Moderna’s new mRNA-based flu vaccine has received approval from the US Food and Drug Administration (FDA) for individuals aged 50 and older, marking a significant development in influenza vaccination methods, reports BritPanorama.
The vaccine, named mFlusiva, is the first of its kind and builds off the mRNA technology established during the COVID-19 vaccination rollout. Approval comes after a tumultuous path, including initial funding cuts for mRNA research and the FDA’s earlier refusal to review Moderna’s application. However, independent advisers ultimately voted unanimously to support its benefits over risks.
Dr. Ronald G. Nahass, president of the Infectious Diseases Society of America, called the approval a welcome advancement, indicating it offers a crucial alternative to protect against a virus responsible for significant hospitalizations and mortality each year. The mFlusiva vaccine is expected to be available by this fall.
How the mRNA flu vaccine is different
Unlike traditional flu vaccines that use inactivated or weakened viruses, mRNA vaccines deploy strands of messenger RNA to instruct the body to produce a viral protein, prompting an immune response. This method allows for more accurate matching of vaccine strains to circulating virus variants, which are often unpredictable.
Dr. William Schaffner, an infectious disease expert, emphasized the adaptability of mRNA vaccines, which can be manufactured more rapidly, allowing for strain selection closer to the upcoming flu season. Traditional methods require decisions about vaccine strains to be made months in advance.
Who can get the vaccine
The mFlusiva vaccine targets those aged 50 and above, receiving standard approval for individuals aged 50 to 64, while it received accelerated approval for those aged 65 and older. This two-tiered approval process came after negotiations with the FDA following initial hurdles regarding the adequacy of trial controls.
The FDA had previously dismissed Moderna’s application, labeling its study design as inadequate. The agency recognized concerns regarding the standard of care during the trial period.
Guidelines from the US Centers for Disease Control and Prevention suggest that people over 65 should ideally receive an enhanced dose vaccine, creating a comparative baseline for evaluating the mRNA vaccine’s efficacy.
When the vaccine will be available
Moderna has indicated that mFlusiva will become available this fall. However, the rollout may face challenges due to earlier ordering patterns by pharmacies ahead of flu season.
Following approval, the CDC’s Advisory Committee on Immunization Practices typically reviews vaccine data to make recommendations. However, the committee has not convened since being disrupted by a judge’s ruling regarding procedural changes, complicating future guidance.
Insurance coverage for the new vaccine
As the CDC panel has yet to issue a recommendation, uncertainty surrounds whether the mRNA flu vaccine will be covered by insurance. Generally, flu vaccines are included under the Affordable Care Act provisions, but existing ambiguity creates concerns over coverage for the new product.
Experts advocate for vaccination among older adults due to their higher risk of severe flu complications. Data from the CDC indicates that a significant majority of flu-related hospitalizations and deaths involve individuals over the age of 65, underscoring the importance of vaccination in this demographic.
Decisions regarding flu vaccinations among older adults remain critical. With ongoing developments in vaccine technology, the conversation surrounding mFlusiva will likely evolve alongside emerging data from its implementation in the coming flu season.
