MenQuadfi Approval and the Pyramid Scheme of Vaccine Safety

This is how the game is played

Recently, FDA shamefully approved Sanofi’s MenQuadfi (a meningococcal vaccine) to be injected into infants 6 weeks to 2 years old based on a trial that compared it to Menveo (another meningococcal vaccine). 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 the FDA definition). But because these rates were “similar,” this product was deemed “safe” by FDA—because it assumes Menveo is also “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 either. In fact—and this is mind-twisting—the package insert for Menomune lists the clinical trial for Menactra (in which Menomune itself 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 3.6% of infants suffering serious adverse reactions and FDA grants licensure.

What makes this even more troubling is that because FDA officials must know these numbers are highly concerning, they have Sanofi conduct a case-by-case review of each serious adverse event. If FDA were confident the control was safe, it would just rely on a statistical comparison between the vaccine being evaluated and the control. But since FDA officials must know Menveo’s safety is unknown (because it was licensed in a trial with a defective control), they ask Sanofi (the company seeking to get approval and profit from this product) to explain away each serious adverse event. And the Sanofi-paid researchers do exactly that in their write-ups to FDA about each serious adverse event.

And when FDA gets these write-ups explaining away each serious adverse event as “unrelated” to MenQuadfi, what does FDA do? The FDA officials reviewing them dutifully agree. What else would they do? Admit that Menveo, used as the control, and which they licensed based on nonsense data, has been harming children? That it is causing 3.6% of children—or even a fraction of that—to have a serious adverse event? If FDA officials do that, the house of cards would start to collapse. It would become clear Menveo wasn’t properly licensed (which it wasn’t), and that Menactra wasn’t properly licensed (which it wasn’t), and the same for Menomune.

FDA’s conflict and bias are dangerous. Letting Sanofi decide if its own product caused harm is beyond dangerous. This entire pyramid scheme, without a valid baseline of safety permitting a statistical comparison, requires injecting a new layer of biased assumptions with each additional licensure.

At this point, the safety of these products is based on dogma and assumptions. FDA has its reputation and any remaining trust to lose—and pharma its billions in profits—if they actually evaluated these products using a true safety comparator. It would reveal the true safety profile of these products (which the reliable data shows will likely be terrifying). Of course, the children whose injuries could be averted by conducting actual safety trials would benefit, but they are not really part of the equation.

References:

MenQuadfi Package Insert

Menveo Package Insert

Menactra Package Insert

Menomune Package Insert

Serious Adverse Event FDA Definition