The Food and Drug Administration refused to review Moderna’s application for its new mRNA flu vaccine — a move the pharma giant’s’s president Dr. Stephen Hoge said left him in “complete shock.”
In an exclusive interview with The Post, Hoge said he was “completely surprised and honestly pretty confused” after receiving a letter from Dr. Vinay Prasad, the FDA’s vaccine director, who said that the company’s application didn’t contain an “adequate and well-controlled” trial of its new vaccine.
According to Prasad, the new shot was not compared to “the best-available standard of care in the United States at the time of the study.”
In drug trials, especially late-stage Phase 3 studies, a new product is typically tested against the current standard treatment doctors would normally give patients.
The FDA told Moderna that it believes its new flu shot was measured up against the wrong benchmark vaccine.
“They actually just said, ‘We’re not even going to open it,’” Hoge told The Post on Wednesday.
A Moderna spokesperson told The Post that the company likely spent “north of a billion” dollars on the clinical trial, which encompassed more than 40,000 people and progressed to phase 3 — the pivotal stage for regulatory approval.
The FDA’s letter did not raise concerns about the safety or efficacy of Moderna’s vaccine, according to Hoge.
The Moderna president warned of potential fallout from the FDA’s decision.
“The rules of the game being changed after the game has been played,” he told The Post, adding that the move “… will make it very hard to invest in making new medicines and cures in this country.”
Hoge told The Post that Moderna had worked “very closely with the FDA over the last five years” on the new shot.
He said the company had previously discussed its trial design with regulators and was told in writing that using a standard-dose flu vaccine as the comparator, or reference point used in a clinical trial, would be “acceptable.”
The 40,000-patient Phase 3 study, he said, showed Moderna’s shot was more effective at preventing influenza than the approved vaccine it was tested against.
But the FDA said this wasn’t good enough. They wanted Moderna to compare it against a high-dose flu vaccine instead, especially for people over 65, since high-dose vaccines are considered the better option for older adults.
“The FDA rejected Moderna’s application for filing because the company refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy,” Health and Human Services spokesperson Andrew Nixon said in a statement.
“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.”
Nixon added that “the most protective flu shots for seniors are a subset of high dose flu shots recommended by the CDC Advisory Committee on Immunization Practices, which would have served as the proper control in this study.”
Under Health and Human Services Secretary Robert F. Kennedy, Jr, the FDA terminated nearly $500 million in federal funding for mRNA vaccine development. The cut impacted projects by companies including Moderna and Pfizer.
RFK Jr. said the new policy was put in place because mRNA vaccines “pose more risks than benefits” and “fail to protect effectively” against respirator infections.
The move was slammed by health officials, including Dr. Peter Lurie, a former FDA official, who told the BBC that the US was “turning its back on one of the most promising tools to fight the next pandemic.”
Joshua Sharlin, a former FDA reviewer who now consults for FDA-regulated companies, said a late-stage objection to a control group would be unusual.
“The control group is a major, major element of protocol design and it would have been a major discussion point,” Sharlin told The Post, calling the agency’s move “very, very surprising.”
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