FDA Declines Review of Moderna Flu Vaccine Amid Guidance Rollback

US Food and Drug Administration Refuses to Review Moderna’s Flu Vaccine Application

The US Food and Drug Administration (FDA) has declined to review Moderna’s application for approval of its flu vaccine. The decision was made after the agency cited concerns over the company’s rationale comparing its mRNA-1010 product to a standard dose for the seasonal flu.

In a letter to Moderna, the FDA stated that it did not identify any safety or efficacy concerns with the product. However, the agency also claimed that the biotech giant’s flu vaccine “does not reflect the best-available standard of care”.

Moderna has pushed back on this allegation, stating that the letter did not cite any specific safety or efficacy concerns.

The lack of guidance from the FDA has raised concerns among experts, who say it makes it difficult for companies to know how to proceed with their applications. Bruce Y Lee, a professor of health policy and management at the CUNY Graduate School of Public Health and Health Policy, stated that “if there are things that need scrutiny, a review process can address them”.

The decision comes amid concerns over transparency within the FDA, with some experts questioning whether the rejection was merit-based or politically motivated. The agency has disputed claims that career scientists were ready to review the application but were overridden by FDA Commissioner Vinay Prasad.

Moderna’s mRNA-1010 vaccine is 26.6 percent more effective than an approved annual flu vaccine from GlaxoSmithKline. The company had previously withdrawn its application for a flu and COVID combination vaccine in 2025, pending efficacy data from a late-stage trial of its influenza vaccine.

The vaccine is currently under review in the European Union, Canada, and Australia, with potential approvals expected in late 2026 or early 2027.

Source: Al Jazeera