Moderna Seeks FDA Approval for First mRNA Flu Vaccine
US health advisers are considering a novel flu vaccine that uses the same mRNA technology that helped end the Covid-19 pandemic. Moderna is seeking Food and Drug Administration (FDA) approval for its new shot, called mFlusiva, for individuals aged 50 and older. The FDA advisory committee meeting is a step toward a final decision before the winter flu season.
Tens of thousands of Americans die from influenza each year, with older adults being particularly vulnerable. While several flu vaccines are already available in the US, including three specifically recommended for those 65 and older, mRNA technology allows for faster manufacturing. This could be crucial if the flu virus mutates and requires new doses quickly.
In a study involving 40,000 people aged 50 and older, Moderna's mRNA vaccine reduced flu cases by about 27% compared to those who received another routinely used vaccine brand. The FDA published a favorable review of the data ahead of the meeting and reported no safety concerns.
Moderna is pursuing full approval for the vaccine in the 50-64 age group and authorization for those 65 and older while additional testing is conducted. Earlier this year, a top FDA official, Dr. Vinay Prasad, blocked the company's application, arguing that the shot should have been compared to a high-dose flu vaccine recommended for seniors rather than a standard-dose brand. This incident highlighted increased FDA scrutiny under Health Secretary Robert F. Kennedy Jr.
Moderna challenged the decision, noting that FDA staff had approved the main study's design and citing a separate, smaller study comparing the mRNA shot with a high-dose vaccine for seniors. The FDA eventually accepted the application. The expert panel will also assess that smaller study, which found that Moderna's shot generated flu-fighting antibodies similarly to a high-dose senior shot. However, the FDA's initial review noted a lack of data on very frail older adults and those with weak immune systems.
