As per their Freedom of Information release 4032, proportional reporting ratios for adverse events relating to the Covid vaccines are giving an alarming safety signal that the TGA is ignoring.

What’s the point of having a regulatory body if it isn’t going to do its job?

https://www.tga.gov.au/foi-disclosure-log

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The Hon. Mark Butler MP
Minister for Health & Aged Care
PO Box 6022
Parliament House
CANBERRA ACT 2600

minister.butler@health.gov.au

16thJanuary 2023

Dear Minister,

It has come to my attention that the Proportional Reporting Ratio (PRR) for the Covid-19 vaccines is showing safety signals that warrant a reassessment of their safety. 

Results reported in FOI 4032 published on the TGA website, relating to the pharmacovigilance surveillance of the Covid-19 vaccines administered to Australians, show high PRRs for numerous adverse events. A PRR of ten, for example, means the drug is reported to cause ten times more injuries than a comparison drug or background rate.

The Advisory Committee on Vaccines (25 September 2021 meeting) set the PRR at which the TGA would conduct date reviews to detect emerging safety signals at just 1. Despite the majority of adverse events exceeding this figure substantially, the TGA continues to ignore alarming safety signals.

Could you please ask the TGA to clarify how high a PRR must be before the Covid vaccine will be reassessed for safety or withdrawn from the market? If the vaccine is not withdrawn, what PRR will warrant a boxed warning and recognition of side effects for compensation purposes?

Your prompt reply is greatly appreciated.

Kind regards,
Gerard Rennick