FDA Rejects Review of Moderna’s mRNA Flu Vaccine Application
The US Food and Drug Administration (FDA) has turned down Moderna’s application to review its first mRNA seasonal flu vaccine. This decision marks another setback for the mRNA technology, which has faced scrutiny from health officials. Moderna disclosed this development on a Tuesday, revealing the FDA’s opinion on the application.
FDA’s Reason for Rejection
According to a letter dated February 3, the FDA stated that the trial presented by Moderna did not meet the criteria for an “adequate and well-controlled” study. Specifically, the control group did not align with the best-available standard of care in the United States at the time of the trial.
Safety and Efficacy Concerns
- The FDA did not cite any safety or efficacy issues.
- Moderna indicated that the refusal contradicted previous communication from the agency.
- The company is seeking a meeting with FDA officials to clarify the next steps.
Clinical Trial Details
In a clinical trial involving 40,700 participants, Moderna used a standard-dose seasonal flu vaccine, Fluarix, as a comparator. In April 2024, the FDA had previously approved this approach, suggesting it also assess the experimental mRNA vaccine against a high-dose flu vaccine for individuals aged 65 and older. Moderna responded by including this additional data.
Agency Communications
Moderna’s application was submitted following a meeting in August, where the FDA indicated its intent to review the filing. Recent feedback highlighted potential issues with the data, but the agency ultimately chose not to proceed with the review.
Background on Moderna and Vaccine Development
Dr. Vinay Prasad, the director of the FDA’s Center for Biologics Evaluation and Research, signed the rejection letter. His previous criticism of the government’s COVID-19 response raises questions about the FDA’s current direction. Moderna, along with Pfizer and Novavax, is one of the three manufacturers of approved COVID-19 vaccines in the US, utilizing mRNA technology.
Future Prospects and Innovations
Despite the setback in the US, Moderna is advancing its combination flu and COVID-19 mRNA vaccine in other countries. The company anticipates that the first approval could be granted in Europe within the year. Moderna’s president, Dr. Stephen Hoge, emphasized that mRNA vaccines could offer faster production timelines, improving the ability to match vaccines to circulating flu strains.
Implications for mRNA Vaccine Technology
The potential advantages of mRNA vaccines include better efficacy and quicker adjustments to changing virus strains. However, recent decisions by the Department of Health and Human Services (HHS) have withdrawn funding for numerous mRNA vaccine projects, further complicating the landscape for this technology in infectious disease applications.
