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Kennedy announced this week that U.S. is pulling all funding from Gavi, the global vaccine alliance, dealing a big blow to health systems and vaccine access in lower-income countries.

This is by no means a surprise as Kennedy is a well-known decades-long opponent of vaccines.

Gavi, the Vaccine Alliance is a world‐class public‑private partnership created in 2000 to expand vaccine access in poorer countries who would otherwise be unable to afford to fund vaccines for their people.

To date, it’s helped immunize over 1 billion kids, preventing more than 19 million future deaths.

In 2023 alone, Gavi-backed immunization efforts averted about 1.3M deaths and delivered lifesaving vaccines like pneumococcus, rotavirus, Hib, and HPV across 57 developing countries.

Vaccines are among the most cost-effective interventions out there with ROIs of 27:1 for many vaccines and all with an ROI greater than 4:1.

Overall, Gavi’s programs have generated roughly $220 billion in economic benefits since 2000.

The U.S. Government and Gavi, the Vaccine Alliance | KFF

Up until this week, the US has been a primary funder of Gavi initiatives, contributing 12-15% of the GAVI budget. Below are the other countries in the top tier of donors

• UK: $2B
• Bill & Melinda Gates Foundation: $1.5B
• United States – $1.3B (now $0)
• Norway – $830M
• Germany – $773M

Of note – the US held one of the 18 representative seats on GAVI’s governing board. After Kennedy’s announcement this week that will no longer be the case. More on that in a bit.

If other donors don’t step up to keep funding vaccines and or entire vaccine campaigns will need to be scaled back or paused. Immunization coverage could drop, leading to worsened outbreaks of measles, pneumonia, rotavirus, and future blasts of vaccine-preventable diseases.

This move, along with the US abandonment of WHO participation and dues paying (Kennedy ended that a few months ago) and Rubio’s elimination of the US Agency for International Development isn’t just bad for global health – it’s a squandering of decades worth of US global soft power.

Editorial Note: My first reaction when I heard Kennedy was pulling the US out of GAVI was – of course he did. Kennedy is against vaccines and now controls the purse strings of 35% of the federal government including the entire health portfolio.

My second reaction was sadness for the loss of vaccine that will be administered in developing countries.

My third reaction however, was – well maybe this isn’t such a bad thing after all. The US only contributes about 12% of GAVI’s budget. Does GAVI really want to have a troublemaker anti-vax zealot from the US on the governing board peppering them with garbage ‘science’ and hijacking meetings for the next 3.5 years?

Is it worth 12% of the budget to not have a knucklehead on the Board? Yeah

There are many wealthy nations not yet contributing substantially to GAVI including Japan, China, Saudi Arabia, Qatar, UAE, etc. who may be willing to make up the difference and not put a wacko on the governing body.

Indeed, Healthwatch reported yesterday that despite the US abandonment of Gavi, they still exceeded their $9 billion pledging goal – with a record number of donors committing to the tune of $11.9B for the coming five years (2026-30). These are pledges – not actual dollars so don’t count the chickens yet.

Perhaps it’s best for the US to not be involved in endeavors like this for the next 3.5 years as with the current HHS leadership we’re more likely to cause harm than good.

About the GAVI Alliance

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.