FDA Rejects Moderna Flu Shot Application in Controversial Decision
The US Food and Drug Administration has unexpectedly refused to consider Moderna's application for a messenger RNA (mRNA) flu vaccine, a move that experts claim is already having a chilling effect on vaccine development and reflects what they describe as an "anti-vaccine agenda."
Trial Design at Center of Controversy
According to FDA officials, the rejection stems from concerns about the design of Moderna's clinical trial. The agency specifically objected to the control group composition, where participants over age 65 received a standard flu shot rather than the high-dose vaccine recommended for older adults.
A senior FDA official, who requested anonymity during a press briefing, characterized Moderna's trial as a "brazen failure" that "raises significant ethical concerns." The official stated that the FDA had explicitly advised Moderna against including the over-65 population in this particular study design.
However, Moderna spokesperson Chris Ridley countered that "this was an FDA-approved trial design" and noted that the agency had frequently weighed in on their process without objecting until now.
Experts Question FDA's Motives
Legal and scientific experts have raised serious concerns about the FDA's decision-making process. Richard Hughes IV, a partner with Epstein Becker Green and law professor at George Washington University, stated: "It's all pretext and obfuscation when the real agenda is rejecting conventional science and serving a predetermined anti-vaccine agenda."
Dorit Reiss, professor of law at UC Law San Francisco, criticized the anonymous nature of the FDA's communication, calling it "a coward's act" that suggests "the government knows it has no case." She emphasized that "personally humiliating a company is not a legitimate reason to refuse to review a submission."
Conflicting Accounts of FDA Guidance
The timeline of FDA guidance to Moderna appears contradictory. According to documents provided by Moderna, in April 2024, the FDA's Center for Biologics Evaluation and Research (CBER) told the company in writing that while using a standard dose vaccine was "acceptable," they recommended using a high-dose vaccine for older adults to help inform recommendations.
Moderna maintains that they included information about using the standard flu shot for all ages in consent forms that all trial participants signed, and that FDA officials had agreed to this plan.
Hughes expressed skepticism that Moderna would have proceeded against clear FDA guidance: "It's too risky for a manufacturer to simply run roughshod over agency guidance. What is more likely is that this FDA turned the tables at the 11th hour."
Broader Implications for Vaccine Development
Angela Rasmussen, an American virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan, warned that "they're just coming up with reasons to not approve mRNA anything, and they're going to eventually do it to all these vaccines."
She emphasized the public health importance of mRNA flu vaccines, noting they would be particularly useful for people with egg allergies and represent a more flexible approach to responding to flu mutations and potential pandemics.
The decision comes amid broader concerns about vaccine development. Hughes pointed out that the FDA last year only approved Covid shots from Novavax and Pfizer for certain groups, and revoked the license for a Chikungunya vaccine entirely rather than adding warning labels after serious side effects were observed.
Internal FDA Conflicts Revealed
According to reports, Vinay Prasad, director of CBER, overrode agency scientists who recommended review of Moderna's application, including a memo from David Kaslow, director of the vaccine office. The FDA official dismissed this reporting as "gossip in the hallways of the FDA" from "a disgruntled person."
Prasad's tenure at the FDA has been marked by controversy, including being fired and reinstated in July, with recent Wall Street Journal reports alleging verbal and sexual harassment claims against him at the agency.
Potential Path Forward and Industry Impact
The FDA official suggested Moderna could modify its application to focus on the 50-64 age group, where there's "more equipoise" in the data. The official stated that if Moderna showed "some humility" and acknowledged not following recommendations, the review team might consider that cohort.
Reiss warned that "changing your position mid-stream is a problem for companies" and that "this really will deter companies from doing vaccine trials. We need better and more influenza vaccines, not less."
Rasmussen echoed these concerns, noting the decision is having "a huge chilling effect" because "if you don't have access to the US market, you can't viably do business."
Andrew Nixon, a spokesperson for the US Department of Health and Human Services, defended the FDA's position, stating that "Moderna exposed participants age 65 and over to increased risk of severe illness by giving them a substandard of care against the recommendation of FDA scientists." He dismissed concerns about targeting mRNA vaccines as "baseless."
