Why did the U.S. FDA decline to review the new mRNA influenza vaccine?

The FDA declined to review Moderna's mRNA influenza vaccine due to inadequate clinical trial comparators for older adults.

Clinical Trials Show Moderna's New mRNA Flu Vaccine Is Safe and Effective. FDA Won't Even Consider It.

The post Clinical Trials Show Moderna's New mRNA Flu Vaccine Is Safe and Effective. FDA Won't Even Consider It. appeared ...
WMNFOpinion

FDA rejects Moderna’s mRNA flu vaccine application – for reasons with no basis in the law

The FDA's requirements that are nowhere to be found in the law creaties uncertainty for companies with pending vaccine ...

FDA refuses to review Moderna's mRNA flu shot

The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday ...

Moderna Promises Revenue Growth In 2026, Even As FDA Flu Vaccine Setback Looms

Moderna beat fourth-quarter sales expectations and forecast growth for 2026, but an FDA refusal on its flu vaccine raises new ...

Moderna Just Crushed Estimates While Everyone Was Looking the Other Way

Moderna (NASDAQ: MRNA) reported fourth-quarter results Friday morning that beat Wall Street’s muted expectations, delivering ...

Moderna beats quarterly revenue estimates on resilient COVID shot sales

Feb 13 (Reuters) - Moderna reported fourth-quarter revenue above Wall Street estimates on Friday, helped by sales of its ...

FDA Refuses to Review Moderna’s New Flu Shot

At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared ...
Infectious Disease Advisor

FDA Declines to Review Moderna’s mRNA Influenza Vaccine Application

Moderna’s mRNA influenza vaccine faces US regulatory delays after a refusal-to-file letter from top FDA official Dr Vinay Prasad.
Fierce Pharma

With the FDA's Moderna decision, vaccine makers face increasingly uncertain regulatory environment

Mani Foroohar, M.D., of Leerink Partners, says that the decision reflects “how sharp the departure has been between the prior ...
Opinion

Letting disease win: FDA’s dangerous refusal of Moderna’s new mRNA flu vaccine

The anti-science, anti-medicine mindset of the nutso Health and Human Services Secretary Robert F. Kennedy Jr. is killing people by quashing life-saving vaccines.

Doctor concerned FDA refusal to review mRNA flu vaccine will affect other research

Moderna said it’s requesting a meeting with the U.S. Food and Drug Administration after receiving a “refusal-to-file” letter, which means the FDA isn’t going to review the company’s advanced-stage ...