The Moderna Inc. headquarters in Cambridge, Massachusetts, on March 26, 2024.<\/p>\n
Adam Glanzman | Bloomberg | Getty Images<\/p>\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’s separate combination flu and Covid jab.<\/p>\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 stand-alone 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 With the new data, the company plans to resubmit the application for the combination vaccine and file for approval of its stand-alone flu shot later this year, Stephen Hoge, the company’s head of research and development, said in an interview.<\/p>\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 Moderna shares climbed nearly 3% in premarket trading Monday.<\/p>\n Hoge said the combination jab simplifies vaccination, which will “help the health-care system” by reducing the workloads of doctors and nurses, slashing costs, and improving uptake among patients.<\/p>\n The company so far appears to be the front-runner 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 multibillion-dollar markets.<\/p>\n “We’re obviously hoping that our products allow us to earn our fair share of them,” he said.<\/p>\n More CNBC health coverage<\/p>\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’s shot, called mRNA-1010, or a standard competitor vaccine. Moderna’s shot was 26.6% more effective than the other vaccine in the overall study population.\u00a0<\/p>\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’s benefit was consistent across different age groups, people with various risk factors and previous vaccination status against the flu.\u00a0<\/p>\n In adults ages 65 and older, the shot was 27.4% more effective than the standard flu vaccine.\u00a0<\/p>\n The efficacy results are “a significant milestone in our effort to reduce the burden of influenza in older adults,” Moderna CEO Stephane Bancel said in a release. “The severity of this past flu season underscores the need for more effective vaccines.”<\/p>\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.\u00a0<\/p>\n The mRNA-1010 vaccine’s safety data was consistent with previous results from another phase three study on the shot.\u00a0<\/p>\n