Date:   4/15/2016 2:41:49 PM ( 8 y ago)
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URL:   https://www.curezone.org/forums/fm.asp?i=2314337

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*READ* The FDA document! There's certainly no smoking gun"admission" of any causal relationship here:

"Adverse events reported during post-approval use of Tripedia vaccine include idiopathic thrombocytopenic purpura, SIDS, anaphylactic reaction, cellulitis, autism, convulsion/grand mal convulsion, encephalopathy, hypotonia, neuropathy, somnolence and apnea. Events were included in this list because of the seriousness or frequency of reporting. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to establish a causal relationship to components of Tripedia vaccine."

Key point: "...it is not always possible to reliably estimate their frequencies or to
establish a causal relationship to components of Tripedia vaccine."

The CFRs regulating new drug and vaccine phase clinical trials mandate reporting of ALL potential adverse reactions OBSERVED both in phase I-II-III (pre-release) and phase IV (post-release). There is no requirement to investigate all reactions reported to establish a definitive causal relationship and only those reactions that appear in a statistically significant volume are followed up. This happened with the Rotavirus vaccine.
 

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