Kennedy built a vaccine chronic-disease case on an insert that disclaims causal inference

An adverse reactions section is a disclosure requirement. Vaccine makers have to list conditions that people reported after being vaccinated, including conditions that are not necessarily correlated with vaccination ^[10]. The hepatitis B insert on the ballroom screens says so in its own text: "It is not possible to reliably estimate their frequency or establish a causal relationship to a vaccine exposure" ^[11]. Kennedy read from the list anyway, tying it to the 18 vaccines once recommended for American children ^[12]. "There are 454 adverse events listed in total, and they include almost all of the injuries, like diabetes, death, sudden infant death syndrome, anorexia, allergic reactions, allergies, asthma, autoimmune diseases," he said ^[13].

His complaint about the trial has a real core. The adverse reaction data in that insert came from 147 healthy infants and children in three clinical trials ^[4], and "They were monitored for only five days, and there was no placebo," Kennedy said ^[5]. That is about 735 infant-days of observation in total ^[22], too little to detect anything rare. The agency had more than those 147 children in front of it. It accepted the trials alongside data from thousands of babies given an older version of the shot, and post-market trials in thousands of children added further evidence of efficacy and low risk, STAT reports ^[7]. So his line that "There's no way any other product would get FDA approval with that few people" ^[6] describes one part of the submission.

Three federal efforts are now pointed at the question. Kennedy said HHS is studying more than 150 of the most serious adverse events reported after vaccination to determine whether they could be linked to certain vaccines ^[15]. He also listed a task force review of the safety, timing and sequence of childhood vaccinations, plus a data project drawing on Medicare and Medicaid, states and private insurers ^[16]. Insurance claims can support causal work. Whether these do turns on the comparison group and on which outcomes are specified before anyone looks at the data. Kennedy described the scope of the projects and did not describe the designs.

Two of his fixes act on the reporting rate instead. HHS is working to make the Vaccine Adverse Event Reporting System more user-friendly and plans to compensate doctors for the time they spend submitting information about possible side effects and injuries ^[17]. He has previously said he wants to automate the system to boost data collection ^[18]. Both raise the number of reports filed, and a report remains a count with no denominator of who was vaccinated and no unvaccinated comparison. Reports filed after the system gets easier to file in will land in the same years as the studies asking whether those events are caused by vaccines.

The speech reached vaccines about halfway through, after a recap of flipping the food pyramid, scrutinizing chemical additives and changing hospital meals, and a mention of agency work on electromagnetic frequency and "chemtrails" ^[21]. Kennedy hedged twice on the way in. He framed the link as an open question, asking "Should we be looking at the potential that some of these chronic illnesses are associated with vaccines?" ^[3]. He called serious harm from vaccines probably "very rare" while suggesting, without evidence, that vaccines underpin an epidemic of chronic illness in the United States ^[19]. STAT reports that he had previously tried to downplay his anti-vaccine activism and has now made it central to his legacy as health secretary ^[20]. The clearest effect size anywhere in the record belongs to a policy that is gone. Universal newborn vaccination cut chronic hepatitis B infections among children and teens by 99% ^[8]. The Trump administration ended it last year ^[9].