Chart shows 'CDC Child and Adolescent Vaccine Schedule is the most horrifying example of regulatory capture in history'

Chart reveals truth about vaccine clinical trials

A new chart, provided by attorney Aaron Siri of the Informed Consent Action Network (ICAN), illustrates how each childhood vaccine was trialed by the manufacturer. It includes information from vaccine clinical trials not previously available to the public, which he obtained through FOIA requests and litigation.

Sudden and Unexpected tweeted the chart. Open VAERS has made it available on its website, stating  ". . . the CDC Child and Adolescent Vaccine Schedule is the most horrifying example of regulatory capture in history."

As Open VAERS noted, they have made the chart available as a searchable document for parents to use when vaccination comes up with their children's pediatrician.

ICAN released this chart as a PDF… At OpenVAERS.com we like to try to make information as search engine friendly and mobile phone friendly as possible. So with the permission of ICAN we are now hosting a web version of this chart that is sortable, searchable, and usable for when you are arguing about this with your pediatrician.

No placebo, too quick safety review

As the chart (image above) shows, examples of vaccines for which there was no placebo control group and an extremely short duration of safety testing are the Hep B vaccines. (Hepatitis B is a viral infection transferred through bodily fluids and semen and is most common in the US among IV drug users and men who have unprotected sex with men.) The vaccine is given to infants at birth, one month, and six months. Marketed under the brand names Recombivax HB by Merck and Engerix B by GlaxoSmithKline (GSK), Merck conducted safety reviews after injection only at five days and GSK only at four days. ICAN’s ironic note for these vaccines includes the FDA’s assertion that robust clinical trials are imperative for vaccines given to children.

Note that to license a vaccine for children, the FDA relies upon the clinical trial conducted with children, not adults, because as the FDA explains, “It’s important that the public recognize that, because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are completed to evaluate the safety and the immune response to a … vaccine in this population. Children are not small adults[.]” 

Non-inert "placebos"

Rotarix by GSK and RotaTeq by Merck, brand names of rotavirus vaccines given in two or three doses at two, four, and six months, are examples of vaccines with “placebo” control groups. A placebo is supposed to be an inert substance, typically saline, yet both the Rotarix placebo group and the RotaTeq placebo group received injections with multiple ingredients. Safety reviews were conducted at 31 days for Rotarix and 42 days for RotaTeq and both conducted a one year review for intussusception, a serious adverse event of rotavirus vaccines. Using a non-inert "placebo" allows a vaccine manufacturer to claim the vaccine is safe, especially when deaths occur, since results are typically the same in the the injection arm and in the (supposedly inert) placebo arm. As explained in the chart note, 

“[T]here were 68 (0.19%) deaths following…ROTARIX…and 50 (0.15%) deaths following placebo…. The most common…cause…was pneumonia…observed in 19 (0.05%) recipients of ROTARIX and 10 (0.03%) placebo recipients.” Its clinical review admits “[t]he placebo consisted of all components of Rotarix, but without any RV particles.” The package insert for RotaTeq similarly admits its “placebo” contains multiple ingredients as seen to the left.

Vaccine as "placebo"

Sometimes manufacturers use a different vaccine as the non-inert “placebo.” An example is the MMR vaccine, given at 12 months and 4 years. GSK used Merck’s M-M-R-II as the placebo for its control group. Merck, however, did not have a placebo group for its M-M-R-II clinical trial. The safety review for Priorix was conducted at six months after injection, and the safety review for M-M-R-II was conducted at 42 days after injection. The note revealed that the children in the clinical trials for both vaccines experienced serious adverse effects. 

M-M-R-II trials totaled only 834 children and a third developed gastrointestinal issues and a third respiratory issues. In Priorix trial, both vaccine groups had high rate of serious adverse events, emergency room visits, and new chronic diseases (e.g., autoimmune disorders, asthma, type I diabetes, celiac, and allergies). See Table 6 of the Supplementary Materials.

What's a parent to do?

Parents viewing this chart may be shocked by what it reveals, yet worried that, without getting vaccines, their children may be at risk of contracting a "vaccine-preventable" disease.  Those parents will need to weigh the risk of their child suffering a serious illness from any of the “vaccine-preventable” diseases against the risk of experiencing the relevant vaccine's adverse effects.

The following are resources that parents can turn to for information on how to treat unvaccinated and vaccinated children who may contract a "vaccine-preventable" illness.

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The information contained in this article is for educational and information purposes only and is not intended as health, medical, financial or legal advice. Always consult a physician, lawyer or other qualified professional regarding any questions you may have about a medical condition, health objectives or legal or financial issues.