FDA just shamefully approved MenQuadfi to be injected into infants 6 weeks to 2 yrs old based on a trial that compared it to Menveo. 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 is the most jewish thing I have read all week.
If you are wondering, the FDA definition of a is severe.
[direct link](https://x.com/AaronSiriSG/status/1931012282768842984)
> FDA just shamefully approved MenQuadfi to be injected into infants 6 weeks to 2 yrs old based on a trial that compared it to Menveo. 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 is the most jewish thing I have read all week.
If you are wondering, the FDA definition of a [serious adverse event](https://archive.ph/jtQzR) is severe.
(post is archived)