FDA Refuses To Review Moderna’s Application For Experimental Flu Shot

Authored by Troy Myers via The Epoch Times,

The Food and Drug Administration (FDA) is refusing to review Moderna’s experimental flu shot, the company announced Tuesday.

Already submitted and accepted for review in the European Union, Canada, and Australia, the experimental shot’s application being denied by the FDA is another sign of President Donald Trump’s administration’s impact on U.S. pharmaceutical companies.

FDA Center for Biologics Evaluation and Research (CBER) Director Vinayak Prasad signed the refusal to review letter, objecting to Moderna’s study design and its lack of an “adequate and well-controlled” study.

Moderna’s CEO refuted to Prasad’s assessment.

“It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting,” Moderna CEO Stéphane Bancel said in the news release.

According to the pharmaceutical company, the FDA did not identify any specific safety or efficacy concerns with the experimental flu shot, called mRNA-1010.

Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., announced its plan in August 2025 to begin winding down mRNA vaccine development, including the cancellation and de-scoping of contracts and solicitations. The decision came after a review of mRNA-related investments started during the COVID-19 pandemic.

“The data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate,” Kennedy said in the news release.

The HHS secretary added that his agency will be investing in better solutions.

In the latest setback with Moderna’s experimental mRNA shot, the company called the move by the FDA “inconsistent” with prior feedback it has received from the agency.

In April 2024, Moderna submitted its phase three study to the FDA’s CBER for review. The agency sent written guidance back, which did not raise any objections about the phase three trial, Moderna said.

Following the completion of the experimental shot’s phase three efficacy trial in August 2025, Moderna held another meeting with the FDA agency for feedback. The Moderna news release said that at no time during the meeting or in written feedback did CBER hint that it would refuse to review the shot’s application.

“This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” Bancel said.

With mRNA-1010’s acceptance for review in the European Union, Canada, and Australia, Moderna said it plans to file more submissions in additional countries this year.

Meanwhile, the drug company has requested a meeting with the FDA agency to understand the path forward.

“We look forward to engaging with CBER to understand the path forward as quickly as possible so that America’s seniors, and those with underlying conditions, continue to have access to American-made innovations,” the CEO said.

The refusal to review Moderna’s experimental flu vaccine comes as the Trump administration is making sweeping changes to the U.S. health complex, like inverting the food pyramid, narrowing the childhood vaccine schedule, the Centers for Disease Control and Prevention admitting vaccines may cause autism, and more.

RFK Jr. helped launch the Make America Healthy Again movement, which is advocating for healthier diets, safer farming practices, more awareness of store-bought foods laden with chemicals, and trying to identify the root causes of chronic disease.

The FDA refusing to review Moderna’s experimental flu shot becomes the latest setback for big pharmaceutical companies under the Trump administration.

The pharmaceutical company said it does not expect impacts to its 2026 financial guidance and forecasts the earliest approvals for its experimental flu shot to begin late 2026 or early 2027.