The Food and Drug Administration (FDA) initially refused to review Moderna’s application for its mRNA-1010 influenza vaccine earlier this month, citing the company’s decision not to adhere to established agency guidance. The FDA demanded Moderna test its vaccine against a CDC-recommended flu vaccine to compare safety and efficacy, a requirement Moderna initially resisted. While the agency has since agreed to review an amended application from Moderna, the initial rejection underscores a growing tension between vaccine manufacturers and the regulatory landscape under Health and Human Services Secretary Robert F. Kennedy Jr.
According to an FDA statement provided to UPI, the agency rejected the initial application because Moderna “exposed participants age 65 and over to increased risk of severe illness by giving them a substandard of care against the recommendation of FDA scientists.” The FDA maintains that the most effective flu vaccines for seniors are high-dose shots recommended by the CDC’s Advisory Committee on Immunization Practices, and these should have been used as a control in Moderna’s study.
Richard Hughes IV, a law professor at George Washington University and an attorney with Epstein Becker Green, described the initial refuse-to-file decision as unusual, noting that the FDA typically requests additional information from manufacturers rather than outright rejecting an application. This approach contrasts with the more collaborative process traditionally seen in vaccine development.
The situation with Moderna’s influenza vaccine is part of a broader trend impacting the vaccine industry. Major U.S. Vaccine makers, including Moderna, Sanofi, and smaller companies, are curtailing research, development, and manufacturing. This pullback is attributed to a changing political and business climate, largely influenced by Kennedy Jr.’s appointment and his long-held skepticism towards vaccines. The Trump administration’s policies have also contributed to the shifting landscape.
The changes include a recent overhaul of the childhood vaccination schedule, reducing the number of recommended immunizations. In November 2024, Kennedy Jr. Was selected as health secretary, a move that signaled a potential shift in federal support for vaccines. The dismantling of this support, coupled with Kennedy’s skepticism of mRNA vaccine technology, has created an increasingly challenging environment for vaccine developers.
The impact is not uniform across the industry. While large pharmaceutical companies have demonstrated some resilience, smaller vaccine developers and manufacturers are disproportionately affected. One small Texas company, for example, canceled plans to build a new vaccine manufacturing plant, and a San Diego-based company was forced to lay off workers. The broader consequences could include fewer new vaccines being developed and reduced access to existing ones, particularly as vaccination rates in the U.S. Have already been declining due to the spread of misinformation.
The New York Times reported that federal policies under Kennedy Jr. Have “sent a chill through the entire industry,” prompting concerns about the future of vaccine innovation. Forbes noted that the entire vaccine ecosystem is under threat, driven less by scientific data than by a perceived desire to dismantle a previously successful system. The situation has also raised concerns about a potential downward financial spiral within the vaccine sector, according to Breakingviews.
