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2021-11-06

Children's Health Defense publish a cooked-up unscientific risk-benefit analysis for the Pfizer vaccine in 5 - 11 yr olds.

So why should anybody pay attention?

Because the Pfizer-FDA analysis was even less scientific. The entire trial cohort consisted of only 1528 children in the vaccination group and 757 in the placebo group.

Bearing in mind that we are talking of an age range whose risk of serious adverse outcomes from Covid itself is in the region of vanishingly small, this number of trial participants is nowhere near large enough to provide useful data (unless a participant actually dies). Since no participant suffered a severe adverse event we can say (unscientifically) that the incidence of serious adverse events from the vaccine might well be less than 1 in 1500. Although it might also be a bit larger than 1 in 1500, given random variation.

This trial size is not even in the right ball-park to provide meaningful insight when the comparable risk of catching Covid and suffering an ensuing severe adverse event from the disease is at least one order of magnitude (probably more) lower than 1 in 1500 for this age group.

So how did the FDA overcome this lack of data? They guessed that adverse events in the 5 - 11s would be similar to the 12 - 16s. On the basis of no known evidence. I think - it's my understanding of the FDA's published reasoning (download) anyway.

So my simple arithmetic above is a bit simple, and CHD have done a more complex job in demolishing the FDA's analysis, but it doesn't alter the picture in any significant way - the bottom line is the same - there is insufficient supporting data for the FDA to be sure of its findings.

This is not science, at best it is "gut feel". If that were adequate, we wouldn't have invented "science".

Read the report.