FDA Reopens the Door to Moderna’s mRNA Flu Shot

 The U. S. Food and Drug Administration (FDA) has decided to review Moderna’s mRNA vaccine for seasonal influenza after initially rejecting its application due to concerns about trial design. The change followed a quick meeting between the FDA and Moderna, shifting the company's prospects for approval and market entry.

1. Initial Rejection and Concerns:

• The FDA previously issued a Refusal-to-File letter, stating that Moderna’s Phase 3 clinical trial for its mRNA flu vaccine, mRNA-1010, was not adequately controlled.

• Concerns centered on the use of a standard-dose seasonal influenza vaccine as a comparator, which the FDA did not consider appropriate for seniors.

2. Moderna's Argument:

• Moderna claimed that previous communications had validated the use of such a comparator and emphasized that there were no specific safety or efficacy issues highlighted by the FDA.

• The company's Phase 3 trial met its predefined success criteria, and they later provided more detailed analyses, including comparisons with licensed high-dose vaccines.

3. Regulatory Path Forward:

• After the RTF letter, Moderna engaged with the FDA to clarify the situation and proposed to seek full approval for adults aged 50-64 and accelerated approval for those 65 and older.

• The FDA accepted the revised application for review, setting a target date for approval by August 5, 2026.

4. Political and Financial Context:

• Reports suggest that there was political pressure influencing the FDA's change in stance, including personal involvement from former President Trump.

• The approval of the vaccine carries significant commercial implications, with major investments made by firms like the Blackstone Group in Moderna’s flu vaccine development.

5. Concerns from Activists and Observers:

• Some critics, including members of the Make America Healthy Again movement, criticized the FDA's decision as unethical, citing issues regarding the trial's comparator and the potential risks of the vaccine.

• Comments from health experts pointed to the high rates of side effects noted in Moderna’s clinical trials compared to conventional flu vaccines.

The FDA's acceptance of Moderna's mRNA flu vaccine for review represents a critical moment in vaccine development, reflecting both the complexities of regulatory approval and the significant political and financial interests involved. The outcome will have major implications, not only for Moderna and its investors but also for public health and vaccine confidence. As the review process continues, the implications of this decision will be closely monitored by both supporters and critics alike. 

https://thenewamerican.com/us/healthcare/fda-reopens-the-door-to-modernas-mrna-flu-shot/