Press release
Moderna Announces Interim Phase 3 Safety and Immunogenicity Results for mRNA-1010, a Seasonal Influenza Vaccine Candidate
mRNA-1010 demonstrated superiority on seroconversion rates for A/H3N2 and A/H1N1, superiority on geometric mean titer ratios for A/H3N2, and non-inferiority
About this update from Moderna, Inc.
[{"type":"text","content":"mRNA-1010 demonstrated superiority on seroconversion rates for A/H3N2 and A/H1N1, superiority on geometric mean titer ratios for A/H3N2, and non-inferiority on geometric mean titer ratios for A/H1N1Non-inferiority was not met for seroconversion rates and geometric mean titer ratios for the influenza B/Victoria- and B/Yamagata-lineage strainsmRNA-1010 showed an acceptable safety and tolerability profileSeparate parallel pivotal Phase 3 efficacy study has now accrued over 200 PCR-confirmed cases, almost all influenza A consistent with the burden of disease in older adults; an independent DSMB is expected to review the first interim analysis of efficacy by the end of 1QmRNA-1010 is one of five influenza vaccine candidates being evaluated by ModernaCAMBRIDGE, MA / ACCESSWIRE / February 16, 2023 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced interim results from its pivotal Phase 3 safety and immunogenicity trial of mRNA-1010 (P301), an mRNA-based seasonal influenza (flu) vaccine candidate, in adults. The Phase 3 randomized trial was designed to evaluate the safety and immunogenicity of mRNA-1010 in adults 18 years and older in the Southern Hemisphere. mRNA-1010 encodes for hemagglutinin (HA) glycoproteins of the four influenza strains recommended by the World Health Organization (WHO) to prevent influenza, including influenza A/H1N1, A/H3N2, and influenza B/Yamagata- and B/Victoria-lineages. Interim results indicate that mRNA-1010 achieved superiority on seroconversion rates for A/H3N2 and A/H1N1, as well as superiority on geometric mean titer ratios for A/H3N2 and non-inferiority on geometric mean titer ratios for A/H1N1. Non-inferiority was not met for either endpoints for the influenza B/Victoria- and B/Yamagata-lineage strains.\"Today's results represent an important step forward in the development of mRNA-based influenza vaccines to address the substantial burden of disease caused by influenza. We are encouraged by the safety and tolerability profile, and by the strong immunogenicity results against Influenza A viruses which cause the overwhelming majority of flu-related disease in older adults. We now look forward to the efficacy results from the ongoing pivotal Phase 3 efficacy study being conducted in parallel,\" said Stephen Hoge, M.D., Moder...