U.S. health advisers are reviewing a new type of flu vaccine developed by Moderna, which utilizes mRNA technology. This approach was instrumental in the development of COVID-19 vaccines and could offer a faster way to produce flu shots if the virus mutates.
Moderna is seeking approval from the Food and Drug Administration for its mFlusiva vaccine, intended for individuals aged 50 and older. This review is a critical step before a final decision is made, ahead of the upcoming winter flu season. Influenza results in tens of thousands of deaths annually in the United States, with older adults being particularly susceptible.
While several flu vaccines are currently available, including formulations specifically for those 65 and older, mRNA vaccines are noted for their speed of manufacturing. This could be a significant advantage in responding to rapid changes in the influenza virus.
A study involving 40,000 participants aged 50 and older indicated that Moderna's mRNA vaccine demonstrated a roughly 27% reduction in flu cases when compared to another standard vaccine. The FDA has released a preliminary review of this data, noting no safety concerns.
Moderna is pursuing full approval for the vaccine's use in adults aged 50 to 64. For the population aged 65 and older, the company is seeking authorization while further testing is conducted.
Earlier this year, the application faced a significant hurdle when a top FDA official raised concerns about the comparative study used. The official suggested that Moderna's shot should have been compared against a high-dose flu vaccine recommended for seniors, rather than a standard-dose vaccine. This disagreement highlighted increased scrutiny on vaccine applications under Health Secretary Robert F. Kennedy Jr. Moderna challenged the decision, pointing to FDA staff's prior approval of the study design and a smaller, separate study. The FDA ultimately accepted Moderna's application.
An additional smaller study will also be evaluated by the expert panel. This study found that Moderna's vaccine generated flu-fighting antibodies at levels comparable to a high-dose vaccine for seniors. However, the FDA's initial review noted that data on very frail older adults and those with compromised immune systems is currently lacking.