‘Vaccine Safety Pyramid Scheme’: FDA Approves Meningococcal Vaccine for Infants Without Placebo-Controlled Trials
The U.S. Food and Drug Administration has expanded its approval of Sanofi Pasteur’s MenQuadfi meningococcal vaccine to include infants as young as 6 weeks old.
The U.S. Food and Drug Administration (FDA) has expanded its approval of Sanofi Pasteur’s MenQuadfi meningococcal vaccine to include infants as young as 6 weeks old.
The vaccine, designed to protect against meningococcal disease — meningitis and meningococcal septicemia — was previously recommended for children ages 2 and older.
According to the package insert, during the six months following the clinical trials, 5.3% of infants ages 6 weeks to 23 months who received the MenQuadfi shot experienced a serious adverse event.
The FDA defines a serious adverse event as a reaction that leads to hospitalization, death, disability, or that requires intervention to prevent permanent damage, or constitutes some other important medical event, such as breathing problems.
The types of serious adverse events ranged from cardiac arrest, respiratory distress and failure, febrile convulsions and seizures, to a wide range of infections, according to reports on the clinicaltrials.gov website.
Children’s Health Defense (CHD) Senior Scientist Karl Jablonowski said the reports of infections and convulsions indicate immune system dysfunction that could be linked to vaccination.
‘Good example of a vaccine safety pyramid scheme’
The FDA approved MenQuadfi for the younger age group because the agency considered adverse event rates to be similar to those found to be associated with GSK’s Menveo, another approved meningococcal vaccine. In the case of Menveo, 3.6% of infants who got the shot experienced serious adverse events.
In other words, because Menveo is considered safe, and MenQuadifi’s serious adverse event rates are only slightly higher than those of Menveo, the FDA can conclude that MenQuadifi is also safe despite the high rates of serious adverse events, according to attorney Aaron Siri, who first reported the expanded approval on X.
However, Menveo was licensed based on a trial in which the vaccine’s safety and efficacy were compared to yet another meningococcal vaccine, Menactra, Siri said.
He wrote:
“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 Menomune was used as the control) as the basis for its safety.”
Siri called this circular evidence for vaccine safety, where vaccine approvals are based on comparisons to other vaccines — none of which were ever safety tested against a true placebo — “a good example of a vaccine safety pyramid scheme.”
The result is that clinical trials show the last two pneumococcal vaccines have 5.3% and 3.6% of infants experiencing serious adverse events, “and no one bats an eye. They grant licensure,” Siri wrote.
He added:
“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.”
Lower age group means more doses in first 18 months of life
According to the package insert for MenQuadfi, younger infants receive more doses.
Adults and children ages 2 and up can receive a single shot. For infants who begin the vaccination course between ages 6-23 months, the vaccine is administered as a two-dose series.
As is typical with vaccines, the dose size — 0.5mL — doesn’t vary from infant to adult.
However, for the newly expanded group of infants who begin the course of vaccination at age 6 weeks, the vaccine is approved as a four-dose series of shots administered during the first 18 months of life.
For this group, in addition to high rates of serious adverse events, there were also high rates of less serious side effects. For example, among infants ages 6 weeks through 34 months, 38.5-45.6% experienced tenderness, 12.5-19.5% experienced erythema, 27.3-42.1% cried abnormally, 7.8%-17.6% experienced fever and 3.5%-13.2% vomited.
The insert also warns that the Guillain-Barré syndrome has been linked to other similar pneumococcal vaccines and may be a potential risk.
Infants in the clinical trials received the pneumococcal vaccines at the same time that they received other vaccines, including diphtheria, tetanus pertussis, inactivated polio and Haemophilus influenzae type b vaccines, Prevnar 13 (a different pneumococcal vaccine), rotavirus vaccine, hepatitis B vaccines, MMRII vaccines and varicella vaccines and hepatitis A vaccines.
Similar to the MenQuadfi vaccine, many of the other vaccines are administered at ages 2 months, 4 months, 6 months and 15-18 months of age, or at some point before the child reaches 18 months.
Vaccine safety advocates have long called for vaccines to undergo safety testing in clinical trials against true inert placebos, rather than against other vaccines or placebos containing the same excipients (preservatives and adjuvants) in the vaccine being tested.
They argue that without true placebo testing, it’s impossible to ascertain true risk profiles for the products, and that such comparative trials are considered the “gold standard” for evaluating all other pharmaceutical products.
The lack of adequate safety testing has also been a concern of Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr., who co-authored a book with CHD Chief Scientific Officer Brian Hooker on the published data comparing outcomes for vaccinated and unvaccinated people.
Kennedy announced earlier this year that all new vaccines will have to undergo placebo testing, a rule that would mark “a radical departure from past practices,” an HHS spokesperson told The Washington Post.
HHS did not at the time indicate how the changes would be implemented, or what would be considered “new” vaccines.
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5.3% serious events is much higher than 3.6% serious events! A 47% increase in serious events is serious, and definitely is NOT a reason to lower the age limit! I would call this approval treasonous.
we just got good news news, quote "Health secretary RFK Jr. abruptly fires CDC vaccine advisory panel", and this here managed to erase the joy.. as usual, sorry, the gov is NOT on our site.