Moderna’s First Mrna Flu Vaccination is Approved by The US FDA

Moderna (MRNA.O) announced on Wednesday that the U.S. Food and Drug Administration had approved a new tab flu vaccine for individuals 50 years of age and older. This is the first time a messenger RNA-based vaccine for seasonal flu has been approved.

Adults between the ages of 50 and 64 received regular approval for the vaccine mFlusiva, while those 65 and above received accelerated approval.

To verify the vaccine’s effectiveness in persons 65 and older, Moderna has consented to conduct second research and provide more data.

According to a statement from Moderna, “mFLUSIVA offers an important new option for America’s seniors, and flu remains a significant public health challenge.”

Data from a late-stage experiment with almost 40,000 persons 50 years of age and older, which shown that the shot was 26.6% more effective than a licensed standard-dose flu vaccine, served as the basis for the approval.

Additionally, the business provided independent late-stage data demonstrating that in persons 65 and older, the vaccination produced better antibody responses than Sanofi’s high-dose flu vaccine.

MFlusiva would be in competition with flu shots from Sanofi (SASY.PA), GSK (GSK.L), CSL Seqirus (CSL.AX), and AstraZeneca (AZN.L). Faster updates to match circulating strains may be possible using Moderna’s vaccine, which uses mRNA technology to stimulate the body to manufacture influenza antigens and initiate an immune response.

Conventional flu vaccinations, on the other hand, contain viral proteins and are mostly egg-based.

Because Moderna missed the contracting cycle for the 2026 U.S. flu season, analysts do not anticipate mFlusiva to produce significant income until the second half of 2027.

Despite opposition from some U.S. health officials, the business has been relying on the flu shot and a future COVID-flu combination shot to replenish some of the lost COVID vaccine income and demonstrate the long-term economic potential of its mRNA technology.

By 2030, Moderna’s flu shot and combo COVID-flu vaccination were expected to sell $750 million in the United States, according to Jefferies analysts.