This article originally appeared onThe Defenderand was republished with permission.
Guest post byMichael Nevradakis, Ph.D.
In a decision that“shocked” Moderna officials, the U.S. Food and Drug Administration (FDA) last weekdeclined to review Moderna’s applicationfor its new mRNA flu vaccine.
The FDA cited the company’s failure to perform an “adequate and well-controlled” clinical trial and its failure to use the “best-available standard of care” during the trial process.
The FDA informed Moderna of its decision in a Feb. 3 “refusal-to-file” letter, signed by Dr. Vinay Prasad, director of the agency’s Center for Biologics Evaluation and Research, which overseesvaccines, the company disclosed Tuesday.
The decision follows the FDA’s adoption of a stricter approach to approving vaccines,The Washington Postreported.
Prasad’s move to not even consider Moderna’s application, filed in December 2025, “signals a new aggressive phase to regulating drugs and forcing drugmakers to performmore rigorous studies,”Bloombergreported.
According to Bloomberg, the FDA rarely issues refusal-to-file letters. Bloomberg cited a 2021JAMA Internal Medicine studyfinding that only 4% of a sample of 2,475 applications the FDA received resulted in the issuance of such a letter.
Moderna’s clinical trial tested itsmRNA-1010 vaccineagainst an existing flu vaccine instead of a placebo. Specifically, it compared the outcomes of the mRNA-1010 vaccine against a standard-dose flu shot.
In a statement released earlier today and cited byFierce Biotech, FDA Commissioner Marty Makary said this clinical trial design put seniors at risk.
Source: The Vigilant Fox
