Slide 1: RSV Data Review and COVID-19 Vaccine Business Update
RSV Data Review and COVID-19 Vaccine Business Update October 20, 2022 Breakthroughs that change patients’ lives 1
Slide 2: Forward-Looking Statements and Other Notices
Forward-Looking Statements and Other Notices This presentation and our discussions during this conference call will include forward-looking statements that are subject to substantial risks and uncertainties, many of which are beyond our control, that could cause actual results to differ materially f
Slide 3: Agenda
Agenda Speaker Introductions RSV RENOIR Phase 3 Data RSV Commercial Considerations COVID Vaccine US Commercial Framework Question & Answer Session RSV and COVID-19 Update 3
Slide 4: Speakers
Speakers Annaliesa Anderson, Ph.D., FAAM William Gruber, M.D., FAAP, FIDSA Angela Lukin SVP and CSO SVP, Vaccine Clinical R&D Global Primary Care and US President Vaccine R&D Christopher Stevo SVP, Chief Investor Relations Officer RSV and COVID-19 Update 4
Slide 5: RSV – Introduction
RSV – Introduction Annaliesa Anderson, PhD, FAAM Breakthroughs that change patients’ lives 5
Slide 6: RSV Causes High Rates of Severe Disease
RSV Causes High Rates of Severe Disease RSVpreF Vaccine Candidate Designed to Generate Potent RSV Neutralizing Antibodies Targeted Indications Maternal Older adult (≥65 years) Annual Global Burden: ~6.6M infants Annual U.S. Burden: ~177,000 hospitalized, <6months sickened, ~45,000 deaths1 ~14,000 de
Slide 7: Efficacy and Safety from Phase 3 Study of Bivalent RSVpreF Vaccine Candidate in Older Adults
Efficacy and Safety from Phase 3 Study of Bivalent Respiratory Syncytial Virus (RSVpreF) Vaccine Candidate in Older Adults Edward E. Walsh,1 Fernando Polack,2 Agnieszka M. Zareba,3 Ann R. Falsey,1 Gonzalo Pérez Marc,4 Qin Jiang,3 Katherine Schneider,5 David Cooper,5 Maria Maddalena Lino,6 Annaliesa
Slide 8: RENOIR Interim Analysis Read-Out
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 Interim Analysis Read-Out William Gruber, M.D., FAAP, FIDSA Breakthro
Slide 9: Study Design of the Ongoing RENOIR Phase 3 Trial
Study Design of the Ongoing RENOIR Phase 3 Trial 240 Study Sites in 7 Countries Targeted Enrollment Key Inclusion/Exclusion Criteria Argentina Canada Up to 40,000 participants Healthy or with stable chronic Adults ≥60 years old conditions Finland Japan Randomized 1:1 to receive Immunocompromised, RS
Slide 10: 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
Slide 11: 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 Sore Sputum Shortness discharge congestion throat Cough
Slide 12: RSVpreF Vaccine Candidate Was Well Tolerated
RSVpreF Vaccine Candidate Was Well Tolerated Systemic events similar between vaccine and placebo groups Percentage of Participants with Reactogenicity Events by Maximum Severity Within 7 Days After Vaccination Local Reactions Systemic Events RSV and COVID-19 Update RSV and Comirnaty Update Breakthro
Slide 13: RSVpreF Vaccine Candidate: Well Tolerated with Favorable Safety Profile
RSVpreF Vaccine Candidate: Well Tolerated with Favorable Safety Profile 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 1,544 (9.0) (8.5, 9.4) 1,453 (8.5) (8.1, 8.9) Related 23
Slide 14: RSVpreF Highly Efficacious Against RSV-LRTI During the First Season
Phase 3: RSVpreF Vaccine Candidate Was Highly Efficacious Against RSV-LRTI During the First Season Both primary efficacy endpoints met prespecified licensure criteria Increasing Total cases Case split severity ≥2 RSV-LRTI RSVpreF/Placebo VE 96.66% CI1 44 11/33 66.7% (28.8%, 85.8%) Total cases Case s
Slide 15: Efficacy Against RSV-LRTI with ≥2 Symptoms
Phase 3: RSVpreF Vaccine Candidate Efficacy Against RSV-LRTI with ≥2 Symptoms Mean active surveillance: 7 pts-months RSV and COVID-19 Update RSV and Comirnaty Update Breakthroughs that change patients’ lives® 15
Slide 16: Efficacy Against RSV-LRTI with ≥3 Symptoms
Phase 3: RSVpreF Vaccine Candidate Efficacy Against RSV-LRTI with ≥3 Symptoms Mean active surveillance: 7 pts-months RSV and COVID-19 Update RSV and Comirnaty Update Breakthroughs that change patients’ lives® 16
Slide 17: RSV-LRTI with ≥3 Signs/Symptoms Associated with More Severe Illness
Phase 3: RSV-LRTI with ≥ 3 Signs/Symptoms Associated with More Severe Illness Frequency of symptoms, % Percentage Percentage Abbreviations: RSV-LRTI, lower respiratory tract illness due to respiratory syncytial virus RSV and COVID-19 Update RSV and Comirnaty Update Breakthroughs that change patients
Slide 18: Consistent Efficacy Observed Across Subgroup Analyses
Phase 3: Consistent Efficacy Observed Across Subgroup Analyses Demographic Baseline Characteristics * Lower bound = –573.8; ** Lower bound = –302.1 RSV and COVID-19 Update RSV and Comirnaty Update Breakthroughs that change patients’ lives® 18
Slide 19: RSVpreF Vaccine Candidate Efficacy Against RSV-ARI
Phase 3: RSVpreF Vaccine Candidate 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: ARI, acute respiratory illness; RSV, respiratory syncytial virus; VE, vaccine efficacy. RSV and COVID-19 Update RSV and Comirnaty Update Bre
Slide 20: Interim Analysis Conclusions from Phase 3 Efficacy in Adults ≥60
Interim Analysis Conclusions from Phase 3 Efficacy in Adults ≥60 Years of Age • RSVpreF was well-tolerated with no safety concerns Safety • Local and systemic events were mostly mild to moderate and short lived • RSVpreF was highly efficacious in reducing RSV-associated LRTI and ARI Efficacy through
Slide 21: RSV Unmet Need and Next Steps & COVID-19 Vaccine Business Update
RSV Unmet Need and Next Steps & COVID-19 Vaccine Business Update Angela Lukin Breakthroughs that change patients’ lives 21
Slide 22: Pfizer's RSV Pipeline Portfolio: Prevention & Treatment Approach
Pfizer’s RSV Pipeline Portfolio: Prevention & Treatment Approach RSVpreF Vaccine Candidate Sisunatovir for PREVENTION* for TREATMENT* Providing potential protection Potential treatment option for patients across generations who become infected Bivalent stabilized prefusion F Antiviral RSV F-protein
Slide 23: RSV: Significant Cause of Serious Respiratory Illness in Older Adults
RSV: Significant Cause of Potentially Serious Respiratory Illness & Hospitalization in Older Adults Common cause of Worst outcomes in 1.5M annual cases of Estimated annual cost acute respiratory illness older adults2 and those RSV-ARI in adults aged ≥65 among adults hospitalized in adults aged ≥651
Slide 24: RSV Older Adult: Phase 3 Study Start to Potential BLA Approval in <2 Years
RSV Older Adult: Phase 3 Study Start to Potential BLA Approval in <2 Years 2021 2022 2023 Breakthrough Phase 3 Therapy Interim BLA RENOIR Potential BLA Anticipated Potential Designation Analysis Submission Study Start Approval ACIP Vote* Launch* Granted (Aug 2022) (2H 2022) (Aug 2021) (Mar 2022) • U
Slide 25: RSV Maternal: Significant Burden of Disease in Infants
RSV Maternal: Significant Burden of Disease in Infants, with Hospitalizations Concentrated in First Year of Life Leading cause of Infection can lead Globally, RSV sickens Supportive care global infant to respiratory distress ~6.6M infants measures. Antibody respiratory disease1,2 and death1,3 <6 mon
Slide 26: COVID-19 Vaccine Business Update
COVID-19 Vaccine Business Update Angela Lukin Breakthroughs that change patients’ lives 26
Slide 27: Transition to a Traditional Commercial Marketplace
Transition to a Traditional Commercial Marketplace Successful vaccination helps save lives, prevent hospitalizations and reduce healthcare costs COVID-19 vaccination Approximately 235,000+ Vaccination against Reductions in COVID-19 was linked to 650,000 lives have been saved COVID-19 was linked to h
Slide 28: Pfizer Commercial Leadership
Pfizer Commercial Leadership Decades of Commercial Launch Experience Robust and Longstanding and Deep Proven and Reliable Leading Share Differentiated Relationships with Manufacturing of Voice Among Contracting Models Key Stakeholders and Distribution Consumers RSV and COVID-19 Update 28
Slide 29: Questions? Answers.
Questions? Answers. RSV and COVID-19 Update 29
Slide 30: Thank You
Thank You Breakthroughs that change patients’ lives 30