Slide 1: Safety and Efficacy of Bivalent RSV Prefusion F Vaccine in Adults ≥ 60 Years of Age
Safety and Efficacy of Bivalent RSV Prefusion F Vaccine in Adults ≥ 60 Years of Age Alejandra Gurtman, MD, FIDSA Vice President, Vaccine Research and Development Medical
Slide 2: Pfizer's RSVpreF Vaccine Candidate Program
Pfizer’s RSVpreF Vaccine Candidate Program Vaccine Bivalent stabilized prefusion F • Sequence based on contemporary RSV A and RSV B strains • Elicited high neutralizing titers for both RSV A and RSV B in Phase 1/2 studies1,2,3 Targeted Indications Maternal Older adult Immunize pregnant women to prev
Slide 3: RSVpreF Older Adult Clinical Development Program
RSVpreF Older Adult Clinical Development Program Study Status Brief Description Age Group First-in-Human C36710011 Dose Ranging Completed +/- Al(OH)3, 18–85 years Phase 1/2 +/- Influenza Vaccine Revaccination C36710022 Completed CpG/Al(OH)3 Adjuvant Safety and Immunogenicity 65–85 years Phase 1/2 WI
Slide 4: RENOIR
RENOIR (The RSV vaccine Efficacy study iN Older adults Immunized against RSV disease): A Phase 3 Study to Evaluate the Efficacy, Immunogenicity, and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Adults Breakthroughs that change patients’ lives® For Pfizer Internal Use On
Slide 5: RENOIR Study Design I
RENOIR Study Design I 240 study sites in 7 countries Targeted enrollment Key inclusion/exclusion criteria Up to 40,000 participants Healthy or with stable chronic Argentina Canada conditions Adults ≥ 60 years Finland Japan Randomized 1:1 to receive Immunocompromised persons Netherlands South Africa
Slide 6: RENOIR Study Design II
RENOIR Study Design II Start of 2nd RSV End of 2nd RSV Informed Vaccination season season Consent Day 1 Day 7 Month 1 Month 6 Reactogenicity Subset Local reactions (N ~ 7,169) Systemic events All participants (N ~ 34,284) SAEs, NDCMCs Unsolicited AEs Weekly active surveillance for acute Weekly activ
Slide 7: Key Study Definitions
Key Study Definitions Weekly active surveillance for ARI symptoms Symptoms trigger nasal swab and possibly a visit Acute Respiratory Illness (ARI) 1 or more of these symptoms (new or worsened from baseline), lasting more than 1 day Nasal Nasal Sputum Shortness discharge congestion Sore throat Cough
Slide 8: Phase 3 Study Objectives
Phase 3 Study Objectives • Describe the safety profile of RSVpreF Local reactions and systemic events within 7 days post-vaccination Safety AEs through 1-month post-vaccination SAEs and NDCMCs throughout study • Prevention of RSV-LRTI in the 1st RSV season Primary VE of 1st episode RSV-LRTI involvin
Slide 9: RENOIR – Statistical Considerations
RENOIR – Statistical Considerations • Preplanned interim analysis (IA), per protocol • Agreement with regulatory agencies on licensure criteria • VE: lower bound of confidence interval >20% • Case definitions (RSV-LRTI, RSV-ARI, RSV-sLRTI) agreed upon with regulatory agencies • Type I error adjustme
Slide 10: RENOIR Results
RENOIR Results Breakthroughs that change patients’ lives® For Pfizer Internal Use Only 10
Slide 11: Demographic Characteristics
Demographic Characteristics (Safety Population) RSVpreF 120 µg Placebo Total (N = 17,215); n (%) (N = 17,069); n (%) (N = 34,284); n (%) Sex Male 8,800 (51.1) 8,601 (50.4) 17,401 (50.8) Female 8,415 (48.9) 8,468 (49.6) 16,883 (49.2) Race1 White 13,475 (78.3) 13,360 (78.3) 26,835 (78.3) Black or Afri
Slide 12: Baseline Characteristics – Prespecified Significant Conditions
Baseline Characteristics – Prespecified Significant Conditions (Safety Population) RSVpreF 120 µg Placebo Total (N = 17,215) (N = 17,069) (N = 34,284) n (%) n (%) n (%) Any prespecified significant condition 8,867 (51.5) 8,831 (51.7) 17,698 (51.6) Heart disease 2,221 (12.9) 2,233 (13.1) 4,454 (13.0)
Slide 13: Local Reactions, by Maximum Severity, within 7 Days After Vaccination
Local Reactions, by Maximum Severity, within 7 Days After Vaccination 100 40 35 Any Pain at Injection Site1 Redness2 Swelling2 30 25 20 15 12.1% 10.5% 10 6.6% 6.0% 5 2.7% 2.4% 0.7% 0.5% 0 RSVpreF Placebo RSVpreF Placebo RSVpreF Placebo RSVpreF Placebo 120µg 120µg 120µg 120µg Mild Moderate Severe 1 S
Slide 14: Systemic Events, by Maximum Severity, Within 7 Days After Vaccination
Systemic Events, by Maximum Severity, Within 7 Days After Vaccination 100 40 Any Fatigue 1 Headache 1 Muscle Pain1 Joint Pain1 Diarrhea2 Nausea1 Fever3 Vomiting4 35 30 27.4% 25.7% 25 20 15.5% 14.4% 15 12.8% 11.7% 10.1% 10 8.4% 7.5% 6.9% 5.9% 5.2% 5 3.4% 3.7% 1.4% 1.4% 0.9% 0.8% 0 RSVpreF Placebo RSV
Slide 15: Adverse Events, by Category, through 1-Month Follow Up and Data Cutoff
Adverse Events, by Category, from Vaccination through 1-Month Follow Up Visit and through Data Cutoff (14Jul2022) — Safety Population RSVpreF 120 µg Placebo (N = 17,215) (N = 17,069) Adverse Event Category n (%) (95% CI) n (%) (95% CI) From Vaccination through 1-Month Follow-Up Visit Any Event
Slide 16: Serious Adverse Events Assessed as Related by the Investigator
Serious Adverse Events Assessed as Related by the Investigator n = 3 (<0.1%) • Hypersensitivity • Delayed allergic reaction • Determined as not anaphylaxis • Miller Fisher Syndrome • Retrospective diagnosis • Anti-GQ1b IgG negative; spinal tap, nerve conduction studies not performed • Brighton crite
Slide 17: Efficacy
Efficacy Breakthroughs that change patients’ lives® For Pfizer Internal Use Only 17
Slide 18: RSVpreF was highly efficacious against RSV-LRTI during the first season
RSVpreF was highly efficacious against RSV-LRTI during the first season Both primary efficacy endpoints met licensure criteria Total cases Case split ≥ 2 RSV-LRTI RSVpreF/Placebo VE 96.66% CI1 44 11/33 66.7% (28.8%, 85.8%) Total cases Case split ≥ 3 RSV-LRTI RSVpreF/Placebo VE 96.66% CI1 16 2/14 85.
Slide 19: RSV-LRTI with ≥ 3 signs/symptoms associated with more severe illness
RSV-LRTI with ≥ 3 signs/symptoms associated with more severe illness Frequency of symptoms, % Percentage Abbreviations: RSV-LRTI, lower respiratory tract illness due to respiratory syncytial virus Percentage Breakthroughs Breakthroughs that change patients’ that change lives® patients’ lives® For Pf
Slide 20: RSVpreF efficacy against RSV-LRTI with ≥ 2 symptoms
RSVpreF efficacy against RSV-LRTI with ≥ 2 symptoms Mean active surveillance: 7 months Abbreviations: RSV-LRTI, lower respiratory tract illness due to respiratory syncytial virus Breakthroughs Breakthroughs that change patients’ that change lives® patients’ lives® For Pfizer Internal Use Only 20
Slide 21: RSVpreF efficacy against RSV-LRTI with ≥ 3 symptoms
RSVpreF efficacy against RSV-LRTI with ≥ 3 symptoms Mean active surveillance: 7 months Abbreviations: RSV-LRTI, lower respiratory tract illness due to respiratory syncytial virus Breakthroughs Breakthroughs that change patients’ that change lives® patients’ lives® For Pfizer Internal Use Only 21
Slide 22: Consistent efficacy was observed across population subgroup analyses
Consistent efficacy was observed across population subgroup analyses ≥ 2 Symptoms Case Split (RSVpreF/Placebo) VE 11/33 66.7% ≥ 4/24 83.4% ≥ 3/14 ≥ 78.7% ≥ 1/5 80.2% 5/17 70.6% ≥ 6/16 62.5% Vaccine Efficacy (%) ≥ 3 Symptoms Case Split (RSVpreF/Placebo) VE ≥ 2/14 85.7% ≥ 3 Symptoms ≥ 1/10 90.0% ≥ 0/5
Slide 23: RSVpreF efficacy against RSV-ARI
RSVpreF efficacy against RSV-ARI Total cases Case split RSV-ARI RSVpreF/Placebo VE 95% CI 80 22/58 62.1% (37.1%, 77.9%) Abbreviations: CI, confidence interval; RSV-ARI, acute respiratory illness due to respiratory syncytial virus; VE, vaccine efficacy. Breakthroughs Breakthroughs that change patient
Slide 24: Consistent efficacy was observed across RSV subgroup A and B
Consistent efficacy was observed across RSV subgroup A and B RSV-LRTI Case Split VE ≥ 2 Symptoms (RSVpreF/Placebo) 1/9 88.9% 10/23 56.5% Vaccine Efficacy (%) Case Split RSV-LRTI (RSVpreF/Placebo) VE ≥ 3 Symptoms * 1/3 66.7% 1/10 90.0% * Lower bound = –393.7 Vaccine Efficacy (%) RSV-ARI Case Split (R
Slide 25: Phase 3 Efficacy Interim Analysis
Phase 3 Efficacy Interim Analysis Safety Conclusions • RSVpreF was safe and well tolerated • Local and systemic events were mostly mild to moderate and short lived • AE profile did not suggest any safety concerns for RSVpreF vaccination in adults 60 years of age and older Efficacy Conclusions • RSVp
Slide 26: Acknowledgments
Acknowledgments Pfizer wishes to thank: • The clinical trial participants • Sites, investigators, CRO, our partners, and their staff Breakthroughs Breakthroughs that change patients’ that change lives® patients’ lives® For Pfizer Internal Use Only 26