The difference between the US childhood vaccination schedule and Denmark's

The need for cluster RCTs.

For the last few weeks, in my writing here and in the Free Press, I have been arguing that differences in childhood immunization between the US and Europe should be explored with a cluster RCT.

Yesterday, my friend, Tracy B-H had a nice comparison that drives this point well. Consider the US and Denmark:

Quite a lot of differences! A user replied with the US graphic updated. Take a look. So many fewer shots.

In prior posts, I have argued that RFK Jr can commission a cluster RCT of childhood immunization, comparing the US schedule to Denmark’s. Let me explain what that means and why it would be a good idea, using this example.

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First, there is some confusion. Randomized trials are run when you don't know if something is beneficial, but you think it might be. Recently I suggested that red 40 and other artificial dyes that are considered for removal be studied with an observational study. Why didn’t I ask for a randomized trial? Because you don't study interventions that you think are harmful with RCTs, only those you think have benefits.

Next, given that many US doctors think the US schedule is better than the one in Europe, a cluster trial is a nice way to test that. Is it the case that kids who follow the US schedule do better?

Here you randomize regions of the country to follow different schedules. Of course, not all parents will agree, but that's ok. It is how studies are run. They are intention to treat. You are testing the recommendation, knowing it is not universally followed. Then, you can measure a range of endpoints. Including the number of times kids are hospitalized. That's a nice endpoint that will capture the effect of influenza, covid and RSV vaccination, among others. I would also measure all cause mortality, and the specific diseases the extra vaccine's target.

Third, some vaccine hesitant people think that the combination of vaccines— and not individual ones— have bad side effects like autism. The cluster trial will also assess this. It will test if all those extra US doses result in differences in neurocognitive development. I would build in routine neuro-cognitive testing.

Fourth, there is equipoise. Equipoise means that on a certain topic, there's genuine uncertainty about what's right. That must be the case here. Because these nations do dramatically different things, and both believe they're doing it in the best interest of their population.

Tracy has ties to Denmark, and this is just a nice and illustrative example. It's difficult to take the media seriously when they do not seriously ask themselves: why are there such profound differences in the schedules across nations.

The answer is in part because the evidence is still uncertain. And because different nations weigh things differently. The way to settle this is better data. And that's what we should be encouraging rather than main steam media dogmatism.