BioNTech Results Presentation Deck slide image

BioNTech Results Presentation Deck

Continued Progress Across Six Key Levers to Expand COVID-19 Vaccine Reach Increased Manufacturing Capacity Global Clinical Program to Generate Data and Support Label Expansion to Additional Populations Regulatory Advancement Across All Geographies Optimize Formulations to Further Simplify Access Worldwide Addressing Waning Immune Reponses Preemptive Prototype Approach to Addressing SARS-CoV-2 Variants 12 ● ● ● ● ● BLA approval in the Unites States for BNT162b2 to prevent COVID-19 in individuals 16 and older Booster dose • U.S. FDA authorization for emergency use in individuals 65 and older, individuals 18-64 at high risk of severe COVID-19, or with frequent exposure, and for third dose in severely immunocompromised individuals ● EC approval in individuals ≥ 18 years of age and for third dose in severely immunocompromised people following positive opinion from EMA CHMP Label extension ● ● Expect to manufacture 2.7 bn to 3 bn doses by end of 2021 Global COVID-19 vaccine supply chain and manufacturing network with more than 20 manufacturing facilities across four continents ● Positive safety and efficacy data reported in children aged 5 to <12 Children cohorts 2-5 years and 6 months to 2 years of age: data expected late Q4 2021 or early Q1 2022 Global Phase 2/3 trial in healthy pregnant women ongoing ● Submitted for variation of CMA to EMA in children 5 to <12 EUA granted in U.S. for children 5 to <12 FDA and EMA authorized storage of current vaccine for up to 9 months at -90 to -60 °C New formulation with further simplified handling and optimized storage - up to 10 weeks at 2 to 8 °C - approved by EC, following positive opinion from EMA CHMP Multiple trials ongoing to address need for booster dose of BNT162b2, including a 10,000-participant efficacy study demonstrating 95.6% relative vaccine efficacy against disease after booster dose during period when Delta variant was prevalent strain Generating data for variant-encoding vaccine candidates to support platform approach to emerging SARS-CoV-2 variants BIONTECH
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