FDA Refuses to Consider Moderna's mRNA Flu Vaccine, Igniting Controversy
The US Food and Drug Administration (FDA) has unexpectedly declined to review Moderna's application for a messenger RNA (mRNA) flu vaccine, a decision experts claim is part of an "anti-vaccine agenda." The agency cited a lack of "adequate and well controlled" trials, but critics argue the move is politically motivated and could stifle vaccine development.
Clinical Trial Design at the Heart of the Dispute
According to the FDA, the issue stems from Moderna's study design, where control group participants over 65 received a standard flu shot instead of a high-dose vaccine. A senior FDA official, speaking anonymously, called the trial a "brazen failure" that raises ethical concerns. However, Moderna maintains the design was FDA-approved, with spokesperson Chris Ridley stating, "This was an FDA-approved trial design."
The FDA provided written recommendations to use a high-dose vaccine for older adults, but Moderna says officials agreed to the use of standard doses in consent forms. Richard Hughes IV, a partner at Epstein Becker Green, suggested the FDA "turned the tables at the 11th hour," arguing it's unlikely Moderna would ignore agency guidance.
Experts Decry Decision as Pretextual and Harmful
Legal and scientific experts have condemned the FDA's refusal. Dorit Reiss, a law professor at UC Law San Francisco, said the anonymous criticism is "a coward's act" and shows the decision is "politically motivated, not substantially valid." Virologist Angela Rasmussen added, "They're just coming up with reasons to not approve mRNA anything."
The rejection overrides recommendations from FDA scientists, including a memo from David Kaslow, director of the vaccine office. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, signed the rejection letter, but his tenure has been marked by turmoil, including allegations of harassment.
Potential Impact on Vaccine Innovation and Public Health
This decision is already having a chilling effect on vaccine development, according to Rasmussen. "No other manufacturers are going to want to make those kinds of investments," she warned, noting that access to the US market is crucial for viability. mRNA technology offers advantages, such as flexibility against flu mutations and suitability for people with egg allergies.
Andrew Nixon, a spokesperson for the US Department of Health and Human Services, dismissed concerns of targeting as "baseless," but Reiss countered that changing standards mid-stream deters companies from conducting trials. "We need better and more influenza vaccines, not less," she emphasized.
The FDA suggested Moderna could reapply for a younger age group, but the broader implications for public health and regulatory trust remain in question.
