Author: Will Humble

Last week, Secretary Kennedy continued to spread lies on national TV claiming that “none of the vaccines on the CDC’s childhood recommended schedule was tested against an inert placebo.” Adding that: “we know very little about the actual risk profiles of these products.”

Those claims are lies.

Vaccines licensed in the US do undergo rigorous placebo-controlled clinical trials before they ever make it to the public. This includes the childhood vaccines on the CDC’s recommended schedule.

Vaccines go through three phases of clinical trials before the FDA even considers licensing them.

• Phase 1, a small group of volunteers receives the vaccine to assess safety and dosing.
• Phase 2 expands the pool to hundreds to assess both safety and immune response.
• Phase 3 involves thousands of participants and includes randomized, placebo-controlled, and blinded trials. That means some participants get the vaccine and others get a placebo, and neither they nor the researchers know who got what until the end of the trial.
• Phase 4 is ongoing safety and effectiveness monitoring in the real world.

The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC)—a panel of independent experts—reviews all the data before any vaccine gets the green light.

Before and after the vaccine is licensed the FDA also closely inspects the manufacturer’s processes, batch-by-batch, to ensure the vaccine is being produced according to rigorous quality standards. Samples from each lot are assessed.

Then comes CDC review. Even after FDA approval, a vaccine isn’t added to the childhood schedule until the CDC’s Advisory Committee on Immunization Practices considers key questions:

• How safe and effective is the vaccine at specific ages?
• How serious is the disease it prevents?
• What would happen if we didn’t vaccinate?

Only after these questions are carefully reviewed—and the benefit-risk ratio is clear—does a vaccine get recommended to the CDC for inclusion in the child and adult immunization schedules.

And then, to top all this off, safety monitoring continues after approval and marketing. Included in the post marketing phase are:

• VAERS (Vaccine Adverse Event Reporting System) collects early warnings of any side effects and reports findings.
• VSD (Vaccine Safety Datalink) lets CDC scientists analyze real-world vaccine data from millions of people for analysis and reporting.
• CISA (Clinical Immunization Safety Assessment) conducts targeted studies to investigate safety in specific populations.

Updates to already licensed and approved vaccines like the annual influenza and COVID vaccines are sometimes evaluated against older versions instead of inert placebos. There are several reasons for this. When an effective vaccine already exists, it’s considered unethical to withhold protection by using an inert placebo in trials each year. Influenza vaccines also produce hemagglutination-inhibition antibody titers which lets researchers and regulators to approve strain updates based on immunogenicity data alone. Also, the annual flu vaccine update needs to be manufactured and distributed months ahead of winter—waiting for full Phase 3 trial data for each new strain would be impossible. Since full trials aren’t repeated annually for influenza, regulators rely on robust post-market monitoring systems to ensure safety through the VAERS, VSD, and CISA systems continuously track safety signals after rollout. They also examine real-world evidence (e.g., hospitalization reductions, side‑effect trends) to assess both safety and efficacy.

Bottom line: Vaccines are among the most rigorously tested and monitored medical products we have. For Secretary Kennedy to keep lying about this is unethical, irresponsible and dangerous. Honestly, it’s quite shocking for an HHS Secretary to continue to spout blatantly false things like this.

And for journalists: platforming Kennedy without correcting or challenging these statements is a failure of responsibility to the public.

Vaccines save lives. The science is clear. The testing is real. And the public deserves better than a steady stream of misinformation and blatant lies from Kennedy.

After wiping out all the previous ACIP members early last week, Mr. Kennedy promptly appointed eight new members (just enough for the Committee to have a quorum).

As expected, most of the new appointees are known for their anti‑vaccine views or skepticism of mainstream immunization policy. With the next meeting scheduled for June 25, the new committee poised to dismantle the current evidence-based recommended child and adult vaccine schedules.

They know they’ve got 3.5 years to unravel the system – so expect them to take it slow at first before they step on the accelerator.

Kennedy Plows the Field to Eliminate Vaccines from the Recommended Schedule, Making them Inaccessible – AZ Public Health Association

Who are the new appointees?

• Vicky Pebsworth: A board member of the National Vaccine Information Center (a misnomer because they don’t provide evidence-based information). This is an anti-vax group notorious for advocating vaccine exemptions and raising vaccine safety alarms without evidence.
• Dr. Martin Kulldorff: A co-author of the Great Barrington Declaration, who has consistently recommended against vaccinating children and champions natural infection.
• Dr. Robert Malone: A leading COVID‑19 vaccine critic, peddling conspiracy theories and misrepresenting mRNA science.
• Retsef Levi: An ‘influencer’ and vocal mRNA vaccine skeptic who claims, without evidence, that vaccines inflict “serious harm and death,” in children.
• Joseph Hibbeln, Cody Meissner, James Pagano, Michael Ross: These people are relatively unknown in the public sphere. Meissner has prior ACIP and FDA advisory experience. The others appear to have little vaccine expertise and have shown skepticism in related health areas – but these 4 don’t seem to be as bad as Pebsworth, Kulldorff, Malone and Levi (at least so far).

Historically, ACIP members examine data without bias. Those decades are over. Under Kennedy, the new appointees will be predisposed to confirm their anti‑vaccine stance, interpreting evidence through via “confirmation bias” – which means folks only want advice or information if it supports what you already want to do.

The upshot is ACIP will begin recommending that the CDC remove several vaccines from the child and adult vaccine schedule. The CDC director (whoever that will be) will rubber stamp the recommendations. That will prompt health plans and Medicaid (through VFC) to stop covering those vaccinations (making them cash pay) – resulting in much lower vaccination rates for the shots they remove from the schedule.

In some cases, ACIP/CDC may not totally pull vaccines off the recommended schedules – they might move the vaccine to a ‘shared clinical decision-making’ category – meaning VFC providers won’t have to stock it.

These actions may not happen right away. Kennedy knows he has 3.5 years to complete his dismantling of vaccination, and I expect him to be methodical about it.

As a public health community, we have an obligation to be a watchdog for the new ACIP’s recommendations and the CDC’s likely rubber stamping of those biased recommendations.

While we may not be able to influence the outcome of Kennedy’s decisions over the next 3.5 years – we can remain a powerful force that will be there to pick up the public health pieces in early 2029.

By now all of you know Kennedy removed all the current members of the Advisory Committee on Immunization Practices (ACIP), the objective federal advisory body responsible for developing vaccine recommendations in the United States. He replaced them with a cadre of mostly well-known confirmation biased anti-vaccine zealots: As Expected – New ACIP Members Picked by Kennedy Have Anti-vax Bias.

RFK Jr. fires all 17 members of CDC vaccine advisory panel

ACIP had been composed of experts who play an important role in our immunization schedules (for kids and adults) and deciding coverage for critical programs like the VFC and affordable care act.

In Kennedy’s confirmation he promised to “maintain” the committee. Those of us who’ve followed his strident anti-vaccine zealotry over the years knew that was BS, and we were right. His end game is of course to greatly reduce the adult and child vaccine schedule and thereby stop reimbursement for vaccines via insurance plans. I don’t think his goal is to revoke vaccine licenses – he simply wants the vaccines to stop being administered to lower immunization rates.

The legal framework governing ACIP gives Kennedy tons of leeway in appointing and removing members, so there’s basically no chance legal actions can reverse this week’s decision.

The new appointees will have the power to end vaccine recommendations—changes that the CDC director will adopt without resistance.

If (when) the new ACIP recommends removing key vaccines like the HPV and meningococcal vaccine from the recommended schedule (the first two in his sights), insurers will no longer have to cover them, drastically reducing access (the PPV vaccine prevents cervical cancer while the meningococcal vaccine prevents deadly bacterial meningitis). In some cases ACIP/CDC may not totally pull vaccines off the recommended schedule – they might move the vaccine to a ‘shared clinical decision-making’ category – meaning they won’t be routine and more importantly VFC providers won’t have to stock it.

While Medicare is legally bound to cover certain vaccines, Medicaid coverage through VFC is directly tied to ACIP’s list.  Because childhood vaccines for kids who are Medicaid members (AHCCCS) is tied directly to the VFC program there would be an immediate impact for those kids, and they will no longer be protected.

The downstream effects are predictable: vaccination rates will drop. We’ve already seen troubling declines in routine immunization across the country in recent years, including in Arizona.

Arizona schoolkids’ immunization coverage declines, new numbers show

Diseases we’ve largely controlled—like measles, pertussis, and even certain cancers prevented by vaccines like HPV—could surge again. The U.S. could become a hotspot for preventable infectious diseases, reversing decades of public health progress.

Arizona confirms 4 measles cases amid national surge

When all is said and done 3.5 years from now, we’ll be able to begin to dig out of the hole Kennedy is excavating – but it’ll take time and resources and a cadre of professionals like yourselves to make it happen.

In the meantime, many people will unnecessarily suffer, and lives will be unnecessarily lost.

Note: Lawsuits have been a key (actually the only) tool for stopping some of the president’s actions this far – with over 64 Preliminary Injunctions or Restraining Orders in place. Sadly, these ACIP/CDC/Antivax actions by Kennedy appear to use existing authority and it seems to me that we won’t be able to successfully challenge the eventual wholesale scale back of the child vaccine schedule (and vaccination rates) that’s sure to result.

However, in 3.5 years we’ll hopefully be able to restore an evidence-based vaccine schedule – although there will be a lot of catching up to do because the vaccines that will shortly be removed from the schedule will become cash pay and immunization rates will plummet.