The Data That Doesn’t Exist

ACIP voted to un-recommend the Hep B birth dose, but here’s the problem: they still can’t weigh the other side of the ledger

ATLANTA, Georgia—Yesterday, something happened that has never happened in the history of American public health: ACIP voted 8-3 to un-recommend the universal birth dose of hepatitis B for babies born to mothers who test negative for the virus. After 34 years of jabbing every American newborn within hours of taking their first breath—regardless of whether their mother had hepatitis B—the committee finally acknowledged what 25 European countries figured out decades ago: it doesn’t make sense.

But watching this vote unfold, I couldn’t help but notice the absurdity of the debate itself. Committee members who opposed the change kept saying variations of the same thing: “We’ve heard ‘do no harm’ as a moral imperative. We are doing harm by changing this wording.” Another said “no rational science has been presented” to support the change.

And therein lies the fundamental problem with ACIP—and with the entire vaccine regulatory apparatus in America. They literally cannot weigh risk versus benefit because they only have data on one side of the scale.

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The Missing Side of the Ledger

When ACIP debates adding or removing a vaccine from the schedule, they can produce endless data on disease incidence. They can show you charts demonstrating how hepatitis B cases in infants dropped from thousands to single digits after 1991. They can model projected infections if vaccination rates decline. They have this data at their fingertips because tracking infectious disease is something our public health apparatus actually does.

But ask them to produce equivalent data on vaccine injury, and you’ll get silence. Not “the data shows injuries are rare.” Not “here’s our comprehensive tracking of adverse events.” Just... nothing. A void where information should be.

This is not an accident. This is by design.

The safety trials for Engerix-B and Recombivax HB—the two hepatitis B vaccines given to American newborns—monitored adverse events for four to five days after injection. That’s it. If your baby developed seizures on day six, or regressed into autism over the following months, or developed autoimmune disease in the following year—none of that would appear in the pre-licensure safety data.

And the post-market surveillance? VAERS is a voluntary reporting system that the CDC itself acknowledges captures only a tiny fraction of adverse events. A Harvard-funded study found it captures perhaps 1% of actual vaccine injuries. Vaccine court has paid out over $5 billion in claims while simultaneously being structured to make filing nearly impossible for average families.

So when Dr. Cody Meissner voted against removing the Hep B birth dose and said he saw “clear evidence of the benefits” but “not the harms,” he was accidentally revealing the entire rotten structure. Of course he doesn’t see the harms. Nobody is systematically looking for them.

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The Invisibility of Vaccine Injury

Here’s what most people don’t understand about vaccine injury: it’s nothing like a gunshot wound.

If you shoot someone, the cause is obvious. There’s a bullet, a wound, blood, a clear mechanism of action visible to any observer. Even a medical examiner who’s never seen the victim before can determine cause of death.

Vaccine injury doesn’t work that way. When aluminum nanoparticles from a vaccine cross the blood-brain barrier via macrophages, when they lodge in brain tissue and trigger chronic neuroinflammation, when a child slowly regresses over weeks or months—there’s no bullet. There’s no smoking gun. There’s just a before and an after, and a desperate parent trying to explain to doctors that something changed.

This invisibility is the vaccine program’s greatest protection. Because the injury mechanism is complex and delayed, because it doesn’t leave an obvious wound, because it requires actually looking to find—and because no one in authority is looking—the injuries simply don’t exist in the official record.

I watched my own son Jamie regress after his vaccines. A healthy, developing toddler who lost his words, stopped making eye contact, and retreated into a world we couldn’t reach. My wife and I know what happened. Thousands of other parents know the same thing happened to their children. But because this type of injury doesn’t show up on a simple blood test, because there’s no autopsy finding that says “vaccine-induced encephalopathy,” ACIP members can sit in a room and say with straight faces that they don’t see evidence of harm.

They’re not lying. They literally can’t see it. Because no one is measuring it.

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The Chicken Pox Conundrum

Here’s an example that illustrates the insanity of our current approach.

The varicella (chicken pox) vaccine was added to the schedule in 1995. It definitely reduces chicken pox cases. The data is clear on that front. Mission accomplished, right?

But what about the other side of the ledger?

Emerging research suggests that wild chicken pox infection provides some protective effect against brain cancers—particularly glioma, the most common type of primary brain tumor. Multiple studies have found that people who had chicken pox as children have significantly lower rates of brain cancer later in life. The hypothesis is that the immune response to wild varicella provides lasting immunological benefits that extend far beyond preventing itchy spots.

Meanwhile, the vaccine itself has been associated with increased rates of autoimmune conditions. Studies have linked varicella vaccination to higher rates of herpes zoster (shingles) outbreaks in younger age groups, to autoimmune disorders, to various adverse events that weren’t captured in the original short-term safety trials.

So what’s the true risk-benefit of the chicken pox vaccine? Does preventing a week of itchy discomfort in childhood justify potentially increased rates of brain cancer and autoimmune disease later in life?

ACIP can’t answer this question. They literally don’t have the data. They can show you chicken pox cases going down. They cannot show you a comprehensive analysis of long-term neurological and immunological outcomes in vaccinated versus unvaccinated populations, because that study has never been done.

And so they keep recommending the vaccine based on the only data they have—the disease prevention data—while remaining willfully blind to consequences they’ve never bothered to measure.

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The ACIP Paradox

Yesterday’s vote was historic, but it also revealed the fundamental paradox of vaccine regulation in America.

The committee members who voted to remove the universal Hep B birth dose recommendation did so largely based on comparative evidence from Europe, parental concerns, and the basic logic that vaccinating a 12-hour-old baby for a sexually transmitted disease their mother doesn’t have makes no medical sense. They were right to do so.

But the committee members who voted against the change weren’t wrong either, from their perspective. They looked at the only data they have—disease prevention data—and concluded that removing the recommendation could lead to more hepatitis B cases. And within their limited framework, they’re correct.

The problem is the framework itself.

True risk-benefit analysis requires data on both risks AND benefits. ACIP has comprehensive data on benefits (disease prevention) and virtually no data on risks (vaccine injury). So every decision they make is fundamentally flawed from the start.

When Dr. Joseph Hibbeln complained that “no rational science has been presented” to support changing the recommendations, he was inadvertently indicting the entire system. Of course no comprehensive vaccine injury data was presented—such data doesn’t exist because no one has been willing to collect it.

This is like asking someone to make an informed financial decision while only showing them potential profits and hiding all possible losses. Of course the decision will be skewed. Of course you’ll end up with a bloated portfolio of high-risk investments that look great on paper.

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The Real Reform

If RFK Jr. and the new HHS leadership want to actually fix the vaccine program, they need to understand that removing individual vaccines or making them “optional” is just rearranging deck chairs on the Titanic.

The real reform is creating the data infrastructure that should have existed from the beginning.

We need a comprehensive, long-term, vaccinated-versus-unvaccinated health outcomes study. Not a five-day safety trial. A multi-decade tracking of neurological, immunological, and developmental outcomes across populations with varying vaccination status. Florida just eliminated all vaccine mandates—that state alone could provide the data we need within ten years if someone had the courage to actually collect it.

We need a vaccine injury surveillance system that actually captures adverse events. Not a voluntary reporting system that misses 99% of injuries. An active surveillance system with trained clinicians looking for the kinds of delayed, complex injuries that vaccines actually cause.

We need accountability for manufacturers. The 1986 National Childhood Vaccine Injury Act removed all liability from vaccine makers—and predictably, the vaccine schedule exploded afterward while safety research stagnated. Why would any company invest in safety when they can’t be sued for injuries?

Without this data, every ACIP meeting will be the same performance we watched this week: members confidently citing disease prevention data while admitting they can’t see evidence of harm—not because harm doesn’t exist, but because no one is looking for it.

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What Comes Next

Yesterday’s vote was a crack in the wall. For the first time, an American regulatory body acknowledged that perhaps vaccinating every newborn within hours of birth for a disease primarily transmitted through sex and IV drug use doesn’t make sense when the mother has already tested negative.

But the forces of institutional inertia are already mobilizing. The American Academy of Pediatrics is “disappointed.” The American Medical Association is calling for the CDC to reject the recommendation. The pharmaceutical industry—which collects over $225 million annually from Hep B birth doses alone—will fight to restore the universal recommendation.

They will cite the same data they always cite: disease prevention data. Cases prevented. Infections avoided. Lives saved—theoretically.

They will not cite vaccine injury data, because that data doesn’t exist in any comprehensive form. They will not present long-term health outcomes in vaccinated versus unvaccinated children, because those studies have been actively avoided for decades. They will not acknowledge the thousands of families who have watched their children regress after vaccination, because those injuries aren’t captured in any official database.

And this is why ACIP will always be hamstrung. Until we build the data infrastructure to actually measure vaccine injury—to put real numbers on the other side of the ledger—every vaccine decision will be based on incomplete information. Every “risk-benefit analysis” will be a fraud, because we’re only measuring half the equation.

The hepatitis B birth dose vote was a small victory. But the larger battle—for actual science, for complete data, for true informed consent—that battle is just beginning.

And until we win it, ACIP will continue making decisions in the dark, confidently citing evidence of benefits while remaining deliberately blind to the harms they’ve never bothered to measure.

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About the author

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J.B. Handley is the proud father of a child with Autism. He spent his career in the private equity industry and received his undergraduate degree with honors from Stanford University. His first book, How to End the Autism Epidemic, was published in September 2018. The book has sold more than 75,000 copies, was an NPD Bookscan and Publisher’s Weekly Bestseller, broke the Top 40 on Amazon, and has more than 1,000 Five-star reviews. Mr. Handley and his nonspeaking son are also the authors of Underestimated: An Autism Miracle and co-produced the film SPELLERS, available now on YouTube.