An article just came out in the journal Pediatrics from the CDC and their research partners investigating the possibility of adverse events following mRNA shots for COVID-19 in children under 5 years old.
The conclusion of this paper is that there are no significant side effects to giving these shots to kids under 5 years.
They looked at nearly 250,000 doses of Pfizer & Moderna mRNA shots given to 6 month- to five year-old kids for evidence of any of twenty one different possible adverse events - from myocarditis to seizures to Guillan-Barre (this represents about 120,000 children - according to their figure 1).
They found no statistically significant issues. Or as they put it: “none of the outcomes met the signaling threshold”.
So this is good news, right!?!
I mean, these shots apparently are safe for kids under 5 years old.
The CDC says so!
But let’s do two things: First, look at the “Methods” section and, Second (and related) look at the seizure results.
Methods matter
The statistics in this paper compare two 21-day intervals to look for potential adverse events. The first is the experimental group and is days 1-21 after receiving any mRNA shot. They call this the “risk interval” group. The control group is days 22-42 after any shot for those same kids. They call this the “comparison interval” group.
See what they did there?
They compared vaccinated kids to vaccinated kids!
You don’t have a real control group.
Why not compare vaccinated kids (even at different time intervals) to unvaccinated kids???? That would be a much better experiment. If side effect manifest themselves 25 days after injection, this paper’s approach would not only miss those effects, but would deliberately minimize both the late and early symptoms.
Most interesting to me is that their original research proposal specifically said they would compare vaccinated kids to an unvaccinated control group:
In my experience, it is extremely unusual to deviate this much from a research proposal: the funding agencies want to know what they are paying for - and don’t usually like significant changes in experimental design. This change is particularly troubling because an unvaccinated control group does not involve any additional patients - it would simply look at records of random, non-vaccinated kids starting on the same day as those getting shots.
In fact, this step is so easy that I am almost certain that the authors have this data (even if in a preliminary form).
Just as telling, these exact same authors did use unvaccinated control groups in previous papers. Why not here???
What did the comparison using a real, unvaccinated control group show?????
Seizure results
Table 2 of the paper (see below) reports on seizure symptoms observed in both the Risk and Comparison Interval groups.
In the Risk Interval groups, 38 Pfizer and 23 Moderna recipients experienced seizures. In the second 21 day window post-shot (Comparison Interval group), 24 Pfizer recipients and 19 Moderna recipients experienced seizures.
This means that 104 kids had seizures after getting these mRNA shots.
If you look at the statistics for the first week, this seizure activity is almost statistically significant (p = 0.11).
But, because just enough kids had seizures three weeks after their shot…. the vaccine is safe???
We may never know the answers to my questions - but those answers are critical:
Methods matter.
If you really care, here is the fine print I wrote on my meme: