Moderna Inc. has encountered a significant setback as the Food and Drug Administration (FDA) has declined to initiate a review of its application for an experimental flu vaccine, known as mRNA-1010. The company announced this news on Tuesday, March 26, 2024, leading to an approximately 7% drop in its stock during after-hours trading.
Moderna asserts that the FDA’s decision contradicts earlier feedback received prior to the submission of the application and the initiation of Phase 3 trials for the vaccine. In response, Moderna has sought a meeting with the FDA to clarify the path forward. Notably, the FDA did not cite any specific safety or efficacy concerns regarding the vaccine; instead, the agency expressed reservations about the study design, which had been previously approved.
Despite this setback, Moderna maintains that this ruling will not affect its financial projections for 2026. The company’s Phase 3 trial data released last year were promising, successfully meeting all trial objectives. According to Moderna, this standalone flu shot is pivotal to their strategy of developing a combined vaccine targeting both influenza and COVID-19.
The FDA’s decision highlights broader shifts in U.S. immunization policies, particularly under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., known for his vaccine skepticism. Moderna also pointed to the return of Vinay Prasad, the FDA’s top vaccine regulator, as a significant factor in this tightening of vaccine regulations. Prasad, who heads the Center for Biologics Evaluation and Research (CBER), has been critical of approval processes and has previously linked adverse outcomes to COVID vaccines.
In a letter dated February 3, Prasad indicated that the FDA’s refusal stemmed from objections to the design of Moderna’s clinical trial, particularly noting that the comparison of its product to an approved flu vaccine did not reflect the best available standard of care. Consequently, the FDA deemed the study inadequate and not well-controlled.
Moderna disputes this reasoning, arguing that existing FDA guidelines do not mandate using the most advanced vaccine as a comparator in clinical studies. “This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” stated Moderna CEO Stéphane Bancel. He emphasized that conducting a comprehensive review of their flu vaccine submission should not be a contentious issue, especially given that the study approach had been discussed and approved by CBER prior to the start of trials.
Looking ahead, Moderna anticipates that the earliest potential approval for its flu vaccine might occur in late 2026 or late 2027, depending on regulatory reviews in the U.S., Europe, Canada, and Australia. The FDA, however, has a policy of not commenting on regulatory communications directed toward individual sponsors.
As this situation unfolds, Moderna and other stakeholders in the vaccine development landscape will be closely monitoring how regulatory policies continue to evolve, and what that may mean for future immunization strategies and innovations in public health.
Original Source: https://www.cnbc.com/2026/02/10/moderna-fda-flu-shot.html
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Publish Date: 2026-02-11 04:41:00
