What to Ask Before Your Child’s Next Vaccine Visit

“Questions for Your Doctor” — fourth in the series

Not a single vaccine on the CDC’s recommended childhood schedule was tested for safety in a clinical trial where the control group received an inert placebo. Not one.

The DTaP vaccines were tested against the older DTP. The DTP was never tested in a modern randomised controlled trial with a placebo group. The combination vaccines were tested against DTaP. The hepatitis B vaccine’s safety section compares its side effect rate to a plasma-derived predecessor. The polio vaccine’s FDA licensing documents describe two small trials, neither with a placebo. When every new vaccine is tested against another vaccine, which was tested against another vaccine, the true rate of adverse events is never established.

This is the central finding of Turtles All the Way Down: Vaccine Science and Myth, and it is the starting point for the fourth instalment of the Questions for Your Doctor series.

The two-month well-child visit is where most parents first encounter the childhood vaccine schedule in full. A baby may receive six or more vaccine doses in a single appointment. The doctor or nurse says it’s time for the shots, hands over a two-page Vaccine Information Statement from the CDC, and waits for you to nod. The VIS lists common side effects — fever, fussiness, redness at the injection site. It does not mention what was given to the control group in the clinical trial, or how long safety was monitored. It says nothing about the IOM finding insufficient evidence to confirm or rule out a causal link for 85% of the vaccine–adverse event pairs it examined. The gap between what parents are told and what the trial data actually shows is the reason this document exists.

The document contains ten questions — nine curious, one assertive — designed for parents sitting in that room. Each question is followed by a Key Fact and two paragraphs of evidence drawn from clinical trial data, FDA licensing documents, manufacturer package inserts, the Institute of Medicine’s 2011 and 2013 reports, and the Harvard Pilgrim electronic reporting study. A routing table at the front identifies which questions to start with depending on where you are: before a visit, after a reaction, when evaluating claims about safety testing, or when considering an alternative schedule. A one-page Quick Reference at the back is designed to be printed and taken to the appointment.

The questions cover what was actually given to the control group in each vaccine’s clinical trial, how long safety was monitored (for the hepatitis B vaccine given to newborns, it was four to five days), the rates of serious adverse events found in the trials, the VAERS reporting system and its documented limitations, whether the full schedule has ever been tested as a package, what the IOM’s own reports found when they looked for the science, and the vaccinated-versus-unvaccinated studies that have never been conducted.

Here is one of the ten questions, with its Key Fact:

Question 7. For how many potential vaccine side effects does the science actually know whether the vaccine caused them?

Key Fact: The IOM’s 2011 report examined 158 vaccine–adverse event pairs. For 135 of them — more than 85% — the scientific evidence was insufficient to confirm or rule out a causal link.

The full document — including two paragraphs of context for each question, the routing table, and the printable Quick Reference — is available for download below.

The primary source is Turtles All the Way Down: Vaccine Science and Myth, which assembles research from clinical trial records, FDA and CDC licensing documents, manufacturer package inserts, the IOM’s 2011 and 2013 reports, the VAERS system, and the government-funded Harvard Pilgrim electronic reporting study. Additional supporting data is drawn from Vax Facts by Dr Paul Thomas and Vax-Unvax by Robert F. Kennedy Jr. Every statistic in the document traces back to a named source.

If you or someone you know has a well-child visit coming up, print the Quick Reference page and take it with you.

The series so far, and what’s coming next:

1. The PSA Test (available now)

2. Mammogram Screening (available now)

3. Colonoscopy (available now)

4. The Childhood Vaccine Visit (available now)

5. Statin Prescription (in development)

If there is a screening test, a prescription, or a procedure where you needed the right questions before you walked into the room, put it in the comments. The next topics will come from what you need most.

The Questions for Your Doctor series is available exclusively to paid subscribers.

The Childhood Vaccine Visit: Questions for Your Doctor is available for download below.