CEPI to Fund Pivotal Phase 3 Trial for Moderna’s mRNA Pandemic Influenza Vaccine Candidate

Up to $54.3 million CEPI investment aims to help advance Moderna’s H5 pandemic influenza vaccine candidate to licensure

Partnership strengthens global preparedness against a significant pandemic threat 

If licensed and in the event of an influenza pandemic, Moderna will allocate 20% of its H5 pandemic vaccine manufacturing capacity for timely supply to low- and middle-income countries at affordable pricing

OSLO, Norway / CAMBRIDGE, MA / ACCESS Newswire / December 17, 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 faster, 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 designed to improve the speed and scale of future pandemic responses, making a significant contribution to CEPI’s 100 Days Mission, a global goal to develop vaccines meeting regulatory requirements for safety and efficacy 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.