Australia’s erosion of informed consent and the avoidable death of children

It seems as though the TGA and Food and Drug Administration (FDA) were in lockstep support of the Dr Eric Rubin 'we're never gonna learn about how safe the vaccine is until we start giving it' model of safety.

In that case, a voting member of the FDA advisory committee replied to the question, 'Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-10 Vaccine when administered as a 2-dose series outweigh its risks for use in children 5-11years of age?' by stating:

'We're never going to learn about how safe the vaccine is until we start giving it. That's just the way it goes.'

It is unlikely that Australian parents feel the same way about their children 'testing' the safety of mRNA vaccines.

The TGA and the Advisory Committee on Vaccines (ACV) knew, or ought to have known from their own reports, that these provisional injections were all risk and no benefit to healthy children. The information provided to parents on these consent forms is not exactly reliable or truthful.

To understand the sheer magnitude of what could be argued is such a profound level of reckless indifference to human life and criminal negligence leading to death, one only needs to review the TGA's Australian Public Assessment reports (AusPAR) for the provisional approval of Pfizer for the 5-11 roll-out and the Moderna 6 months and up. After this brief comparison of the information found on the AusPAR's with the information provided to parents on the consent forms the public can decide for themselves if the information is accurate for informed consent or misleading deception.

These vaccines are not approved as stated on the consent forms; they are provisionally approved. Provisional, by definition, means experimental because they lack sufficient safety data. The Provisional Approval Pathway is an expedited pathway based on preliminary data with manufacturers provided six years to supply the government with safety and efficacy data. Claiming they are approved is not truthful, reliable information as is required for informed consent.

Parents may also be interested to note in July 2021 the Therapeutic Goods Regulation Act was amended to reduce the safety and efficacy requirements for any medicine that is for the treatment or prevention of Covid. Not only do manufacturers have six years to provide the government with safety and efficacy data on these provisionally approved injections, but they also no longer have to demonstrate they could provide a greater benefit than other available medicines or that the medicine is likely to provide a major therapeutic advance. The only requirement is to claim Covid is a life-threatening or seriously debilitating condition. It is shown below that for most children Covid is neither life-threatening nor does it result in a seriously debilitating condition.

Nowhere on the Pfizer consent form for age 5-11, or the Moderna 6 months to 5 years, is it stated these gene therapy vaccines are experimental lipid nanoparticle synthetic messenger RNA technology never before used for vaccines. Nowhere does it say this technology turns a child's body into a spike protein manufacturing plant. Nowhere does it say that the TGA is unaware of some of the contents of these injections because they remain commercial in confidence. Nowhere on these forms does it state these vaccines are part of the black triangle scheme which is supposed to be a reminder to people to report any adverse events related to these new medicines.

If parents knew this, would they give consent?

Before even considering the safety and efficacy of these provisionally-approved vaccines it must be understood that healthy children have a statistically nil infection fatality risk from Covid. The TGA AusPAR report from December 2021 and the Australian Technical Advisory Group on Immunisation (ATAGI) in February 2022 advised that, '…most children who get COVID-19 have mild symptoms or no symptoms at all. Children with some underlying medical conditions might be at higher risk of severe illness, but very few with COVID-19 get sick enough to need hospitalisation. Fatal outcomes in children are very rare.'

This conclusion is supported by the Paediatric SARS-CoV-2 serosurvey 2022, Australia Summary report from November 2022 that found, 'most children and adolescents in Australia have been infected with the virus that causes COVID-19', noting that high rates of infection in unvaccinated preschool aged children has not been accompanied by a high rate of hospitalisation.