The Fort Worth Press - Moderna Announces Initiation of Phase 1 Clinical Trial of mRNA-1469, Moderna's Investigational Vaccine Against Bundibugyo Ebolavirus

CAMBRIDGE, MA / ACCESS Newswire / August 4, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that following Health Canada's authorization of the study, the first participants have been vaccinated in a Phase 1 clinical study in Canada evaluating mRNA-1469, the Company's investigational mRNA vaccine being evaluated to prevent Bundibugyo ebolavirus, or BDBV, disease.

The vaccine candidate is being developed using Moderna's mRNA platform, the same technology that demonstrated rapid development, scalability, and global deployment capabilities during the COVID-19 pandemic. The program also builds on Moderna's existing research and development efforts in filoviruses, including Ebola-related viruses.

"Vaccinating the first participants with mRNA-1469 marks an important milestone in advancing a vaccine candidate against Bundibugyo ebolavirus, for which no approved vaccine currently exists," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are grateful to CEPI, Health Canada, the investigators and study participants for their contributions to advance this work."

mRNA-1469 is being advanced under Moderna's expanded strategic collaboration with CEPI, who has committed up to US $50 million to support preclinical testing and the Phase 1 clinical trial. The collaboration also supports the scaled manufacture of additional clinical trial doses in parallel with early clinical development. This approach is intended to enable larger Phase 2 and Phase 3 studies to begin rapidly if Phase 1 results support further development.

"Getting Moderna's vaccine candidate into a Phase 1 trial this rapidly is a major step forward in the fight against this deadly outbreak," said Dr Richard Hatchett, CEPI's Chief Executive Officer. "This fast-growing epidemic is already the second-largest Ebola outbreak in history, and cases are rising more quickly than they did in the 2014 - 2016 West Africa epidemic which remains the largest on record. Every day matters, and every vaccine candidate in clinical trials gives us another shot at getting a safe, effective vaccine to the people who need it as swiftly as possible."

The first-in-human Phase 1 study (ClinicalTrials.gov identifier: NCT07737717) is being conducted at three sites in Canada, and will evaluate the safety, tolerability and immunogenicity of mRNA-1469 in healthy adult participants. The study is expected to enroll approximately 80 participants.

BDBV is one of the viruses that can cause Ebola disease and has been responsible for the active outbreak in the Democratic Republic of the Congo. Although vaccines are available against Zaire ebolavirus, no vaccine is currently approved to protect against disease caused by BDBV. The current outbreak was declared a Public Health Emergency of International Concern (PHEIC) and a Public Health Emergency of Continental Security (PHECS) by the World Health Organization and Africa CDC, respectively. It has already caused more than 3,000 confirmed cases and more than 1,400 deaths, making it one of the largest filovirus outbreaks in history.[1]

If licensed, Moderna is committed to enabling rapid supply and access of its BDBV vaccine to affected countries and to the populations that need them. As part of its agreement with CEPI, Moderna will make available at a minimum 500,000 doses for timely supply to low- and middle-income countries under access pricing.

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: Moderna's Phase 1 clinical trial of mRNA-1469; the capabilities of Moderna's mRNA platform; Moderna's strategic collaboration with CEPI and CEPI's investment; the ability to rapidly advance into Phase 2 and Phase 3 studies; and the potential for future licensure of a BDBV vaccine 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:
Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651 [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.

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C.M.Harper--TFWP