Slide 1: Safety and Immunogenicity of an mRNA-Based Seasonal Influenza Vaccine (mRNA-1010) in Healthy Adults
Safety and Immunogenicity of an mRNA-Based Seasonal Influenza Vaccine (mRNA-1010) in Healthy Adults Mieke Soens, Raffael Nachbagauer, Bryony Hicks, Greg Livermore, Kristi Schaefers, Carole Henry, Angela Choi, Andrei Avanesov, Ren Chen, Evelyn Du, Alicia Pucci, and Jintanat Ananworanich April 29, 202
Slide 2: Disclosures and Acknowledgments
Disclosures and Acknowledgments • Mieke Soens, Raffael Nachbagauer, Bryony Hicks, Greg Livermore, Kristi Schaefers, Carole Henry, Angela Choi, Andrei Avanesov, Ren Chen, Evelyn Du, Alicia Pucci, and Jintanat Ananworanich are employees of Moderna, Inc., and may hold stock or stock options • Medical w
Slide 3: Forward-Looking Statements
Forward-Looking Statements • This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: target product profile; efficacy and safety; and the potential for regulatory approval. In some c
Slide 4: mRNA-1010: A Quadrivalent mRNA-Based Seasonal Influenza Vaccine Candidate
mRNA-1010: A Quadrivalent mRNA-Based Seasonal Influenza Vaccine Candidate • Licensed seasonal influenza vaccines (produced by egg-, cell-, or recombinant-based methods) show variable effectiveness,1-3 particularly due to antigenic mismatch with circulating strains such as A/H3N24,5 • mRNA-based vacc
Slide 5: Phase 3 Study of mRNA-1010 in Adults (NCT05827978)
Phase 3 Study of mRNA-1010 in Adults (NCT05827978) A Randomised, Observer-Blind, Active Controlled Study Evaluating the Safety, Reactogenicity, and Immunogenicity of an Optimised mRNA-1010 Formulation in Adults Participants Safety End Points • 2416 adults ≥18 years old who have not received influenz
Slide 6: Disposition and Demographics
Disposition and Demographics • 2416 participants were randomly assigned; 2401 (99%) received mRNA-1010 or active comparator and were included in the full analysis set • Baseline demographics and characteristics were comparable between vaccine groups • Most participants were White, and not Hispanic o
Slide 7: mRNA-1010 Met All Primary Immunogenicity End Points
mRNA-1010 Met All Primary Immunogenicity End Points Geometric Mean Ratios to Active Comparator at Day 29 Immunogenicity criteria for licensure according to regulatory guidance were met for all coprimary end points • A trend towards higher GMRs with mRNA-1010 versus the comparator was observed in the
Slide 8: mRNA-1010 Met All Primary Immunogenicity End Points
mRNA-1010 Met All Primary Immunogenicity End Points Seroconversion Rate Differences to Active Comparator at Day 29 Immunogenicity criteria for licensure according to regulatory guidance were met for all coprimary end points • Based on prespecified noninferiority criteria, noninferiority was met for
Slide 9: Solicited Local Adverse Reactions
Solicited Local Adverse Reactions Grade 1 Grade 2 Grade 3 • Most local adverse reactions were grade 1 or 2 in severity and resolved within 2 to 3 days • No grade 4 local adverse reactions were reported • Pain and axillary swelling were the most commonly reported local adverse reactions AR, adverse r
Slide 10: Solicited Systemic Adverse Reactions
Solicited Systemic Adverse Reactions Grade 1 Grade 2 Grade 3 Grade 4 • Most systemic adverse reactions were grade 1 or 2 in severity and resolved within 2 days • There were 2 grade 4 events, both of which were fever in the mRNA-1010 group • Fatigue, myalgia, and headache were the most commonly repor
Slide 11: Solicited Adverse Reactions by Age Group
Solicited Adverse Reactions by Age Group Aged 18 to 49 Years Aged 50 to 64 Years Aged ≥65 Years Grade 1 Grade 2 Grade 3 Grade 4 • The frequency and severity of solicited ARs decreased with age and were lowest in adults aged ≥65 years AR. Adverse reaction. Solicited safety set. Aged 18-49: Fluarix, n
Slide 12: No Safety Concerns Were Identified for mRNA-1010
No Safety Concerns Were Identified for mRNA-1010 • Unsolicited AEs were reported at similar rates between mRNA-1010 and the active comparator – Up to day 28 days after vaccination: 11.8% vs 11.4%, respectively – Up to end of study: 23.0% vs 21.5%, respectively – Profiles were similar based on freque
Slide 13: Conclusions
Conclusions • In this phase 3 trial, a single 50 µg dose of optimised mRNA-1010 induced strong immune responses against influenza A and B strains, meeting prespecified noninferiority success criteria for all 8 coprimary immunogenicity end points – Although not prespecified, immune responses were con
Slide 14: Moderna's Investigational Seasonal Influenza Vaccine Strategy
Moderna’s Investigational Seasonal Influenza Vaccine Strategy Seasonal trivalent Using WHO-recommended Established regulatory pathway flu vaccine strains (subject to discussions with regulators) Trivalent (mRNA-1010) vaccine Broader antigen Aims to improve immunity by targeting flu vaccines Adding n
Slide 15: Thank you
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Slide 16: Back-Up Slides
Back-Up Slides © 2024 Moderna, Inc. All rights reserved.
Slide 17: mRNA-1010 Induced Higher HAI Titres Than The Comparator at Day 29 Across All Age Groups
mRNA-1010 Induced Higher HAI Titres Than The Comparator at Day 29 Across All Age Groups for All 4 Influenza Strains The immunogenicity profile of mRNA-1010 relative to the active comparator was consistent across all age groups • Higher GMTs were induced by mRNA-1010 versus the comparator for all str