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A Shift in the Rules: The Story of mFLUSIVA’s Approval When a new medicine is approved, most people assume it has already been fully proven to work safely and effectively in the real world. However, the regulatory history of Moderna’s new mRNA flu shot, mFLUSIVA, reveals that the public is effectively being asked to step into the role of trial participants. The "Test Later" Strategy The vaccine was granted traditional approval for adults aged 50 to 64, but for seniors aged 65 and older—the group that accounts for up to 85% of flu deaths—the FDA granted accelerated approval. This pathway allows a drug to go to market based entirely on a surrogate endpoint (blood antibody levels) rather than proof that it actually prevents severe illness or death. To determine if the shot actually provides superior clinical protection compared to the enhanced vaccines seniors currently receive, the FDA is allowing the real experiment to happen after the rollout. A massive postmarketing trial involving up to 800,000 seniors will take place while the vaccine is already being administered to the public. This was not the FDA's original plan. The agency initially issued a strict "Refusal to File" letter because Moderna failed to compare mFLUSIVA against the standard-of-care enhanced vaccines recommended for seniors. However, following public pushback from Moderna and reported pressure from the White House, the FDA completely reversed its stance in just 14 days, accepting the application without the missing data. The top officials who signed the original refusal departed the agency shortly after. What the Data Actually Showed In the pivotal trial of over 40,000 adults, mFLUSIVA was reported as having a "26.6% relative vaccine efficacy" over a standard-dose shot. In real numbers, this means an absolute risk reduction of just 0.73 percentage points. Statistically, 137 people have to switch to mFLUSIVA to prevent just one single case of laboratory-confirmed flu. Meanwhile, the systemic side effects were notably higher. Roughly 5.5% of participants experienced vaccine reactions severe enough to completely prevent normal daily activities, compared to just 0.9% in the standard vaccine group. Furthermore, for every 137 people who switch to the vaccine, about six additional people will experience a reaction that stops their daily routine, just to prevent one case of the flu. Unresolved Safety Explanations The pooled safety database of over 71,000 participants revealed an unexplained mortality imbalance. Coded categories for unexplained death, sudden death, and sudden cardiac death occurred 29 times in the mFLUSIVA group compared to 12 times in the comparison groups. The FDA openly acknowledged that a lack of autopsy data severely limited its ability to interpret this data or rule out vaccine-related inflammatory responses. Yet, instead of pausing to demand autopsies and find definitive answers, the agency approved the vaccine anyway and moved safety monitoring into post-licensure surveillance. The Big Picture Ultimately, mFLUSIVA was expedited not because it was proven to save more senior lives, but because of its "plug-and-play" manufacturing platform. By securing this first approval, a regulatory foundation is now established that makes it much easier for future mRNA combination and pandemic vaccines to bypass rigorous, independent testing. Below are the official records, trial documents, and independent analyses used to compile these findings: Dr Malone News: https://www.malone.news/p/modernas-mrna-flu-shot Official FDA Briefing Document (Data on Trial Outcomes, Reactions, and Mortality Imbalance): fda.gov FDA Clinical Review Memorandum (In-depth Regulatory and Statistical Analysis): https://www.fda.gov/media/194140/download FDA Official Approval Letter for mFLUSIVA (Details on Postmarketing Commitments and Accelerated Approval Terms): https://www.fda.gov/media/194121/download?attachment Data Reanalysis by Dr. Peter McCullough, Nicolas Hulscher, and John Catanzaro: zenodo.org STAT News Report on Internal FDA Pushback and the Initial Refusal to File: statnews.com Click on the text to follow the link ✤ Website: freedomalliancesa.org ➥ Join: @WeAreFASA ✤ Freedom Alliance SA Chat Group ✤ Freedom Alliance SA WhatsApp Group ✤ Please read FASA's DISCLAIMER HERE