Moderna President Criticizes FDA for Skipping Flu Vaccine Review
Moderna’s president, Stephen Hoge, has criticized the Food and Drug Administration (FDA) for abandoning its previous commitment to review the company’s influenza vaccine application. In an interview on the podcast “The Readout LOUD,” Hoge detailed the unexpected decision made by the FDA, which has sparked concern within the biopharmaceutical community.
Background of the Situation
In August, FDA officials informed Moderna that they would analyze data from a Phase 3 trial of its new flu vaccine. This assurance followed guidelines established under earlier agency leadership. However, a recent turnaround has left Moderna puzzled and frustrated.
Unexpected Letter from the FDA
Moderna received a “refusal-to-file” letter this month, signed by Vinay Prasad, the head of the FDA’s vaccine office. Hoge expressed that the letter came as a shock, stating, “It really does feel like it came out of the blue to us.”
FDA’s Concerns
The FDA’s refusal hinged on concerns regarding the comparator arm selected for the trial. While Moderna initially reported that the FDA deemed their choice of using a standard flu vaccine acceptable, there were strong preferences for a high-dose version used in older adults. This inconsistency has raised questions about the agency’s communication and decision-making.
Impact on Future Development
Hoge emphasized the complexity and risk involved in developing new vaccines, noting that Moderna invested nearly $1 billion in this project over five years. The abrupt change in the FDA’s stance could have broader implications for the pharmaceutical industry, as companies may now question the reliability of regulatory guidance.
- Key Players: Moderna, FDA, Stephen Hoge, Vinay Prasad
- Investment: Nearly $1 billion in development for the flu vaccine
- Timeline: Initial assurance in August, refusal-to-file letter received this month
Moving forward, Hoge indicated that Moderna plans to reassess its strategy in light of the FDA’s decision. The company’s experience could serve as a pivotal case study for navigating regulatory processes in vaccine development. With Moderna’s commitment to transparency, the future of their influenza vaccine remains uncertain but crucial for public health.
