Topic: mrna vaccine

  • FDA Rejects Moderna's mRNA Flu Vaccine Application

    FDA Rejects Moderna's mRNA Flu Vaccine Application

    The FDA rejected Moderna's application for its mRNA flu vaccine, citing concerns over the design of its pivotal clinical trial, which the company claims had received prior agency feedback. The agency specifically questioned the comparator vaccine used in Moderna's large Phase 3 study, even though...

    Read More »
  • Trump official overruled FDA to reject Moderna flu shot

    Trump official overruled FDA to reject Moderna flu shot

    A top FDA political appointee, Vinay Prasad, unilaterally rejected Moderna's mRNA flu vaccine application, overriding the consensus of career scientists who were prepared to review it. Senior FDA scientists formally objected, arguing the rejection was misguided, as the agency had previously appro...

    Read More »