Last mentioned: Feb 19, 2026
Anticipated PDUFA
Expected deadline for the FDA's final approval decision.
FDA U-Turn
FDA agrees to review the application after resolving the public dispute.
FDA U-Turn
Moderna confirms the FDA has resolved the dispute and will now consider the vaccine for approval.
Regulatory Reversal
FDA agrees to review the application after Moderna addresses concerns.
Regulatory U-Turn
The FDA officially agrees to consider the application after resolving the internal and public dispute.
Public Dispute
Moderna and administration officials engage in a public disagreement over the regulatory path forward.
Public Dispute
Reports emerge that career FDA scientists were overruled, leading to a public standoff between Moderna and the agency.
Political Controversy
Reports emerge that the vaccine chief overruled career scientists to block the shot.
Initial Rejection
Reports emerge that the FDA vaccine chief overruled scientists to reject Moderna's flu shot filing.
Initial Rejection
Trump administration vaccine chief refuses to review Moderna's mRNA flu shot application.
Refusal to File
FDA issues a shocking rejection of the application, sparking a public dispute.
Refusal to File
FDA issues an RTF citing deficiencies in the initial application.
Initial BLA Submission
Moderna submits its Biologics License Application for mRNA-1010.
BLA Submission
Moderna submits Biologics License Application for mRNA-1010.
The FDA has agreed to review Moderna’s mRNA-based influenza vaccine after a high-profile rejection by the Trump administration's vaccine chief. The reversal follows a public dispute where scientific staff were reportedly overruled, marking a significant shift for the first-of-its-kind vaccine candidate.
The FDA has rescinded its initial refusal to file Moderna’s Biologics License Application for its seasonal flu vaccine, mRNA-1010. This rare regulatory pivot clears the path for a formal review of the first mRNA-based influenza shot, a critical milestone for Moderna’s post-pandemic growth strategy.
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.
Moderna has confirmed that the FDA will officially review its mRNA-based influenza vaccine following a highly publicized regulatory standoff. The reversal comes after reports that the Trump administration's vaccine leadership initially overruled career scientists to block the application.