Moderna (MRNA.US) plunges after hours! FDA refuses to accept application for flu vaccine launch.

Moderna (MRNA.US) announced on Tuesday that the US Food and Drug Administration (FDA) will not review its application for the approval of its flu vaccine. As a result of this news, Moderna's US stock fell nearly 9% after hours on Tuesday. In the refusal to accept letter, the FDA pointed out that the only reason for rejecting the initiation of the approval review for Moderna's mRNA-1010 vaccine was that Moderna chose to compare its vaccine with an approved standard dose seasonal flu vaccine. Moderna stated that the letter specifically noted the lack of a "sufficient and good control" control group in the study, which "did not reflect the current best medical standard." Moderna CEO Stphane Bancel said, "This decision by the Center for Biologics Evaluation and Research (CBER) does not indicate any safety or efficacy issues with our product, which goes against our shared goal of advancing America's leadership in the innovation and drug development field." The company stated that the content of the letter is inconsistent with previous written communications with the FDA. Bancel stated, "The submission of a flu vaccine application against an FDA-approved vaccine as a control, and the agreement reached with CBER on the study design before initiation, should not have been controversial for a comprehensive review of this application." The company's submission for the approval of mRNA-1010 included two late-stage studies, both of which met the primary endpoints of the trials. Last year, Moderna stated that its mRNA-1010 vaccine was 26.6% more effective than the flu vaccine approved by GlaxoSmithKline plc Sponsored ADR (GSK.US). The company said it has requested a meeting with the FDA to clarify the next steps. This development comes as the US is overhauling its long-standing guidance on childhood immunization and withdrawing recommendations for routine vaccination of six infectious diseases, including the flu, more than a month later. Moderna had indicated earlier this year in interviews that it does not plan to invest in new late-stage vaccine clinical trials due to increasing opposition to vaccination by US officials. Currently FDA-approved flu vaccines include products produced by Astrazeneca PLC Sponsored ADR (AZN.US) and Sanofi (SNY.US). Moderna withdrew its application for the approval of its flu-COVID combo vaccine last year, awaiting efficacy data from its late-stage flu vaccine trial. The vaccine is currently under review in the EU, Canada, and Australia, and the company expects to receive approval by late 2026 or early 2027.