phase 1/2 data showcasing an encouraging safety profile and early anti-tumor activity. BNT211 combines CAR T-cell therapy targeting Claudin-6 with a CAR-T cell amplifying RNA vaccine, potentially offering significant therapeutic benefits.

BioNTech has begun construction of its first mRNA manufacturing facility in Kigali, Rwanda, with the aim of establishing a decentralized vaccine production network in Africa. The facility, which will employ around 100 staff by 2024, is set to receive its first BioNTainers by the end of 2022. This site aims to support local vaccine production for African Union members, including potential malaria and tuberculosis vaccines. The project aligns with BioNTech’s commitment to climate neutrality, utilizing renewable energy sources for operations.

BioNTech will host its first Innovation Series virtual event on June 29, 2022, at 8:00 a.m. EDT. This event aims to offer insights into the company's clinical advancements and technological innovations. Investors and the public can register for a listen-only webcast. Attendees can access the presentation and audio via a provided link, with the platform opening ten minutes before the event. A replay will be accessible for 30 days post-event. BioNTech specializes in pioneering therapies for cancer and infectious diseases, leveraging mRNA technology and global collaborations.

Pfizer Inc. and BioNTech SE have received FDA emergency use authorization for their COVID-19 vaccine, now available for children aged 6 months to 4 years. The 3-µg dose showed a strong immune response and a favorable safety profile similar to the placebo in a Phase 2/3 clinical trial involving 4,526 children. The trial demonstrated immunogenicity comparable to older age groups, meeting regulatory non-inferiority criteria. The vaccine rollout is anticipated to begin following CDC recommendations, ensuring free access for U.S. residents.

The FDA has granted emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine as a 3-µg dose series for children aged 6 months to 4 years. This decision follows a Phase 2/3 clinical trial involving 4,526 children, which demonstrated a strong immune response and a safety profile comparable to a placebo. The vaccine elicited SARS-CoV-2-neutralizing antibody GMTs of 1,535.2 for children aged 2-4 years and 1,406.5 for infants 6-23 months. Vaccinations for this age group are expected to commence following CDC recommendations.

BioNTech will host its African partners in Kigali, Rwanda on June 23, 2022, to mark the groundbreaking of its first mRNA manufacturing facility.

With the delivery of BioNTainer modules expected by the end of 2022, BioNTech plans to enhance vaccine production capabilities on the continent.

High-level attendees include heads of state and representatives from the African Union, European Union, and WHO, showcasing international collaboration in vaccine development.