MELBOURNE, Australia—A clinical trials and pharmaceutical regulation affairs expert has urged Australia’s Therapeutic Goods Administration (TGA) to suspend the “provisional approval” status granted to COVID-19 vaccines and declared Australia’s drug adverse event reporting system “broken.”
This comes after the TGA reported 135,978 cases of total adverse events following COVID-19 immunisations to Sept. 4. The TGA has also identified 13 reports where the cause of death was “linked” to vaccinations from the 937 reports it received and reviewed.