As if there aren’t enough already. The FDA just approved yet another shot to be given to babies. Of course there wasn’t a placebo trial, the new shot (which requires four doses, BTW) was compared to another shot for the same thing (Invasive meningococcal disease) that is being given to older children.
And even though there was a higher rate of serious side effects (5.3% for the new one vs 3.6% for the older one), the FDA basically said fuck it and passed it along anyway.
But you need to see the Gordian knot of trials to really understand how messed up this is:
In the trial, 5.3% of infants receiving MenQuadfi and 3.6% of infants receiving Menveo had a serious adverse reaction (which means something very serious, see definition below). But because these rates were “similar,” this product was deemed “safe” by FDA because it assumes Menveo is “safe.”
But Menveo was licensed based on a trial in which Menactra (among other vaccines) was used as a control; and Menactra was licensed based on a trial in which Menomune was used as a control; and Menomune was not licensed based on a proper placebo-controlled trial. In fact – and this is mind twisting – the package insert for Menomune lists the clinical trial for Menactra (in which Menomume was used as the control) as the basis for its safety. I couldn’t even dream of making this stuff up.
This provides a good example of the vaccine safety pyramid scheme: Menomune was licensed without a proper placebo-controlled trial and was then used as the control to license Menactra; Menactra is then used as the control to license Menveo; and then Menveo is used as the control to license MenQuadfi. And then we get a trial with 5.3 % and 3.5% of infants suffering serious adverse reactions and no one bats an eye. They grant licensure.
I would like to point out that, per the CDC’s own data, there were 12 cases of IMD in children less than 1 year old in 2023 and 17 cases in children from 1-4 with 3 deaths.
950 ‘subjects’ were enrolled in the study. That means that 50 babies suffered from serious effects. Extrapolate that out to the number of babies that they want to shoot this stuff in to.
Worth it?? Thinking not-so-much.
Midwest Chick's Place 
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