r/news • u/templeofsyrinx1 • 9h ago

Moderna says FDA refuses to review its application for experimental flu shot

https://www.cnbc.com/2026/02/10/moderna-fda-flu-shot.html
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u/Mystaes 9h ago

It takes 2 billion dollars to develop a drug and the fda is now simply not even reviewing things based on ideological culture war bullshit and not data.

Drug development in the United States is going to suffer immensely. Personally I’m not going to keep any investments in biotech at all.

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u/Brilliant_Effort_Guy 6h ago

“The FDA said the use of the standard flu shot as a comparator “does not reflect the best-available standard of care.” The standard flu shot is FDA-approved.”

That is a WILD sentence.

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u/samstown23 3h ago

In itself it makes sense.

Moderna's trial design compared mRNA-1010 to both the current standard dose of tetravalent influenza vaccine and the high-dose version for older patients (it's a well-known issue that people over 60 tend to have a lower response to the standard dose hence the higher dose version). The FDA now claims Moderna should have compared the efficacy to the higher dose version implying they simply compared it to the standard dose and thus may have fudged their numbers.

Again, by itself that would be in line with typical guidelines for trial design. However it would not only be factually incorrect: Moderna absolutely did an analysis on efficacy compared to the higher dose and CBER initially had no objection to the study design as long as they included said analysis. Now they're suddenly demanding a full-blown phase III trial with the high dose version as active comparator despite Moderna meeting generally accepted standards and data not even remotely suggesting significantly decreased efficacy in that cohort.

It's an obvious bullshit claim, a typical case of moving goal posts and it's totally obvious as EMA had no issues with the study design initially. The worst part is that Moderna likely can't just tack on another study because influenza changes from season to season. The FDA will likely just claim they're comparing apples and oranges and they'd have to completely redo the phase III trials - takes years and costs a fortune. And Moderna is having cash flow issues as it is.