10 votes

US Food and Drug Administration declines to review Moderna's mRNA flu shot

2 comments

  1. skybrian
    Link
    From the article: [...] [...]

    From the article:

    The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday.

    [...]

    In a release Tuesday, Moderna said the FDA did not identify any safety or efficacy concerns with the vaccine. Instead, it said the FDA took issue with the “comparator” in its clinical trial — the vaccine the company used as a benchmark to evaluate its own shot.

    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.

    However, Moderna said that the agency’s stated reason is “inconsistent” with what regulators had told the company in 2024 and 2025.

    “It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting,” Moderna CEO Stéphane Bancel said in the release, referring to the FDA’s Centers for Biologics Evaluation and Research, which reviews and approves vaccines, as well as other treatments such as gene therapies.

    Moderna said last year that its mRNA flu shot was 26.6% more effective than the standard flu shot, based on a Phase 3 clinical trial.

    [...]

    Regulators in the European Union, Canada and Australia have accepted Moderna's mRNA flu vaccine application, the company said.

    4 votes
  2. snake_case
    Link
    I’m missing a lot of context here Doesn’t Moderna also have a regular flu shot on the market? Isn’t it some huge pharma company? Is Moderna American? I thought it was European but I forget? Is...

    I’m missing a lot of context here

    Doesn’t Moderna also have a regular flu shot on the market? Isn’t it some huge pharma company?

    Is Moderna American? I thought it was European but I forget?

    Is there any other mRNA based general flu shot available? Or is it all just specific to covid?

    Does this just mean we’ll have the not-as-good flu shots now? What do other flu shot companies have to gain from this? Would Americans not just start to buy flu shots from other countries off the internet or something if the good ones aren’t available here?

    Is the ultimate goal to make all the pro-government regulations people say the words “why don’t we just let the consumer decide” ?

    2 votes