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In instances where a vaccine was used as a control, it too was never licensed based on a placebo-controlled trial. That is not conjecture. It is a fact based on FDA’s clinical trial data. (See http://sirillp.com/noplacebo). As Secretary of @HHSGov, acknowledging this lamentable truth is part of my promise of radical transparency.
The 257 studies cited by CNN unwittingly reflect the lack of safety trials underpinning CDC’s schedule. Despite CNN’s worldwide effort to crowdsource trials with a placebo control (per US_FDACDCgov, an “inert substance”*), this list, on its face, reflects that 236 of the studies clearly did not use an “inert” safety comparator in a trial to license an injected routine vaccine for children on CDC’s schedule.
For the remaining 21 studies CNN’s list claims used an inert injection, 9 plainly did not:
• RCT 251, 252 (Varivax) injected an antibiotic, neomycin – not inert.
• RCT 84, 97 (HPV-16 and 16/18) injected aluminum adjuvant – not inert.
• RCT 215 (Almevax) injected another vaccine – not inert.
• RCT 55 (Lyophilized PedvaxHIB) injected lactose, aluminum adjuvant, and thimerosal – not inert.
• RCT 197 (Salk vaccine) injected 199 solution, synthetic tissue culture, ethanol, phenol red, antibiotics, and formalin – not inert.*
• RCT 168 (Dow’s MMR) injected full vaccine minus virus, including all stabilizers, antibiotics, diluent, preservative, and buffers – not inert.****
• RCT 189 (Menveo) injected Tdap+saline or Menveo+saline – not inert.
For the remaining 12 listed studies which may have had an inert injection, none was a trial relied upon to license a routine vaccine on CDC’s childhood schedule:
• RCT 170, 171, 172 (MMR VaxPro), 228 (PCV11), 136 (Vaxigrip), 242 (Antitetanus), and 122 (Chinese flu shots) trialed vaccines never licensed in the U.S. nor relied upon to license a U.S. vaccine.
• RCT 124 (Fluzone IIV3), 102 (WVV/SPV), and 188 (Menveo) trials occurred after each respective vaccine was licensed, hence were not relied upon for their licensure.
• RCT 176 (Mumps vaccine) was not relied upon by the FDA to license the current MMR vaccine. (See MMR-II clinical trial report in link above.)
• RCT 53 (PRP-D) was for a vaccine withdrawn soon after its introduction and not relied upon by the FDA to license any U.S. vaccine.
While these 12 studies were not relied upon to license a routine vaccine on the CDC’s schedule, they do reflect that a placebo-controlled trial of a vaccine is possible. They also reflect what can be learned when a placebo trial is performed. For example: RCT 136 found the vaccine ineffective; RCT 122 found that “severe adverse effects occurred in 69 (0·6%, 95% CI 0·5–0·8) recipients of vaccine compared with one recipient (0·1%, 0–0·2) of placebo.”; and RCT 124 found “the rate of hospitalization was actually higher in the [Fluzone IIV3] vaccine group than in the placebo group.”
The unfortunate reality is that placebo-controlled trials, however, do not occur and have not been relied upon when FDA licenses vaccines for injection during childhood or ACIP recommends the shot for addition to the CDC’s routine schedule.
CNN would have reached the same conclusion had it reviewed the FDA documentation for each vaccine, instead of relying upon a random, crowd-sourced list from the internet. CNN’s list ironically proves the lack of adequate safety trials for routine childhood vaccines.
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