Dear Professor Skerritt,
Further to my email of the 19th October 2021, in regards to my concerns that the TGA had approved the Moderna (Spikevax) Covid vaccine to be injected into Australian teenagers aged 12-17, despite the fact that in the country of manufacture (the USA) that the American regulators have refused to allow Moderna to be injected into American teenagers, and your reply of the 25th October 2021, advising that the TGA believes that American regulators are wrong and that;
“The TGA decided that the Moderna vaccine is effective and safe for use in adults and adolescents aged 12 years and above”
I would like to draw to your most urgent attention, that your Database of Adverse Event Notifications (DAEN) lists a case where a death has been reported on the 20th October 2021, as having been suspected of being caused by the Moderna (Spikevax) covid vaccine. It also appears that this death was that of a 14 year-old girl (Case no.647663)
- Can you confirm, that this reported death, suspected as a result of the Moderna (Spikevax) covid vaccine, is in fact that of a 14 year-old Australian girl ?
- If so, following the death of this 14 year-old girl, together with the 626 other adverse events already reported (from the 1st Oct 2021 – 22nd Oct 2021) suspected to be caused by the Moderna vaccine – does the TGA continue to maintain the stance that the Moderna vaccine is “effective and safe for use in adults and adolescents aged 12 years and above” ?
- I assume that the TGA is urgently investigating this death, and therefore assuming that TGA adheres to the ‘Precautionary Principle’ can you confirm if the TGA will immediately suspend any further injections of the Moderna Vaccine into Australian teenagers until the completion of the investigation in the death of this 14 year-old girl ?
- If the TGA continues to maintain the stance that the Moderna vaccine is “effective and safe for use in adults and adolescents aged 12 years and above” (contrary to the views of the American regulators), how many deaths of young Australians aged 12-17 (suspected to be a result of Moderna covid vaccine – and reported to DAEN) would it take for the TGA to change its view ?
- Given the principle of ‘Informed Consent’, can you confirm if the parents of this deceased 14 year-old girl where informed that the Moderna (Spikevax) covid vaccine had not been given approval in the USA for injection into American 14 year-old girls due to safety concerns ?
- Do you have any concerns that TGA’s conduct of rejecting and acting contrary to the advice of the American medical regulators on Moderna (especially when Moderna is manufactured in the USA) and continuing to allow the injections of Moderna into Australian teenagers, following the death of this 14 year-old Australian girl, may expose Australian taxpayer’s to substantial claims for compensation and/or that private action may be commenced against the decision makers at the TGA ?
I look forward to most urgent reply.
Craig Kelly MP
Member for Hughes
Leader, United Australia Party