Moderna Announces Initiation of Phase 3 Study of Investigational mRNA Pandemic Influenza Vaccine Candidate
Rhea-AI Summary
Moderna (NASDAQ:MRNA) announced dosing of the first U.S. and UK participants in a Phase 3 study of its investigational H5 pandemic influenza mRNA vaccine candidate, mRNA-1018, on April 21, 2026. The trial aims to enroll ~4,000 adults 18+ to evaluate safety and immunogenicity. CEPI committed up to $54.3 million in December 2025 to advance mRNA-1018 to licensure. Positive Phase 3 data would support global regulatory submissions alongside data from Moderna's seasonal candidate mRNA-1010, currently accepted for review in the U.S., EU, Canada and Australia. Moderna will reserve 20% of H5 manufacturing capacity for low- and middle-income countries if licensed.
Positive
- CEPI funding commitment of $54.3 million
- Phase 3 trial sized at approximately 4,000 adults
- mRNA-1010 data accepted for regulatory review in major jurisdictions
- Commitment to allocate 20% of H5 capacity to low- and middle-income countries
Negative
- No efficacy or final safety data yet; Phase 3 has only initiated
- Regulatory approvals depend on future positive Phase 3 readouts
News Market Reaction – MRNA
In the Apr 22 session, MRNA gained 2.53%, reflecting a moderate positive market reaction. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 17 | Oncology trial data | Positive | -1.8% | Strong Phase 1/2 melanoma combo data with high ORR and FDA Fast Track. |
| Jan 20 | Five-year trial data | Positive | +2.8% | Five-year Phase 2b melanoma data showing 49% lower recurrence risk vs KEYTRUDA alone. |
| Dec 18 | Pandemic flu funding | Positive | +1.4% | CEPI to fund up to $54.3M for pivotal H5 influenza mRNA-1018 Phase 3 trial. |
| Nov 03 | First patient dosed | Neutral | -8.3% | First patient dosed in Phase 1/2 study of mRNA T-cell engager for multiple myeloma. |
| Oct 22 | Trial failure | Negative | -2.2% | Phase 3 CMV vaccine mRNA-1647 missed primary endpoint; congenital program discontinued. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial headlines have produced mixed reactions, with several positive updates met by flat to negative price moves and an average move of -1.61% on such news.
Over the last six months, Moderna’s clinical trial news has ranged from strong oncology efficacy data to mixed vaccine outcomes. Notably, a CEPI-backed H5 flu funding announcement on Dec 18, 2025 outlined plans for this same mRNA-1018 Phase 3 program and a 20% capacity commitment to low- and middle-income countries. Other updates included a failed CMV Phase 3 and multiple oncology advances. Today’s Phase 3 initiation fits this pattern of pipeline execution steps following earlier funding and planning milestones.
Key Terms
phase 3 medical
immunogenicity medical
mrna-based medical
pandemic influenza medical
licensure regulatory
regulatory submissions regulatory
manufacturing capacity technical
coalition for epidemic preparedness innovations medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Phase 3 study is supported by the Coalition for Epidemic Preparedness Innovations to help strengthen global preparedness against a significant pandemic threat
CAMBRIDGE, MA / ACCESS Newswire / April 21, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the first participants in the U.S. and UK have been dosed in a Phase 3 study of the Company's investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018. In December 2025, the Coalition for Epidemic Preparedness Innovations (CEPI) and Moderna announced that CEPI will invest up to
"H5 influenza, or bird flu, remains a pandemic threat. The start of our Phase 3 trial for an H5 influenza vaccine marks a significant milestone in our ongoing efforts to strengthen global pandemic preparedness," said Stéphane Bancel, Chief Executive Officer of Moderna. "Our platform technology's efficiency and scalability are critical to supporting global health security and responding to potential future threats."
"The first-of-its-kind pivotal trial of an mRNA-based pandemic influenza vaccine underscores the potential of this technology to reshape how we confront emerging pathogens," said Dr. Richard Hatchett, CEO of CEPI. "If successful, these efforts could transform our ability to respond swiftly and equitably to one of the world's most enduring threats."
The Phase 3 study will evaluate the safety and immunogenicity of mRNA-1018 in healthy adults ages 18 years and older and is expected to enroll approximately 4,000 adults in the U.S. and UK. If successful, global regulatory submissions for mRNA-1018 will be further supported by positive data from the pivotal Phase 3 trial of Moderna's investigational seasonal influenza vaccine, mRNA-1010, which has been accepted for review in the U.S., the European Union, Canada and Australia.
"Although the current risk to the human population of avian influenza remains low, the virus continues to evolve and spread in birds and various animal hosts in the UK and elsewhere," said Dr. Richard Pebody, Director of Epidemic and Emerging Infections at the UK Health Security Agency (UKHSA). "UKHSA remains alert to the potential that this pathogen could adapt to spread from person to person, and will continue to monitor all available data. This important initiative to trial a new mRNA pandemic influenza vaccine is a key step towards further strengthening our ability to protect people against future influenza pandemics."
If licensed and in the event of an influenza pandemic, Moderna will allocate
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.
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 help advance Moderna's H5 pandemic influenza vaccine to licensure; the potential future licensure of mRNA-1018; the potential of mRNA to strengthen global pandemic preparedness; expected enrollment in the Phase 3 study of mRNA-1018; plans for potential global regulatory submissions for mRNA-1018 if the Phase 3 study is successful; ongoing regulatory review of mRNA-1010 in various jurisdictions; and Moderna's allocation of H5 pandemic vaccine manufacturing capacity. 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
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