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FDA OKs First Meningococcal Vaccine for Babies Even Though Testing Shows Serious Problems
The FDA has approved the first-ever invasive meningococcal vaccine (IMD) for babies as young as 6 weeks old. It is recommended that children take up to four doses.
Attorney Aaron Siri explained that the FDA is playing a shell game by deeming a new vaccine [MenQuadfi] to be ‘safe’, based on an existing vaccine [Menveo], that was compared to an older vaccine [Menactra], that was compared to another vaccine [Menomune] that was never tested against a proper placebo-controlled trial. In an extreme twist of logic, Menomune lists the clinical trial for Menactra, in which Menomune was used as the control, as the basis for its safety.
MenQuadfi has a 5.3 % rate of infants suffering serious adverse reactions while Menveo showed an injury/adverse reaction rate of 3.5%.
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 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.
A pyramid scheme of safety, at the bottom of which there is no baseline on which safety is being judged. Just a get-it-licensed-to-profit shell game. FDA and pharma have nothing to lose here. We, as taxpayers, will pay for all of the harms suffered and, worst of all, the children who are injected and harmed and their families will really pay for the harms.
MenQuadfi Package Insert:
https://www.fda.gov/media/137306/download