FDA refuses to review Moderna’s seasonal flu vaccine application
The US Food and Drug Administration (FDA) has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, marking a significant setback for the technology, reports BritPanorama.
The FDA informed Moderna that its application lacked an “adequate and well-controlled” trial, citing that the control arm did not represent the “best-available standard of care in the United States at the time of the study.” This information was detailed in a letter dated February 3, which Moderna later shared publicly.
Moderna contested that this refusal contradicted previous feedback received from the agency and expressed its intention to meet with FDA officials to gain clarity on how to proceed.
“The complete stunner here is at no point in any of this did anybody say that it was not adequate” to run its clinical trial in the manner discussed with the agency, stated Moderna’s president, Dr. Stephen Hoge.
In its clinical trial involving 40,700 participants, the company used a standard-dose seasonal flu vaccine called Fluarix as a comparator to demonstrate the safety and efficacy of its experimental mRNA vaccine. Moderna noted that the FDA had approved this comparative plan in April 2024 and had recommended that the company also incorporate data comparing its vaccine with an approved high-dose flu vaccine for individuals over 65, which Moderna claims it completed.
According to Moderna, as recently as August, the FDA indicated during a pre-application meeting its intent to review the submitted information and would consider the comparator issues in that assessment.
However, the agency’s refusal to review the application last week was confirmed in the letter signed by Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, which oversees vaccine regulation.
Dr. Prasad has previously voiced critiques regarding the government’s response to Covid-19 prior to his appointment at the FDA under Secretary Robert F. Kennedy Jr. He claimed late last year, although without detail, that Covid-19 vaccines had been linked to fatalities in 10 children and has indicated that changes to the agency’s vaccine approval processes are forthcoming.
Furthermore, the administration has withdrawn support for mRNA technology in treating infectious diseases, with the Department of Health and Human Services (HHS) cancelling 22 projects worth around $500 million dedicated to mRNA vaccine development this August, arguing against evidence that “these vaccines fail to protect effectively against upper respiratory infections like COVID and flu.”
This unfolding situation raises further questions about the future direction of vaccine development in the United States and the ongoing role of mRNA technologies.
