FDA Blocks Moderna's mRNA Flu Vaccine Application Amid Heightened Scrutiny

The FDA has refused to consider Moderna's application for a new flu vaccine using mRNA technology, criticizing the design of its clinical trial. Despite the agency's concerns, Moderna argues there are no safety or efficacy issues. The refusal is part of increased FDA scrutiny under Health Secretary Robert F Kennedy Jr.

The US Food and Drug Administration (FDA) has declined Moderna's application for a new flu vaccine developed with mRNA technology, expressing concerns over the clinical trial's structure. This decision is the latest instance of escalated scrutiny on vaccines, particularly those involving mRNA, under Health Secretary Robert F. Kennedy Jr.'s tenure.

According to the FDA's refusal-to-file letter, the agency questioned the adequacy of Moderna's 40,000-person trial, which compared the new vaccine with a standard flu shot. Moderna's trial indicated the vaccine's increased effectiveness in adults over 50, but the FDA noted the trial did not use the best available standard of care as the benchmark.

Moderna argued that the FDA was initially supportive of the study's methodology and emphasized the absence of safety or efficacy issues. Meanwhile, the refusal comes as part of broader FDA shifts, including rollback of recommendations for COVID-19 shots and a move against streamlined vaccine approval processes, sparking significant debate.

(With inputs from agencies.)