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.Recommended Stories list of 4 itemsend of listThe 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 reflect the best-available standard of care”.The company has pushed back on the allegation, and CEO Stephane Bancel said the letter “did not identify any safety or efficacy concerns with our product”.Experts say the lack of guidance isn’t helpful.“If there are things that need scrutiny, a review process can address them. At the end of the review, they can identify the issues that need to be corrected. That gives the company an opportunity to make changes and adapt. When that guidance isn’t provided, it makes it very difficult for someone submitting materials to know how to proceed,” Bruce Y Lee, a professor of health policy and management at the CUNY Graduate School of Public …
