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FDA Criticized For “Shamefully” Approving Vaccine For Infants
The Food and Drug Administration (FDA) approved the MenQuadfi meningococcal quadrivalent conjugate vaccine, manufactured by Sanofi, for infants six weeks to two years old.
The vaccine had previously gained approval for individuals two years and older.
The #FDA has approved MenQuadfi for infants as young as 6 weeks, making it the only MenACWY vaccine available from this age and enhancing early protection against invasive #meningococcal disease caused by serogroups A, C, W, and Y.
Read more using the link in the replies below. pic.twitter.com/clg0MamdxS
— Pharmacy Times (@Pharmacy_Times) June 3, 2025
“Invasive meningococcal disease (IMD) remains a major global health challenge because it can strike quickly and with devastating effects, potentially taking a life in less than 24 hours. As infants continue to have the highest risk of IMD, Sanofi considers it an important milestone that the US Food and Drug Administration (FDA) has expanded the indication for MenQuadfi,” a Sanofi spokesperson told Contagion.
“With this expanded indication, healthcare professionals can now offer MenQuadfi to infants as young as 6 weeks of age to help protect them against IMD caused by N meningitidis serogroups A, C, W, and Y. Previously, MenQuadfi was approved for use in individuals 2 years of age and older. Now, MenQuadfi becomes the only MenACWY vaccine that can help protect for individuals 6 weeks of age and older, with no upper age limit,” the spokesperson added.
More from Contagion:
In terms of dosing, for infants aged from 6 weeks, a 4-dose series at 2, 4, 6 and between 12 and 18 months of age. The first dose may be given as early as 6 weeks. For infants 6 months through 23 months, this is a 2-dose series with the second dose administered in the second year of life and at least 3 months after the first dose. For everyone aged 2 years or older, it is 1 vaccine.
MenQuadfi is available as a fully liquid solution that does not require reconstitution and is supplied in a single-dose vial. FDA approval of MenQuadfi for use across a broad age range was based on a robust clinical research program, which demonstrated safety and efficacy of the vaccine from infancy to adulthood, explained Sanofi.
Since introduction of the first MenACWY conjugate vaccine in 2005, IMD caused by serogroups C, W, and Y has declined by approximately 90% among adolescents and young adults, according to the company.
“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,” attorney Aaron Siri said.
“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,'” he added.
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…
— Aaron Siri (@AaronSiriSG) June 6, 2025
Full text:
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.
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