FDA Rejects Moderna’s mRNA Influenza Vaccine Application

The Food and Drug Administration has declined to review Moderna’s application for a new mRNA influenza vaccine. Dr. Stephen Hoge, the president of Moderna, expressed that he found this decision to be “completely shocking.”

In an exclusive conversation, Hoge admitted to being “completely surprised and frankly quite confused” after receiving a letter from Dr. Vinay Prasad, the FDA’s vaccine chief. The letter indicated that Moderna’s application lacked “adequate and well-controlled” testing for the vaccine.

Prasad pointed out that the new vaccine was not tested against “the best standard of care available in the United States at the time of the study.”

Typically, late-stage Phase 3 trials compare new products to current standards of care commonly administered to patients.

The FDA stated that it believed the evaluation of the vaccine was done against an inappropriate benchmark.

“In fact, they just said, ‘We’re not going to open it,'” Hoge reported to the Post on Wednesday.

A spokesperson for Moderna mentioned that the company invested “more than $1 billion” in clinical trials involving over 40,000 participants and has reached Phase 3, which is critical for regulatory approval.

Hoge noted that the FDA’s communication did not express any concerns about the safety or effectiveness of the vaccine.

He cautioned about the broader implications of the FDA’s decision, saying, “The rules of the game will change after the game is over” and added that this could complicate investments in developing new drugs and treatments in the country.

Hoge revealed that Moderna has been collaborating closely with the FDA for the last five years on this vaccine.

Previously, he stated that the company had discussed trial designs with regulators, who had confirmed in writing that using a standard-dose influenza vaccine as a comparison was acceptable.

A Phase 3 study involving 40,000 patients found that Moderna’s vaccine proved more effective in preventing influenza compared to the approved vaccines evaluated.

However, the FDA indicated this wasn’t sufficient, emphasizing that the vaccine should be compared to a high-dose flu vaccine, especially for those aged 65 and older, as high-dose vaccines are deemed a better option for older adults.

The Department of Health and Human Services’ spokesperson Andrew Nixon commented that Moderna’s application was rejected because the company did not adhere to clear FDA guidance, which recommended using CDC-recommended influenza vaccines starting in 2024 for trials to assess safety and effectiveness.

Nixon added that employing a substandard treatment for individuals aged 65 and older put them at greater risk for severe illness, counter to FDA scientists’ recommendations.

He emphasized that the most effective flu vaccinations for older adults are high-dose options recommended by the CDC’s Advisory Committee on Immunization Practices.

The FDA has recently seen a cut of around $500 million in federal funding for mRNA vaccine research during Robert F. Kennedy Jr.’s tenure as under Secretary of Health and Human Services. This reduction impacted projects from companies like Moderna and Pfizer.

Kennedy Jr. argued that the new policy emerged because mRNA vaccines “do not effectively protect” against ventilator infections, suggesting that “the risks outweigh the benefits.”

Health officials, including former FDA official Dr. Peter Lurie, condemned this move, stating it represents a setback in the fight against future pandemics.

Joshua Shearlin, a former FDA examiner now advising FDA-regulated companies, pointed out that last-minute changes to the control group are unusual. He referred to the control group as a critical element in the protocol design, calling the agency’s recent decision “very surprising.”