Tetravalent influenza vaccine(Split, inactivated)(Sanofi)

Moderna’s combination vaccine against influenza and COVID-19 met the primary endpoints of a late-stage study, eliciting a higher immune response than comparator shots used in the trial. CEO Stéphane Bancel said on Monday "we are very delighted about the results,” as they position Moderna as “the only company with a positive Phase III flu and COVID combination vaccine.”The jab, dubbed mRNA-1083, comprises components of Moderna’s vaccine candidate for seasonal flu mRNA-1010 and its next-generation COVID-19 shot mRNA-1283.The study consisted of one group of adults 65 years and older who received mRNA-1083 or separate doses of Sanofi’s flu vaccine Fluzone HD and Moderna’s currently licensed COVID-19 jab Spikevax. The second group, comprising adults ages 50 to 64, received mRNA-1083 or separate shots of GSK’s flu vaccine Fluarix and Spikevax.Results showed that the immune response from a single dose of mRNA-1083 was non-inferior to the co-administered vaccines, eliciting significantly higher immune responses against the H1N1, H3N2 and B/Victoria flu strains, as well as against SARS-CoV-2. Bancel suggested that the better performance compared to Spikevax was likely because mRNA-1083 has been designed to combat more recent variants of the coronavirus.Moderna added that mRNA-1083 had an acceptable tolerability and safety profile in the study, with the majority of adverse reactions being Grade 1 or 2 injection-site pain, fatigue, myalgia and headache. The company plans to present the data at an upcoming medical conference and engage with regulators on next steps. Meanwhile, Bancel suggested that mRNA-1083 could be launched next year and be more widely available in 2026.Earlier this year, Moderna reached an agreement to bring in external funding of up to $750 million from Blackstone Life Sciences to support development of its mRNA-based flu vaccines, including mRNA-1010, as well as other combination shots to provide protection against flu, respiratory syncytial virus (RSV) and COVID-19. The drugmaker recently gained FDA approval for its RSV vaccine mRESVIA, marking the first step in its commercial efforts beyond COVID-19.For further analysis, read Spotlight On: Will Moderna’s RSV vaccine help to deliver on the promise of mRNA?

mRNA-1083 met its primary endpoints, eliciting higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older, including an enhanced influenza vaccine in adults 65 years and older CAMBRIDGE, MA / ACCESSWIRE / June 10, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the trial. "Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," said Stéphane Bancel, Chief Executive Officer of Moderna. "Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine. Building on the momentum of positive Phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health." mRNA-1083 comprises components of mRNA-1010, Moderna's vaccine candidate for seasonal influenza, and mRNA-1283, Moderna's next-generation COVID-19 vaccine candidate. Each investigational vaccine has independently demonstrated positive Phase 3 clinical trial results. The ongoing Phase 3 clinical trial (ClinicalTrials.gov Identifier:NCT06097273) is a randomized, observer-blind, active control study evaluating the safety, reactogenicity and immunogenicity of mRNA-1083 in two independent age group cohorts of approximately 4,000 adults each. One cohort, consisting of adults 65 years and older, compared mRNA-1083 to co-administered Fluzone HD®, an enhanced influenza vaccine, and Spikevax®, Moderna's currently licensed COVID-19 vaccine. The other cohort of adults 50 to 64 years of age compared mRNA-1083 to co-administered, Fluarix®, a standard dose influenza vaccine, and Spikevax. The immune responses from a single dose of mRNA-1083 were found to be non-inferior versus the co-administered, routinely recommended, licensed comparators. In both age cohorts, mRNA-1083 also elicited statistically significantly higher immune responses against three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2. In the 65 years and older cohort, overall Geometric Mean Ratios (GMRs) of the mRNA-1083 group compared to the Fluzone HD group for the influenza strains were 1.155 (95% CI: 1.094, 1.220) for A/H1N1, 1.063 (95% CI: 1.007, 1.122) for A/H3N2 and 1.118 (95% CI: 1.070, 1.167) for B/Victoria. The GMR of mRNA-1083 compared to Spikevax for the SARS-CoV-2 variant Omicron XBB.1.5 was 1.641 (95% CI: 1.526, 1.765). In the 50 to 64 years of age cohort the GMRs of the mRNA-1083 group compared to the Fluarix group for the influenza virus strains were 1.414 (95% CI: 1.333, 1.500) for A/H1N1, 1.380 (95% CI: 1.310, 1.454) for A/H3N2, and 1.216 (95% CI: 1.163, 1.270) for B/Victoria. The GMR of mRNA-1083 compared to Spikevax for the SARS-CoV-2 variant Omicron XBB.1.5 was 1.308 (95% CI: 1.219, 1.404). Immunogenicity was also tested against the B/Yamagata strain of influenza and mRNA-1083 met non-inferiority criteria in both age cohorts. Due to the disappearance of the B/Yamagata lineage from circulation, WHO has recommended a trivalent influenza vaccine composition without B/Yamagata for 2024/2025 vaccines. mRNA-1083 showed an acceptable tolerability and safety profile. The majority of solicited adverse reactions were grade 1 or 2 in severity and consistent with the licensed vaccines used in the trial. The most commonly solicited adverse reactions were injection site pain, fatigue, myalgia and headache. Moderna plans to present the Phase 3 clinical data for mRNA-1083 at an upcoming medical conference as well as submit it for publication. The Company will engage with regulators on next steps. 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. Spikevax® is a registered trademark of Moderna. Fluzone HD® is a registered trademark 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 potential for mRNA-1083 specifically, and combination vaccines generally, to reduce the burden of respiratory virus season; the safety and efficacy of mRNA-1083; and Moderna's plans to present data related to mRNA-1083 and to engage with regulators. 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, 2023, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, 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: Elise Meyer Sr. Director, Corporate Communications +1 617-852-7041 Elise.Meyer@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 Lavina.Talukdar@modernatx.com SOURCE: Moderna, Inc. 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