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Ann Tomoko Rosen's avatar

There are so many more. The WHO also redefined "causality" ..."In the new causality assessment, only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine, are classified as a vaccine-product–related-reactions. Reactions observed for the first time during post-marketing surveillance (Phase 4 clinical trial) are not considered as ‘consistent with causal association with vaccine’. All new serious adverse reactions are labelled as coincidental events ‘inconsistent with causal association,’ or ‘unclassifiable’ and the association with vaccine is not acknowledged. (5). It has, in effect, made phase 4 trials redundant."

https://www.bmj.com/content/365/bmj.l2268/rr-0

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