TL/DR –
The Food and Drug Administration approved mFLUSIVA, Moderna’s mRNA-based seasonal flu shot, making it the first flu vaccine built on mRNA. The vaccine showed a quarter fewer flu cases among those administered with it compared to those given the standard-dose flu vaccine. However, mRNA projects, including flu and COVID vaccines, had their funding canceled by the Health and Human Services department, and the essential federal requirement for synthetic biology companies to screen their orders for dangerous sequences falls outside the purview of this legislation, causing a potential risk in the context of epidemics or pandemics.
“`html
A Revolution in Flu Vaccination: mFLUSIVA Gets FDA Approval
Wednesday night witnessed a significant milestone in health science as the Food and Drug Administration granted approval to mFLUSIVA, the seasonal flu vaccine of Moderna. This mRNA-based vaccine represents the first of its kind for influenza.
The Journey to Approval
The FDA’s approval came on the target action date of August 5th. Earlier this year, the agency had initially refused to file Moderna’s application due to concerns raised by former vaccine division head, Dr. Vinay Prasad. The point of contention was Moderna’s testing methodology, which was against a standard-dose flu vaccine rather than the most robust version for older adults.
Moderna, however, managed to get its application reconsidered by the FDA after making necessary amendments and demonstrating convincing results from a phase III trial involving 40,805 participants. The agency’s vaccine advisory committee voted unanimously in favor of the vaccine’s benefits outweighing the risks.
The Clinical Trial Results
According to the pivotal trial, Moderna’s flu shot resulted in 25% fewer flu cases compared to the standard dose flu shot. While 2.8% of individuals on the standard-dose flu vaccine contracted the flu, only 2.0% of those on mFLUSIVA became ill. However, the side effects reported were roughly twice as high as those for the standard-dose flu vaccine.
COVID and Influenza Vaccine Developments
Despite the promising results for mFLUSIVA, funding for mRNA vaccines has seen a significant reduction. In 2025, the HHS announced a $500 million NIH initiative for creating universal flu and coronavirus vaccines, referred to as Generation Gold Standard. However, HHS later cancelled $766 million in federal funding for mRNA vaccines, including a $590 million contract for developing vaccines against potential pandemic-causing flu strains.
Insurance Coverage and Policy Matters
Whether a vaccine can be sold is determined by FDA approval, but the decision on whether insurers should cover it for free lies with the Advisory Committee on Immunization Practices (ACIP). The Affordable Care Act mandates that private plans should cover ACIP-recommended shots without any copay.
Looking Forward
While the approval of mFLUSIVA is a significant stride in influenza vaccination, it also highlights the need for robust biosecurity measures. A 2025 study in Science points to the challenges with screening software that detect dangerous sequences in synthetic biology products. A group of experts, including representatives from OpenAI, Google DeepMind, and Microsoft AI, have penned a letter to Congress, advocating for mandatory nucleic acid synthesis screening in the United States.
“`
—
Read More US Economic News