On August 6, 2026, the U.S. Food and Drug Administration (FDA) approved mFlusiva, the first mRNA-based seasonal influenza vaccine to receive licensure in the United States. This milestone followed a unanimous recommendation from the FDA's advisory committee, which concluded that the vaccine's benefits significantly outweighed its risks for adults aged 50 to 64 and for those 65 and older. The approval marked a pivotal moment in medical innovation, underscoring the potential of mRNA technology beyond its initial role in combating the coronavirus pandemic. One year earlier, on August 5, 2025, the Department of Health and Human Services (HHS) abruptly terminated 22 mRNA vaccine development projects valued at approximately $500 million and halted all federal funding for the platform. At the time, HHS Secretary Robert F. Kennedy Jr. asserted that the available data demonstrated that mRNA vaccines failed to provide effective protection against upper respiratory infections such as influenza and that the funds should instead be redirected toward alternative technologies deemed safer. He also claimed that mRNA vaccines posed greater risks than benefits and could potentially prolong pandemics, arguments that have since been widely refuted by scientific evidence. Jeff Coller, a Bloomberg Distinguished Professor of RNA biology and therapeutics at Johns Hopkins University and co-founder of the Alliance for mRNA Medicines, expressed personal and professional concerns about the decision. With over three decades of experience in mRNA research and having contributed to the design of the mRNA sequence used in the Moderna COVID-19 vaccine, Coller emphasized that the HHS's stance was not supported by the existing body of evidence. He noted that the decision came just 12 months after the data had clearly shown otherwise. Five weeks prior to the cancellation of the mRNA projects, on June 30, 2025, Moderna released results from a Phase 3 influenza trial involving 40,805 adults across 11 countries. The findings revealed that the mRNA vaccine, which would later be named mFlusiva, outperformed the standard-dose flu shot by 26.6%. Notably, the vaccine maintained its effectiveness in individuals over the age of 65, directly contradicting claims made by HHS officials. These results were published shortly before the decision to terminate the projects, yet they were ignored in favor of politically motivated assertions. The path to approval of mFlusiva was further complicated by regulatory hurdles. On February 3, 2026, the FDA initially rejected the vaccine application, citing concerns raised by Vinay Prasad, who at the time led the center responsible for evaluating vaccines. His sole objection was that Moderna had compared the vaccine to a standard-dose flu shot rather than the high-dose formulation typically used for elderly populations. This criterion was not outlined in the FDA’s official influenza guidance, and Prasad’s own office had previously informed Moderna that the standard-dose comparator was acceptable. Regulatory agencies in Europe, Canada, and Australia had reviewed the identical application without issue. After a public outcry and a brief meeting, the FDA reversed its decision within 15 days, agreeing to review the application and setting a final decision date for August 6, 2026. The change was attributed to political pressure rather than new evidence. This reversal highlighted the inconsistency between the HHS’s previous stance and the subsequent validation of mRNA technology through real-world outcomes. Further undermining the credibility of HHS’s position was the continued success of mRNA-based therapies. In June 2026, researchers reported five-year results from an individualized mRNA therapy combined with pembrolizumab for treating high-risk melanoma. The treatment reduced the risk of cancer recurrence or death by nearly 50% and decreased the likelihood of metastasis by almost 60%. These findings reinforced the broader efficacy of mRNA technology in diverse therapeutic applications. Meanwhile, HHS Secretary Robert F. Kennedy Jr. faced criticism for his public statements questioning the reliability of scientific consensus. During an appearance on CNN’s State of the Union, he accused Dr. Anthony Fauci of fabricating information and claimed that the evidence supporting the safety and efficacy of the COVID vaccine was nonexistent. When confronted with the lack of empirical support for his claims, Kennedy demanded specific studies to substantiate his assertions, despite overwhelming peer-reviewed data demonstrating the vaccine’s protective effects. His remarks sparked controversy and underscored the growing divide between scientific evidence and political rhetoric.
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