Authored by Troy Myers via The Epoch Times,
The Food and Drug Administration (FDA) is refusing to review Moderna’s experimental flu shot, the companyannouncedTuesday.
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.
Source: ZeroHedge News
