BioNTech Results Presentation Deck
BNT162b2: Global Phase 2b/3 design
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Planned to enroll up to 30,000 participants between 18 and 85 years of age at approximately 120 clinical
investigational sites around world
Designed as 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune
response, and efficacy data needed for regulatory review
Co-Primary endpoints:
Prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization
▪ Prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2
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Secondary endpoints include prevention of severe COVID-19
Design allows for interim analyses and unblinded reviews by independent external Data Monitoring Committee
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Goal of filing for emergency authorization or approval as early as October,
if trial is deemed to be successful
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