The U.S. Food and Drug Administration is cancelling development of a new flu vaccine from biotech giant Moderna, with one unnamed senior FDA official calling the clinical trial a “brazen failure.”
In a rare move, the FDA refused to consider the mRNA vaccine, which could be more effective at preventing flu infections, per a press release from Moderna. A letter signed by director of the Center for Biologics Evaluation and Research, Dr. Vinay Prasad, said the clinical trial was not “adequate and well-controlled” since it did not compare the vaccine to “the best-available standard of care in the United States at the time of the study.”
The issue came down to the study design: control group participants over 65 did not receive the high-dose flu shot; instead, they received a regular flu shot. Moderna CEO Stéphane Bancel said the FDA approved both the study design and the vaccines used.
“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,” Bancel said in the press release.
The senior unnamed FDA official told reporters on Wednesday that Moderna’s study design “raises significant ethical concerns.”
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“We told you not to run it in over 65,” the official said. “You didn’t do what we told you, so go back to the drawing board.”
Experts are themselves rejecting the FDA’s reasoning. “It’s all pretext and obfuscation when the real agenda is rejecting conventional science and serving a predetermined anti-vaccine agenda,” Richard Hughes IV, a law professor at George Washington University, told The Guardian. Hughes further criticized the FDA’s handling of the Moderna trial, saying they “turned the tables at the 11th hour.”
Under Health and Human Services Secretary Robert F. Kennedy Jr., the FDA has undergone a major upheaval on vaccines, driven by Kennedy’s longtime, controversial vaccine skepticism.
Angela Rasmussen, an American virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan, saw no legitimate reason for the vaccine to be canned.
“They’re just coming up with reasons to not approve mRNA anything,” she told The Guardian. “They’re going to eventually do it to all these vaccines,” she warned.
