Annika Kim Constantino@annikakimc<\/p>\n\n\n\n
Key Points<\/p>\n\n\n\n
Moderna<\/a> on Monday said its experimental mRNA-based flu vaccine<\/a> produced a stronger immune response than a currently available shot in a late-stage trial, clearing a path forward for the product and the company\u2019s separate combination flu and Covid jab.<\/p>\n\n\n\n Moderna in May voluntarily withdrew an application<\/a> seeking approval of its combination shot targeting Covid-19 and influenza, saying it had plans to resubmit it with efficacy data from the phase three trial on its standalone flu vaccine. That decision came after discussions with the Food and Drug Administration, which is grappling with a massive overhaul under Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic.<\/p>\n\n\n\n With the new data, the company plans to resubmit the application for the combination vaccine and file for approval of its standalone flu shot later this year, Stephen Hoge, the company\u2019s head of research and development, said in an interview.<\/p>\n\n\n\n If regulators approve the flu vaccine, the company can then advance the combination shot, Hoge said. He added that Moderna expects approvals for both shots next year pending reviews.<\/p>\n\n\n\n Moderna shares climbed more than 5% in premarket trading Monday.<\/p>\n\n\n\n Hoge said the combination jab simplifies vaccination, which will \u201chelp the health-care system\u201d by reducing workloads of doctors and nurses, slashing costs and improving uptake among patients.<\/p>\n\n\n\n The company so far appears to be the frontrunner in the race against Pfizer<\/a> and Novavax<\/a> to bring a combination shot to the market. While Moderna does not have specific revenue projections for its individual products, Hoge said Covid, flu and respiratory syncytial virus are each multi-billion-dollar markets.<\/p>\n\n\n\n \u201cWe\u2019re obviously hoping that our products allow us to earn our fair share of them,\u201d he said.<\/p>\n\n\n\n The phase three trial followed more than 40,000 adults ages 50 and above, who were randomly assigned to receive a single dose of Moderna\u2019s shot, called mRNA-1010, or a standard competitor vaccine. Moderna\u2019s shot was 26.6% more effective than the other vaccine in the overall study population. <\/p>\n\n\n\n The mRNA-1010 jab also demonstrated strong efficacy for each of the major influenza strains in the shot, including A\/H1N1, A\/H3N2 and the B\/Victoria lineages. Moderna said the vaccine\u2019s benefit was consistent across different age groups, people with various risk factors and previous vaccination status against the flu. <\/p>\n\n\n\n In adults ages 65 and older, the shot was 27.4% more effective than the standard flu vaccine. <\/p>\n\n\n\n The efficacy results are \u201ca significant milestone in our effort to reduce the burden of influenza in older adults,\u201d Moderna CEO Stephane Bancel said in a release. \u201cThe severity of this past flu season underscores the need for more effective vaccines.\u201d<\/p>\n\n\n\n Moderna cited data <\/a>from the Centers for Disease Control and Prevention showing that seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024 to 2025 season of the virus. More than 600,000 Americans<\/a> were hospitalized due to flu-related illness last year, according to the CDC. <\/p>\n\n\n\n The mRNA-1010 vaccine\u2019s safety data was consistent with previous results from another phase three study on the shot. <\/p>\n\n\n\n