WASHINGTON, February 7, 2024 — Moderna’s latest flu vaccine submission faced an unexpected setback this week, as the Food and Drug Administration deemed the clinical trial data “not adequate and well-controlled.” The core issue? The agency believes the comparison vaccine used in the trial doesn’t represent the current “best-available standard of care,” raising questions about the evaluation process for new vaccines.
Regulatory Dispute Over Flu Vaccine Trial
The FDA’s decision hinges on the comparator vaccine used in Moderna’s trial, sparking debate over regulatory standards.
- On February 3, the FDA informed Moderna that its mRNA-1010 flu vaccine trial didn’t meet agency standards.
- The disagreement centers on whether the comparator vaccine used in the trial was the “best-available standard of care.”
- Moderna maintains the trial design was discussed and agreed upon with the FDA prior to commencement.
- The vaccine has already been accepted for review in the European Union, Canada, and Australia.
According to a letter dated February 3 from Vinay Prasad, the FDA’s top vaccine regulator under the Trump administration, the agency found the trial lacking because the comparator vaccine didn’t align with current best practices. Moderna swiftly responded, noting in a news release that neither FDA regulations nor industry guidance explicitly require the use of a “best-available standard of care” comparator in these types of trials.
“This decision by [the FDA’s Center for Biologics Evaluation and Research], 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 Stéphane Bancel, Moderna CEO, in the release. “It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting.”
What exactly is the FDA looking for in vaccine trials? The agency typically assesses safety and efficacy, but the definition of an acceptable comparator—the vaccine or placebo against which the new vaccine is measured—is now under scrutiny. This case highlights the potential for differing interpretations of regulatory guidelines.
Moderna has requested a meeting with the FDA to clarify the basis for the refusal and to discuss a path forward. The company emphasized its commitment to ensuring access to its American-made innovations for seniors and individuals with underlying health conditions. “We look forward to engaging with CBER to understand the path forward as quickly as possible so that America’s seniors, and those with underlying conditions, continue to have access to American-made innovations,” Moderna stated.
The Global Perspective
The situation underscores the varying regulatory landscapes across different regions. While the FDA has raised concerns, mRNA-1010 has already been accepted for review in the European Union, Canada, and Australia, suggesting differing interpretations of trial data and regulatory requirements.
This dispute raises broader questions about the consistency of vaccine evaluation standards and the potential impact on innovation within the pharmaceutical industry. The outcome of Moderna’s discussions with the FDA will likely set a precedent for future vaccine submissions and regulatory reviews.
