Core Insights - Moderna's experimental mRNA-based flu vaccine has shown a stronger immune response compared to the currently available vaccine in late-stage trials, paving the way for further development of both the flu vaccine and a combination flu and Covid jab [1][3]. Company Developments - In May, Moderna voluntarily withdrew its application for the combination vaccine targeting Covid-19 and influenza, planning to resubmit it with efficacy data from the phase three trial of its standalone flu vaccine [2]. - The company intends to resubmit the application for the combination vaccine and seek approval for its standalone flu shot later this year, with expectations for regulatory approvals for both products next year [3]. Market Position - Moderna is currently a frontrunner against competitors Pfizer and Novavax in the race to market a combination vaccine, with the potential for significant revenue from the multi-billion-dollar markets of Covid, flu, and respiratory syncytial virus [4][5]. Efficacy Data - The phase three trial involved over 40,000 adults aged 50 and above, showing that Moderna's mRNA-1010 vaccine was 26.6% more effective than the standard competitor vaccine [5]. - The mRNA-1010 vaccine demonstrated strong efficacy against major influenza strains, with a 27.4% higher effectiveness in adults aged 65 and older compared to the standard flu vaccine [6]. Public Health Context - Moderna's CEO highlighted the importance of effective vaccines, especially given that flu-related hospitalizations reached a 15-year high during the 2024 to 2025 season, with over 600,000 hospitalizations reported [7]. Safety and Regulatory Engagement - The safety data for the mRNA-1010 vaccine aligns with previous phase three study results, indicating a consistent safety profile [8]. - Moderna is actively engaging with the FDA to clarify regulatory requirements and believes it has a clear path regarding flu vaccine approval [9].