FDA to Review Moderna’s mRNA Flu Vaccine
The Food and Drug Administration (FDA) has announced that it will review Moderna’s application for a groundbreaking mRNA flu vaccine. This decision comes after Moderna agreed to conduct further studies focused on older adults.
Background of FDA’s Reversal
Last week, the FDA initially decided not to review Moderna’s application for the first mRNA flu vaccine. However, a shift occurred when the FDA revealed it would reassess the proposal with certain modifications.
Insights from FDA Officials
During a recent event, FDA Commissioner Marty Makary indicated that the earlier refuse-to-file letter should not be considered the final word. He emphasized that such interactions are part of an ongoing dialogue between the FDA and vaccine developers.
Concerns Raised by Health Experts
Despite the FDA’s change of heart, concerns linger within the healthcare community. Rena Conti, a health economist at Boston University, criticized the FDA’s decision-making process, suggesting it reflects a disturbing trend in regulatory practices.
Moderna’s Progress and Investments
Moderna is leveraging its successful mRNA technology, previously employed in COVID-19 vaccine development, to create a flu vaccine. The company has invested over a billion dollars into this project, with $750 million sourced from Blackstone, an asset management firm.
Revisions to Clinical Trials
Initially, the FDA had expressed reservations regarding the absence of a study comparing the new vaccine with a high-dose flu vaccine aimed at older populations. Moderna claims the FDA had approved the study design 18 months prior.
Moderna’s Response and Future Steps
In a statement, Moderna clarified that it included data from a separate trial in its application, providing a comparison against a high-dose flu vaccine. The company contended that the FDA did not previously indicate any intention to refuse the application during pre-submission communications.
FDA’s Requirements for Approval
- The FDA rejected total submission due to concerns about trial design.
- The agency emphasized the need for clinical trial comparisons with CDC-recommended vaccines.
- After discussions, Moderna amended its application to include a confirmatory study in older adults.
Health and Human Services Department spokesperson Andrew Nixon confirmed that the FDA maintained its commitment to rigorous standards for all vaccine reviews. Moderna anticipates that the mRNA flu vaccine will be prepared for the upcoming flu season, provided it secures FDA approval.
