Tetravalent influenza vaccine(Split, inactivated)(Sanofi)

With an FDA advisory panel meeting set to scrutinise Moderna's experimental mRNA flu vaccine mFlusiva (mRNA-1010) later this week, agency staff released briefing documents raising questions about missing data for certain patient groups. However, the report concludes that there were "no major deficiencies" with the vaccine's application, sending Moderna shares up more than 6% on Tuesday.The meeting scheduled for June 18 follows a turbulent review process so far, including an earlier refusal by the agency to even consider the application over the lack of an "adequate and well-controlled" study. That stance was later reversed after discussions with the company and reported pressure from the White House.Moderna is seeking full approval of mFlusiva for adults 50 to 64 years of age and accelerated approval for those 65-plus; it plans to conduct a post-marketing study in the older cohort. The US regulator has set a PDUFA date of Aug. 5.One season of dataIn the FDA briefing documents, agency scientists recognised that mFlusiva met all prespecified sequential efficacy and immunogenicity criteria versus standard-dose and high-dose comparators. However, they noted that one of the supporting studies ran for only a single influenza season, despite being designed to enrol participants across up to two seasons. The late-stage trial, called Study P304, showed relative vaccine efficacy (rVE) of 26.6% versus a licensed standard-dose seasonal influenza vaccine in the overall population of adults aged 50-plus and was consistent across age subgroups, including 28% among 65-74s and 25.3% for over-75s. The rVE was 47.9% against higher-level health outcomes such as hospitalisations and urgent care visits.Immunogenicity is the primary basis for accelerated approval in the 65-plus age group, and results here were also generally favourable. In Study P303 Part C, mFlusiva produced stronger immune responses than Sanofi's Fluzone HD in adults 65 and older; it generated higher antibody levels against all four vaccine-matched influenza strains, measured both at about one month and six months after vaccination.Additionally, safety data across nearly 36,000 participants pooled from four Phase III studies showed similar rates of serious adverse events (AEs), AEs of special interest and deaths between treatment groups, with no identified cases of myocarditis or pericarditis tied to mFlusiva.Vulnerable populationsHowever, agency scientists highlighted "evidence gaps" in populations at highest risk for severe influenza outcomes. Aside from there being only one influenza season of data, they noted that efficacy hasn't been established in immunocompromised individuals and very frail older adults."This gap is significant because these populations face the highest absolute risk of severe influenza-related complications and may respond differently to mRNA-based vaccine platforms," FDA staff said in their report. "The study exclusion of these groups limits direct applicability of the efficacy data to a substantial portion of the intended patient population."The briefing also flags the absence of data on coadministration with other commonly used vaccines, including COVID-19, respiratory syncytial virus and pneumococcal products. Further, it suggests mFlusiva's efficacy against the B/Victoria strain of influenza is uncertain because too few of those infections occurred during the study to draw a firm conclusion.While the adcom calendar has been off to a slow start this year, there are signs the pace may be picking up following the resignation of former Commissioner Marty Makary a month ago (see – Spotlight On: Will adcoms return under new FDA leadership?).

mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive marketing authorization and Moderna's fourth authorized product mCOMBRIAX will be made available in the European Union, subject to national regulatory and access procedures CAMBRIDGE, MA / ACCESS Newswire / April 21, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for mCOMBRIAX ® (mRNA-1083), the Company's mRNA combination vaccine for active immunization for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. This marketing authorization follows the positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and is valid in all 27 European Union member states, as well as Iceland, Liechtenstein and Norway. mCOMBRIAX is Moderna's fourth authorized product, further strengthening the Company's respiratory portfolio and commitment to the European Union. "We welcome the European Commission's approval of mCOMBRIAX, the world's first flu plus COVID-19 combination vaccine," said Stéphane Bancel, Chief Executive Officer of Moderna. "By combining protection against two significant respiratory viruses in a single dose, our vaccine aims to simplify immunization for adults, particularly those at high risk. mCOMBRIAX offers an important new option for Europeans, while also aiming to strengthen the resilience of healthcare systems across Europe." mCOMBRIAX builds on the advances from the clinical development of mNEXSPIKE ® , Moderna's COVID-19 vaccine, and mRNA-1010 , Moderna's investigational seasonal influenza vaccine, which has been accepted for review in the European Union, United States, Canada and Australia. The EC's authorization is based on the results from the pivotal Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06097273 ), a randomized, observer-blind, active-controlled study evaluating the safety, reactogenicity, and immunogenicity of mRNA-1083 in two independent age cohorts of approximately 4,000 adults each. One cohort included adults 65 years of age and older and compared mRNA-1083 to co-administered Fluzone HD ® (licensed in the European Union as Efluelda ® ), a high-dose influenza vaccine, and Spikevax ® , Moderna's licensed COVID-19 vaccine. The second cohort included adults 50 to 64 years of age and compared mRNA-1083 to co-administered Fluarix ® , a standard-dose influenza vaccine, and Spikevax. All primary endpoints demonstrating the non-inferiority of immune responses were met. Following a single dose, mRNA-1083 elicited statistically significantly higher immune responses against three influenza virus strains (A/H1N1, A/H3N2, and B/Victoria) and against SARS-CoV-2 in both age cohorts. The B/Yamagata strain, which is no longer recommended for inclusion in seasonal influenza vaccines, was the only strain for which a statistically significantly higher immune response was not observed for adults 65 years of age and older compared to the co-administered licensed comparator vaccines. [1] mRNA-1083 demonstrated an acceptable safety and tolerability profile. The majority of solicited adverse reactions were grade 1 or 2 in severity and consistent with the licensed vaccines used in the trial. mCOMBRIAX will be made available across the European Union, subject to national regulatory and access procedures, with Moderna working closely with national authorities to support local access and implementation. 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. mCOMBRIAX ® , mNEXSPIKE ® and Spikevax ® are registered trademarks of Moderna. Fluzone HD ® and Efluelda ® are registered trademarks of Sanofi Pasteur. Fluarix ® is a registered trademark of the GlaxoSmithKline group of companies. 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 availability of mCOMBRIAX in Europe, subject to national regulatory and access procedures; Moderna's work with national authorities to support local access and implementation; the potential of combination vaccines to simplify vaccination and support improved health outcomes; ongoing regulatory review of mRNA-1010 in several jurisdictions, and the potential for approval; and the safety, reactogenicity and immunogenicity of mRNA-1083. 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 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: Global: Chris Ridley Vice President, Global Head of Communications +1 617-800-3651 Chris.Ridley@modernatx.com EU: Clothilde Caillet Director, Country and Europe Communications Lead (+33) 07 60 87 68 72 Clothilde.caillet@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 Lavina.Talukdar@modernatx.com [1] Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years: A Randomized Clinical Trial. JAMA: The Journal of the American Medical Association, published online 7 May 2025, SOURCE : Moderna, Inc. View the original press release on ACCESS Newswire