Last mentioned: 4d ago
FDA U-Turn
Moderna confirms the FDA has resolved the dispute and will now consider the vaccine for approval.
Public Dispute
Moderna and administration officials engage in a public disagreement over the regulatory path forward.
Initial Rejection
Reports emerge that the FDA vaccine chief overruled scientists to reject Moderna's flu shot filing.
The U.S. Food and Drug Administration has unexpectedly reversed its previous position, agreeing to review Moderna’s mRNA-based influenza vaccine candidate. This regulatory pivot marks a critical victory for Moderna as it seeks to diversify its portfolio beyond COVID-19 and challenge the traditional seasonal flu market.
The U.S. Food and Drug Administration has agreed to review Moderna’s experimental mRNA flu vaccine, reversing a previous decision that sparked a public dispute. The initial rejection, which reportedly saw political appointees overrule career scientists, had briefly cast doubt on the regulatory path for the company's post-COVID pipeline.