Regulatory filings are under review in the U.S., Europe, Canada and Australia, with potential approvals expected to begin in 2026
CAMBRIDGE, MA / ACCESS Newswire / May 6, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced a publication in the New England Journal of Medicine of the positive Phase 3 study results evaluating mRNA-1010, its vaccine candidate for seasonal influenza. The peer-reviewed article summarizes the safety and efficacy data from Moderna's Phase 3 study (P304) evaluating the relative vaccine efficacy (rVE) of mRNA-1010 against influenza illness compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older.
As previously reported, mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with an rVE of 26.6% (95% CI; 16.7%, 35.4%) in the overall study population. Additionally, strong rVE was observed for each influenza strain contained in the vaccine, including A/H1N1 (rVE=29.6%), A/H3N2 (rVE=22.2%), and the B/Victoria lineages (rVE=29.1%). Subgroup analyses confirmed a consistently strong rVE point estimate across age groups, risk factors and previous influenza vaccination status. In participants aged 65 years and older, mRNA-1010 demonstrated an rVE of 27.4%.
"The publication of these peer-reviewed positive results in the New England Journal of Medicine reflects the strength of the clinical evidence supporting our ongoing regulatory submissions," said Stéphane Bancel, Chief Executive Officer of Moderna. "In addition to demonstrating superior relative vaccine efficacy compared to a standard-dose flu vaccine, our mRNA-based seasonal flu vaccine has the potential to more precisely match circulating strains and help reduce the substantial burden of disease caused by influenza in older adults."
According to the U.S. Centers for Disease Control (CDC), seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-2025 season. More than 545,000 Americans were hospitalized due to flu-related illness last year, leading to substantial direct and indirect costs, as well as widespread disruption to daily life and work.[1]
mRNA-1010 has been accepted for regulatory review in the U.S., Europe, Canada and Australia. Moderna has received a U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Regulatory submissions in additional countries are planned for 2026.
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: Moderna's regulatory filings for mRNA-1010 and ongoing regulatory review; the potential for approvals of mRNA-1010 to begin in 2026; the safety and efficacy of mRNA-1010; the potential of mRNA-1010 to more precisely match circulating strains; Moderna's PDUFA goal date; and regulatory submissions for mRNA-1010 planned for additional countries in 2026. 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
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
[1] https://www.cdc.gov/flu/whats-new/2025-2026-influenza-activity.html
SOURCE: Moderna, Inc.
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https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/moderna-announces-new-england-journal-of-medicine-publication-of-pivo-1164301
