US FDA declines Moderna flu vaccine review amid vaccine guidance rollback

The United States Food and Drug Administration (FDA) has refused to review Moderna’s application for approval of a flu vaccine, raising concerns amid a recent rollback of longstanding vaccine guidelines.

In a letter to Moderna, the FDA pushed back on the Massachusetts-based biotech company’s rationale comparing its mRNA -1010, a product already on the market, to a standard dose for the seasonal ...