The Fort Worth Press - Moderna Advances Investigational Bundibugyo Ebolavirus Vaccine Toward Phase 2/3 Study

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
[email protected]

Sacha Kennedy
Director, Communications and Media, Canada
[email protected]

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

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

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

B.Martinez--TFWP