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Pfizer and BioNTech have initiated a clinical trial for an Omicron-based COVID-19 vaccine candidate aimed at healthy adults aged 18 to 55. The study will enroll up to 1,420 participants across three cohorts, evaluating different regimens of the current vaccine versus the Omicron candidate. Senior officials stress the importance of preparing for potential waning effectiveness of current vaccines. The companies continue to expect production of four billion doses in 2022, regardless of the adaptation requirements.

Pfizer and BioNTech have commenced a clinical trial for an Omicron-based COVID-19 vaccine, evaluating safety and immunogenicity in 1,420 healthy adults aged 18-55. This study will assess various dosing regimens of the existing vaccine alongside the Omicron variant candidate. With the ongoing risk of waning vaccine effectiveness against emerging variants, the companies aim to provide longer-lasting protection. The trial is part of an extensive strategy to address evolving COVID-19 challenges while maintaining production capabilities of the current vaccine.

BioNTech and InstaDeep have developed an Early Warning System (EWS) for detecting high-risk SARS-CoV-2 variants using AI. This scalable system combines structural modeling of the viral Spike protein with predictive analytics, identifying over 90% of WHO-designated variants two months in advance. The EWS can evaluate new variants in minutes and has detected variants like Omicron on the same day their sequences were uploaded. The study, available on BioRxiv, aims to enhance preparedness against future COVID-19 variants.

BioNTech and Crescendo Biologics have announced a multi-target discovery collaboration to develop novel immunotherapies for cancer treatment. BioNTech will have exclusive worldwide development and commercialization rights to the therapies generated from this partnership. Crescendo will receive an upfront payment of $40 million, along with potential milestone payments exceeding $750 million, plus royalties on global net sales. The collaboration will leverage Crescendo's Humabody® VH platform, known for high-affinity binding and enhanced tissue penetration, over an initial term of three years.

Pfizer and BioNTech have announced a collaboration to develop an mRNA-based vaccine for shingles, targeting the herpes zoster virus. This partnership marks their third collaboration in infectious diseases, building on their previous successes with COVID-19 and influenza vaccines. Under the agreement, BioNTech will receive $225 million upfront, while Pfizer will secure $25 million for its proprietary antigen sequences. Clinical trials are set to begin in the second half of 2022, with cost-sharing and profit-sharing on potential vaccine sales.

BioNTech and Pfizer announced a collaboration to develop a potential mRNA-based vaccine for shingles, targeting the herpes zoster virus (HZV) that affects one in three individuals in the U.S. The partnership, their third in infectious diseases, aims to leverage BioNTech’s mRNA technology alongside Pfizer’s antigen technology. Under the agreement, BioNTech will receive $225 million upfront and can earn up to $200 million in future milestone payments. Clinical trials are expected to commence in the latter half of 2022, with Pfizer holding global commercialization rights.

The U.S. FDA has expanded the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include booster doses for individuals aged 12 and older. The booster maintains the same 30-µg dosage as the primary series, addressing rising COVID-19 cases. Additionally, the waiting time for the booster after primary series completion has been reduced from six to five months. A third primary series dose is also authorized for immunocompromised children aged 5-11. Pfizer and BioNTech have delivered 1 billion doses to low- and middle-income countries, with an additional billion expected in 2022.

BioNTech SE (Nasdaq: BNTX) announced that CEO and Co-founder Ugur Sahin will present a corporate overview at the virtual 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 9:45 am ET. A live webcast of the presentation will be accessible on the Company’s website, with a replay available for 30 days post-conference.

BioNTech is a leading biopharmaceutical company specializing in innovative immunotherapies for cancer and other serious diseases. It develops mRNA vaccines and collaborates with major pharmaceutical partners, advancing its oncology pipeline and infectious disease therapies.

Pfizer and BioNTech announced an agreement with the European Commission to deliver over 200 million additional doses of their COVID-19 vaccine, COMIRNATY, in 2022. This brings the total planned doses for the year to more than 650 million. The contract will include potential vaccines adapted for the Omicron variant at no additional cost. Pfizer and BioNTech had previously agreed to supply 900 million doses to the EC for 2022 and 2023, with an option for up to an additional 900 million doses.