As support from the U.S. government has evaporated, Moderna is leaning on an old ally to carry plans for its prospective mRNA bird flu vaccine forward.
The Coalition for Epidemic Preparedness Innovations (CEPI)—already engaged in a strategic partnership with Moderna—has agreed to plug up to $54.3 million into a pivotal phase 3 trial for mRNA-1018, Moderna’s mRNA-based H5 pandemic influenza vaccine candidate.
The late-stage study is slated to kick off in early 2026 and will assess Moderna’s pandemic influenza shot in populations across both the U.S. and the U.K., CEPI and Moderna said in a Dec. 17 press release.
Moderna has already generated positive phase 1/2 results on its candidate in adults ages 18 and older, and the Cambridge-based mRNA specialist also plans to use data from the late-stage study of its seasonal influenza vaccine to inform a potential approval of the H5 influenza prospect, according to the announcement.
CEPI tied the funding pledge back to its 100 Days Mission, which Moderna joined in 2023. In line with the program’s pandemic preparedness goals, Moderna’s mRNA avian influenza vaccine—if approved—would grow the world’s H5 armamentarium with a “rapid-response platform that could revolutionize future pandemic responses,” the companies said in their release, alluding to Moderna’s mRNA technology.
“With this partnership, we are not just advancing vaccine science, we are fundamentally changing the game,” Richard Hatchett, M.D., CEPI’s chief executive, said in a statement. “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.”
Unlike traditional vaccines that necessitate virus growth in eggs or cell culture—which can be a monthslong process—mRNA vaccines can be designed in hours or days and quickly manufactured at scale, the partners pointed out.
Meanwhile, recognizing that there cannot be gaps in the world’s response to the next viral emergency, Moderna has, as part of the funding agreement, pledged to allocate 20% of its H5 pandemic vaccine manufacturing capacity for “timely supply” to low- and middle-income countries. Those doses will be provided “at affordable pricing,” Moderna and CEPI said.
CEPI’s financial backing serves as a lifeline for Moderna’s pandemic influenza candidate mRNA-1018, which entered uncertain territory after a hefty chunk of U.S. government funding for the program was taken back earlier this year.
In January, at the tail-end of the Biden administration’s run in the White House, the U.S. handed Moderna $590 million to accelerate work with the Department of Health and Human Services’ (HHS') Biomedical Advanced Research and Development Authority (BARDA) on developing mRNA vaccines to stave off a potential flu pandemic, including from the avian influenza strain H5N1.
Then, in May, the HHS said it had terminated the award for late-stage development and the right to purchase pre-pandemic influenza vaccines. The move came three months after the department said it was evaluating its Moderna contract and just a few weeks after noted vaccine skeptic Robert F. Kennedy Jr. was sworn in as the controversial new chief of the public health agency.
At the time, Moderna noted that it was hunting for alternatives for the late-stage development and manufacturing of its prospective bird flu vaccine.
Moderna’s contract cancellation apparently showed which way the wind was blowing at the HHS, which, in August, said it was ending roughly $500 million in collective mRNA vaccine work funded by BARDA.
Moderna, for its part, has continued to push ahead, though not without a few bumps in the road. Aside from mounting policy shifts in the U.S. that seem to be undermining the safety and efficacy of vaccines, Moderna has also struggled—like all pandemic shot makers—to recapture the sales highs it achieved when COVID-19 was in full swing.
In November, the company said it was laying out a three-year strategy for growth and set the ambition to lift revenue by 10% in 2026, which Moderna says will hinge on the build-out of a large seasonal vaccine franchise for people in at-risk patient populations. Moderna then plans to channel the proceeds from its commercial vaccines into its late-stage oncology and rare disease programs, setting the stage for potential further growth in the latter half of the decade.