Moderna Inc.’s head office in Cambridge, Massachusetts, March 26, 2024.
Adam Glanzman | Bloomberg | Getty images
Modern On Monday, its experimental mRNA vaccine produced a stronger immune response than a shooting currently available in a late stage test, erase a path to follow for the separate product and influenza from the company and the Jab Cavid.
Moderna in May voluntarily withdrew an application by looking for approval of its combined photo targeting COVID-19 and Fluenza, claiming that it intended to submit it with efficiency data of phase three tests on its vaccine against autonomous flu. This decision was made after discussions with Food and Drug Administration, which is struggling with a massive overhaul of the Secretary of Health and Social Services Robert F. Kennedy Jr., a leading vaccination skeptic.
With the new data, the company plans to submit the request for a combination of combination again and file the approval of its autonomous flu vaccine later this year, Stephen Hoge, responsible for the research and development of the company, in an interview.
If the regulators approve the flu vaccine, the company can advance combined shooting, Hogge said. He added that Moderna is expecting approvals for both shots next year while waiting for opinions.
Moderna’s shares climbed more than 5% in the negotiations prior to the market on Monday.
Hoge said that the JAB combination simplifies vaccination, which “will help the health system” by reducing the workloads of doctors and nurses, reducing costs and improving adoption in patients.
Until now, society seems to be the first runner in the race against Pfizer And Novavax To bring a combined photo on the market. Although Moderna has no specific income projections for its individual products, Hoge said that the flu and virus syncytial respiratory virus are each several billion dollars.
“We obviously hope that our products allow us to win our fair share,” he said.
Phase three tests followed more than 40,000 adults aged 50 and over, who were randomly assigned to receive a single Moderna shooting dose, called ARNM-1010, or a standard competitor vaccine. Moderna shooting was 26.6% more efficient than the other vaccine in the global study population.
The JAB MRNA-1010 has also demonstrated a high efficiency for each of the main influenza strains in the plan, including A / H1N1, A / H3N2 and B / Victoria lines. Moderna said the benefit of the vaccine was consistent in different age groups, people with various risk factors and previous vaccination status against flu.
In adults 65 and over, the shooting was 27.4% more efficient than the standard flu vaccine.
The results of efficiency are “an important step in our efforts to reduce the burden of flu in the elderly,” Moderna CEO, Stephane Bancel said in a statement. “The severity of this last season of the flu highlights the need for more effective vaccines.”
Moderna cited the data from Centers for Disease Control and Prevention showing that hospitalizations and ambulatory visits to seasonal flu has reached a 15 -year summit during the 2024 to 2025 virus season. According to the CDC, more than 600,000 Americans have been hospitalized due to influenza disease.
The security data of the mRNM-1010 vaccine was consistent with the previous results of another phase three study on the shooting.
Moderna’s shares have decreased by more than 30% for the year who entered Monday, largely fed by a series of measures by the Trump administration to modify the vaccine policy and undermine vaccinations. The administration in May has canceled a contract awarded to Moderna for the late development of her bird flu vaccine for humans.
Asked about the uncertain regulatory environment in the United States, Hoge declared that Moderna engages in close collaboration with the FDA to understand what its requirements are and how to meet them.
“I believe, with regard to the flu, I think we have a fairly clear path,” he said.