BioNTech Results Presentation Deck slide image

BioNTech Results Presentation Deck

Clinical Data Support Label Extension of BNT162b2 to Children 5 to 11 Years of Age¹ Robust immune response in children 5 to 11 years one month after the second dose of BNT162b2 ● ● 50% serum neutralizing titer 100,000 10,000 1000 100 10 BNT162b2 10 µg 5-11 years old (n=264) GMFR (95% CI) 118.2 (109.2, 127.9) 10 (9.9, 10.3) I 1198 (1106.1, 1296.6) Before 1 month vaccination after dose 2 BNT162b2 30 μg 16-25 years old (n=253) GMFR (95% CI) 111.4 (101.2, 122.7) 10 (9.8, 10.8) T 1147 (1045.5, 1257.2) Placebo 5-11 years old (n=130) GMFR (95% CI) 1.1 (1.0, 1.2) 10 (10.0, 10.0) 11 (9.7, 11.8) 1 month Before 1 month Before vaccination after dose 2 vaccination after dose 2 Placebo 16-25 years old (n=45) GMFR (95% CI) 1.0 (1.0, 1.0) 10 (10.0, 10.0) 10 (10.0, 10.0) 1 month Before vaccination after dose 2 Two doses of 10µg administered 21 days apart Well tolerated with mainly transient mild-to-moderate side effects Robust neutralizing antibody responses similar (GMT of 1,197.6) compared to control group 16 to 25 years old (GMT of 1,146.5) at one month post dose two, meeting the predefined immunobridging success criterion 13 1 These data are currently under review by the regulatory authorities and have been submitted for publication. The vaccine has received U.S. EUA for 5 to <12 year olds. A decision has not yet been issued in the E.U. BNT162B2 efficacy across age groups 16 years and older: 95% efficacy against symptomatic COVID-19 in Phase 3 pivotal trial with ~44,000 participants 16 years and older: 91% efficacy against symptomatic COVID-19 and 95.3% efficacy in preventing severe disease through to 6 months post second dose ● ● 12-15 year old children: 100% efficacy against COVID-19 infection and 100% efficacy against severe disease Further pediatric expansion Pediatric cohorts: 2-5 years and 6 months to 2 years of age Data expected in late Q4 2021 or early Q1 2022 ● 5-11 year old children: 90.7% efficacy against symptomatic COVID-19 infection and no cases of severe COVID-19 BIONTECH
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