Authored by Troy Myers via The Epoch Times,
The Food and Drug Administration (FDA) has declined to review Moderna’s experimental flu vaccine, as announced by the company on Tuesday.
The FDA’s refusal to review the application for the experimental shot, already accepted for review in the European Union, Canada, and Australia, is seen as a reflection of the impact of President Donald Trump’s administration on U.S. pharmaceutical companies.
The FDA’s Center for Biologics Evaluation and Research (CBER) Director Vinayak Prasad cited concerns with Moderna’s study design and the lack of an “adequate and well-controlled” study in the refusal letter.
Moderna’s CEO disagreed with Prasad’s assessment, stating, “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.”
Despite no specific safety or efficacy concerns identified by the FDA, the Health and Human Services (HHS) under Secretary Robert F. Kennedy Jr. announced plans to shift funding away from mRNA vaccine development towards safer vaccine platforms.
Moderna expressed disappointment in the FDA’s decision, calling it inconsistent with prior feedback received from the agency.
The company plans to file submissions for review in additional countries this year and has requested a meeting with the FDA to understand the path forward.
The refusal to review Moderna’s experimental flu vaccine is part of broader changes in the U.S. health complex under the Trump administration, including adjustments to the food pyramid, childhood vaccine schedule, and acknowledgment of vaccine-autism links by the CDC.
RFK Jr. is involved in the Make America Healthy Again movement, advocating for healthier diets and farming practices.
Moderna does not anticipate financial impacts from the FDA’s decision and expects potential approvals for its flu shot in late 2026 or early 2027.
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