(LifeSiteNews) — The U.S. Food and Drug Administration (FDA) will be reviewing pharmaceutical giant Moderna’s application for a trial of its new mRNA-based flu vaccine after all, reversing its prior rejection following reported intervention from President Donald Trump.
LifeSiteNews reported on Wednesday that on February 3, the FDA sent Moderna a Refusal to File letter declaring its application “is not sufficiently complete to enable a substantive review.” FDA Center for Biological Evaluation & Research (CBER) director Dr. Vinayak Prasad reportedly 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.”
However, Politico reports that following the letter, President Donald Trump met with FDA Commissioner Marty Makary at the White House, where he “expressed frustration” at the FDA’s “handling of vaccine issues,” after which Moderna was granted a follow-up meeting faster than is routine, resulting in the application being accepted.
A White House official denied that the president influenced the decision, and Moderna did offer an amended filing that addressed issues cited in the original rejection, such as “seek[ing] full approval for 50- to 64-year-olds and accelerated approval for adults 65 and older, with a post-marketing requirement to study the vaccine further in the older age group.”
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Moderna CEO Stéphane Bancel responded. “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
The FDA is expected to make a decision whether or not to approve the vaccine by August 5.
The reversal calls into question 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 the first Trump administration’s Operation Warp Speed (OWS) initiative, which prepared and released the COVID shots in a fraction of the time any previous vaccine had ever been developed and tested, which the president has refused to disavow.
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, 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.