Better in their words…

And I am mad as hell about it. R.W. Malone

I reserve judgment on RFK. Jr. The full tale has not been told, but I certainly feel the frustration that Dr. Malone shares here. mrossol

DR. ROBERT W. MALONESEP 25

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Something deeply corrupt has happened inside the CDC

The agency has just issued its COVID-19 vaccination guidance for the 2026–2027 season. Buried inside that guidance is an extraordinary admission. CDC recommends COVID vaccination through “shared clinical decision-making” for healthy children beginning at six months of age, while simultaneously acknowledging that vaccination of people six months through 64 years without a qualifying high-risk condition is off-label.

Read that again. And remember:

• FDA has not approved these vaccines for healthy babies. 
• The ACIP did not approve these vaccines for healthy babies.

For Moderna’s Spikevax, FDA and the ACIP limited approval to below age 65 is restricted to people with at least one underlying condition placing them at high risk for severe COVID-19. Yet CDC has placed healthy children, beginning at six months, within its COVID vaccine recommendation through something called “shared clinical decision-making.” CDC itself now acknowledges that this recommendation extends beyond the FDA-approved indication.

I have a particular interest in how this happened.

I was vice-chair of the Advisory Committee on Immunization Practices when the relevant vote was taken in September 2025. I was sitting at the table. I participated in the discussion. And the proposition now being implemented by CDC is not what we were voting for.

What FDA Had Already Decided

Two months before the ACIP meeting, FDA had examined Moderna’s application to expand approval of Spikevax in children.

FDA’s July 9, 2025 decisional memorandum is remarkably direct. FDA’s Center for Biologics Evaluation and Research asked whether there was sufficient certainty of net clinical benefit from vaccinating healthy children with this mRNA vaccine.

Its answer was no.

FDA noted that severe COVID disease, hospitalization and death had become extremely uncommon in children, particularly healthy children. It also noted that Moderna had never demonstrated in a randomized pediatric trial that vaccination reduced severe COVID-19, hospitalization, intensive-care admission or death. FDA therefore approved the vaccine for children with risk factors, but not healthy children.

The memorandum states the conclusion plainly:

“For healthy children that standard is not met.”

The standard being discussed was FDA’s requirement for sufficient certainty that the benefits of vaccination outweigh its risks. FDA said randomized trials measuring clinical outcomes and safety would be needed to change that conclusion.

That was the regulatory landscape when ACIP met in September.

What ACIP Was Told

This is where the current CDC recommendation can not be reconciled with the meeting at which I served as vice-chair.

The COVID-19 workgroup presented its guiding principles to the committee. The first was:

“Access within the FDA authorized population.”

The next was that benefits, risks, and uncertainties must be communicated as part of proper informed consent.

Only then did the workgroup describe its debate between individual-based decisions and group recommendations. That ordering of the discussion and vote matters.

The universe being discussed was not every American six months of age and older regardless of FDA indication. The workgroup expressly defined the boundary as the FDA-authorized population.

Then came Vote #4.

The motion concerned updating the pediatric and adult immunization schedules for administration of “FDA-approved COVID-19 vaccines.” For people six months through 64 years, ACIP adopted “individual-based decision-making,” with an explicit warning that the risk-benefit balance was most favorable for those at increased risk of severe COVID and lowest for those who were not.

That was the framework we were voting on: individual medical decision-making within the population for whom FDA had approved the vaccine. This is clear in the ACIP transcript record that I have reviewed extensively this morning.

WE, the ACIP, did not vote to recommend off-label COVID vaccination for healthy six-month-old babies.

Individual Decision-Making Becomes Something Else

Then the administrative machinery took over.

On October 6, 2025, CDC announced that Acting CDC Director and HHS Deputy Secretary Jim O’Neill had approved ACIP’s recommendations.

His own statement recognized the FDA limitation. CDC Director O’Neill said FDA had granted marketing authorization to people with one or more qualifying risk factors and to people 65 and older.

Then came an extraordinarily consequential sentence.

CDC announced that “individual-based decision-making” would appear on its immunization schedules as “shared clinical decision-making.”

That sounds like bureaucratic wordplay. It isn’t.

Shared clinical decision-making is an existing CDC category of vaccine recommendation. Keeping COVID vaccination inside that category preserved access through Medicare, Medicaid, CHIP, the Vaccines for Children Program and ACA-regulated insurance. CDC expressly said so in the same announcement.

Thus an ACIP vote framed around individual decision-making within the FDA-authorized population became an official CDC recommendation with significant programmatic and reimbursement consequences.

And then the language broadened further.

By November 4, 2025, the CDC was telling healthcare professionals that the 2025–2026 COVID vaccine was “recommended for people ages 6 months and older based on individual-based decision-making.” 

Frankly, I do not think any of us on ACIP understood at the time that CDC would mis-interpret our vote this way. It took going back through the transcripts, video, slides and subsequent CDC guidance, aided by AI analysis, to reconstruct exactly how the language changed and what the bureaucracy ultimately did with our vote. 

Why didn’t we catch it at the time? Perhaps we were naive. We assumed that when the workgroup told us the recommendation applied “within the FDA authorized population,” that was what it meant. We did not expect CDC officials to subsequently interpret our vote as authorization for an off-label recommendation that we had never knowingly made.

That limiting principle presented to ACIP and which they voted on was: “Access within the FDA-authorized population.” The CDC ignored the very vote by the ACIP and even the director’s recommendations. They made up the wording themselves.

Now CDC Admits It Is Off-Label

Fast-forward to September 2026.

CDC’s new guidance finally makes explicit what the agency’s implementation means.

Spikevax is FDA-approved for people 65 and older and for people six months through 64 years with at least one underlying condition putting them at high risk for severe COVID-19.

And then CDC states:

“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.”

There it is.

CDC is now expressly recommending, through shared clinical decision-making, an off-label use in the very population FDA declined to approve.

For children, CDC says a 2026–2027 COVID vaccine is recommended for moderately or severely immunocompromised children six months through 17 years. For all other children, CDC recommends vaccination through shared clinical decision-making between parents and healthcare professionals.

That includes healthy babies.

This Is Bigger Than CDC

It would be easy to treat this as another CDC controversy. I think that misses the larger problem. This is how the administrative state operates.

Congress creates agencies. Political appointees come and go. Advisory committees meet publicly, debate evidence and cast recorded votes. But underneath those visible structures sits a permanent administrative apparatus that writes guidance, interprets recommendations, maintains schedules, defines terminology, determines implementation and converts broad policy decisions into the rules healthcare systems actually follow.

That bureaucracy has enormous practical power.

In this case, FDA had examined the evidence and declined to approve an mRNA COVID vaccine for healthy children. ACIP then met under an explicitly stated principle of access within the FDA-authorized population.

Yet the system eventually produced a CDC recommendation encompassing vaccination of healthy children outside that FDA indication.

• No new FDA approval for healthy babies was required.
• No new randomized trial demonstrating clinical benefit in healthy babies was required.
• And there was no ACIP vote explicitly recommending off-label vaccination of healthy babies. And no CDC director approved this either.

Instead, the result emerged through administrative interpretation.

That should concern people regardless of what they think about COVID vaccines.

Follow the Institutional Incentives

There is another part of this story that cannot be ignored: money. A CDC vaccine recommendation is not merely medical advice. It drives clinical practice, insurance reimbursement, federal purchasing and access through Medicare, Medicaid, CHIP and the Vaccines for Children Program. CDC itself emphasized that its October 2025 decision preserved coverage through these programs. Keeping healthy children inside the COVID vaccine recommendation therefore had substantial commercial consequences for the mRNA vaccine manufacturers.

That does not prove that Moderna or Pfizer directed CDC’s reinterpretation of the ACIP vote. But it makes the paper trail essential. Who inside CDC decided that a vote explicitly framed around “Access within the FDA authorized population” could become an off-label recommendation for healthy children? 

• Did FDA agree? 
• Did CDC lawyers review it? 
  
  And were CDC officials communicating with Moderna, Pfizer, their lobbyists, trade associations, consultants or organizations financially connected to the manufacturers about pediatric access, insurance coverage or preserving the recommendation?

Those are not conspiracy theories. They are basic questions of regulatory accountability. The emails, draft guidance, redlines, legal reviews, and meeting records exist. Produce them. 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.

For the record, nearly one in ten American children, approximately 7 million children ages six months through 17 years, were estimated by CDC to be up to date with the 2025–2026 COVID vaccine by May 2026. How many of these children were vaccine injured? God only knows.

The Administrative State Has a Paper Trail

People sometimes imagine the administrative state as a conspiracy conducted in secret rooms.

Usually it is much more mundane than that.

It operates through definitions, guidance documents, footnotes, implementation memoranda, interagency clearance, staff recommendations, and interpretations written after the public meeting has ended.

That is precisely why these details matter.

ACIP meetings are supposed to provide public accountability for federal vaccine recommendations. Experts present evidence in public. Committee members question them in public. The committee deliberates in public. Members cast recorded votes in public.

If career officials can subsequently interpret those votes beyond the boundaries under which they were presented, the public proceeding becomes substantially less meaningful.

And in this instance the boundary could hardly have been clearer.

“Access within the FDA authorized population.”

That was on the slide.

FDA had already determined that its benefit-risk standard was not met for healthy children.

I was sitting at the ACIP table when we voted.

We did not vote to recommend off-label mRNA COVID vaccination for healthy babies.

The CDC has a great deal to answer for here. Frankly, if there were an organization genuinely committed to defending children, and if that organization had the courage to take on the federal public-health bureaucracy, another lawsuit against the CDC would already be underway. Sadly, that does not appear to be happening.

Please share this article far and wide. It is the only way we can get people to know what is going on within the “hallowed halls” of HHS.

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The Cult of Bobby

And where is Robert F. Kennedy Jr. while this is happening? He is the Secretary of Health and Human Services. CDC answers to his department. Yet under his watch, CDC is recommending off-label COVID-19 vaccination for healthy children as young as six months, even though FDA has not approved these vaccines for that population and the ACIP on which I served as vice-chair did not recommend vaccination outside the FDA-approved indication. CDC’s new guidance now acknowledges that vaccination of healthy children in these age groups is off-label.

Kennedy once promised sweeping scrutiny of the COVID vaccines. The mRNA COVID vaccines remain licensed. CDC continues recommending them in circumstances extending beyond their FDA-approved indications. And the federal reimbursement machinery continues supporting their use. Yet much of the medical freedom movement that spent years demanding accountability from HHS, CDC and FDA now seems remarkably reluctant to apply that same standard when Kennedy is the man running HHS.

I recently spoke with Dr. Mary Tally Bowden. She told me she has been communicating with Del Bigtree, and my clear impression from that conversation was that the organizations and people surrounding Kennedy want to move on from the mRNA vaccine fight and concentrate their efforts on autism. Autism deserves serious investigation. But autism cannot become a political permission slip to ignore what is happening with mRNA vaccines right now. One issue does not erase the other.

If that is indeed where Children’s Health Defense and ICAN now stand, then perhaps CHD and ICAN have run their course as an effective force on the mRNA vaccine issue. And if the same position extends to Del Bigtree and The HighWire, the same question must be asked there. Organizations that built their audiences, reputations and influence by demanding transparency and accountability from the federal public-health establishment cannot suddenly decide those principles are negotiable because their friends are now running the establishment.

That is the Kennedy exception in its purest form. The organizations that insisted no public-health official should be above scrutiny are increasingly unwilling to scrutinize this one. Kennedy runs HHS. CDC operates within his department. At some point, responsibility for what that department permits, recommends, and funds belongs with the Secretary himself.

The force of the cult of Bobby is strong.

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