Moderna Inc. has announced that the U.S. Food and Drug Administration (FDA) has decided not to initiate a review of the company’s application for its experimental flu shot, mRNA-1010. This decision reflects broader regulatory trends under the Trump administration, impacting vaccine approvals. Following the announcement, Moderna’s stock saw a decline of approximately 7% in after-hours trading.
Moderna expressed confusion over the FDA’s decision, citing a lack of specific concerns regarding safety or efficacy tied to the vaccine. The FDA’s objection centers instead on the design of the clinical trial, which Moderna had previously discussed and received approval for. The agency criticized Moderna for comparing its vaccine to a standard, already approved flu shot, contending that the study did not adhere to the definition of an “adequate and well-controlled” trial.
Despite the disagreement, Moderna emphasized that this latest decision would not alter its financial outlook for 2026. The flu shot is part of the company’s strategy to develop a combined vaccine that targets both influenza and COVID-19. Furthermore, changes to U.S. immunization policy over the past year, driven by Health and Human Services Secretary Robert F. Kennedy Jr. and FDA vaccine regulator Vinay Prasad, have raised concerns in the industry regarding regulatory scrutiny.
Moderna anticipates that approval for its flu shot could come as early as late 2026 or late 2027, pending regulatory evaluations across multiple regions, including the U.S., Europe, Canada, and Australia. The FDA has refrained from commenting on specific communications with the company.
Why this story matters
- Changes in FDA vaccine regulations could impact future vaccine approvals and public health strategies.
Key takeaway
- Moderna’s proposed flu vaccine faces hurdles due to regulatory concerns over clinical trial design, despite the absence of safety or efficacy objections.
Opposing viewpoint
- Some argue that stricter regulations are necessary to ensure vaccine safety amidst growing health concerns linked to previous COVID-19 vaccines.
