In a heated session of Australia's Senate estimates in December 2025, Senator Alex Antic grilled officials from the Therapeutic Goods Administration (TGA) over the agency's failure to investigate reported child deaths following COVID-19 vaccinations. This scrutiny comes amid growing international concerns, including a U.S. investigation into similar fatalities tied to mRNA vaccines, highlighting potential lapses in Australia's vaccine safety protocols.
The revelations stem from a report by the National Centre for Immunisation Research and Surveillance (NCIRS), which was uploaded in September 2025 but detailed adverse events from the 2022 vaccine rollout — the period when COVID-19 shots were first extended to children under 12. According to the document, Australia saw 18,398 adverse event reports linked to COVID-19 vaccines that year, including 160 fatalities. Alarmingly, six of these deaths were in children aged 0-17, with a median time from vaccination to death of just 4.5 days. For young adults (18-29), the median was even shorter at three days.
Despite these figures, the NCIRS report maintained that the vaccines had a "reassuring safety profile," emphasizing that reported deaths do not automatically imply causation. However, critics argue this dismisses key principles of causality assessment, such as temporal proximity under frameworks like the Bradford Hill criteria, where events occurring soon after vaccination warrant closer examination.
What has sparked outrage is the disclosure that only two of the 160 deaths — and none involving children — were escalated to the Vaccine Safety Investigation Group (VSIG), the expert panel tasked with causality reviews. Senator Antic directly questioned TGA's acting principal medical adviser, Dr. Daniel Dascombe, on this oversight. Dascombe explained that VSIG was primarily used early in the rollout for conditions like myocarditis, when the vaccines' risk-benefit profile was still unclear. As safety data accumulated, he said, the criteria for convening VSIG evolved.
This response failed to satisfy Antic, who pointed out the inconsistency: these deaths happened during the initial paediatric rollout, a time of high uncertainty, especially given children's low risk from COVID-19 itself. The VSIG's own guidelines state that serious events potentially shifting the risk-benefit balance — such as deaths — should trigger review. Yet, no child cases were referred.
A Freedom of Information (FOI) document sheds light on a possible reason: a "pilot" process within the TGA for preliminary assessment of fatal cases. This internal protocol instructs staff to screen reports and avoid referring incomplete cases (e.g., lacking autopsy results) to prevent "burning out" the VSIG panel. The document claims this aligns with World Health Organization (WHO) guidance, but a review of WHO's Global Manual on Surveillance of Adverse Events Following Immunization reveals no such mention of "burn out." Instead, WHO urges thorough assessment of serious events, recommending external expertise if needed.
This filtering mechanism may explain why so few cases reached experts, raising questions about transparency and rigour in Australia's pharmacovigilance system. Compounding the issue, it wasn't until March 2025 — nearly three years after the first child vaccinations — that the Australian Technical Advisory Group on Immunisation (ATAGI) quietly withdrew recommendations for healthy children under 18. The update acknowledged that the risk of severe COVID-19 in this group was "extremely low," and vaccination benefits no longer outweighed potential harms. This reversal, made without fanfare, has fuelled accusations of delayed action despite early warning signs.
Dr. Julie Sladden, a retired Australian physician and advocate for healthcare transparency, highlighted these concerns in a guest post on investigative journalist Maryanne Demasi's platform. Sladden argues that the failure to investigate child deaths represents a "failure of the process in real time," particularly in a low-risk population where even rare harms could tip the scales.
The episode underscores broader debates on vaccine oversight post-pandemic. With U.S. regulators now probing child deaths linked to mRNA shots, Australian officials face calls for an independent review of TGA decisions. Senator Antic's persistence has forced these uncomfortable questions into the open, but answers remain elusive. As public trust in health institutions wanes, experts like Sladden call for full disclosure of internal protocols to ensure future surveillance prioritises safety over expediency.
https://blog.maryannedemasi.com/p/australian-senate-forces-answers