CureZone   Log On   Join
*READ* The FDA document!
 
zoho Views: 1,061
Published: 8 y
 
This is a reply to # 2,311,193

*READ* The FDA document!


*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.
 

 
Printer-friendly version of this page Email this message to a friend
Alert Moderators
Report Spam or bad message  Alert Moderators on This GOOD Message

This Forum message belongs to a larger discussion thread. See the complete thread below. You can reply to this message!


 

Donate to CureZone


CureZone Newsletter is distributed in partnership with https://www.netatlantic.com


Contact Us - Advertise - Stats

Copyright 1999 - 2024  www.curezone.org

0.109 sec, (1)