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

Moderna supported the study and contributed to its design and publication, but did not collect, manage or analyze the data.

Rhea-AI Summary

Moderna (NASDAQ:MRNA) announced publication in JAMA Network Open of a real-world study comparing mNEXSPIKE with Comirnaty in older U.S. veterans.

The analysis included 294,499 matched participants aged 65 and older during the 2025-2026 respiratory virus season. mNEXSPIKE was associated with 35.9% relative vaccine effectiveness against medically attended COVID-19 versus Comirnaty (95% confidence interval: 20.4%-49.7%). Relative effectiveness against COVID-19-associated hospitalization was 47.0% (95% confidence interval: 5.4%-74.8%). An exploratory analysis found 39.3% relative effectiveness against hospitalization involving a major adverse cardiovascular event (95% confidence interval: 11.8%-57.0%).

The observational findings do not establish causality. Residual differences between groups could affect results, and the predominantly older, male population limits broader applicability.

3 points · 0 major

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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

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0 major · 2 points

How the balance works

Positive

• Moderate pointmNEXSPIKE showed 35.9% relative effectiveness against medically attended COVID-19 versus Comirnaty (95% confidence interval: 20.4%-49.7%).
• Minor pointCOVID-19-associated hospitalization results favored mNEXSPIKE: 47.0% relative effectiveness versus Comirnaty (95% confidence interval: 5.4%-74.8%).
• Minor pointExploratory cardiovascular-event hospitalization analysis showed 39.3% relative effectiveness versus Comirnaty (95% confidence interval: 11.8%-57.0%).

Negative

• Minor pointObservational findings do not establish causality and remain subject to residual confounding.
• Minor pointThe predominantly older, male veteran population may limit generalizability to broader populations.

Key Figures

Matched participants: 294,499 participants Relative vaccine effectiveness: 35.9% (95% CI: 20.4%-49.7%) Relative vaccine effectiveness: 47.0% (95% CI: 5.4%-74.8%) +1 more

Matched participants

294,499 participants

U.S. Veterans Health Administration analysis

Relative vaccine effectiveness

35.9% (95% CI: 20.4%-49.7%)

Medically attended COVID-19 vs. Comirnaty

Relative vaccine effectiveness

47.0% (95% CI: 5.4%-74.8%)

COVID-19-associated hospitalization vs. Comirnaty

Relative vaccine effectiveness

39.3% (95% CI: 11.8%-57.0%)

Exploratory MACE hospitalization analysis vs. Comirnaty

Previous Covid-19 Reports

1 past event · Latest: Feb 17

Same Type 1 event

1. Feb 17

   mNEXSPIKE authorization

   24h Move

   +4.0%

   Phase 3 reported higher relative efficacy versus Spikevax, including in adults aged 65 and older.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

inverse probability of treatment weighting, residual confounding, major adverse cardiovascular event, myocarditis, +1 more

5 terms

inverse probability of treatment weighting technical

"used inverse probability of treatment weighting to further reduce potential confounding"

A statistical method used in observational studies to estimate the effect of a treatment or exposure by weighting each subject by the inverse of their probability of receiving the treatment they actually received (their propensity score). Weighting creates a synthetic sample in which measured baseline characteristics are balanced across treatment groups, so differences in outcomes can be attributed to the treatment under the assumption that all confounders are measured and the propensity model is correctly specified; if those assumptions fail, the estimates can be biased.

residual confounding technical

"the study is subject to residual confounding"

Residual confounding is the distortion that remains in an estimated association between an exposure and an outcome after researchers have adjusted for known confounding factors; it arises because some confounders were not measured, were measured inaccurately, or were modeled imperfectly. It means the observed relationship may still be partly driven by those unaccounted-for differences rather than a true causal effect, and the direction and size of that remaining bias depend on the unmeasured or mismeasured factors.

major adverse cardiovascular event medical

"hospitalization involving a major adverse cardiovascular event (MACE)"

A composite clinical-trial endpoint that counts a set of serious heart- and blood-vessel–related outcomes as a single measure, most commonly including cardiovascular death, nonfatal myocardial infarction (heart attack), and nonfatal stroke. Exact components and how they are adjudicated can vary between studies or regulatory settings—some definitions add events such as hospitalization for heart failure or urgent revascularization—so the precise meaning in any press release depends on the study’s stated definition.

myocarditis medical

"Myocarditis (inflammation of the heart muscle) and pericarditis"

Inflammation of the heart muscle that can weaken the heart’s ability to pump and cause symptoms such as chest pain, shortness of breath, or abnormal heart rhythms. Investors care because myocarditis can affect healthcare costs, clinical trial outcomes, regulatory decisions, product safety perceptions, workforce availability, or lead to legal and reputational risks for companies, similar to how a car engine problem can halt a business until it's fixed.

pericarditis medical

"pericarditis (inflammation of the lining outside the heart)"

Pericarditis is inflammation of the thin sac that surrounds the heart, like irritation of a protective sleeve or a balloon around the organ. It can cause chest pain, fatigue and other symptoms and is important to investors because cases linked to a drug, vaccine or medical device can change regulatory decisions, affect sales and trigger safety reviews or legal risk, which can move a company’s stock and future outlook.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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
Chris.Ridley@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Moderna's mNEXSPIKE study find compared with Comirnaty?

mNEXSPIKE was associated with 35.9% relative vaccine effectiveness against medically attended COVID-19 versus Comirnaty (95% confidence interval: 20.4%-49.7%). The analysis included 294,499 matched U.S. veterans aged 65 years and older during the 2025-2026 respiratory virus season. These observational findings do not establish causality.

How were participants selected and followed in Moderna's mNEXSPIKE study?

The retrospective study included veterans aged 65 years and older who received LP.8.1-formulated mNEXSPIKE or Comirnaty between August 27, 2025, and January 31, 2026. Follow-up lasted up to 150 days or through May 1, 2026. Participants were matched by home county and vaccination week, with additional statistical weighting to reduce potential differences between groups.

What role did Moderna have in the mNEXSPIKE comparative effectiveness study?

Moderna supported the study and contributed to its 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.

What counted as medically attended COVID-19 in Moderna's mNEXSPIKE study?

The study's primary outcome, medically attended COVID-19, included hospitalization, emergency room visits, urgent care, outpatient visits and antiviral treatment.