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Moderna's Flu Vaccine Review Paused Amid FDA Dispute

  //food-wine.news-articles.net/content/2026/02/18 .. -flu-vaccine-review-paused-amid-fda-dispute.html
  Published in Food and Wine on Wednesday, February 18th 2026 at 23:34 GMT by Seattle Times
      Locales: Massachusetts, Maryland, Washington, UNITED STATES

Cambridge, MA - February 19th, 2026 - The future of Moderna's ambitious expansion into influenza vaccination is currently uncertain as the Food and Drug Administration (FDA) has paused its review of the company's experimental mRNA-based flu vaccine, mRNA-1021. The delay stems from a highly unusual public disagreement between Moderna and the agency regarding the interpretation and analysis of clinical trial data.

This dispute, revealed last week in a Moderna investor presentation, has sent ripples through the pharmaceutical industry, raising questions about the approval process and the potential impact on Moderna's broader vaccine strategy. While disagreements between pharmaceutical companies and the FDA are not unheard of, the public airing of this particular conflict is a rare occurrence.

Moderna's mRNA-1021 utilizes the same messenger RNA (mRNA) technology that proved highly effective in the development of its COVID-19 vaccine. The company believes this technology represents a significant advancement in vaccine development, offering the potential for faster production, greater flexibility in targeting variants, and potentially broader protection compared to traditional flu vaccines. Early trial results were promising, showing participants developed high levels of antibodies in response to the vaccine, suggesting robust immune response.

Specifically, Moderna claims the vaccine demonstrated protection against a wider range of influenza strains than current vaccines, which often require annual updates to match circulating strains. This broader coverage could significantly reduce the need for frequent vaccine reformulation, simplifying the vaccination process and potentially improving public health outcomes. The company had hoped mRNA-1021 would be a cornerstone of its post-COVID vaccine portfolio.

The FDA, however, has expressed concerns over the methodology employed by Moderna in analyzing the trial data. While details remain limited, sources close to the agency suggest the concerns center around statistical analysis and the interpretation of efficacy data. The FDA has not publicly detailed the specifics, stating only that further clarification is needed before the review can continue.

"We remain confident in the potential of mRNA-1021 and are working toward a resolution that will allow the FDA to review the data," stated Stephane Bancel, Moderna's CEO, during the investor presentation. The company is actively collaborating with the FDA, providing additional data and explanations to address the agency's concerns. The expectation is that the review process will resume once a consensus is reached.

The delay presents a potential setback for Moderna, which has been actively seeking to diversify its revenue streams beyond COVID-19 boosters. The company has invested heavily in developing vaccines for respiratory syncytial virus (RSV) and other infectious diseases, and the flu vaccine was considered a crucial component of this expanded portfolio.

Analysts are divided on the potential long-term impact. Some believe the dispute is a temporary hurdle and that the vaccine will ultimately receive approval once the data concerns are addressed. They point to Moderna's successful track record with its COVID-19 vaccine and the agency's generally collaborative relationship with the company. However, others are more cautious, suggesting that a protracted delay could erode investor confidence and impact Moderna's future growth prospects.

"This is definitely a situation to watch," says Dr. Evelyn Reed, a vaccine specialist at the National Institute of Health. "Data integrity and accurate analysis are paramount in vaccine approval. The FDA is right to scrutinize the data thoroughly. A public disagreement suggests there's a significant difference in interpretation, and resolving that will take time and transparency."

Beyond the immediate implications for Moderna, this situation could also have broader ramifications for the development of mRNA vaccines. If the dispute highlights challenges in analyzing data from these novel vaccine platforms, it may lead to stricter regulatory requirements and potentially slow down the approval process for other mRNA-based therapies.

The coming weeks will be crucial as Moderna and the FDA work to resolve their differences. The outcome will not only determine the fate of mRNA-1021 but also shape the future of mRNA vaccine development and the landscape of influenza prevention.