On March 26th, 2024, the headquarters of Moderna Company in Cambridge, Massachusetts.
Adam Grantzman | Bloomberg | Getty Images
Moderna On Monday, its experimental mRNA-based influenza vaccine produced a stronger immune response than the currently available shot in late trials, clearing the progression of separate product and company influenza and Covid JAB.
Moderna in May said it plans to withdraw its application for approval for a combined shot targeted at Covid-19 and flu and resubmit efficacy data from phase 3 trials of the standalone flu vaccine. The decision came after discussion with the Food and Drug Administration. This is tackling a massive overhaul of prominent vaccine skeptics Robert F. Kennedy Jr. of the Health and Human Services Department.
With new data, the company plans to resubmit its application for a combination vaccine and file for approval of standalone flu shots later this year.
If regulators approve the flu vaccine, the company can proceed with the combination shot, Hoge said. He added that Hyundai expects approval for both shots pending reviews next year.
Modanya’s shares rose more than 5% in pre-market trading on Monday.
According to Hoge, the JAB combination simplifies vaccination. It said it will “support the healthcare system” by reducing workloads for doctors and nurses, reducing costs and improving patient uptake.
So far, the company appears to be at the forefront of competitive competition Pfizer and Novavax Bring the combination shot to the market. Moderna does not have specific revenue forecasts for individual products, but Hoge said Covid, Flu and respiratory syncytial viruses are each multi-billion dollar markets.
“We obviously hope that our products can help us get a significant share of them,” he said.
The Phase 3 trial was randomly assigned to administer one shot of modern, called MRNA-1010 or a standard competitive vaccine, following over 40,000 adults aged 50 and over. Modanya’s shot was 26.6% more effective than other vaccines in the entire study population.
mRNA-1010 JAB showed strong efficacy against each of the major influenza strains in the shot, including A/H1N1, A/H3N2, and B/Victoria Lineages. Modanya said the benefits of the vaccine are consistent across different age groups, people with different risk factors, and previous vaccination situations against the flu.
In adults over the age of 65, this shot was 27.4% more effective than the standard flu vaccine.
The effectiveness outcome is a “significant milestone in efforts to reduce the burden of flu in older adults,” Moderna CEO Stephen Bansel said in a release. “The severity of this past flu season underscores the need for a more effective vaccine.”
Moderna cited data from the Centers for Disease Control and Prevention showing seasonal influenza-related hospitalizations and outpatient visits reached 15-year highs during the 2024-2025 virus season. More than 600,000 Americans were hospitalized last year due to flu-related illnesses, according to the CDC.
Safety data for the mRNA-1010 vaccine were consistent with previous results from another phase 3 study on shots.
Moderna’s shares fell more than 30% in the year that entered Monday, with fueled largely by changing vaccine policies and undermining vaccinations, largely due to a string of moves by the Trump administration. The May administration cancelled a contract awarded to Moderna for the late stage development of avian influenza vaccines for humans.
When asked about the uncertain regulatory environment in the US, Hoge said Moderna is closely involved with the FDA to understand what its requirements are and how to satisfy them.
“I think we have a pretty clear path, like it’s related to the flu,” he said.
