Slide 1: Efficacy and Safety of Bivalent RSVpreF Vaccine in Older Adults
Efficacy and Safety of Bivalent Respiratory Syncytial Virus (RSVpreF) Vaccine 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 S. Anderson,5 Kathrin U. Jan
Slide 2: Disclosures
Disclosures • Edward E. Walsh reports grants from Merck, Pfizer, and Janssen; and has served as an unpaid consultant to Novavax, Merck, GlaxoSmithKline, and Janssen. • Fernando Polack holds stock in iTrials SA, and is a consultant for Janssen, Merck, and Novovax. • Ann F. Falsey reports grants from
Slide 3: RSV is a hidden annual epidemic in older adults
RSV is a hidden annual epidemic in older adults True burden in older adults is underestimated because testing is not routinely done and when performed is unreliable Annual burden Important cause of morbidity Who is at risk? US adults 65 years and older and mortality that rivals influenza Older adult
Slide 4: RSVpreF vaccine
RSVpreF vaccine 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 studies1-3 Targeted indications Maternal Older adult Immunize pregnant women to Active immunization to prevent pr
Slide 5: Study design
Study design 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 old Finland Japan Randomized 1:1 to receive Immunocompromised, persons Netherlands South Africa RSVpr
Slide 6: Study schedule
Study schedule Pre-planned 7 days efficacy interim Analysis after Vaccination post-vaccination analysis 1 season Reactogenicity subset Local reactions Based on case (N ~ 6450) Systemic events accrual Primary efficacy Efficacy of RSVpreF in preventing RSV-LRTI with ≥2 or ≥3 symptoms/signs in the firs
Slide 7: Demographic and baseline characteristics
Demographic and baseline characteristics RSVpreF Placebo (N=17,215) (N=17,069) Male, n (%) 8800 (51.1) 8601 (50.4) Race, n (%) White 13,475 (78.3) 13,360 (78.3) Black or African American 2206 (12.8) 2207 (12.9) Asian 1352 (7.9) 1333 (7.8) Hispanic/Latino ethnicity, n (%) 6384 (37.1) 6260 (36.7) Age
Slide 8: RSVpreF was well tolerated
RSVpreF was well tolerated Percentage of participants with reactogenicity events by maximum severity within 7 days after vaccination Local reactions Systemic events Breakthroughs Breakthroughs that change patients’ that change lives® patients’ lives® Confidential 8
Slide 9: RSVpreF was highly efficacious against RSV-LRTI during the first season
RSVpreF was highly efficacious against RSV-LRTI during the first season Frequency of symptoms, % 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 85.7% (32.0, 98.7) 1CI obtained using
Slide 10: RSVpreF efficacy against RSV-LRTI with ≥2 symptoms
RSVpreF efficacy against RSV-LRTI with ≥2 symptoms Mean active surveillance: 7 pts-months Breakthroughs Breakthroughs that change patients’ that change lives® patients’ lives® 10
Slide 11: RSVpreF efficacy against RSV-LRTI with ≥3 symptoms
RSVpreF efficacy against RSV-LRTI with ≥3 symptoms Mean active surveillance: 7 pts-months Breakthroughs Breakthroughs that change patients’ that change lives® patients’ lives® 11
Slide 12: Consistent efficacy was observed across subgroup analyses
Consistent efficacy was observed across subgroup analyses Demographic baseline characteristic * Lower bound = –573.8. ** Lower bound = –302.1. Breakthroughs Breakthroughs that change patients’ that change lives® patients’ lives® 12
Slide 13: 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: ARI, acute respiratory illness; RSV, respiratory syncytial virus; VE, vaccine efficacy. Breakthroughs Breakthroughs that change patients’ that change lives® patients’
Slide 14: Interim analysis conclusions from phase 3 efficacy in adults ≥60 years of age
Interim analysis conclusions from phase 3 efficacy in adults ≥60 years of age Safety • RSVpreF was safe and well tolerated • Local and systemic events were mostly mild to moderate and short lived Efficacy • RSVpreF was highly efficacious in reducing RSV-associated LRTI and ARI through the interim an
Slide 15: Acknowledgments
Acknowledgments The authors wish to thank: • The clinical trial participants • Sites, investigators, CRO, our partners, and their staff Breakthroughs Breakthroughs that change patients’ that change lives® patients’ lives® 15
Slide 16: Backup slides
Backup slides Breakthroughs Breakthroughs that change patients’ that change lives® patients’ lives® 16
Slide 17: ≥2 or ≥3 symptoms, by RSV subgroup
Vaccine efficacy of RSVpreF against first episode of RSV-LRTI with ≥2 or ≥3 symptoms, by RSV subgroup Total cases Case split ≥2 RSV-LRTI RSVpreF/Placebo VE 96.66% CI Overall1 44 11/33 66.7% (28.8, 85.8) Subgroup A 10 1/9 88.9% (10.6, 99.8) Subgroup B 33 10/23 56.5% (−0.7, 82.8) Total cases Case spli