FDA Declines Review of Moderna’s mRNA Flu Vaccine
The FDA has declined to review Moderna’s mRNA flu vaccine, specifically named mRNA-1010, stating that the clinical trial design was insufficient. This decision has drawn attention to the regulatory expectations for vaccine approval and the standards applied during assessments.
FDA’s Decision on Moderna’s mRNA Flu Vaccine
In a letter dated February 3, Vinay Prasad, a prominent vaccine regulator from the former Trump administration, informed Moderna that the trial was not considered “adequate and well-controlled.” The primary concern was that the comparator vaccine used in the trial did not meet the best-available standard of care.
Moderna’s Response
Moderna’s leadership responded to the FDA’s decision, emphasizing that the agency’s regulations do not specify a requirement for a comparator of the “best-available standard of care.” Stéphane Bancel, CEO of Moderna, voiced disappointment over the FDA’s stance, stating that it does not advance shared goals for innovation in healthcare.
- FDA’s letter dated February 3.
- Concerns about trial adequacy and comparator standards.
- CEO Bancel addressed the absence of safety or efficacy issues cited by the FDA.
Request for Further Engagement
Moderna has officially requested a meeting with the FDA to clarify the reasoning behind the refusal. The company aims to expedite discussions to ensure that vulnerable populations, such as seniors and those with pre-existing conditions, can access new treatments.
International Status of mRNA-1010
Despite the setback in the United States, mRNA-1010 has received acceptance for review in multiple other regions, including:
- European Union
- Canada
- Australia
As Moderna works toward resolving the FDA’s concerns, the future of its mRNA flu vaccine remains a critical point of interest for public health and innovation in medicinal development.
