Moderna : ESCMID 2026 (mRNA-1083 Phase 3 study in adults 50+ in Japan)

MRNA

Published on 04/19/2026 at 08:20 am EDT

Hiroyuki Fukase, Alexander Rumyantsev, Osamu Kogawara, Koichi Hashizume, Seun Osibajo, Lusine Kostanyan

April 18, 2026

Presented at The European Society of Clinical Microbiology and Infectious Diseases

Munich, Germany

© 2026 Moderna, Inc. All rights reserved.

Alexander Rumyantsev, Seun Osibajo, and Lusine Kostanyan are employees of Moderna, Inc., and may hold stock or stock options

Osamu Kogawara and Koichi Hashizume are employees of Moderna Japan Co., Ltd. and may hold stock or stock options

Fukase Hiroyuki has no conflicts of interest to disclose

Medical writing and editorial assistance were provided by Agnieszka Looney, PhD, of MEDiSTRAVA in accordance with Good Publication Practice guidelines (GPP 2022), funded by Moderna, Inc., and under the direction of the authors

This study was funded by Moderna, Inc.

Additional information

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For additional information please contact Lusine Kostanyan ([email protected])

2 © 2026 Moderna, Inc. All rights reserved. Fukase H, et al. Immunogenicity, reactogenicity, and safety of an mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine, mRNA-1083, in adults aged ≥50

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 cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this presentation are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those described in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at https://www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements in this presentation in the event of new information, future developments, or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

© 2026 Moderna, Inc. All rights reserved. Fukase H, et al. Immunogenicity, reactogenicity, and safety of an mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine, mRNA-1083, in adults aged ≥50

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Influenza and COVID-19 remain major causes of morbidity worldwide and in Japan, particularly among older adults1,2

Despite vaccine availability, uptake of influenza and COVID-19 vaccines remains below WHO-recommend levels3-5

Viral evolution and seasonal circulation support the need for recurrent immunization strategies6,7

mRNA-based vaccines are a well-established vaccine platform capable of inducing robust immune responses with favorable safety profiles, demonstrating effectiveness across diverse populations, including older adults8

A combined influenza and COVID-19 vaccine could simplify vaccination within increasingly complex immunization schedules and improve vaccine coverage9

In a phase 3 study in the United States(NCT06097273), mRNA-1083, an investigational multicomponent mRNA vaccine targeting seasonal influenza and SARS-CoV-2, met non-inferiority criteria; higher immune responses were induced with mRNA-1083 compared with recommended standard-of-care influenza and COVID-19 vaccines against SARS-CoV-2 and the 3 clinically relevant influenza strains in adults ≥50 years; mRNA-1083 also had an acceptable safety and tolerability profile10

APAC, Asia-Pacific WHO, World Health Organization.

1. Arashiro T, et al. Influenza Other Respir Viruses. 2024;18(11):e70032. 2. WHO. WHO COVID-19 Dashboard. https://data.who.int/dashboards/covid19/cases?n=c. 3. WHO. Global COVID-19 vaccination strategy in a changing world: July 2022 update. https://www.who.int/publications/m/item/global-covid-19-vaccination-strategy-in-a-changing-world--july-2022-update 4. WHO. Understanding the drivers of influenza vaccine uptake. https://www.who.int/news-room/feature-stories/detail/understanding-drivers-of-influenza-vaccine-uptake 5. Goldin S, et al. Vaccine. 2024;42:126274. 6. Centers for Disease Control and Prevention. How Flu Viruses Can Change: "Drift" and "Shift". https://www.cdc.gov/flu/about/viruses/change.htm. 7. Yewdell, J.W. Immunity, 2021. 54(12):2681-2687. 8. Gote V, et al. Int J Mol Sci. 2023; 24: 2700. 9. Domnich A, et al. Pharmaceuticals. 2022;15:322. 10. Rudman Spergel AK, et al.

JAMA. 2025;333(22):1977-1987.

© 2026 Moderna, Inc. All rights reserved. Fukase H, et al. Immunogenicity, reactogenicity, and safety of an mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine, mRNA-1083, in adults aged ≥50

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Here, we present findings from Part 1 (Japan) of the APAC regional program phase 3 trial

evaluating immunogenicity, reactogenicity, and safety of mRNA-1083 in adults aged ≥50 years

Part 3 (South Korea)

Part 2 (Taiwan)

Part 1 (Japan)

≥50 Years

≥50 Years

≥50 Years

mRNA-1083 +

Placebo N = 75

Licensed Influenza HA vaccinec + mRNA-1273b

N = 75

Licensed Influenza HA vaccinec + mRNA-1273b

N = 150

mRNA-1083 +

Placebo N = 150

1:1 Randomization

1:1 Randomization

1:1 Randomization

Licensed Influenza HA vaccinea + mRNA-1273b

N = 1000

mRNA-1083 +

Placebo N = 1000

HA, hemagglutinin.

Comparator vaccines: aJapan-licensed influenza HA vaccine; bSPIKEVAX®; cFluarix Tetra. Database Lock: August 11, 2025.

© 2026 Moderna, Inc. All rights reserved. Fukase H, et al. Immunogenicity, reactogenicity, and safety of an mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine, mRNA-1083, in adults aged ≥50

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© 2026 Moderna, Inc. All rights reserved.

Disclaimer

Moderna Inc. published this content on April 19, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 19, 2026 at 12:19 UTC.