The FDA issued limited approvals for COVID vaccines targeting elderly and high-risk Americans. The CDC took that approval, ignored the limitations, and recommended that all healthy adults and children as young as six months old receive the shots "off-label." The agency accomplished this by reinterpreting an Advisory Committee on Immunization Practices vote that approved "individual medical decision-making" for FDA-approved populations and turning it into "shared clinical decision-making" — bureaucratic code for recommending the vaccines to everyone.
Robert Malone, the mRNA technology pioneer who served as former vice chair of the CDC's own ACIP, published an essay titled "Criminal mRNA Malfeasance by the CDC." Not "questionable." Not "concerning." Criminal.
"I am mad as hell about the recommendations," Malone wrote, warning that if "career officials transformed a public ACIP vote into something the committee did not vote for, while preserving a commercially valuable market for the manufacturers," the implications go beyond bad policy.
Medical scientist-turned-journalist Maryanne Demasi called it a "staggering surrender." As reported by Just the News, the CDC's move came despite the agency's own data showing that only 18% of adults and 10% of children were "up to date" on COVID vaccines during the 2025-2026 season. The public has already voted with their arms. The CDC overruled them.
The FDA's own findings identified 10 children who died after receiving COVID vaccines. The peak age range for vaccine-associated myocarditis is 16 to 24. Then-FDA Commissioner Marty Makary had established a framework requiring "randomized, placebo-controlled" trials before expanding vaccine recommendations. The CDC's off-label push has no direct human evidence for the new formulation's efficacy compared to placebo.
Vaccine injury lawyer Aaron Siri put the institutional damage in plain terms: "The CDC's lack of respect for informed consent and individual rights will continue to erode what little trust remains."
This isn't happening in a vacuum. HHS Secretary Robert F. Kennedy Jr. and Vice President JD Vance are both scheduled to speak at the MAHA Summit this week. The Make America Healthy Again movement had already warned of "political war" against any "bait and switch" on vaccine policy. Medical freedom activist Mary Talley Bowden has been sounding alarms. Students for Life of America sent a "notice of intent to sue" the FDA on September 24. The pressure was building from every direction — and the CDC chose this moment to expand recommendations that the public, the scientific community, and the administration's own health reformers didn't ask for.
The same public health establishment that demanded we "trust the science" is now pushing drugs off-label to healthy six-month-olds based on a vote it had to reinterpret to get the answer it wanted. Former FDA regulatory review officer Jessica Adams and ACIP member Retsef Levi, an MIT professor, are among those raising concerns from inside the system.
Eighteen percent of adults complied. The CDC's response wasn't to ask why. It was to recommend harder.