The headquarters of Modern Inc. in Cambridge, Massachusetts, on March 26, 2024.
Adam Glanzman | Bloomberg | Getty images
Modern On Monday, he said his experimental vaccine in the RNM -based flu produced a stronger immune response currently available in a late stage test, eliminating a forward path for the product and the combination of flu and the covid soap separated from the company.
Modern in May voluntarily withdrew an application in search of the approval of its shooting combination aimed at COVID-19 and influenza, saying that it had plans to send it again with efficacy data of the three phase test in its vaccine against the independent flu. That decision occurred after discussions with the Food and Medicines Administration, which is dealing with a massive review under the Secretary of Health and Human Services, Robert F. Kennedy Jr., an outstanding vaccine skeptic.
With the new data, the company plans to return to the application for the combined vaccine and the file for the approval of its independent flu vaccine at the end of this year, said Stephen Hoge, head of research and development of the company, in an interview.
If the regulators approve the flu vaccine, the company can advance the combination shot, Hoge said. He added that Modern expects approvals for both shots next year waiting for reviews.
Modern shares rose more than 5% in the negotiation prior to the market on Monday.
Hoge said that the combination JA simplifies vaccination, which “will help the medical care system” reducing workloads of doctors and nurses, reducing costs and improving absorption among patients.
The company until now seems to be the favorite in the race against Pfizer and Novávax To bring a combination of combination to the market. While modern has no specific income projections for its individual products, Hoge said that Covid, the flu and the respiratory syncitial virus are each multimillionaire markets.
“Obviously we expect our products to allow us to win our fair part of them,” he said.
Phase three trial followed more than 40,000 adults of 50 years or more, who were randomly assigned to receive a unique dose of modern taking, called ARNM-1010, or a vaccine against standard competition. Modern's shot was 26.6% more effective than the other vaccine in the general study population.
The MRNA-1010 soap also demonstrated a strong efficacy for each of the main influenza strains in the shot, including A/H1N1, A/H3N2 and the B/Victoria lineages. Modern said that the benefit of the vaccine was consisting of the different age groups, the people with several risk factors and the state of prior vaccination against the flu.
In adults over 65, the shot was 27.4% more effective than the standard flu vaccine.
The efficiency results are “a significant milestone in our effort to reduce the burden of influenza in older adults,” said the CEO of Modern, Stephane Banlel, in a statement. “The seriousness of this last season of influenza underlines the need for more effective vaccines.”
Modern cited data from the centers for the control and prevention of diseases that show that seasonal hospitalizations related to flu and outpatient visits reached a maximum of 15 years during the 2024 to 2025 season of the virus. According to CDC, more than 600,000 Americans were hospitalized due to flu -related diseases last year.
The safety data of the MRNA-1010 vaccine were consistent with the previous results of another phase three study on the shot.
Modern shares fell more than 30% during the year that entered Monday, bossessed largely by a series of movements of the Trump administration to change vaccine policy and undermine immunizations. The Administration in May canceled a contract granted to Modern for the development of its vaccine against Aviating Flu for Humans.
When asked about the uncertain regulatory environment in the United States, Hoge said Modern is being involved closely with the FDA to understand what their requirements are and how to satisfy them.
“I think, in relation to the flu, I think we have a fairly clear path,” he said.
