CEO Stephane Bancel said the letter refusing review did not cite “ any safety or efficacy concerns” 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 flu, the company revealed on Tuesday evening. The federal agency cited that as the reason it declined to review the application, which claimed there was a lack of “adequate and well-controlled” data. Moderna said the letter claimed that the FDA thought the biotech giant’s flu vaccine “does not refl...