BioNTech Results Presentation Deck slide image

BioNTech Results Presentation Deck

Significant Progress Across Six Key Levers to Expand COVID-19 Vaccine Reach Increased Manufacturing Capacity Label Expansion to Additional Populations Regulatory Advancement Across All Geographies Optimize Formulations to Further Simplify Access Worldwide Addressing Waning Immune Reponses Addressing SARS-CoV-2 Variants ... 14 EMA, European Medicines Agency; FDA, U.S. Food and Drug Administration; ● ● ● ● ● South African collaboration with Biovac to expand BNT/Pfizer manufacturing network with fill and finish and distribution Continued efforts to establish multi-continent manufacturing capabilities to support global vaccine needs Expansion of authorizations for adolescents 12 years of age and older in U.S., EU and other countries Ongoing trial in children 2 to 11 years and 6 months to 2 years of age: data expected Q3 and Q4 2021 Global Phase 2/3 trial in healthy pregnant women: data expected Q3 2021 U.S. rolling BLA submission finalized; FDA granted priority review; PDUFA date: Jan. 2022 Converting existing emergency use authorizations into regulatory approvals globally Regulatory submission for BLA in China underway Storage at 2-8 °C for 31 days approved by multiple regulators, including EMA and FDA Phase 3 trial for ready-to-use and lyophilized formulations: data expected Q3 2021 ‒‒‒‒‒‒‒‒‒ ‒‒‒‒‒‒‒‒‒‒‒‒‒‒‒‒‒‒‒‒ Expanded trials for third booster dose of BNT162b2 and multiple variant-specific approaches in both vaccine-naive and previously vaccinated individuals 6-12 months post dose 2 Initial, preliminary booster data: ~6 months after dose 2 of BNT162b2 show overall consistent tolerability profile while eliciting SARS-CoV-2 neutralization titers against wild type, Beta and Delta variant BIONTECH
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