115. There are fifty adverse event reports in children under 17 years old for Moderna Spikevax (100 ug of mRNA) and roughly the same amount in the 5 to 11 year old group where an adult dose of 30 ug was given instead of the provisionally authorised 10 ug all since January 10 – Feb 3. That’s roughly 100 children incorrectly given a much stronger dose and unauthorised for their age. What is the TGA doing about the administrators of vaccines giving wrong dosage amounts to children. I note Phase I dose finding studies halted the 30 ug dose in the sentinel group after a safety committee deemed it too unsafe to continue in that dose for that age group? 217. Why did ATAGI approve the Pfizer vaccine for children given it wasn’t powered to detect rare adverse events? 218. How can ATAGI guarantee that there will no long-term adverse events in children if no long-term testing was carried out on the vaccine? 219. How can ATAGI guarantee that there will no long-term adverse events in children if no long-term testing was carried out on the vaccine? 220. There have already been reports of severe adverse events in children aged 5-11 that weren’t detected in the initial children’s trials including strokes, tardive dyskinesia, chest pain, myocarditis and pericarditis. Given the large number and the broad range of adverse events will ATAGI withdraw its recommendation that the vaccine be rolled out to children?

Question Number: 104
PDR Number: SQ22-000244
Date Submitted: 24/02/2022
Department or Body: Department of Health

115. In the rare event that a vaccine administration error occurs, appropriate clinical management is provided to the patient by their health care provider.

Regular communication directly to peak bodies, Primary Health Networks and health care practitioners reinforces appropriate administration protocols. Updates to clinical advice are distributed regularly through training packages and regular electronic updates.

217. The medical experts from the Australian Technical Advisory Group on Immunisation (ATAGI) approved the 5–11 years COVID-19 Pfizer vaccine following approval from the Therapeutic Goods Administrator (TGA). Through the TGA’s stringent assessment and approval process, consideration was given to the vaccine’s safety, quality and effectiveness.

In addition to the TGA’s approval, ATAGI reviewed the results of real-world data from millions of children in the USA who had received the 5–11 years COVID vaccine. It was noted there were no significant adverse events attributed to the vaccine in this cohort. Once a vaccine is being used in the community both ATAGI and the TGA monitors and reviews data both in Australia and overseas for safety signals.

218. ATAGI’s recommendations are based on a thorough risk-benefit assessment. These recommendations are made by a range of medical experts who consider all available information, including clinical trials data, published research and reports from other international regulators, as well as real world experience of the vaccine.

ATAGI’s recommendations consider the direct benefits of vaccination for the child in preventing illness and the indirect benefits of vaccination for the child, their family and for the broader community. Whilst many children may experience only a mild disease if infected with SARS-CoV2, some children will experience a very significant illness and ongoing health issues. Evidence from Australia and overseas shows that COVID-19 vaccination provides protection from serious illness and disease.

219. ATAGI is an independent expert technical advisory body that advises the Minister of Health and the Department of Health is unable to comment on ATAGI’s decisions. The Australian Health Protection Principal Committee, ATAGI and the TGA will continue to constantly monitor the COVID-19 pandemic and the emerging evidence on vaccines – both domestically and internationally – and will continue to provide expert, independent advice to the Government.