FDA panel reviews Moderna’s mRNA flu vaccine for older adults
9 reported2 unconfirmed
US health advisers are debating a new kind of flu vaccine Thursday, the first made with the same mRNA technology used in Covid-19 vaccines. Moderna is seeking FDA approval of its shot, called mFlusiva, as an option for people 50 and older. The FDA advisory committee meeting is a step toward a final decision ahead of the winter flu season. In a study of 40,000 people age 50 and older, Moderna’s mRNA vaccine reduced flu cases by about 27% compared to another routinely used vaccine brand. The FDA published a favorable review of that data and reported no safety concerns. Moderna is seeking full approval for ages 50 to 64 and authorization for those 65 and older while conducting additional testing. Earlier this year, a then-top FDA official blocked the application, leading to a public dispute over study design. The expert panel will also assess a smaller study comparing the mRNA shot with a high-dose vaccine for seniors.
What’s reported
US health advisers are debating a first-of-its-kind flu vaccine made with mRNA technology.
Moderna is seeking FDA approval for its shot, mFlusiva, for people 50 and older.
In a study of 40,000 people age 50 and older, the vaccine reduced flu cases by about 27% compared to another routinely used vaccine.
The FDA published a favorable review of that data and reported no safety concerns.
Moderna seeks full approval for ages 50 to 64 and authorization for those 65 and older while conducting additional testing.
Earlier this year, a then-top FDA official, Dr Vinay Prasad, blocked the application, saying the shot should have been compared to a high-dose flu vaccine for seniors.
The FDA accepted Moderna’s application after the company challenged the decision.
The expert panel will assess a smaller study that found the mRNA shot generated flu-fighting antibodies similarly to a high-dose senior shot.
The FDA’s initial review noted the new vaccine lacks data on very frail older adults and those with weak immune systems.
Open questions
Whether the FDA will approve or authorize the vaccine for use.
What the advisory committee will recommend.
Key figures
Moderna (company seeking approval)
Dr Vinay Prasad (former FDA vaccine chief)
Robert F Kennedy Jr (health secretary)
Sources: The Guardian
