CIDRAP Op-Ed: Don’t be distracted—ACIP was never the only play

Cheese with face on it

Stanislav Sablin / iStock

When I want to clip my dogs' nails, I divert their attention with a treat—a chunk of stinky cheese they can't resist. They're completely absorbed while I go in with the clippers and deal with the pointy ends of the paws that (lovingly) rake across my skin. They barely notice.

The March 16 federal court ruling worked a lot like that cheese.

The ruling was good news for the plaintiff (the American Academy of Pediatrics) and for all of us. Judge Brian Murphy looked at what had been done to the Advisory Committee on Immunization Practices (ACIP)—the firing of qualified experts, the ideological replacements, the unilateral schedule changes—and said the process was likely illegal. The March 18-19 ACIP meeting was canceled, and the altered childhood immunization schedule was frozen in its pre-January state. People who have spent the better part of a year watching federal vaccine infrastructure get dismantled allowed themselves a moment of relief. It was a much-needed (even if temporary) victory.

But while we celebrated, our nails got clipped.

Four days after the ruling, while attention was still fixed on the temporary legal victory, Aaron Siri, vaccine injury lawyer and longtime ally of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., submitted a petition to HHS on behalf of the Informed Consent Action Network, demanding that more than 300 new conditions be added to the Vaccine Injury Table. He gave Kennedy 60 days to act, telling an audience at the Kennedy Center shortly after filing: "If not, we do intend to bring [federal] lawsuits."

What’s at stake regarding vaccine ‘injuries’

To understand why that matters, you need to understand what the Vaccine Injury Table actually is and what's at stake if it gets blown open.

The Vaccine Injury Table sits at the heart of the National Vaccine Injury Compensation Program (VICP), the no-fault system created in 1986 to compensate people harmed by vaccines without requiring them to sue manufacturers directly. It currently lists 47 vaccine-injury pairs, each pairing a specific injury with a specific vaccine and a time window for onset. If your injury appears on it, you receive expedited compensation without having to prove the vaccine caused it. The program works better than most people realize, and it often compensates claims more efficiently than civil litigation. It also keeps vaccine manufacturers in the market by giving them defined liability protection. However, this all depends on the table being grounded in scientific evidence.

While we celebrated, our nails got clipped.

Siri's petition argues that the federal government's mere consideration of a potential vaccine injury—studying it, identifying it as hypothesis-generating—is a legally sufficient “association” and enough to require adding it to the table. Dorit Reiss, PhD, a vaccine law expert at UC Law San Francisco, has stated that the petition “argues that simply analyzing potential harms establishes an association, even if the government found no evidence of one”—an interpretation that stretches the legal definitions. Richard Hughes, the attorney who led the legal effort that produced the Boston ruling, called the reasoning “ridiculous” and warned it would chill future government research into vaccine injuries. The logic collapses on itself: If studying a potential harm automatically establishes legal causation, why would anyone study anything?

Kennedy has previously suggested the table could be expanded to include symptoms associated with autism. The scientific record has examined that question exhaustively and does not support it. But as Politico reported, the more likely play—one that a Kennedy adviser floated publicly at a September Make American Healthy Again event—is broadening the definitions of encephalopathy and encephalitis, both already on the table under tightly drawn clinical criteria, so that autism cases qualify through the back door rather than through an explicit addition that would directly challenge existing legal precedent.

Either path leads to the same place. And the fiscal math is not subtle.

About 16,000 children who are vaccinated will eventually be diagnosed with profound autism each year—not because vaccines cause autism, but because that's the baseline prevalence in our largely vaccinated population. If those cases become eligible for VICP compensation, the program would face roughly $32 billion in annual claims. The VICP Trust Fund currently holds about $4 billion, accumulated over nearly 40 years. Its sole income is a $0.75 excise tax per vaccine dose, generating around $250 million per year. Because claimants can file for injuries diagnosed within the past three years, the program could face an initial docket approaching $100 billion in claims on day one.

The fund would be insolvent almost immediately.

We have seen this movie before. In the 1980s, a surge of lawsuits—many decided by juries with little scientific support for claims of vaccine causation—nearly drove every childhood vaccine manufacturer out of the market. By 1986, there were $3.2 billion in pending lawsuits against these companies. The economics simply didn't work. You can't sell a vaccine for around $20 that provides lifelong protection while defending against an unlimited number of lawsuits based on speculative claims. Manufacturers left the vaccine market en masse. Congress created the VICP as a buffer specifically to bring them back.

If the fund collapses, that buffer disappears. Manufacturers face the same calculus they faced 40 years ago, except the exposure would be exponentially larger. They've exited before, and they will again.

Those with true vaccine injuries will be hurt most

The cruelest part of this is who gets hurt most. Families with true vaccine injuries—the ones the VICP was actually built to help—would be pushed back into civil litigation, where outcomes depend on jury sympathy rather than science, where cases drag on for years, and where only those who can afford prolonged legal battles have any real chance at compensation. 

The program that currently works in their favor would be gone. Its collapse would leave everyone worse off except the people who wanted the system dismantled in the first place.

Families with true vaccine injuries—the ones the VICP was actually built to help—would be pushed back into civil litigation.

What makes the Siri petition particularly important to watch is that it doesn't need ACIP. It doesn't need the Boston ruling to be overturned. It runs on its own track, its own timeline, and almost entirely outside the frame everyone is currently focused on.

Don’t let the cheese distract you

ACIP's unfinished business has other potential homes, too. The confidential work group memo set to be presented at the canceled March meeting proposed a new diagnostic syndrome -- Post-Acute COVID-19 Vaccination Syndrome, or PACVS—along with dedicated ICD-10 codes, clinical guidelines, and a Centers for Disease Control and Prevention (CDC) research network. 

The ICD codes were the load-bearing piece. A billing code can formalize a condition in clinical practice and create downstream implications for surveillance, reimbursement, and legal claims that are very hard to walk back. The court stopped ACIP from pursuing that path. But a separate CDC process was already scheduled, independent of ACIP, to review whether COVID vaccine adverse effects should receive ICD codes. And if PACVS-adjacent conditions reach the injury table through the Siri petition, that creates its own pressure on the coding question. These tracks are nominally separate, but they tend to move together.

ACIP itself isn't gone either. The ruling is preliminary, an appeal is coming, and Kennedy will likely reconstitute ACIP with new folks who have the same old agenda. The committee is one court decision away from reconvening with that same memo.

The 60-day clock on the Siri petition started March 20th. 

Don't get distracted by the cheese.

Dr. Steier is a public health scientist and scientific communicator. She is the founder of Unbiased Science, an organization that uses data visualizations, real-world analogies, and human voice to communicate complex scientific concepts for public understanding via multiple media modalities.

The opinions voiced in CIDRAP Op-Ed pieces are the authors' own and do not necessarily represent the official position of CIDRAP.

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