Moderna Advances Investigational Bundibugyo Ebolavirus Vaccine Toward Phase 2/3 Study

CEPI has committed up to US$58.5 million to support preclinical testing, Phase 1 trials and additional clinical trial doses.

Rhea-AI Summary

Moderna (MRNA) announced that its Bundibugyo ebolavirus vaccine candidate, mRNA-1469, was recommended for advancement into a Phase 2/3 efficacy study. The WHO technical advisory group's recommendation followed an October 22 evidence review. Inclusion in the Tumaini study in the Democratic Republic of the Congo remains subject to regulatory approval.

Interim Phase 1 results in healthy adults ages 18 to 65 in Canada showed the candidate was generally well tolerated across all tested doses. A single dose generated virus-specific binding antibody responses; preclinical models showed protective responses. CEPI has committed up to US$58.5 million for preclinical testing, Phase 1 trials in Canada and Uganda, and additional Tumaini trial doses. Moderna will supply the candidate and support its clinical evaluation. Deployment arrangements are being developed, contingent on demonstrated efficacy and authorization.

6 points · 0 major

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0 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointWHO advisory group recommendation supports advancing mRNA-1469 into the Phase 2/3 Tumaini efficacy study.
• Minor pointInterim Phase 1 results showed generally good tolerability across all doses tested in healthy adults ages 18 to 65.
• Minor pointA single dose generated Bundibugyo ebolavirus-specific binding antibody responses in Phase 1.
• Minor pointPreclinical data demonstrated protective responses in relevant models.
• Minor pointUp to US$58.5 million committed by CEPI supports preclinical testing, Phase 1 trials and additional Tumaini doses.
• Minor point. Forward-looking: it has not happened yet and may not happen.Procurement and supply mechanisms are being developed with global health partners to support potential rapid deployment.

Negative

• Minor pointRegulatory approval remains a condition for mRNA-1469's evaluation in the Phase 2/3 Tumaini study.
• Minor point. Forward-looking: it has not happened yet and may not happen.Deployment depends on demonstrated vaccine efficacy and authorization from relevant health authorities.

Key Figures

Study advancement: Phase 2/3 Dose: 1 dose CEPI commitment: Up to US$58.5 million

Study advancement

Phase 2/3

Recommended for evaluation in the Tumaini efficacy study, subject to regulatory approval

Dose

1 dose

Generated BDBV-specific binding antibody responses

CEPI commitment

Up to US$58.5 million

Preclinical testing, Phase 1 trials in Canada and Uganda, and manufacture of additional clinical trial doses

Previous Clinical trial Reports

1 past event · Latest: Aug 04

Same Type 1 event

1. Aug 04

   clinical trial

   24h Move

   +3.4%

   Moderna initiated Phase 1 testing of mRNA-1469 after Health Canada authorization.

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

Key Terms

first-in-human, active-controlled, adaptive platform trial, ring-vaccination

4 terms

first-in-human medical

"Moderna's first-in-human Phase 1 study in healthy adults"

A first-in-human study is the initial test of a new drug, medical device, or therapy in people to check safety, side effects and appropriate dosing. It matters to investors because it marks a major development milestone: successful early human testing can reduce scientific and regulatory uncertainty, much like moving a prototype from the workshop to a real-world test drive, and often affects a company’s valuation and funding prospects.

active-controlled medical

"a randomized, blinded, active-controlled adaptive platform trial"

An active-controlled study is a trial in which the new treatment is compared against an existing, approved treatment instead of a placebo. For investors, this matters because results show how the new product stacks up against the current standard—like testing a new phone by comparing it to a popular model rather than to no phone—so positive results can indicate real competitive advantage and clearer market value.

adaptive platform trial medical

"an active-controlled adaptive platform trial using a ring-vaccination approach"

An adaptive platform trial is a flexible clinical study design that tests multiple treatments at once and adjusts which drugs, doses, or patient groups are pursued as results come in. Think of it like a single kitchen testing several recipes and quickly favoring the ones that work while dropping or changing the others — this can speed development, cut costs, and reduce risk for investors by identifying winners and failures faster than traditional one-at-a-time trials.

ring-vaccination medical

"using a ring-vaccination approach to evaluate multiple vaccine candidates"

A targeted vaccination strategy that immunizes people who have been in contact with a confirmed case and often their close contacts as well, creating an immune “ring” around the case to stop disease spread. It relies on rapid case detection and contact tracing so that vaccines are given to those most likely to have been exposed, rather than vaccinating an entire population at once; its effectiveness depends on how quickly contacts can be identified and reached and on the vaccine’s ability to prevent infection or transmission.

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CAMBRIDGE, MA / ACCESS Newswire / November 4, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that mRNA-1469, the Company's investigational mRNA vaccine candidate against Bundibugyo ebolavirus (BDBV), has been recommended to advance into a Phase 2/3 efficacy study in the Democratic Republic of the Congo (DRC), supported by encouraging preclinical and Phase 1 clinical data.

The recommendation follows an October 22 review of available evidence by the World Health Organization's Technical Advisory Group on Candidate Vaccine Prioritization (TAG-CVP). Subject to regulatory approval, mRNA-1469 will be evaluated in the Phase 2/3 Tumaini study, which is being conducted as part of the DRC government's response to the Bundibugyo virus disease outbreak.

"The ability to rapidly develop and advance vaccine candidates against emerging infectious diseases is an important part of the promise of mRNA technology," said Stéphane Bancel, Chief Executive Officer of Moderna. "With encouraging early clinical data, we now have an opportunity to evaluate whether our investigational vaccine can help protect people against Bundibugyo virus disease. We are grateful to CEPI, the DRC authorities and our global health partners and clinical trial participants for their collaboration in advancing this important work."

Interim results from Moderna's first-in-human Phase 1 study in healthy adults ages 18 to 65 in Canada showed that mRNA-1469 was generally well tolerated across all doses tested. A single dose generated robust BDBV-specific binding antibody responses, building on encouraging preclinical data demonstrating protective responses in relevant preclinical models.

Moderna is advancing mRNA-1469 through its expanded strategic collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), which has committed up to US$58.5 million to Moderna for preclinical testing, Phase 1 trials in Canada and Uganda, and the manufacture of additional clinical trial doses for Tumaini. CEPI is also providing separate funding for the Tumaini study. As part of the study, Moderna will supply mRNA-1469 and support its clinical evaluation.

"Safe and effective vaccines are urgently needed to help bring the devastating outbreak in the DRC under control. Our longstanding partnership with Moderna and the company's dedication to meeting this challenge enabled the vaccine candidate to move rapidly into clinical trials, and the recommendation from WHO's technical advisory group to include it in the Tumaini study is an important milestone," said Dr. Richard Hatchett, CEO of CEPI. "It brings us a step closer to finding out, as quickly as possible, whether BDBV-specific vaccines can protect people against this disease and, if they can, getting them to the communities that need them most."

The Phase 2/3 Tumaini study is a randomized, blinded, active-controlled adaptive platform trial using a ring-vaccination approach to evaluate multiple vaccine candidates, including mRNA-1469, among contacts of confirmed Bundibugyo virus disease cases. The study is co-sponsored by the Institut National de Recherche Biomédicale (INRB) and the University of Antwerp, under the national leadership and oversight of the DRC Ministry of Health.

Moderna is working with CEPI, Gavi, the Vaccine Alliance, and other global health partners to support rapid and equitable access to mRNA-1469, including establishing procurement and supply mechanisms that could enable rapid deployment to affected populations if the vaccine demonstrates efficacy and receives authorization from relevant health authorities.

Bundibugyo virus is one of four orthoebolaviruses known to cause disease in humans. There is currently no licensed vaccine specifically indicated for the prevention of Bundibugyo virus disease.

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.

Moderna Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: encouraging data from Moderna's Phase 1 clinical trial of mRNA-1469; advancement to a Phase 2/3 study, subject to regulatory approval; the safety, tolerability and immunogenicity of mRNA-1469; the capabilities of Moderna's mRNA platform; Moderna's strategic collaboration with CEPI and CEPI's investment; and Moderna's ability to enable rapid supply and access. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "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 press release 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, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, 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 www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release 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 of this press release.

Moderna Contacts

Media:
Emma Gilgunn-Jones
Director, Communications, UK
emma.gilgunn-jones@modernatx.com

Sacha Kennedy
Director, Communications and Media, Canada
sacha.kennedy@modernatx.com

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

[1] https://www.who.int/emergencies/alert-and-response

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

FAQ

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Why was Moderna's mRNA-1469 recommended for a Phase 2/3 study?

The recommendation followed a WHO technical advisory group review of preclinical and Phase 1 evidence. Interim Phase 1 results showed generally good tolerability across tested doses and virus-specific binding antibody responses after a single dose. Preclinical models also showed protective responses.

How will Moderna's mRNA-1469 be evaluated in the Tumaini study?

Tumaini is a randomized, blinded, active-controlled adaptive platform trial evaluating multiple vaccine candidates among contacts of confirmed Bundibugyo virus disease cases. It uses ring vaccination, which targets those contacts. The study is co-sponsored by the Institut National de Recherche Biomédicale and the University of Antwerp, under DRC Ministry of Health leadership and oversight.