Vax-unvax

If you had a simple way to compare the long-term health of vaccinated and unvaccinated people before making decisions for your family, would you want to see it? In Vax-Unvax, Robert F. Kennedy Jr. and Brian Hooker argue that U.S. health authorities have avoided the most basic question in modern public health—how the total vaccine program compares, in real-world health outcomes, to taking fewer vaccines or none at all. They contend that long-term, placebo-controlled trials are rare; that post-licensure surveillance is fragmented; and that the most direct, policy-relevant study—vaccinated versus unvaccinated (vax–unvax) comparisons—has been systematically discouraged. Their thesis is bold: when you examine studies that do make this comparison (intentionally or incidentally), the signal often runs in the same direction—more chronic illness in vaccinated cohorts across multiple domains.

A Bigger Schedule, Narrower Safety Lens

Kennedy and Hooker open with the reality of the modern schedule: in the 1960s, a handful of vaccines; since 1986, after Congress created a no-fault vaccine injury program and liability shield, a rapidly expanding schedule culminating in 70+ doses by age 18. Yet, they say, most licensure trials observe subjects for days—not months or years—and use active comparators (another vaccine or adjuvant), not inert saline, making subtle or delayed harms hard to detect. They cite the National Academy of Medicine (formerly IOM) 2011 and 2013 reports, which concluded that data were inadequate to accept or reject causality for most hypothesized adverse events and that no studies had comprehensively examined health outcomes associated with the entire childhood schedule.

What the Book Promises

You’re walked through a tour of vax–unvax evidence: studies comparing cohorts of children visiting the same clinics; retrospective analyses embedded in large databases like the Vaccine Safety Datalink (VSD); surveys of unvaccinated families; and safety signals around ingredients (thimerosal/mercury, aluminum) or specific products (MMR, rotavirus, HPV, DTP, hepatitis B, influenza, COVID-19). You’ll see odds ratios, rate ratios, and hazard ratios, alongside names and dates—Mawson 2017, Hooker & Miller 2020/2021, Lyons-Weiler & Thomas 2020, Enriquez 2005, Daley 2022 (aluminum and persistent asthma), DeStefano 2004 (MMR timing), Hooker 2018 (reanalysis), and Thompson 2007 (tics).

Why the Authors Say This Matters

For you as a parent, clinician, or policymaker, their point is practical: you weigh risk and benefit every day. If a program prevents some infections but correlates with more asthma, allergies, neurodevelopmental diagnoses, or autoimmune events, that trade-off should be quantified transparently—not assumed away. The authors underscore that benefits like reduced chickenpox or measles appear in the data; what they argue is missing is a credible accounting of potential off-target harms (so-called “non-specific effects”). They highlight Peter Aaby’s work in West Africa on DTP and mortality, influenza studies linking H1N1 vaccination to narcolepsy in Europe, and multiple myocarditis/pericarditis analyses following mRNA COVID-19 vaccination.

The Roadblocks They Describe

The book recounts a 2017 meeting at NIH with Anthony Fauci and Francis Collins, where Kennedy and colleagues asked for placebo-controlled trials and access to VSD data to run vax–unvax comparisons. They describe promises unfulfilled, FOIA requests, and court filings documenting missing safety reports. They also cite the Lazarus VAERS project (AHRQ), which found automated systems could detect far more adverse events than voluntary reporting captured—an initiative the authors say was halted when high reporting rates appeared. (Note: federal and academic bodies broadly maintain that vaccines are rigorously tested and continuously monitored; they generally dispute these characterizations.)

How the Book Is Structured

After framing the evidence gap, the authors present chapter-by-chapter vax–unvax findings for: the schedule overall; thimerosal; live-virus vaccines (MMR, polio, rotavirus); HPV; Gulf War vaccines; influenza; DTP; hepatitis B; COVID-19; and vaccines in pregnancy. Each chapter summarizes study designs and numbers, provides charts (e.g., asthma odds ratios, intussusception risks), and spotlights methodological disputes (saline placebos vs aluminum adjuvants; withdrawal of papers; the role of VAERS).

Reading with a Critical Eye

Because health recommendations affect millions, you’ll want to understand where the mainstream stands: CDC, WHO, and major medical societies conclude vaccines’ benefits outweigh risks and contest many interpretations highlighted here (pointing to biases, confounding, and stronger evidence for safety). Kennedy and Hooker respond that this is precisely why independent, blinded vax–unvax analyses across the schedule are vital. Whether you agree or not, the book equips you with study names, effect sizes, and methods—the minimum you need to interrogate claims and make your own risk–benefit judgments.

In the rest of this summary, you’ll see the most-cited comparisons, how ingredients and timing factor in, pregnancy and product-specific chapters, and the policy reforms the authors propose. If you’ve ever wanted “the graph behind the slogan,” this is the book’s promise to you.

Kennedy and Hooker say your everyday medical choices hinge on a basic comparison: what happens if you do a thing versus if you don’t. With vaccines, they argue, that comparison has rarely been done in the most direct way. Instead, licensure trials commonly evaluate single products for brief windows and often use active comparators—another vaccine or adjuvant—rather than an inert saline placebo. The authors contend this design can mask adverse events, especially those that are delayed, cumulative, or non-specific to the target infection.

The Gold Standard—and What’s Used

In drug development, randomized controlled trials (RCTs) with saline placebos are routine, and follow-up can stretch months or years (e.g., Lipitor 4.8 years). Vax-Unvax contrasts that with vaccine trials the authors highlight: Engerix-B (hepatitis B) monitored adverse events for 4 days; Infanrix (DTaP) 4 days; ActHIB 48 hours. They also single out HPV trials where controls received amorphous aluminum hydroxyphosphate sulfate (AAHS), not saline; and Gardasil 9 where the comparator was the earlier Gardasil vaccine itself. To the authors, this “blunts the contrast” and narrows what you can infer about safety beyond short, local reactions.

Why Not Randomize? The Ethics Debate

When asked why not do randomized vax–unvax trials, public health leaders (e.g., Paul Offit) have said it’s unethical to withhold “proven” preventive tools. Kennedy and Hooker push back: they cite common RCTs in oncology, cardiology, and respiratory disease where life-saving therapies are randomized because risks and benefits need quantification. Their compromise proposal: use retrospective designs that compare existing vaccinated and unvaccinated populations—something the Institute of Medicine (2013) also considered feasible through the Vaccine Safety Datalink (VSD). (Mainstream view: observational designs can be confounded by healthcare-seeking behavior, socioeconomic status, or differences in under-vaccination reasons; careful adjustment is needed.)

A Data Asset Few Can Use

The VSD, a CDC-linked network of large HMOs covering millions of children, is—on paper—ideal for this question. The authors describe difficulty gaining independent access, noting that only limited pre-2000 data have been sharable at CDC’s research data center and that requests from outsiders face hurdles. They recall a 2017 exchange with NIH Director Francis Collins and NIAID Director Anthony Fauci where, after a meeting about vax–unvax, promised documentation never arrived. To you, the subtext is about scientific governance: big databases matter only if multiple teams can interrogate them.

If Not Trials, Then Signals

Without broad RCTs, surveillance systems shoulder the burden. Here the authors point to two systems. First, VAERS, a passive database to which anyone can report suspected vaccine adverse events. Kennedy and Hooker cite the AHRQ-funded Lazarus project, which found automated EHR-based reporting could surface far more adverse events than manual VAERS reporting; they say CDC didn’t scale it despite promising results. Second, the VSD itself, where near-real-time monitoring runs in the background; they argue the most consequential comparisons—fully vaccinated vs. entirely unvaccinated across broad outcomes—have not been published.

The Stakes for Your Decisions

For a new parent, the difference between a 2% and a 4% risk of chronic ear infections or a relative risk of 1.5 vs. 3.0 for asthma is concrete. For a school or military policy-maker, myocarditis rates per 100,000 young men matter. Kennedy and Hooker’s message is pragmatic: better data make for better consent and better policy. Whether you arrive where they do, the case for more transparent, targeted comparison studies is hard to dismiss.

(Context: major reviews by WHO/CDC, Cochrane, and the National Academy of Medicine affirm vaccine programs’ net benefit and find many alleged associations unsupported after adjustment; this book asserts that different designs and subsets reveal signals those syntheses miss.)

The book’s core is a catalog of studies that did compare vaccinated and unvaccinated groups, sometimes by design, sometimes because the data allowed it. You learn the names, sample sizes, and effect sizes so you can judge for yourself. Several threads recur: respiratory problems (asthma, ear infections), neurodevelopmental diagnoses, atopy/allergies, gastrointestinal issues, and all-cause healthcare use.

Clinic-Based Cohorts: Hooker & Miller 2020/2021

Brian Hooker, PhD, and Neil Miller analyzed electronic charts from pediatric practices. In a 2020 SAGE Open Medicine paper following 2,047 kids from birth to at least age 3, children who received vaccines before age 1 had higher odds of developmental delays (OR 2.18), asthma (OR 4.49), and ear infections (OR 2.13) than those who didn’t. In a 2021 follow-up (Journal of Translational Science) including 1,565 children (60% fully unvaccinated), the fully vaccinated group showed higher odds of severe allergies, autism, asthma, GI disorders, ADHD, and chronic ear infections. The authors also explored combined effects—e.g., unvaccinated and breastfed for ≥6 months had the lowest asthma odds; vaccination plus no breastfeeding had the highest.

Household Surveys: Mawson 2017

Anthony Mawson, an epidemiologist, surveyed 666 homeschooled children (261 unvaccinated). Vaccinated children had significantly fewer cases of chickenpox and pertussis, but higher odds of allergic rhinitis (OR ~30), eczema (OR 2.9), learning disabilities (OR 5.2), ADHD (OR 4.2), autism (OR 4.2), and “neurodevelopmental disorders” as a group (OR 3.7). A companion analysis reported that preterm birth plus vaccination was associated with a much higher odds of neurodevelopmental diagnoses (OR 14.5) versus term, unvaccinated peers. (Note: publication history included a withdrawal from one journal amid criticism about survey design and verification; the final versions appear in Journal of Translational Science.)

Office-Visit Burden: Lyons‑Weiler & Thomas 2020

Studying an Oregon pediatric practice that allowed flexible schedules, James Lyons‑Weiler, PhD, and Paul Thomas, MD, used a novel metric—the Relative Incidence of Office Visits (RIOV)—as a proxy for disease burden. Among 2,763 vaccinated and 561 unvaccinated children, vaccinated patients had more office visits for ear infections, conjunctivitis, anemia, eczema, behavioral issues, gastroenteritis, and respiratory infections; unvaccinated children had more chickenpox and pertussis. The paper was later retracted amid methodological debate; a follow-up by Lyons‑Weiler and neurosurgeon Russell Blaylock argued that differing healthcare-seeking behavior in that practice did not explain the patterns.

Population Samples and National Data

Older work like Enriquez et al. (Journal of Allergy and Clinical Immunology, 2005) reported higher risks of asthma (RR 11.4) and hay fever (RR 10) in vaccinated U.S. children compared to unvaccinated peers. The Dutch Association for Conscientious Vaccination (NVKP) in 2004 tallied more hospital visits, seizures, and antibiotic use in vaccinated children (while noting protection against measles and pertussis). A 2021 report by The Control Group compared self-reported unvaccinated cohorts to CDC national prevalence, finding large differences in ADHD, autism, and chronic illness (critics would highlight possible selection and reporting biases; the book lists these as signals warranting formal studies).

An Ingredient Signal: Aluminum and Asthma

A recent Kaiser Permanente VSD analysis by Daley et al. (Academic Pediatrics, 2022) associated cumulative aluminum exposure from vaccines before 24 months with higher risk of persistent asthma ages 24–59 months (36% higher with >3mg Al; 61% higher in children with eczema). Because aluminum salts are adjuvants in several infant vaccines, the authors flag this as an urgent, testable hypothesis.

(Context: mainstream systematic reviews consider many of these studies limited by confounding, non-representative samples, or verification issues; they conclude broader evidence supports vaccine safety. The book’s claim is that these signals persist precisely where schedules are dense and ingredients like aluminum are concentrated.)

Thimerosal, an ethylmercury preservative used historically in multi-dose vials and still present in some flu shots, is a focal point for Kennedy and Hooker. They recount how, in 1999, vaccinologist Neal Halsey tallied the cumulative mercury in the infant schedule and found exposures exceeding FDA/EPA safety guidelines, prompting internal reviews.

Verstraeten’s Early Findings and Simpsonwood

The authors spotlight a 1999 Epidemic Intelligence Service (EIS) abstract by CDC epidemiologist Thomas Verstraeten: infants exposed to the highest thimerosal levels in the first month had a 7.6-fold higher risk of autism versus unexposed, plus increased risks for neurodevelopmental disorders, sleep disorders, and speech delay. They describe a 2000 closed-door meeting at Simpsonwood, where participants discussed the data and analytic revisions. By 2003, Verstraeten et al. in Pediatrics reported no consistent association; in 2004, Verstraeten wrote that the study was “neutral” and couldn’t rule out risk. To the authors, this arc reflects data massage to quell concerns.

VSD Analyses: Geier, Young, and Colleagues

Using the VSD (with congressional help for access), Young, Geier, and Geier (Journal of Neurological Sciences, 2008) reported that 100 mcg differences in mercury dose by 7 months were associated with higher rates of autism (RR 2.87), ASD (RR 2.44), ADHD (RR 3.15), and tics (RR 3.59). Follow-up case-control papers associated thimerosal-containing hepatitis B vaccination with higher odds of specific developmental delays and tic disorders (ORs ~1.6 to 3.0), and later with emotional disturbance and premature puberty. Gallagher & Goodman (2008/2010) linked neonatal hepatitis B thimerosal exposure to higher odds of special education and autism in boys.

CDC- and UK-Led Studies: Tic Signal Persists

Even in studies that the authors say were not set up to find harm, a “tics” signal appears. William Thompson et al. (NEJM, 2007) found boys with higher thimerosal exposure by 7 months had ~2.2x higher odds of motor tics and ~2.4x higher odds of phonic tics versus low exposure; less than 2% had zero exposure. In the UK, Andrews et al. (Pediatrics, 2004) reported increased hazard ratios for tics with higher thimerosal exposure from DTP/DT vaccines at 3–4 months. While titles concluded “no causal association” overall, the tic signal recurs across geographies.

Where Mercury Went

Between 2001–2004, thimerosal was reduced in several infant products in the U.S., but the authors note it remained in multi-dose flu vaccines. They highlight the paradox that flu shots—including thimerosal versions—were recommended in pregnancy and for infants ≥6 months, meaning many Americans still receive mercury via annual shots. In lower-income countries, multi-dose vials (with thimerosal) are common. (Mainstream position: ethylmercury clears faster than methylmercury and has not been linked causally to neurodevelopmental harm; the book argues multiple epidemiologic and mechanistic studies say otherwise.)

For your choices today: check whether a flu shot offered is thimerosal-free; know that single-dose prefilled syringes typically are, while multi-dose vials often aren’t. That simple question is something the authors believe every clinic should proactively address.

Live-attenuated vaccines can mimic natural infection more closely, and the authors argue timing matters. With MMR, they focus on whether earlier administration (before 36 months) correlates with autism subtypes in certain subgroups; with rotavirus, they examine intussusception risk; with polio and measles, they examine autoimmune and inflammatory bowel outcomes.

MMR Timing and Subgroup Effects

A CDC-led case-control analysis by DeStefano et al. (Pediatrics, 2004) reported higher odds of autism if MMR was given before 36 months vs. after (OR 1.49 overall; OR 1.67 in boys). The authors note that findings in African American children were not reported in the final paper; CDC whistleblower William Thompson later provided data showing African American children vaccinated before 36 months had 2.4x higher odds of autism than those vaccinated later. Brian Hooker’s 2018 reanalysis reported African American boys vaccinated before 36 months had OR 3.86 for autism relative to later-vaccinated peers, and a distinct signal for “autism without mental retardation” (so‑called “isolated autism”).

Measles Vaccination, Atopy, and IBD

Two 1990s Lancet papers appear here. Thompson et al. (1995) found measles vaccination associated with higher relative risks for Crohn’s disease (RR 3.01) and ulcerative colitis (RR 2.53) in a UK cohort. In Guinea‑Bissau, Shaheen et al. (1996) reported vaccinated youth had ~2.8x higher odds of atopy compared with those who had natural measles infection (atopy: a tendency toward allergic diseases). The authors suggest vaccination might shape immune responses differently than wild-type infection, with downstream allergy implications. (Mainstream: subsequent studies did not confirm a causal role for measles vaccine in IBD; the book says signals justify revisiting subgroup effects.)

Polio Vaccines and Type 1 Diabetes, IBD

John Barthelow Classen’s work in Denmark reported that children receiving all three doses of oral polio vaccine (OPV) had higher incidence of type 1 diabetes (20.86/100,000 vs. 8.27/100,000 unvaccinated; RR 2.52). A 2015 meta‑analysis (Clinical Gastroenterology and Hepatology) associated childhood poliomyelitis vaccination with higher odds of Crohn’s disease and ulcerative colitis in case-control cohorts. These findings are debated; the authors include them to illustrate a theme: autoimmune endpoints may move with vaccine exposures in ways standard safety trials aren’t designed to detect.

Rotavirus and Intussusception

Rotashield® was withdrawn for intussusception, and later products were closely monitored. Patel et al. (NEJM, 2011) observed elevated odds of intussusception within 1–7 days after the first dose of Rotarix® in Mexico (~5.8 odds ratio in case-control). Kassim & Eslick (Vaccine, 2017) pooled case-control and cohort data, finding OR 8.45 for intussusception after the first dose and OR 1.59 after any dose. For you, that means timing and acute post-vaccination windows matter; clinicians already counsel parents on early signs of intussusception for prompt care.

Practical for you: confirm with your pediatrician the recommended age windows and known acute risk periods (e.g., the first week after rotavirus dose one). Ask how rare events are recognized and treated quickly.

HPV vaccines are framed publicly as “anti-cancer” tools, and the authors say that framing can overshadow trial design questions. They argue the pivotal trials did not use inert placebos: Gardasil’s comparator included the AAHS aluminum adjuvant; Gardasil 9’s control was Gardasil; Cervarix’s control was a hepatitis A vaccine containing aluminum and a novel adjuvant (monophosphoryl lipid A). If both arms receive reactogenic components, comparative safety signals can be muted.

Disproportionate Reporting in VAERS

Tomljenovic & Shaw (AJPH, 2012) observed that a large share of serious adverse events in young women reported to VAERS clustered with HPV vaccines at that time—over 60% of serious AEs and 63.8% of deaths in their analysis period. VAERS is noisy and non-causal, but the authors argue disproportionate reporting is precisely what should trigger deeper, controlled studies.

Clinical and Animal Signals

In Nagoya, Japan, Yaju et al. (2019) reported higher odds of neurological impairment, involuntary movement, and dyscalculia in HPV-vaccinated 15–16-year-old girls compared with unvaccinated controls. In Israel, Inbar et al. (2017) found female mice given human weight-equivalent Gardasil doses developed markedly higher titers of anti-brain protein and anti-phospholipid antibodies than controls—immunologic signs consistent with autoimmunity risk. Hviid et al. (2018) in a large Scandinavian cohort reported increased risk of celiac diagnoses after HPV vaccination; David Geier (2019) reported ~8x higher odds of asthma in NHANES respondents who reported HPV vaccination. (Mainstream bodies cite large background safety studies that don’t confirm broad autoimmune risk; the book highlights the subset patterns and biological plausibility of adjuvant-driven autoimmunity.)

What About Efficacy vs. Precancer?

The authors note cervical cancer is already rare in screened populations and that precancerous lesions can be managed with Pap testing and LEEP. They argue the benefit side of the ledger isn’t the slam-dunk it’s often presented as for all groups and ages, especially males and older women. They push for individualized assessment—your daughter’s age, sexual debut, screening adherence—balanced against the unresolved safety questions they outline.

For your conversation at the clinic: ask which adjuvant is used, what placebo controlled trials exist, and how local policy has integrated signals from Japan and Scandinavia. That keeps your consent grounded in the actual designs behind the brochures.

The whole-cell DTP (diphtheria–tetanus–pertussis) vaccine is no longer used in the U.S. but remains in use globally; its acellular successor (DTaP) is routine in the U.S. The authors argue DTP offers a clear case of “non-specific effects” (NSEs)—impacts on health beyond the target disease. They lean on work by Peter Aaby and colleagues in West Africa and on older studies about sudden infant death syndrome (SIDS), allergy, and asthma.

Mortality in African Cohorts

In Guinea‑Bissau, Mogensen et al. (EBioMedicine, 2017) found infants vaccinated with DTP (with or without oral polio) between 3–5 months had ~5x higher mortality than unvaccinated infants during follow-up, with the strongest signal in girls. Aaby et al. (Archives of Disease in Childhood, 2012) similarly reported that low-birthweight girls vaccinated at 2 months were 5.68x more likely to die by the 6‑month visit than girls not yet vaccinated; pooled analyses suggested sex-differential effects. A 2016 meta‑analysis by Aaby concluded DTP in BCG‑vaccinated girls was associated with increased mortality (with no increase in boys). (WHO-commissioned reviews have debated methods; the authors say signals across cohorts and timing sequences—DTP before/after measles vaccine—deserve policy attention.)

SIDS, Allergy, Asthma

In the U.S., Walker et al. (AJPH, 1987) reported a 7.3‑fold higher SIDS risk within 3 days after DTP among infants >2,500g, comparing to a later post-vaccination window. Pediatric neurologist William Torch (AAN abstract, 1982) reported 70% of 70 SIDS cases occurred within 3 weeks of DTP and clustered at 2–3 weeks post‑dose. On atopy, Hurwitz & Morgenstern (2000) found DTP/tetanus vaccination associated with a 63% increase in allergy-related symptoms; McKeever et al. (AJPH, 2004) reported vaccinated UK children were 14x as likely to be diagnosed with asthma and ~9.4x with eczema as unvaccinated controls (critics cite healthcare-seeking bias; the authors counter the magnitudes exceed plausible bias).

Sequence Matters

Aaby’s group found that giving DTP together with or after measles vaccine increased mortality compared with measles vaccine alone as the most recent shot, suggesting that the order in which live and inactivated vaccines are administered may influence non-specific immunity. For you: this implies schedules may need to optimize for immune training—something rarely discussed in standard well‑visit scripts.

If you engage with global health, this chapter is a call to ensure mortality audits and RCTs (where feasible) look beyond target disease outcomes—and that schedule sequence research is prioritized, not treated as an afterthought.

The book separates seasonal flu shots from the 2009 H1N1 pandemic vaccines because the signal patterns differ. For H1N1 (Pandemrix), you see strong associations with narcolepsy in children and teens in northern Europe; for seasonal shots, the recurrent association is Guillain‑Barré syndrome (GBS). The authors also discuss “virus interference” and odd findings like higher hospitalization for flu among vaccinated asthmatic children in one study.

H1N1 & Narcolepsy in Europe

In England, Miller et al. (BMJ, 2013) reported ~16x higher odds of narcolepsy within 6 months after Pandemrix in children; Sweden’s Szakács et al. (Neurology, 2013) recorded a jump from 0.26 to 6.6 per 100,000 child‑years post‑campaign; Finland’s Partinen et al. (PLoS One, 2012) saw a ~17‑fold increase nationwide. Since narcolepsy involves autoimmune damage to hypocretin neurons, these converging signals concern the authors greatly.

Seasonal Flu & GBS

Three large studies across decades (Lasky 1998 NEJM; Juurlink 2006 JAMA; Kwong 2013 Lancet Infectious Diseases) found elevated relative risks of GBS after seasonal influenza vaccination (RRs ~1.45–1.7). During H1N1 2009–2010 in the U.S., Wise et al. (AJE, 2012) saw ~57% higher GBS in vaccinated vs. unvaccinated; Tokars (2012) and Salmon (2013) using self-controlled windows estimated ~2–3x higher risk within 42 days. For you, absolute risks remain low, but the association is consistent enough that it’s discussed in consent materials.

Virus Interference & Respiratory Illness

Wolff (Vaccine, 2020) reported higher odds of non‑influenza respiratory viruses (coronavirus OR 1.36; human metapneumovirus OR 1.51) among vaccinated DoD personnel in 2017–2018, hypothesizing that natural infection might provide broader “training” that vaccination doesn’t. In Hong Kong, Cowling et al. (CID, 2012) randomized children to TIV vs. placebo and found a ~4.4x higher risk of confirmed non‑influenza respiratory infection in the vaccinated group over 9 months. Rikin et al. (Vaccine, 2018) saw transiently higher hazards of non‑influenza acute respiratory illness in children ≤4 in the 14 days post‑shot. Joshi et al. (AAP, 2012) reported vaccinated asthmatic children were more likely to be hospitalized for influenza (RR ~3.67), a provocative outlier that spurs the authors to ask for subgroup analyses rather than averages.

If you’re considering timing, one actionable tip is to avoid crowded events for ~2 weeks after vaccination in toddlers (reflecting the transient respiratory-illness window). Also, confirm whether a thimerosal-free option is available if you’re concerned about mercury exposure.

Kennedy and Hooker bracket the schedule with two flashpoints: hepatitis B at birth, and COVID‑19 in adolescents and adults. For hepatitis B, they ask whether a blood‑borne adult infection risk justifies a day‑one dose, pointing to liver problems, autoimmunity in animal models, and neurological outcomes. For COVID‑19, they emphasize myocarditis/pericarditis in young males, shingles and hearing loss signals, and FDA post‑marketing alerts in seniors.

Hepatitis B: Liver, Neuro, Autoimmunity

Fisher & Eklund (Epidemiology, 1999) reported higher odds of liver problems in vaccinated U.S. children <6 years (OR 2.94; in those with vaccine records OR ~13). Hernán et al. (Neurology, 2004) found a ~3.1x higher risk of multiple sclerosis within 3 years of hepatitis B vaccination in UK data. Classen (1997) reported rising type 1 diabetes incidence in New Zealand following hepatitis B program rollout. In mice, Agmon‑Levin et al. (Journal of Autoimmunity, 2014) found Engerix‑B triggered SLE‑like disease, kidney pathology, and higher proteinuria than control injections. A Korean study (Yon 2018) linked seropositivity after infant series with higher rates of asthma, allergic rhinitis, and allergen sensitization at age 12 (and found only ~31% seropositive—implicating waning immunity). VAERS reviews have tallied SIDS reports after hepatitis B as well. For you: the authors’ pragmatic ask is to revisit the birth dose rationale versus targeted maternal screening plus later vaccination.

COVID‑19: Myocarditis, Pericarditis & More

Across Nordic, Italian, U.S., and Israeli datasets, myocarditis risk concentrates in males 12–29 within 7–28 days after dose two (and to a lesser extent after boosters): Karlstad et al. (JAMA Cardiology, 2022) found IRR 13.83 after Moderna dose two and 5.31 after Pfizer in 16–24‑year‑old males; Massari (PLOS Medicine, 2022) observed ~12x myocarditis/pericarditis risk in males 12–39 within 7 days of Moderna doses; Goddard (Vaccine, 2022) documented elevated risks in VSD. Simone (IJC, 2022) found 10x myocarditis risk within 7 days of dose two and 6x after dose three vs. baseline. Lai et al. (Annals, 2022) reported higher odds of carditis after Pfizer in hospitalized patients. Wan et al. (CID, 2023) and Shibli et al. (Lancet Regional Health, 2021) found increased risks of Bell’s palsy.

Other Signals & Seniors

Simpson et al. (Nature Medicine, 2021) and Berild et al. (JAMA Network Open, 2022) reported increased thrombocytopenia and cerebral venous thrombosis after ChAdOx1 (AstraZeneca). Wan et al. (Lancet Regional Health—West Pacific, 2022) found increased shingles hospitalizations after Pfizer and CoronaVac in defined windows. Yanir et al. (JAMA Otolaryngology, 2022) reported increased sudden sensorineural hearing loss after Pfizer. An FDA Medicare study (Wong et al., Vaccine, 2023) flagged statistical signals after Pfizer in seniors for pulmonary embolism (RR 1.54), acute MI (RR 1.42), DIC (RR 1.91), and immune thrombocytopenia (RR 1.44). A re‑analysis of the blinded mRNA trials (Fraiman/Doshi, Vaccine, 2022) found a higher risk of serious adverse events of special interest in vaccine vs. placebo arms (risk differences ~10–15 per 10,000).

Practical for you: if vaccinating adolescent males for COVID‑19, weigh spacing doses, choosing product types, and monitoring for chest pain within a month of dose two or three. With hepatitis B, ask about maternal HBsAg screening and whether delaying to a later well‑visit is clinically acceptable in your setting.

Vaccination during pregnancy raises a specific consent question for you: what human trial evidence exists, and what outcomes have registry and case‑control data actually shown? The authors emphasize that package inserts for Tdap, flu, and mRNA COVID‑19 vaccines historically acknowledged limited or no clinical trials in pregnant women, with later observational studies used to support safety. They argue that several signals—chorioamnionitis, post‑partum hemorrhage, miscarriages in defined windows, and short‑term systemic reactions—warrant frank discussion.

Influenza: ASD, SAB, Inflammation

Zerbo et al. (JAMA Pediatrics, 2017) observed increased ASD risk after first‑trimester flu vaccination (HR 1.20; overall any trimester HR 1.10) before applying a multiple-testing correction; Kennedy and Hooker argue the correction was inappropriate given interdependent comparisons. Irving et al. (Obstetrics & Gynecology, 2013) found higher odds of spontaneous abortion (SAB) when flu vaccine was given just prior to conception; Donahue et al. (Vaccine, 2017) reported ~2x higher SAB odds within 28 days of H1N1 vaccination, rising to 7.7x if women were vaccinated in both the prior and current season. Christian et al. (Vaccine, 2011) documented increased inflammatory markers (CRP, TNF‑α) 2 days post vaccination in pregnant women, underscoring biological plausibility for effects in susceptible subgroups.

Tdap: Chorioamnionitis & Hemorrhage

Two large VSD studies—Kharbanda et al. (JAMA, 2014) and DeSilva et al. (Vaccine, 2017)—reported increased risks of chorioamnionitis in Tdap‑vaccinated pregnancies (adjusted RRs ~1.19–1.23). Layton et al. (Vaccine, 2017) also found higher risk of post‑partum hemorrhage with Tdap, both when given early (<27 weeks; RR 1.34) and at recommended timing (≥27 weeks; RR 1.23). (Mainstream sources generally frame these increases as small and of uncertain clinical significance; the authors argue even modest relative increases translate to large numbers when applied to millions.)

COVID‑19 in Pregnancy

DeSilva et al. (NEJM, 2022) reported higher short-term rates of fever, malaise/fatigue, local reactions, and lymphadenopathy in vaccinated vs. unvaccinated pregnant women within 42 days—expected reactogenicity that still matters for consent. Dick et al. (AJOG MFM, 2022) found triple‑vaccinated pregnant women were ~3x more likely to have post‑partum hemorrhage and ~1.5x more likely to be diagnosed with gestational diabetes than unvaccinated controls in their Israeli cohort. The authors also cite VAERS tallies of spontaneous abortion and fertility reports and an Israeli semen donor study (Gat et al., Andrology, 2022) showing decreased sperm concentration and total motile count 75–125 days post vaccination, with partial recovery by ~150 days but high variability.

A practical path for you is to time vaccinations outside conception windows if possible (re: SAB studies), to monitor for signs of chorioamnionitis or hemorrhage in Tdap‑vaccinated pregnancies, and to consider product choice and timing if COVID‑19 boosters are planned in late pregnancy.

Vax-Unvax doesn’t end with signals; it proposes a governance overhaul. If you’re a clinician, educator, or policymaker, this is the chapter you can act on. Children’s Health Defense’s Vaccine Safety Project lays out six steps the authors say would align vaccine safety science with standard pharmacovigilance and informed consent.

1) Restore Rigorous Approval Standards

Use true inert placebos in licensure trials; extend follow-up windows to detect non‑acute harms; require product‑specific RCTs where feasible (noting ethical debates) or well‑matched retrospective studies otherwise. Ban adjuvant or other‑vaccine comparators as “placebos.”

2) Modernize Adverse Event Reporting

Automate VAERS via EHRs (as AHRQ/Lazarus piloted), so events are captured passively at scale. Open the VSD to independent teams under privacy safeguards. Without robust detection, you fly blind.

3) Eliminate Conflicts of Interest

Tighten rules for ACIP and VRBPAC: no members with financial ties to manufacturers; no patent royalty recipients voting on related products; publish all waivers; include vaccine safety advocates as voting members. (The book cites past Inspector General reports on CDC conflict management shortcomings.)

4) Re‑review Pre‑2013 Schedule

Before 2013, ACIP didn’t use a formal GRADE framework. Re‑assess earlier recommendations using current evidence-based standards, explicitly weighing non‑specific effects and vax–unvax outcomes.

5) Study Susceptibility Profiles

Identify which children are at higher risk of adverse events (e.g., family autoimmunity, eczema in aluminum–asthma link). Mine compensated cases in the National Vaccine Injury Compensation Program to uncover patterns and predictors.

6) Enforce Informed Consent

Deliver Vaccine Information Statements before administration; disclose known uncertainties (e.g., lack of pregnancy RCTs); discuss alternatives, including timing changes (e.g., spacing doses, product choice, or deferral when clinically justified). Kennedy and Hooker emphasize that “safe and effective” should be a conclusion supported by transparent data, not a slogan.

For your institution, these steps can translate into IRB‑approved vax–unvax audits, EHR‑triggered AE reporting, and consent updates that reflect real study designs, not marketing copy. Whether you ultimately defend the current schedule or revise it, this playbook makes your process defensible to the people you serve.