'Staggering surrender': CDC pushes COVID vaccines for healthy people 'off-label,' infuriating MAHA

The second Trump administration increasingly resembles the Biden administration on two issues that played a major role in President Donald Trump's 2024 victory, raising the question of how many foot soldiers Republicans can turn out in November midterms.

The Centers for Disease Control and Prevention blew past its sibling Food and Drug Administration's targeted approvals of updated COVID-19 vaccines for elderly and high-risk Americans, quietly issuing recommendations last week that all healthy adults and children starting at 6 months old take the non-sterilizing mRNA products off-label.

The expansion is even more surprising because the FDA approved Pfizer-BioNTech and Moderna mRNA vaccines without direct human evidence for the efficacy of the new formulations compared to a placebo, putting tens of millions of Americans who still get COVID vaccines for themselves or their children at risk of becoming guinea pigs.

The CDC cryptically cited "legal uncertainties and inquiries" for its one-size-fits-all jab recommendations, which simply reinstate its recommendations from the July 2025 immunization schedule for the upcoming "respiratory illness season."

Heidi Overton, nominee for FDA commissioner, pointedly affirmed at her confirmation hearing last week that the agency has deemed "all" approved vaccines on the market "safe and effective," giving the CDC cover for its off-label push.

Neither the CDC nor Department of Health and Human Services answered Just the News queries to explain the recommendations in light of the FDA's targeted approvals.

Hours before Overton's hearing Thursday, Students for Life of America sent the FDA a "notice of intent to sue," alleging failure to follow the Endangered Species Act when it approved an abortion pill in 2000 because it didn't consult with relevant agencies about mifepristone's threat to wildlife when it arrives in waterways via wastewater.

SFLA made the same legal argument when the Supreme Court reviewed mifepristone's approval, while several GOP state attorneys general asked the Environmental Protection Agency to add the abortion pill to its next "contaminant candidate list," with both citing the surge in mifepristone's at-home use since the Supreme Court overturned federal abortion rights.

The FDA's refusal to reinstate in-person prescribing requirements for mifepristone that were removed by the Biden administration, and the Trump administration's argument that states don't have legal standing to challenge FDA changes to mifepristone's conditions, had already created a rift with one of the GOP's most loyal voter bases ahead of midterms.

'Criminal malfeasance'

The updated vaccine recommendations were posted just two days after the old guard of the Make America Healthy Again movement, founded by HHS Secretary Robert F. Kennedy Jr., threatened political war against Trump and Kennedy for a "bait and switch" that swapped out mRNA removal with food reform.

"For an administration that promised to challenge the medical establishment, it is a staggering surrender," medical scientist-turned-journalist Maryanne Demasi wrote Friday in flagging the recommendations, which "almost mirror" those of the American Academy of Pediatrics. (Kennedy blasted AAP a year ago for "corporate-friendly" recommendations.)

The recommendation for "shared clinical decision-making" between families and providers, on whether to vaccinate healthy children, is undermined by lack of information for parents to make an informed decision, according to Demasi.

"The agency does not quantify what benefit a healthy baby can realistically expect from vaccination or clearly explain the limits of that protection," in contrast to other countries' disclaimers on the tradeoffs of the vaccines for various demographics, she said.

"I am mad as hell" about the recommendations, mRNA technology pioneer-turned-critic Robert Malone wrote in an essay titled "Criminal mRNA Malfeasance by the CDC."

He was vice chair of the CDC's Advisory Committee on Immunization Practices last fall when the agency discussed and voted to recommend "individual medical decision-making within the population for whom FDA had approved the vaccine" – elderly and high-risk, Malone said. 

Over the next several months, culminating with last week's updated recommendations, the CDC bureaucracy ignored its then-acting Director Jim O'Neill and unilaterally reinterpreted ACIP's vote as having approved "shared clinical decision-making," meaning "an off-label use in the very population FDA declined to approve," Malone said. 

"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 public deserves to know who made that decision and who was sitting on the other side of the table," he said.

The recommendations are "[i]ncredibly unethical" given the FDA's findings that 10 children died from COVID vaccines and peer-reviewed research that vaccine-associated myocarditis peaks between the ages 16-24, ACIP member and MIT professor Retsef Levi said. His peer-reviewed research drew early attention to the vaccine-heart inflammation link for young people.

Levi questioned how many CDC, FDA and HHS personnel "and the physicians pushing these recommendations actually use these product[s]." 

The CDC estimated about 18% of adults and 10% of children were "up to date" on COVID vaccines in the 2025-2026 season.

Former FDA regulatory review officer Jessica Adams puzzled over the agency's abandonment of "equipoise" – genuine uncertainty – in favor of recommending COVID vaccines for healthy adults, while also recently "releasing manufacturers from prospective studies FDA had said were needed to address remaining questions."

Then-Commissioner Marty Makary rolled out a framework requiring "randomized, placebo-controlled" trials to justify COVID vaccines for on-the-bubble groups such as healthy adults ages 50-64, and even his predecessor, Robert Califf, called the conditions "quite reasonable, and even advisable," Adams noted.

"The framework and rationale for generating this evidence were rolled out publicly and extensively," she wrote, fearing public trust in health agencies will plunge even further. "If significant pieces of that framework are subsequently rolled back, shouldn’t the rollback receive a commensurate public explanation?" 

"The CDC’s lack of respect for informed consent and individual rights will continue to erode what little trust remains in this agency and will ultimately be its undoing," vaccine injury lawyer Aaron Siri wrote. The recommendations boil down to "just inject" adults and unhealthy kids, and seek parents' consent to inject their healthy kids, he said.

'Irrelevant outside attacks' by mRNA opponents

The timing of the updated recommendations threatens to sour Wednesday's MAHA Summit near the White House, which features high-profile administration leaders including Kennedy and Vice President JD Vance. It's run by Tony Lyons, who co-founded a PAC supporting Kennedy's 2024 presidential campaign.

The gathering drew criticism from MAHA purists for corporate sponsorship, which Bloomberg reported topped out at $300,000 for a speaking slot, "meaningful input" on panel topic and participants, and a "private dinner" with Kennedy and Centers for Medicare & Medicaid Services Administrator Mehmet Oz. 

Lyons told Bloomberg it was "reasonable" to question the sponsorships but said corporate influence in Congress should be probed too. His MAHA PAC has only spent $800,000 to support "MAHA-aligned" Republican candidates, most of that to defeat Louisiana Sen. Bill Cassidy in the GOP primary, and has less than $300,000 cash, Politico reported.

HHS told the Financial Times government speakers weren't involved in planning or sponsoring the summit by Lyons' nonprofit MAHA Center or aware of corporate sponsorship. It dismissed criticism by vaccine skeptics including medical freedom activist Mary Talley Bowden, who coordinated last week's political threat letter, as "[i]rrelevant outside attacks."