The Fort Worth Press - Moderna Announces JAMA Network Open Publication of Real-World Comparative Effectiveness Data for mNEXSPIKE (COVID-19 Vaccine, mRNA) in Adults Aged 65 Years and Older

CAMBRIDGE, MA / ACCESS Newswire / November 11, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced the publication of results from a large real-world study evaluating the comparative effectiveness of mNEXSPIKE® (COVID-19 Vaccine, mRNA) and Comirnaty® (COVID-19 Vaccine, mRNA) among U.S. Veterans aged 65 years and older during the 2025-2026 respiratory virus season. The analysis, published in JAMA Network Open, included 294,499 matched participants in the U.S. Veterans Health Administration (VHA).

The study's primary outcome was medically attended COVID-19, including hospitalization, emergency room visits, urgent care, outpatient visits, and antiviral treatment. mNEXSPIKE was associated with 35.9% relative vaccine effectiveness against medically attended COVID-19 compared with Comirnaty (95% CI: 20.4%-49.7%). The study found that vaccination with mNEXSPIKE was associated with a 47.0% relative vaccine effectiveness against COVID-19-associated hospitalization compared with Comirnaty (95% CI: 5.4%-74.8%), and point estimates consistently favored mNEXSPIKE across all individual components of medically attended COVID-19.

"These findings demonstrate differentiated real-world performance for mNEXSPIKE in older adults, including against COVID-19-associated hospitalization," said Francesca Ceddia, M.D., Chief Medical Affairs Officer of Moderna. "This evidence further supports the role mNEXSPIKE can play in protecting older adults from the health consequences of COVID-19, while providing important insight into its performance in a population that remains particularly vulnerable to severe disease."

An exploratory analysis also evaluated hospitalization involving a major adverse cardiovascular event (MACE), including myocardial infarction, stroke or heart failure. mNEXSPIKE was associated with 39.3% relative vaccine effectiveness for MACE hospitalization compared with Comirnaty (95% CI: 11.8%-57.0%). COVID-19 has been associated with worsening of underlying chronic conditions, including cardiovascular disease. The data highlight the importance of understanding the potential broader health impact of COVID-19 prevention in older adults, beyond the acute respiratory illness.

"Older adults continue to face a substantial burden from COVID-19, and vaccination remains one of our most important tools to help protect this population," said Stefan Gravenstein, M.D., Professor of Medicine at Brown University and principal investigator of the study. "Studies like this can help clinicians and patients make informed vaccination decisions by providing a better understanding of how different vaccine options perform in real-world settings."

The retrospective, active-comparator matched cohort study included VHA-enrolled veterans aged 65 years and older who received an LP.8.1-formulated mNEXSPIKE or Comirnaty vaccine between August 27, 2025, and January 31, 2026. Participants were followed for up to 150 days or through May 1, 2026. The analysis matched participants by home county and calendar week of vaccination and used inverse probability of treatment weighting to further reduce potential confounding.

As an observational real-world analysis, the study is subject to residual confounding, including differences in testing behavior, undocumented prior infection and vaccine availability. The predominantly older, male VHA population may limit generalizability to broader populations. Findings are associative and do not establish causality. Despite these potential limitations, the study provides important real-world comparative evidence on COVID-19 vaccine effectiveness in older adults, a population that remains at increased risk of severe COVID-19 and its complications.

The study was supported by Moderna, which contributed to the study design, data interpretation, manuscript preparation, review and approval, and the decision to submit for publication. Moderna did not conduct the study or collect, manage or analyze the data.

About Moderna

Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.

With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.

mNEXSPIKE® is a registered trademark of Moderna.

INDICATION

What is mNEXSPIKE (COVID-19 Vaccine, mRNA)?

mNEXSPIKE is a vaccine to protect against COVID-19. mNEXSPIKE is for people who have received a COVID-19 vaccine before and are:

• 65 years of age and older, or

• 12 years through 64 years of age at high risk for severe COVID-19.

Vaccination with mNEXSPIKE may not protect all people who receive the vaccine.

IMPORTANT SAFETY INFORMATION

You should not get mNEXSPIKE if you had a severe allergic reaction after a previous dose of either mNEXSPIKE, SPIKEVAX (COVID-19 Vaccine, mRNA), or any Moderna COVID-19 vaccine or to any ingredient in these vaccines.

What are the risks of mNEXSPIKE?

There is a very small chance that mNEXSPIKE could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of mNEXSPIKE. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine. Signs of a severe allergic reaction can include:

• Trouble breathing
• Swelling of your face and throat
• A fast heartbeat
• A rash all over your body
• Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. You should seek medical attention right away if you or your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:

• Chest pain
• Shortness of breath
• Feelings of having a fast-beating, fluttering, or pounding heart

Side effects that have been reported in clinical trials with mNEXSPIKE include:

• Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness.
• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, and fever

Tell your vaccination provider about all of your medical conditions, including if you:

• have any allergies
• had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
• have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
• have a fever
• have a bleeding disorder or are on a blood thinner
• are immunocompromised or are on a medicine that affects your immune system
• are pregnant or plan to become pregnant
• are breastfeeding
• have received any other COVID-19 vaccine
• have ever fainted in association with an injection

These may not be all the possible side effects of mNEXSPIKE. Ask your healthcare provider about any side effects that concern you. You may report side effects to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.

Please click for mNEXSPIKE Full Prescribing Information and Information for Recipients and Caregivers.

Moderna Contacts

Media:
Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
[email protected]

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
[email protected]

SOURCE: Moderna, Inc.

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J.Barnes--TFWP