After years of appeals from medical freedom advocates, front-line physicians, researchers, and others who urged federal regulators to remove Covid vaccines from the market, the Trump administration continues to preserve and expand their use.
The Centers for Disease Control and Prevention (CDC) quietly updated its 2026-2027 guidance in September. It now recommends Covid vaccination even for healthy children and young adults whose vaccination would fall outside Food and Drug Administration (FDA) approved indications.
The FDA, for its part, had narrowed approval for people under 65 largely to those at “higher risk” of severe Covid. That approach itself drew fierce criticism from those who argued that concentrating vaccination on medically vulnerable populations amounted to a form of eugenic policy.
And manufacturers still enjoy sweeping liability protection under the Public Readiness and Emergency Preparedness (PREP) Act. That means people injured or killed by the vaccines generally cannot pursue ordinary product liability claims against the companies that made them.
The change drew attention from investigative journalist Maryanne Demasi, Ph.D., who reported on September 25 that the CDC had effectively reverted to its earlier Covid vaccine recommendations without an announcement or public rollout.
CDC and FDA Part Ways
The apparent conflict between the CDC and FDA is unusually direct.
The FDA currently approves updated Covid vaccines broadly for people 65 and older. For younger people, approval is limited to those with at least one underlying condition that puts them at “high risk” of severe Covid.
The FDA’s list of “qualifying” conditions is expansive. It includes cancer; heart, kidney and lung disease; HIV; diabetes; obesity; depression and other mood disorders; Down syndrome; physical inactivity; and current or recent pregnancy, among others.
The restrictions apply to Moderna’s Spikevax and mNexspike, Pfizer’s Comirnaty, and Novavax’s Nuvaxovid.
The CDC goes considerably further.
In its September 23 update, the agency states:
A 2026-2027 COVID-19 vaccine is recommended for all adults ages 18 years and older.
A 2026-2027 COVID-19 vaccine is also recommended for all children ages 6 months-17 years with moderate to severe immunocompromise; for all other children in this age group, a COVID-19 vaccine is recommended through shared clinical decision-making.
The CDC explicitly acknowledges the regulatory discrepancy:
Recommendations for an age-appropriate COVID-19 vaccination in persons ages 6 months-64 years without at least one underlying high-risk condition are based on off-label use. (Emphasis in original)
For children six months through four years, Spikevax is now the only FDA-approved Covid vaccine available. But FDA approval for people younger than 65 is limited to those considered at “high risk” for severe Covid. The CDC nonetheless provides a vaccination schedule that includes healthy infants and young children under its “shared decision” framework.
The agency says the change reflects a return to recommendations contained in the July 2025 immunization schedules. It cites “legal uncertainties and inquiries” surrounding the federal vaccine advisory process as the reason those earlier recommendations remain in effect for the 2026 to 2027 season.
That effectively reverses the approach adopted last fall.
In November 2025, CDC guidance moved away from a broad recommendation and placed Covid vaccination for people six months and older under what it called “individual-based decision-making,” also known as “shared clinical decision-making.” The agency said the risk-benefit calculation was most favorable for people at increased risk of severe Covid and lowest for those who were not. That assessment was widely contested.
At the time, then-acting CDC Director Jim O’Neill declared that “informed consent is back.”
But changing the language of a recommendation does not, by itself, establish informed consent.
As The New American reported last October:
Under U.S. and international medical ethics, informed consent requires that individuals receive clear, accurate, and complete information about a medical intervention’s risks, benefits, and alternatives. Providers then must tailor this information to each person’s specific health status and social circumstances. Informed consent is not just a communication goal. It is a legal and ethical obligation, grounded in patient autonomy and medical transparency.
Yet no agency within the sprawling Department of Health and Human Services (HHS) moved meaningfully closer to full transparency about the safety and efficacy profile of Covid vaccines, even as evidence of serious adverse events continued to accumulate.
Nor was the right to legal recourse restored.
HHS Secretary Robert F. Kennedy Jr. kept the PREP Act liability shield in place. That leaves vaccine manufacturers and other covered entities protected from most ordinary civil claims related to Covid countermeasures.
The Myocarditis Problem
The CDC’s decision comes amid continuing scrutiny of the safety profile of Covid vaccines, particularly the risk of myocarditis in younger males.
In June 2025, the FDA strengthened myocarditis and pericarditis warnings for Pfizer’s Comirnaty and Moderna’s Spikevax. It said the observed risk was highest among males ages 12 through 24. Using insurance claims data, the agency estimated roughly 27 cases per million doses in that group following the 2023 to 2024 formulation.
The FDA also cited follow-up cardiac imaging showing that abnormal MRI findings associated with myocardial injury persisted in many patients months after vaccine-associated myocarditis. The agency said the long-term clinical significance remains unknown.
The safety debate widened later that year.
In a November 2025 internal memo, then-FDA vaccine official Vinay Prasad said agency staff had reviewed 96 reported pediatric deaths and concluded that at least 10 were “related” to Covid vaccination under classifications of possible, probable, or likely causation. He also acknowledged that regulators lacked reliable data showing the absolute benefit of vaccination against severe disease and death in healthy children.
Yet the FDA stopped short of adding its strongest safety warning.
As we reported last December, then-FDA Commissioner Marty Makary said the agency had “no plans” to add a black-box warning.
“International Consensus”
The new CDC position also sits awkwardly beside the administration’s stated effort to follow the prevailing vaccine policies of other developed countries.
Demasi recalls Kennedy’s argument in January, when HHS revised the childhood immunization schedule.
“We are aligning the U.S. childhood vaccine schedule with international consensus while strengthening transparency and informed consent,” Kennedy said.
On Covid vaccination, however, much of Europe has moved toward a far narrower, risk-based approach. The U.K., Denmark, Norway, Sweden, Germany, and the Netherlands generally concentrate vaccination on older people and those at elevated medical risk, while healthy children are typically excluded from routine recommendations.
Medical-freedom advocates make a broader argument. They contend that the accumulated evidence of serious harms means these products should not be recommended for either healthy or medically vulnerable people. At the same time, letting Washington “align” American healthcare with any foreign model, however effective, is itself the wrong framework. Under our constitutional structure, healthcare policy of this kind should rest primarily with the states, not the federal government.
Even setting these arguments aside, the government’s own positions remain difficult to reconcile. The FDA restricts approved use in younger people to those at “higher risk.” HHS invokes “international consensus” and “informed consent.” Yet the CDC now recommends vaccination beyond those indications, including for healthy babies and young adults.
And the dispute is hardly theoretical.
A September 18 open letter to Kennedy and President Donald Trump, signed by Demasi and more than 160 physicians, scientists, researchers, activists, and public figures, claimed that more than 50 million Americans would receive mRNA Covid shots this year, including seven million children. The signatories cited the continued vaccination of children as one of their central objections, and demanded removal of the mRNA platform from the market.
Days later, the CDC moved in the opposite direction.
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