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

Rhea-AI Summary

Moderna (NASDAQ:MRNA) and CEPI announced up to $54.3 million in funding to support a pivotal Phase 3 trial of Moderna's investigational mRNA H5 pandemic influenza vaccine candidate, mRNA-1018. The Phase 3 study is planned to begin early 2026 in the UK and U.S. and follows positive Phase 1/2 immune-response data.

If licensed, Moderna will allocate 20% of H5 manufacturing capacity for timely supply to low- and middle-income countries at affordable pricing.

Positive

• $54.3M CEPI investment to fund Phase 3
• Phase 3 trial planned to start early 2026 in UK and U.S.
• Moderna commits 20% of H5 capacity for low- and middle-income countries
• Builds on positive Phase 1/2 rapid and persistent immune responses

Negative

• None.

Key Figures

CEPI funding commitment $54.3 million Maximum investment to support pivotal Phase 3 H5 trial

Phase Phase 3 Pivotal trial for mRNA-1018 H5 pandemic influenza vaccine

Prior study phase Phase 1/2 Earlier H5 study showed rapid, persistent immune responses

Age group 18 years and older Population in earlier Phase 1/2 H5 study

Planned trial start Early 2026 Start of Phase 3 H5 trial in UK and U.S.

Manufacturing allocation 20% Share of H5 capacity reserved for low- and middle-income countries

100 Days Mission 100 days Global goal to develop vaccines within 100 days of new threat

Market Reality Check

$30.86 Last Close

Volume Volume 11,516,587 is 1.15x the 20-day average of 10,038,104, indicating modestly elevated activity ahead of this news. normal

Technical Shares at $30.51 are trading above the 200-day MA of $27.53 and about 37.63% below the 52-week high.

Peers on Argus

MRNA was up 2.07% with slightly elevated volume while close peers showed mixed, mostly smaller moves (e.g., HALO +1.48%, ROIV -1.33%, MDGL -1.03%), pointing to a stock-specific reaction to pipeline progress rather than a broad sector swing.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 15	Regulatory opinion	Positive	+1.6%	EMA committee backed marketing authorization for mNEXSPIKE COVID-19 vaccine.
Nov 20	Strategy update	Positive	-7.5%	Analyst Day outlined growth strategy, cost cuts and pipeline milestones.
Nov 20	Credit facility	Positive	-7.5%	Closed up to $1.5B five-year term loan to support late-stage pipeline.
Nov 19	Manufacturing expansion	Positive	-3.0%	Onshoring U.S. drug product capabilities with >$140M investment and new jobs.
Nov 18	Conference appearance	Neutral	+0.7%	Announcement of upcoming presentation at Piper Sandler healthcare conference.

Pattern Detected

Recent history shows several strategic or positive pipeline updates followed by negative price reactions, suggesting a tendency for the stock to sell off or underperform on good news.

Recent Company History

Over the last months, Moderna reported multiple strategic and clinical milestones. On Dec 15, 2025, a positive EMA opinion for mNEXSPIKE led to a +1.56% move. In November, Analyst Day strategy and a new $1.5B term loan coincided with a -7.53% reaction, and a U.S. manufacturing expansion on Nov 19 saw a -2.97% move. A conference appearance on Dec 2 brought a modest +0.65% gain. Today’s CEPI-funded H5 Phase 3 trial fits into this pattern of advancing the mRNA vaccine platform across infectious diseases.

Market Pulse Summary

This announcement details CEPI’s commitment of up to $54.3 million to fund a pivotal Phase 3 trial of Moderna’s H5 pandemic influenza mRNA vaccine, with the study expected to start in early 2026. It builds on prior positive Phase 1/2 immunogenicity data and leverages experience from Moderna’s seasonal flu program. Investors may focus on trial design, enrollment progress in the UK and U.S., and how results compare with earlier influenza and CMV vaccine readouts.

Key Terms

mRNA medical

"By harnessing the speed and adaptability of mRNA technology, we could shave months..."

mRNA, short for messenger ribonucleic acid, is a biological molecule that carries instructions from a cell’s genetic blueprint to make specific proteins — like a recipe or software code that tells a kitchen or computer what to produce. Investors care because mRNA is used as a flexible drug and vaccine platform that can be developed and scaled faster than many traditional medicines; its commercial prospects, manufacturing needs, regulatory approval path, and patent position can strongly affect a company’s value.

pandemic influenza medical

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

Pandemic influenza is a large-scale outbreak of a flu virus that spreads widely across countries and populations because people have little or no immunity to that strain. Like a wildfire that jumps boundaries, it can quickly disrupt workplaces, supply chains and consumer behavior, so investors watch it closely for risks to company revenues, costs, workforce availability and broader market volatility that can affect the value of many investments.

phase 3 medical

"support a pivotal Phase 3 clinical trial that aims to help advance Moderna's..."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 1/2 medical

"It will build upon positive Phase 1/2 results which showed rapid and persistent immune..."

Phase 1/2 is a combined early-stage clinical trial that first tests a new drug or treatment for safety and the right dose, then quickly expands to check if it shows any signs of working in patients. For investors, results from a Phase 1/2 study offer an early read on both risk and potential reward—like a prototype test that both confirms a product won’t harm users and suggests whether it could sell—helping guide valuation and development decisions.

immunogenicity medical

"The Phase 3 trial... will evaluate the safety and immunogenicity of Moderna's H5 vaccine..."

Immunogenicity is the ability of a substance, such as a vaccine or medication, to provoke an immune response in the body. It matters to investors because high immunogenicity can affect the effectiveness and safety of a product, potentially leading to increased costs or regulatory challenges. Understanding immunogenicity helps assess the long-term viability and market potential of pharmaceutical and biotech investments.

licensure regulatory

"advance Moderna's investigational mRNA-based H5 pandemic influenza vaccine candidate... to licensure."

Licensure is an official government or regulatory permission that lets a company, product, facility, or professional legally operate or sell a regulated good or service after meeting specific safety, quality, or competency standards. For investors, licensure is like a driver's license for a business: lacking it can block sales and growth, while gaining or losing it can materially change revenue prospects, costs, and risk, so it directly affects valuation and investment risk.

AI-generated analysis. Not financial advice.

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 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: press@cepi.net
Phone: +44 7387 055214

Moderna Contacts

Media:
Chris Ridley
Head of Global Media Relations
+1 617-800-3651
Chris.Ridley@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

FAQ

What funding did CEPI commit to Moderna's H5 vaccine (MRNA) on December 18, 2025?

CEPI committed up to $54.3 million to support a pivotal Phase 3 trial of Moderna's H5 vaccine candidate.

When will Moderna's Phase 3 trial for the mRNA-1018 H5 vaccine (MRNA) begin?

The Phase 3 trial is planned to begin early 2026 in the UK and U.S.

What manufacturing allocation did Moderna (MRNA) agree for low- and middle-income countries?

Moderna will allocate 20% of its H5 pandemic vaccine manufacturing capacity for timely, affordable supply to low- and middle-income countries if licensed.

What clinical data supports Moderna's H5 program (MRNA) ahead of Phase 3?

Positive Phase 1/2 results showed rapid and persistent immune responses in healthy adults aged 18 and older.

Is this the first mRNA-based pandemic influenza vaccine to enter a pivotal trial?

Yes, the announcement describes this Phase 3 as the first mRNA-based vaccine targeting pandemic influenza to enter a pivotal trial.

How does the mRNA H5 program (MRNA) relate to CEPI's 100 Days Mission?

The program is intended to support rapid-response vaccine capability aligned with CEPI's 100 Days Mission to develop vaccines within 100 days of a new pandemic threat.