Also known as: high-dose flu vaccine
The FDA agreed to review Moderna's mRNA-based flu vaccine after initially rejecting the application, following a Type A meeting that led to a revised regulatory approach splitting approval pathways by age group.
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
The FDA reversed its initial rejection and will now review Moderna's mRNA-based flu vaccine application after the company proposed a revised regulatory approach, targeting approval by August 2026.
The FDA reversed its refusal to review Moderna's mRNA flu vaccine application after the company amended its submission. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision expected by August 5, 2026.
