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
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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
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EC approval in individuals ≥ 18 years of age and for third dose in severely immunocompromised people following positive
opinion from EMA CHMP
Label extension
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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
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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
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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
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