(LifeSiteNews) — The U.S. Food and Drug Administration (FDA) has notified pharmaceutical giant Moderna that it will not be reviewing its application for a new mRNA-based flu vaccine, continuing the Trump administration’s pivot away from the technology that was introduced to the country with the controversial COVID-19 shots.
Time magazine reports that almost two years ago, Moderna submitted Phase 3 data touting the purported effectiveness of mRNA 1010.6, the first influenza vaccine to use mRNA, and has been in talks with the government ever since. But on February 3, it received a Refusal to File letter from the FDA declaring its application “is not sufficiently complete to enable a substantive review.”
In the letter, FDA Center for Biological Evaluation & Research (CBER) director Dr. Vinayak Prasad explains that his office does “not consider the application to contain a trial ‘adequate and well-controlled,’” because “your control arm does not reflect the best-available standard of care in the United States at the time of the study. I note that this determination is consistent with FDA’s advice given to you prior to your study.”
Moderna has the option of requesting a meeting to discuss the refusal, and if that does not change CBER’s mind, submitting a request for the application to be filed over protest.
STAT News reports that its sources say Prasad overruled staff reviewers who would have approved the application, but an FDA spokesperson said Moderna “refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended [high-dose] flu vaccine to compare safety and efficacy” and “exposed participants age 65 and over to increased risk of severe illness by giving them a substandard of care against the recommendation of FDA scientists.”
Moderna claims CBER “did not raise any objections or clinical hold comments about the adequacy of the Phase 3 trial after the submission of the protocol in April 2024 or at any time before the initiation of the study in September 2024.”
Regardless of the two parties’ dueling claims, the refusal is consistent with National Institutes of Health (NIH) director Jay Bhattacharya’s announcement in an August 2025 Washington Post op-ed that the Trump administration would be “pivoting away from mRNA vaccines,” which he maintained were a “promising technology,” simply because it did not have “public trust,” for which he blamed the Biden administration’s efforts to mandate the mRNA-based COVID-19 shots developed by the Trump administration.
That same month, U.S. Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. announced the government would be “winding down” almost $500 million worth of mRNA vaccine projects and rejecting future exploration of the technology in favor of more conventional vaccines.
Such news has been welcomed by Americans who fault the medical establishment for pushing too many vaccines on their children, as well as those who believe a broader review of vaccine safety is needed after the controversy with the COVID-19 shots. As LifeSiteNews has extensively covered, a large body of evidence indicates those shots carry significant risks.
Democrats are largely united in favor of all such vaccines, but the response among Republicans has been conflicted, largely due to President Donald Trump’s leading role in the original COVID response.
The first Trump administration’s Operation Warp Speed (OWS) initiative prepared and released the COVID shots in a fraction of the time any previous vaccine had ever been developed and tested. Though he never backed mandates like former President Joe Biden did, for years Trump refused to disavow the vaccines to the chagrin of his base, seeing OWS as one of his crowning achievements. At the same time, during his latest run he embraced the “Make America Healthy Again” movement and its suspicion of the medical establishment more broadly.
So far, Trump’s second administration has rolled back several recommendations for the shots but not yet pulled them from the market, despite hiring several vocal critics of the COVID establishment and putting HHS under the leadership of Kennedy, America’s most prominent anti-vaccine activist. The administration has largely settled on leaving the current vaccines optional but not supporting work to develop successors and limiting recommendations to those in high-risk groups for COVID itself.
In a July 2025 interview, FDA Commissioner Marty Makary asked for patience from those unsatisfied by the administration’s handling of the shots, insisting more time was needed for comprehensive trials to get more definitive data. The FDA has reportedly begun acknowledging child deaths caused by the shots, but, at the same time, the Trump Justice Department is in court arguing against the revival of a whistleblower’s lawsuit against Pfizer.