After talks with Food and Drug Administration, company plans to resubmit vaccine application later this year

After talks with Food and Drug Administration, company plans to resubmit vaccine application later this year

Moderna said on Wednesday it had withdrawn an application seeking approval for its flu and Covid combination vaccine candidate after discussions with the US Food and Drug Administration.

The company said it would resubmit the application later this year with vaccine efficacy data from a late-stage trial of its experimental seasonal influenza vaccine, which it expects to report this summer.

The decision comes a day after the US FDA said it would require new clinical trials for approval of annual Covid-19 boosters for healthy people under 65 years.

  • CompactFlaxEnglish
    42·
    10 days ago

    Chilling effects.

    It wasn’t long ago that some conservatives in my country wanted to outsource drug approval to FDA because “why do the work twice?” Overlooking the fact that while being a fraction of the population our regulatory environment is so much better.