FDA Approves Baby Jab Despite 1-in-20 Serious Adverse Events

The U.S. Food and Drug Administration has just greenlit expanded use of Sanofi’s meningococcal vaccine MenQuadfi for infants. This despite trial data showing 1 in 20 babies suffering a serious adverse event (SAE) — defined as death, hospitalisation, or permanent disability.

That should’ve been an automatic red flag. Instead, it’s business as usual at the FDA.

“This isn’t science. It’s a shell game,” said attorney Aaron Siri, who has represented families harmed by vaccines and spent years exposing the FDA’s collapsing credibility. He called the agency’s decision “shameful.”

Dr. Maryanne Demasi, former medical scientist turned whistleblowing journalist, echoed the alarm. And for good reason.

The Shell Game

MenQuadfi was previously licensed for children over 2. The FDA just extended approval down to 6-week-old infants — based on trials where babies received up to four doses, and 5.3% suffered SAEs over the study period.

In the comparator group (Menveo), 3.6% had serious events.

Instead of asking why any babies are being seriously harmed in clinical trials, the FDA concluded the rates were “comparable.” Therefore, safe. Circular logic. Dangerous precedent.

Because Menveo is assumed safe, and MenQuadfi caused a similar amount of harm, the FDA reasoned that MenQuadfi must also be safe.

Siri puts it bluntly: “Menomune was licensed without a placebo. It was used to approve Menactra. Menactra was used to approve Menveo. And now Menveo is used to approve MenQuadfi. There’s no solid baseline. Just a daisy chain of assumptions stacked on regulatory quicksand.”

The Real Risk Game

In countries like Australia, the risk of a baby contracting meningococcal disease in their first year of life is about 0.005% to 0.01% — that’s 5 to 10 cases per 100,000 infants.

Now compare that to the MenQuadfi trial: 5.3% of vaccinated babies suffered a serious adverse event — that’s 5,300 per 100,000.

• Risk of meningococcal disease: 5–10 in 100,000
  
  
• Risk of serious harm from the vaccine: 5,300 in 100,000
  
  

That’s 530 to 1,060 times higher risk from the vaccine than from the disease.

This is a math problem any parent can solve — and the answer is: no thanks.

A System Designed to Fail You

MenQuadfi is already on the CDC’s schedule for older children. That means full liability protection under U.S. vaccine injury laws. If your baby is harmed, pharma doesn’t pay. You do. Through your taxes. Through your child’s suffering.

As Siri said: “FDA and pharma have nothing to lose here. The children, and their families, pay the price.”

This isn’t about preventing disease. It’s about preserving the bottom line.

But parents aren’t stupid.

We’re waking up.