Kennedy’s FDA REVERSES Approval—Moderna Blindsided

The FDA under the Trump administration has refused to review Moderna’s new mRNA flu vaccine application, marking a stunning reversal after years of development and raising serious questions about political interference in America’s medical innovation pipeline.

Story Snapshot

FDA issued rare “refusal-to-file” letter to Moderna on February 10, 2026, blocking review of its mRNA-based flu vaccine despite no identified safety or efficacy concerns
Agency rejected the 40,000-person clinical trial design over the control group methodology, contradicting previous guidance given under the Biden administration
Decision follows HHS Secretary Robert F. Kennedy Jr.’s cancellation of over $500 million in mRNA vaccine funding and implementation of new COVID vaccine warnings
Moderna CEO sharply rebuked the FDA’s rationale, publicly releasing the rejection letter and calling the decision harmful to American innovation leadership

FDA Reverses Course on Approved Trial Design

The FDA sent Moderna a refusal-to-file letter on February 10, 2026, rejecting the company’s biologics license application for mRNA-1010, its experimental flu vaccine. The agency’s objection centered on Moderna’s use of a standard-dose flu shot as the control arm in its phase 3 trial, rather than a high-dose version preferred for seniors aged 65 and older. This rationale contradicts feedback the FDA provided in 2024 under the Biden administration, when regulators allowed Moderna to proceed with the standard-dose comparator. The rejection came from Dr. Vinay Prasad, the FDA’s vaccine director, who cited concerns about comparing against the “best-available standard of care.”

Kennedy Administration’s Growing Scrutiny of mRNA Technology

The FDA’s decision reflects heightened scrutiny of mRNA vaccines under Health and Human Services Secretary Robert F. Kennedy Jr., who has long criticized this Nobel Prize-winning technology. Throughout 2025, the Trump administration systematically dismantled support for mRNA vaccine development, canceling more than $500 million in contracts and funding. The FDA rolled back COVID-19 vaccine recommendations, added new mRNA vaccine warnings, and removed critics from advisory panels. BARDA abruptly terminated mRNA flu research programs in summer 2025, while Kennedy endorsed disputed safety claims about mRNA COVID vaccines during Senate testimony. These actions signal a coordinated policy shift away from the technology that dominated America’s pandemic response.

Moderna’s Trial Data Shows Superior Performance

Moderna’s application included data from approximately 40,000 participants demonstrating that mRNA-1010 outperformed standard-dose flu vaccines in adults aged 50 and older. The company also provided a separate comparison against high-dose vaccines, addressing the FDA’s stated preference for seniors. Moderna submitted the application with a Priority Review Voucher, seeking expedited evaluation. CEO Stephane Bancel emphasized that the FDA identified no safety or efficacy issues with the vaccine itself, stating the rejection “does not further America’s leadership” in medical innovation. The company has requested an urgent meeting with FDA officials to resolve the impasse, though no timeline has been established.

Rare Rejection Raises Concerns About Regulatory Integrity

Refusal-to-file letters are exceptionally rare for vaccine applications, particularly after extensive pre-submission consultations between manufacturers and regulators. The decision broke with standard FDA practice, where trial designs receive thorough vetting before companies invest hundreds of millions of dollars in clinical studies. Moderna took the unusual step of publicly releasing the FDA’s rejection letter, underscoring the company’s frustration with what it perceives as arbitrary rulemaking. Twelve former FDA commissioners previously condemned a 2025 memo authored by Dr. Prasad that ended streamlined approval pathways for flu vaccines, warning it would undermine public health preparedness. This latest action compounds concerns about whether scientific standards or political considerations now drive FDA decision-making under the current administration.

International Regulators Proceed with Review Process

While the FDA has blocked consideration of Moderna’s flu vaccine, regulatory agencies in the European Union, Canada, and Australia continue their reviews of mRNA-1010. This divergence highlights the isolated nature of the U.S. decision and raises questions about whether American patients will have access to potentially superior flu protection available elsewhere. Moderna has indicated it plans additional international filings, effectively pivoting away from the U.S. market for this product. The company stated it expects no financial impact to its 2026 guidance from the FDA’s rejection, having already shifted significant research and development resources toward oncology applications. This strategic retreat from vaccine development in America represents a direct consequence of the hostile regulatory environment created by Kennedy’s policy changes.