Food and Drug Administration officials told Moderna in August that they would review its application for a new influenza vaccine, reiterating guidance set under previous leadership, but ultimately setting the stage for an abrupt change of opinion this month.
In August, “we specifically asked them about the data we had from [our Phase 3 trial]. And would they review this as a matter? And again, they said they would review the file,” Moderna’s president, Stephen Hoge, said in a wide-ranging interview on STAT’s ”The Readout LOUD” podcast on Thursday. He added that the agency asked for supporting analyses from other studies the company had already run, and Moderna put all of that in its submission.
That’s why when Moderna got the “refusal-to-file” letter this month, signed by head vaccine regulator Vinay Prasad, the company was blindsided, Hoge said. “The letter, refusing to even review, really does feel like it came out of the blue to us.”
Prasad took issue with the comparator arm Moderna used in its trial. STAT reported that staff in the vaccine office was ready to review the application, but Prasad overruled them.
Hoge also spoke about what Moderna now plans to do going forward, how this decision will affect the rest of the biopharma industry, and much more.
The conversation has been lightly edited for clarity.
Matthew Herper: Moderna released text of a communication from the FDA where the FDA said Moderna’s choice of a comparator in this trial, the standard flu vaccine, was acceptable. But the FDA was also pretty clear it would have preferred a high-dose vaccine in older seniors. Did the FDA ever change that guidance to Moderna before your trial started, before it was completed, before the review? Had you heard this before this letter?
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Hoge: No. And the letter, refusing to even review, really does feel like it came out of the blue to us. These are incredibly large and complicated development programs. You know this, but it’s very risky to try and bring forward a medicine. And so we were investing almost a billion dollars in that Phase 3. So over five years of working closely with the FDA, we wanted to make sure the trial we were running was acceptable to them.
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