Authored by Rachel Roberts via The Epoch Times,
The U.S. Food and Drug Administration has approved Moderna's flu shot for over-50s, marking the first time the agency has licensed a messenger ribonucleic acid (mRNA) vaccine for seasonal influenza.
Moderna bivalent COVID-19 vaccine at a clinic, in Richmond, Va., on November 17, 2022. AP Photo/Steve Helber, FileThe shot, known as mFlusiva, was given a traditional approval for adults aged 50 to 64, and an accelerated approval for the over-65s, the pharmaceutical giant said on Wednesday.
Moderna has agreed to run an additional study and submit further data on the over-65s in a bid to demonstrate the vaccine's benefit for that age group.
The approval was based on data from a late-stage trial involving more than 40,000 adults aged 50 and older, which found the shot was 26.5 percent more effective than a licensed standard-dose flu vaccine.
Moderna had to submit separate late-stage data showing the shot generated stronger antibody responses than Sanofi's high-dose flu vaccine in the over-65s after problems with the methodology in its phase 3 trial.
The vaccine uses mRNA technology, intended to prompt the body to produce influenza antigens and trigger an immune response. Scientists say this approach could potentially allow faster upda
