The Fort Worth Press - CEPI to Fund Pivotal Phase 3 Trial for Moderna's mRNA Pandemic Influenza Vaccine Candidate

OSLO, NORWAY and CAMBRIDGE, MA / ACCESS Newswire / December 18, 2025 / The Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $54.3 million to support a pivotal Phase 3 clinical trial that aims to help advance Moderna's investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018, to licensure. The funding marks a significant step forward in global pandemic preparedness that could enable fast, equitable access to vaccines for one of the world's most pressing health threats.

This Phase 3 study would be the first mRNA-based vaccine targeting pandemic influenza to enter a pivotal trial. If the vaccine candidate is licensed, it would expand the current global portfolio of H5 vaccines with a rapid-response platform that could revolutionize future pandemic responses, making a significant contribution to CEPI's 100 Days Mission, a global goal to develop safe and effective vaccines within 100 days of a new pandemic threat being identified.

Dr Richard Hatchett, Chief Executive Officer of CEPI said:

"Pandemic influenza remains one of the greatest threats to global health security. With this partnership, we are not just advancing vaccine science, we are fundamentally changing the game. By harnessing the speed and adaptability of mRNA technology, we could shave months off the response time, deliver vaccines at scale, and enable equitable access for all. This is how we plan to protect the world from the next flu pandemic."

Stéphane Bancel, Chief Executive Officer of Moderna said:

"We are proud to have the support of CEPI to advance our pandemic influenza vaccine candidate, research that is critical to our commitment to pandemic preparedness. mRNA technology can play a vital role in addressing emerging health threats quickly and effectively, and we look forward to continuing our partnership with CEPI as we advance our health security portfolio, and in parallel, further the 100 Days Mission."

A potential first-in-class mRNA vaccine for pandemic influenza

Conventional influenza vaccines require virus growth in eggs or cell culture, a process that can take months. By contrast, an mRNA vaccine can be designed in hours or days as soon as the virus's genetic sequence is known and swiftly manufactured at scale. The combination of speed, adaptability and scalability offered by mRNA technology is a potential critical advantage when a new pandemic strain emerges and every day that passes could cost lives.

If licensure is granted, Moderna is committed to working to provide people around the world with rapid, equitable access to the resulting H5 vaccine in the event of a pandemic. As part of this agreement, Moderna will allocate 20% of its H5 pandemic vaccine manufacturing capacity for timely supply to low- and middle-income countries at affordable pricing.

The Phase 3 trial, set to begin early in 2026, will evaluate the safety and immunogenicity of Moderna's H5 vaccine candidate in populations in the UK and U.S. It will build upon positive Phase 1/2 results which showed rapid and persistent immune responses in healthy adults aged 18 years and older. Potential licensure of the vaccine will also leverage data from a pivotal Phase 3 trial of Moderna's investigational seasonal influenza vaccine, mRNA-1010.

This project is part of CEPI and Moderna's strategic partnership, which aims to harness Moderna's mRNA platform to accelerate epidemic and pandemic vaccine development.

ENDS

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 70 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI's pandemic-beating plan is the '100 Days Mission' to accelerate the time taken to develop safe, effective and accessible vaccines against new threats to just 100 days. Learn more at CEPI.net.  

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: CEPI's investment to advance Moderna's H5 pandemic influenza vaccine candidate; the potential for licensure of mRNA-1018; the safety and immunogenicity of mRNA-1018; the potential for mRNA technology to effectively address emerging health threats; and Moderna's ability to manufacture at scale. 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, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, 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.

CEPI Media Contacts

Email: [email protected]
Phone: +44 7387 055214

Moderna Contacts

Media:
Chris Ridley
Head of Global Media Relations
+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.

View the original press release on ACCESS Newswire

T.Gilbert--TFWP