Moderna Announces Update on Investigational Pandemic Influenza Program

Rhea-AI Summary

Moderna (NASDAQ:MRNA) announced positive interim results from a Phase 1/2 clinical study of its investigational pandemic influenza vaccine, mRNA-1018, targeting H5 avian influenza. The study involving 300 healthy adults showed that 97.8% of participants achieved protective antibody levels with a 44.5-fold increase in titers from baseline. The vaccine demonstrated a rapid, potent, and durable immune response with good tolerability. However, Moderna also revealed that the U.S. Department of Health and Human Services (HHS) will terminate funding for the late-stage development and purchase rights of pre-pandemic influenza vaccines. Despite this setback, CEO Stéphane Bancel emphasized the positive clinical data and announced plans to explore alternative paths for the program's development.

Positive

• 97.8% of participants achieved protective antibody levels in Phase 1/2 trial
• 44.5-fold increase in antibody titers from baseline
• Vaccine demonstrated good safety profile with mostly Grade 1 or 2 adverse reactions
• Strong immunogenicity data supports mRNA platform's effectiveness

Negative

• HHS terminates funding for late-stage development of pre-pandemic influenza vaccines
• Loss of government purchase rights for pre-pandemic influenza vaccines
• Uncertainty in program's future development and commercialization path

Insights

Biotechnology and Vaccine Development Expert

Moderna's H5 avian flu vaccine shows positive Phase 1/2 results, but HHS funding termination creates uncertainty for program advancement.

Moderna's interim Phase 1/2 data for mRNA-1018 targeting H5 avian influenza shows impressive immunogenicity, with 97.8% of participants achieving protective antibody levels (HAI titers ≥1:40) by Day 43. This represents a substantial 44.5-fold increase from baseline, where only 2.1% of participants had protective levels. The safety profile appears favorable with mostly Grade 1-2 adverse reactions that didn't worsen with subsequent dosing.

However, the HHS termination of funding for late-stage development creates significant challenges. Government partnerships typically provide both financial support and procurement commitments critical for pandemic preparedness products where commercial markets are uncertain. Without this backing, Moderna faces hurdles in advancing the program through costly Phase 3 trials and establishing manufacturing capacity.

The timing is particularly noteworthy - receiving positive clinical data simultaneously with funding termination creates a strategic dilemma. While the technology demonstrates efficacy, the path to commercialization is now unclear. Moderna's statement about "exploring alternatives" suggests no immediate replacement partnership, leaving the program in limbo despite promising results.

The contrast between strong clinical data and program uncertainty exemplifies the complex landscape of pandemic preparedness development, where scientific success doesn't guarantee program advancement without sustained government partnership. This situation highlights Moderna's dependence on government collaborations for certain pipeline programs, particularly those addressing potential public health emergencies like avian influenza.

Pharmaceutical Investment Analyst

Mixed news for Moderna: positive H5 flu vaccine data offset by loss of HHS funding creating revenue uncertainty.

The termination of HHS funding represents a significant setback for Moderna's pandemic influenza program. Government contracts provide crucial non-dilutive capital for vaccine development and, more importantly, guarantee purchase commitments. Without this partnership, Moderna loses both development funding and a predetermined customer, substantially increasing commercial risk for a product with uncertain market demand outside of government stockpiling.

While the clinical data appears strong with protective antibody levels achieved in nearly all participants, the commercial viability of pandemic-focused vaccines typically depends on government contracts. Unlike seasonal flu vaccines with established annual markets, pandemic/pre-pandemic vaccines rely heavily on government procurement for stockpiles. The loss of the HHS award removes a potentially significant revenue stream that investors likely factored into future projections.

This development comes amid Moderna's ongoing efforts to diversify beyond COVID-19 vaccines and demonstrate the broader applicability of its mRNA platform. The company now faces difficult decisions about allocating resources to a program without guaranteed return on investment. Bancel's statement about "exploring alternative paths" suggests no immediate replacement partnership, creating uncertainty about the program's future despite the positive clinical data.

For investors, this news introduces questions about Moderna's pipeline prioritization and capital allocation strategy. While the clinical success validates the technology platform, the commercial pathway has become significantly more challenging, likely requiring either substantial internal investment or securing new partnerships to replace the terminated HHS support.

Phase 1/2 H5 avian flu vaccine study shows positive interim results

Company has been notified that HHS will terminate Moderna's award for late-stage development of pre-pandemic influenza vaccines

CAMBRIDGE, MA / ACCESS Newswire / May 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive interim data from a Phase 1/2 clinical study (NCT05972174) evaluating the safety and immunogenicity of its investigational pandemic influenza vaccine, mRNA-1018, in approximately 300 healthy adults aged 18 years and older. The interim results focus on a vaccine candidate targeting the H5 avian influenza virus subtype.

The Company had previously expected to advance the program to late-stage development with the U.S. Department of Health and Human Services (HHS); however, today Moderna received notice that HHS will terminate the award for the late-stage development and right to purchase pre-pandemic influenza vaccines.

"While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program," said Stéphane Bancel, Chief Executive Officer of Moderna. "These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats."

The Phase 1/2 study evaluated a two-dose regimen of Moderna's investigational avian influenza vaccine. mRNA-1018 demonstrated a rapid, potent and durable immune response. At baseline, pre-existing immunity was minimal, with only 2.1% of participants showing hemagglutination inhibition (HAI) antibody titers ≥1:40, an HAI titer considered to correlate with protection. At Day 43, three weeks after the second vaccination, 97.8% of participants achieved titers ≥1:40 with a 44.5-fold increase of titers from baseline.

The investigational vaccine was generally well-tolerated, with no dose-limiting tolerability concerns observed. Most solicited adverse reactions were Grade 1 or 2 and did not increase significantly with number of doses or between first and second doses. Further data is expected to be submitted for presentation at an upcoming scientific meeting.

Moderna will explore alternatives for late-stage development and manufacturing of the H5 program consistent with the Company's strategic commitment to pandemic preparedness.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives 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 (formerly Twitter), 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: the clinical development of mRNA-1018, the safety and immunogenicity data from the Phase 1/2 study; the cancellation of the development contract for Moderna's pandemic flu program by the U.S. Department of Health and Human Services; and the exploration of alternative paths for development of the vaccine program. 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.

Moderna Contacts

Media:
Chris Ridley
Global Head of 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 are the Phase 1/2 trial results for Moderna's H5 avian flu vaccine (MRNA)?

The trial showed 97.8% of participants achieved protective antibody levels with a 44.5-fold increase in titers from baseline. The vaccine demonstrated good tolerability with mostly Grade 1 or 2 adverse reactions.

Why did HHS terminate Moderna's (MRNA) pandemic flu vaccine funding?

The press release does not specify the reason for HHS's decision to terminate the funding for late-stage development and purchase rights of pre-pandemic influenza vaccines.

What is the safety profile of Moderna's (MRNA) mRNA-1018 flu vaccine?

The vaccine was generally well-tolerated with no dose-limiting concerns. Most adverse reactions were Grade 1 or 2 and did not increase significantly with number of doses or between first and second doses.

What are Moderna's (MRNA) next steps for the H5 flu vaccine program?

Moderna will explore alternatives for late-stage development and manufacturing of the H5 program, maintaining their strategic commitment to pandemic preparedness.

How many doses of Moderna's (MRNA) H5 flu vaccine were tested in the trial?

The Phase 1/2 study evaluated a two-dose regimen of the investigational avian influenza vaccine in approximately 300 healthy adults aged 18 years and older.