A new FDA analysis finds COVID vax probably causes seizures in young kids (2-4/5)

Likely vaccination in this age group was harmful. We don't know b/c no good studies of efficacy. That's not good enough

Recently, I was reading this paper

The paper makes two claims. First, COVID19 vaccination with mRNA products is linked to myocarditis in young men. We knew that. This study confirms that. But more concerningly, it finds increased risk of seizures/ convulsions in young kids.

As a first pass check when I read vaccine safety data, I look at safety signals I know. Multiple datasets show that myocarditis in young men should occur as often as 1 in 3000 to 1 in 5000. This dataset does not have that frequency. It combines men and women (also classic mistake — see paper by Knudsen and Prasad), but back calculating, I get a rate of approximately 1 in 10,000 in men. This means that it is likely this dataset is missing at least half of the events, since it uses administrative claims.

For this reason, my first concern is that other safety signals represent floor risk and not ceiling risk. In other words, that the real risk is higher than what is seen. The authors find the safety signal of seizures for 2 different products in comparable ages in kids, which lend clearance to the fact it is real. Yes, it vanishes in sensitivity using 2022 baseline rates (not 2020), but I am far more concerned the real signal is higher in magnitude (it is reported as 1 in 12k, but perhaps double? triple?). Moreover it is supported by trial data as well (divide 3k by 5)

Are we ever going to get an accurate estimate of this risk?

I doubt it. Not from the US at least. The US system is not designed to find safety signals that providers do not know to look for, or may wish to discount or ignore (as they doggedly pursue what they view as an unalloyed good— vaccination). US vaccine safety methods are broken. We learned of both myocarditis and VITT from abroad. The US needs a revamp.

Is vaccination always good?

Just as some drugs can be beneficial, some vaccines can be wonderful. But not all drugs are great, and not not all vaccines are good and useful to people. In the case of COVID19 vaccines, we have shown a net harm to young men getting boosters— that is easy to demonstrate— it is possible there is a net harm to vaccinating young kids (2-4/5) based on these data?

How much does vaccinating kids 2-4/5 improve COVID19 outcomes?

Here is the key point. There is no way to weigh the excess in seizures against the gains from vaccination. First, we don’t have a precise estimate of the seizure risk, and second, we have no idea what the absolute risk reduction in bad COVID19 outcomes is from vaccinating kids of this age.

Remember, vaccines were not debuted in young kids until much later than adults (years later!), and based on very low credibility data that was not significant for clinical endpoints (detailed here).

We have no data showing us the absolute risk reduction for severe disease or death at the time it was debuted. The virus had already evolved towards less mis-c and less lethality (it was always less than flu level risk for healthy kids). The few studies we do have on VE (vaccine effectiveness) in kids are confounded.

So is the gain of covid vaccines in young kids (2-4/5) bigger than 1 in 5k, 1 in 10k, 1 in 20k? We have no clue. Given the absolutely low risks of COVID to healthy kids in this age group, I doubt it.

As such, I would be concerned that vaccinating kids of this age group might represent a net harm. Ultimately, the available datasets are inadequate to adjudicate the question.

That just isn’t good enough.

The FDA and CDC have gambled with the health of young kids. They did not demand appropriately sized randomized data to demonstrate net benefit. They added these vaccines to the childhood schedule without these data.

As time goes on, the FDA and CDC won’t be able to hide the fact that boosting young men was harmful and that, very likely, vaccinating young kids was harmful. If that is conclusively proven, I suspect credibility in these agencies will go down further.