BIONTECH - BNTX STOCK NEWS

The FDA has expanded the emergency use authorization for Pfizer and BioNTech's COVID-19 vaccine, allowing a second booster dose for adults aged 50 and older who have had a first booster. This also includes individuals 12 years and older with certain immunocompromises. The additional dose is to be given at least four months after the first booster. Immunogenicity data show significant increases in antibody levels post-second booster, suggesting improved protection against COVID-19 variants, particularly for vulnerable populations. The same formulation as prior doses will be used.

BioNTech SE (Nasdaq: BNTX) is set to announce its financial results for the fourth quarter and full year 2021 on March 30, 2022. The company will host a conference call and webcast for investors and analysts at 8:00 a.m. EDT (2:00 p.m. CEST) to discuss these results and provide corporate updates. Participants can access the webcast via the company’s website, and a replay will be available for 30 days post-call. BioNTech is known for its innovative immunotherapy developments, particularly in mRNA vaccine technology.

Pfizer and BioNTech have submitted an application to the FDA for Emergency Use Authorization (EUA) of an additional booster dose of their COVID-19 vaccine for individuals aged 65 and older. This application is supported by real-world safety and efficacy data from Israel, showing a twofold reduction in confirmed infections and a fourfold reduction in severe illness for those receiving the additional booster compared to those who only received the initial booster. The data suggests that this booster significantly enhances immunogenicity and neutralizing antibodies against the Omicron variant.

BioNTech and Regeneron announced a collaboration to conduct clinical trials for the FixVac candidate BNT116 combined with Libtayo for advanced non-small cell lung cancer (NSCLC). This partnership will focus on advancing clinical development in a patient population with significant unmet medical needs. The investigation will start with Phase 1/2 trials, with development costs equally shared. BNT116, an mRNA-based vaccine, aims to enhance T cell responses against tumor-associated antigens. This initiative builds on previous successful collaborations in melanoma and prostate cancer.

BioNTech and Medigene have initiated a three-year collaboration to develop T cell receptor (TCR) immunotherapies for cancer. BioNTech will acquire a preclinical TCR program targeting PRAME, alongside licenses for Medigene’s PD1-41BB switch receptor and precision pairing technologies. The agreement includes an upfront payment of EUR 26 million to Medigene, with additional milestone payments and royalties based on sales. BioNTech will retain exclusive worldwide development and commercialization rights to resulting therapies, significantly enhancing its cell therapy portfolio.

BioNTech is advancing its efforts to enhance vaccine supply in Africa by developing turnkey mRNA manufacturing facilities. Key leaders from various African nations and international organizations gathered in Marburg to discuss the establishment of an end-to-end manufacturing network. The first facility is planned to start construction in mid-2022 in Senegal. Each BioNTainer can produce up to 50 million doses annually, addressing critical public health needs in the region.

BioNTech SE (Nasdaq: BNTX) announced a high-level meeting in Marburg aimed at promoting sustainable vaccine manufacturing within the African Union. This initiative, led by the kENUP foundation, includes distinguished participants such as the President of Senegal and the Director General of the WHO. Public statements will occur on February 16, 2022, followed by a digital press conference detailing BioNTech's vaccine manufacturing efforts in Africa. This meeting underscores the company's commitment to expanding its vaccine production capabilities.

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) announced plans to extend a rolling submission to the FDA to amend the Emergency Use Authorization for their COVID-19 vaccine, targeting children aged 6 months to 4 years. Ongoing trials are evaluating a three-dose regimen, with data expected in early April, aimed to enhance protection amidst the Omicron surge. The study involves around 8,300 children and is supported by an independent Data Monitoring Committee, underscoring the vaccine's tolerability and potential efficacy.

On February 1, 2022, Pfizer and BioNTech announced submitting data to the FDA for amending the Emergency Use Authorization (EUA) of their COVID-19 vaccine to include children aged 6 months to 4 years. The initial submission seeks authorization for two 3 µg doses, with plans for a third dose in the future. Over 10.6 million children in the U.S. have contracted COVID-19, with a notable increase in hospitalizations among children under 4. If approved, this vaccine would be the first for this age group, addressing a critical public health need.