Slide 1: PREVENT-19 Phase 3 Adolescent Results
PREVENT - 19 PHASE 3 ADOLESCENT RESULTS 1 © 2022 NOVAVAX. All rights reserved. February 10, 2022
Slide 2: Safe Harbor Statement
SAFE HARBOR STATEMENT Certain information, particularly information relating to the future of Novavax, its operating plans and prospects, its partn ers hips, the ongoing development of NVX - CoV2373, including Novavax’ plans for a subsequent pediatric study planned for Q2 2022, COVID - NanoFlu combi
Slide 3: PREVENT-19 Phase 3 Trial Design
Randomized, observer - blinded, placebo - controlled trial evaluating efficacy, immunogenicity and safety PREVENT - 19 PHASE 3 TRIAL DESIGN • Primary endpoint : PCR - positive symptomatic mild, moderate or severe COVID - 19 illness diagnosed ≥ 7 days after second dose • 2:1 randomization 3 © 2022 NO
Slide 4: PREVENT-19 Phase 3: Pediatric Expansion to Adolescents
Licensure - enabling Effectiveness Endpoint confirmed with regulators PREVENT - 19 PHASE 3: PEDIATRIC EXPANSION TO ADOLESCENTS 4 © 2022 NOVAVAX. All rights reserved. • Primary Effectiveness Endpoint : Non - inferiority of neutralizing antibody responses versus young adults (18 to <26 years) • Primar
Slide 5: Delta Strain Dominated Prevalence During Efficacy Collection Window
Dose 1 : April 26 – June 5, 2021 Dose 2 : May 17 – July 12, 2021 Per Protocol Efficacy Endpoint Accrual : May 24 – September 27 19B DELTA STRAIN DOMINATED PREVALENCE DURING EFFICACY COLLECTION WINDOW 5 © 2022 NOVAVAX. All rights reserved. Figure source: Nextstrain.org
Slide 6: Demographics Well Balanced Between Placebo and Vaccine
DEMOGRAPHICS WELL BALANCED BETWEEN PLACEBO AND VACCINE, WITH ADEQUATE RACE AND ETHNIC REPRESENTATION 6 © 2022 NOVAVAX. All rights reserved. NVX - CoV2373 n=1,487 Placebo n=745 Female 49.2% 44.2% 12 to <15 years of age 67.1% 67.1% 15 to <18 years of age 32.9% 32.9% White 75.0% 73.2% Black or African
Slide 7: Safety Events Were Balanced Between Vaccine & Placebo
16.3% 6.4% 0.4% 0.1% 0.5% 0.0% 15.8% 6.8% 0.3% 0.1% 0.3% 0.0% 0% 20% 40% 60% 80% 100% Any AE Any Medically Attended AE Any Severe AE AE leading to vaccine discontinuation Serious AE Deaths NVX-CoV2373 Placebo Overview up to crossover SAFETY EVENTS WERE BALANCED BETWEEN VACCINE & PLACEBO 7 © 2022 NOV
Slide 8: Local Reactogenicity: No Difference in Younger vs Older Adolescents
0% 20% 40% 60% 80% 100% 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 Pain Tenderness Redness Swelling 0% 20% 40% 60% 80% 100% 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 Pain Tenderness Redness Swelling Any Grade 3+ Pain Tenderne
Slide 9: Systemic Reactogenicity: No Difference in Younger vs Older Adolescents
Reactogenicity in 12 to <15 y/o vs 15 to <18 y/o SYSTEMIC: NO DIFFERENCE IN YOUNGER VS OLDER ADOLESCENTS 9 © 2022 NOVAVAX. All rights reserved. 0% 20% 40% 60% 80% 100% 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15
Slide 10: Effectiveness Endpoint Achieved: Adolescents Non-Inferior to Adults
LICENSURE - ENABLING EFFECTIVENESS ENDPOINT ACHIEVED: ADOLESCENTS NON - INFERIOR TO ADULTS (18 TO <26 Y/O) Day 35 WT neutralization * response 10 © 2022 NOVAVAX. All rights reserved. Main Study 18 to <26 years Adolescents 12 to <18 years GMT 2,634 (95% CI: 2,389, 2,904) 3,860 (95% CI: 3,423, 4,352)
Slide 11: Day 35 IgG Magnitude Higher Than Adults in Main Study
DAY 35 I g G * MAGNITUDE HIGHER THAN 18 TO <25 Y/O ADULTS IN MAIN STUDY 11 © 2022 NOVAVAX. All rights reserved. 12 to <18 137,671 EU/mL 12 to <15 145,817 EU/mL 15 to <18 121,732 EU/mL 18 to <26 99,386 EU/mL IgG by Age Group GMR = 1.4 (95% CI: 1.2, 1.6) in adolescents vs 18 to <26 y/o * Validated pro
Slide 12: Variant IgG Responses 2-3X Higher Than in Adults
Adolescent IgG following 2 - dose primary series (Day 35) VARIANT I g G RESPONSES 2 - 3X HIGHER THAN IN ADULTS; 100% SEROCONVERSION AGAINST ALL VARIANTS 12 © 2022 NOVAVAX. All rights reserved. Anti - rS IgG Titer (EC50) 1 10 100 1,000 10,000 100,000 1,000,000 Prototype Alpha Beta Delta Delta+ Gamma
Slide 13: Adolescent Functional Immune Responses Against Variants
Adolescent hACE2 receptor inhibition following 2 - dose primary series (Day 35) ADOLESCENT FUNCTIONAL IMMUNE RESPONSES AGAINST VARIANTS 2.4 - 4X HIGHER THAN IN ADULTS 13 © 2022 NOVAVAX. All rights reserved. LOD = 10 50% Receptor Inhibition Titer (log 10 ) 1 10 100 1,000 Prototype Alpha Beta Delta De
Slide 14: Vaccine Efficacy: 79.5%
VACCINE EFFICACY: 79.5% 14 © 2022 NOVAVAX. All rights reserved. • Sequence available for 11/20 cases: 100% of sequenced cases determined to be Delta variant • Lower bound of 95% CI >30% • 95% CI includes estimate from large adult population VE = 90.4% (95% CI: 82.8, 94.6) Efficacy Endpoint: PCR+ mil
Slide 15: Efficacy Consistent Between Adolescent Age Groups
EFFICACY CONSISTENT BETWEEN ADOLESCENT AGE GROUPS 15 © 2022 NOVAVAX. All rights reserved. • Small number of cases yields wide 95% CI • 95% CI include estimate from large adult dataset • Efficacy endpoint : PCR+ mild, moderate or severe COVID - 19 occurring ≥7 days after 2nd dose in baseline seronega
Slide 16: 82.0% Efficacy Against Delta COVID Illness
82.0% EFFICACY AGAINST DELTA COVID - 19 ILLNESS 16 © 2022 NOVAVAX. All rights reserved. • Lower bound of 95% CI >30% • All VOC/VOI were Delta • Efficacy endpoint : PCR+ mild, moderate or severe COVID - 19 occurring ≥7 days after 2nd dose in baseline seronegative participants Sequence is available fo
Slide 17: Summary
SUMMARY 17 © 2022 NOVAVAX. All rights reserved. • No safety signal observed in preliminary dataset up to crossover • Vaccine was well tolerated • Reactogenicity was generally similar or lower magnitude and severity compared to adult part of the study • Overall IgG and wild - type neutralization resp
Slide 18: Next Steps in Pediatric Program
NEXT STEPS IN PEDIATRIC PROGRAM 18 © 2022 NOVAVAX. All rights reserved. • Supplement Global Filings with Pediatric Data: Q1 2022 • Pediatric investigations plan: Agreed to by FDA, MHRA, EMA • Subsequent pediatric study planned for Q2 2022