It's Just the Coffee Talking: No justification for giving babies and preschoolers the experimental mRNA shot. None. Zero. Zilch.

This article was originally published by the Brownstone Institute.

The article was reproduced with permission by The Pulse: link

 

You can read the entire article at the links above but I've used bits and pieces I thought were interesting to post here to ponder over morning coffee. 

 

In a historically embarrassing decision, the FDA recently became the only international regulatory body to authorize the use of mRNA vaccines from Moderna and Pfizer for children aged six months to five years.

For the overwhelming majority of young children and toddlers, there is likely no justification or need for this concerning authorization.

They are at vanishingly small risk of serious complications from COVID, meaning that the risk-benefit calculation is precarious at best, and potentially negative at worst.

It’s also a testament to the disturbingly successful politicization of the US regulatory agencies that essentially no other internationally respected country anywhere on earth has made this bewildering decision.

Sweden, for example, has stopped the rollout of the Moderna vaccine for anyone under 30

Not 18. Not 12. Not 5. 30.

The United States is now going to be vaccinating children as young as six months old with the same product that Sweden has banned for use in anyone under 30, citing side effects that tilt the risk-benefit numbers.

The FDA did generate some vaccine efficacy estimates for both ages 6-23 months and 2-4 years and the figures they arrived at show why they had to resort to antibody response instead of actual proven reduction.

There was 1 case in the vaccination group and 2 in the placebo group. That’s it. 

That’s how you get to confidence intervals of -369.1% to 99.6%. The vaccine could have nearly 400% negative efficacy for babies, or it could be one of the greatest vaccines ever created with near perfect effectiveness. Who knows! Certainly not the FDA based on 3 total cases of COVID in this age group. 

But don’t worry, they collected a lot more data for the 2-4 year age group.

That data set had 7 total cases

 


The confidence intervals for every single efficacy calculation for participants 6-23 months drop below zero. Every single one.

The overall estimate is 14% and even that could be as low as -21.2%.

It’s just laughable. Well, it would be laughable if it weren’t such an important decision.

It’s also worth noting that the time period between the administration of Dose 1 and Dose 2 was associated with negative efficacy in both age groups.

This has likely contributed to data reporting issues when calculating vaccine effectiveness in the real world. Any case occurring during this time period is considered “unvaccinated,” except in these age groups, which is when efficacy is at its lowest point.

The fact that the FDA authorized these vaccines for kids based on this data is quite simply inexcusable.

The sample sizes didn’t meet their protocol specified 21 cases.

Vaccine efficacy calculations, even excluding the gigantic confidence intervals, were far below the arbitrary 50% target they created for emergency use authorization among adults.

It’s yet another terrifying indicator of just how politically motivated the FDA has become, and how activism has distorted intellectual honesty.

“Experts” are so desperate to maintain their reputations and avoid being labeled an “anti-vaxxer” by influencers like Eric Feigl-Ding, Angela Rasmussen and others that they appear to be unwilling to call out flaws in the decision making process.

It’s simultaneously hard and easy to believe that this was all it took to justify an “emergency” use vaccination for age groups at extremely low risk of severe illness.

This decision deservedly will be yet another reason for the ever-increasing erosion of trust in public health’s supposed “experts,” an embarrassment for U.S. regulators captured by politics.