Moderna has filed for marketing authorization in the U.S., EU, Canada and Australia for mRNA-1010
CAMBRIDGE, MA / ACCESS Newswire / January 5, 2026 / Moderna, Inc. (NASDAQ:MRNA) today provided an update on regulatory submissions for its investigational seasonal influenza vaccine, mRNA-1010, for adults aged 50 years and older. The Company has filed for marketing authorization with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and the Therapeutic Goods Administration (TGA) in Australia.
“We are proud to announce these filings for the use of our seasonal flu vaccine candidate, a major milestone for our respiratory portfolio,” said Stéphane Bancel, Chief Executive Officer of Moderna. “The issue of vaccine mismatch due to virus mutations has long worried influenza experts and, as we have seen this flu season, can lead to a heightened public health burden. The agility and flexibility of mRNA technology offer the potential to more closely match evolving strains and more effectively respond to one of the world’s most persistent respiratory threats. If approved, this potential new product launch and geographic expansion represent an important opportunity to support Moderna’s continued growth in 2027 and beyond.”
The regulatory applications are based on positive data from multiple Phase 3 studies. In a Phase 3 efficacy study (P304), mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with a relative vaccine efficacy (rVE) of 26.6% (95% CI; 16.7%, 35.4%) across all adults aged 50 years and older. 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%. In a previous Phase 3 study (P303), mRNA-1010 had demonstrated superior seroconversion rates and geometric mean titer ratios (GMR) against all strains included in the vaccine compared to both high-dose and standard-dose licensed seasonal influenza vaccine.
mRNA-1010 has been found to be well tolerated with a favorable safety profile. The majority of solicited adverse reactions (SARs) have been mild. Injection site pain was the most common local SAR, and fatigue, headache and myalgia were the most common systemic SARs reported.
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 submissions; mRNA-1010’s efficacy and safety; and the ability of mRNA technology to more closely match evolving strains and more effectively respond to respiratory threats. 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
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
