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

A letter recently published by the Australian Medical Professionals Society (AMPS) sent to the Department of Health in response to the extension of provisional approvals of these injections to 6-month-old babies and pre-schoolers outlined substantial evidence showing Covid poses a statistically zero infection fatality risk.

A statistically zero infection fatality risk for healthy babies and children means that it could be argued that these Covid vaccinations do not appear to meet the legislative threshold for extension of provisional approval. To grant approval to make an experimental therapeutic available under the new 2018 provisional approval pathway there must be evidence the condition is serious and life-threatening. The government's reports and the AMPS heavily-referenced letter show Covid is not serious or life-threatening to healthy children.

Claims made on the consent forms that the vaccines reduce transmission to older family members who are at higher risk from Covid are baseless. The AusPAR confirms that protection against asymptomatic infection and the effect on viral transmission offered by the vaccine in children is not known.

In fact, according to an FDA news release from December 2020, 'At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.'

There is no evidence to support the claim made to parents that vaccination reduces or slows the spread. Even if there were evidence they reduced transmission, any society that advocates experimental therapeutics in children who don't need them as shields to potentially protect adults is counter-intuitive having regard to the evidence that there has never been any evidence that the injections stop transmission, hospitalisations, or deaths.

If Australian parents had been provided with reliable information about the lack of evidence these injections reduced transmission would they have consented? Indeed, the suppression of information, denigration, and censorship by key Australian institutions potentially acting as 'gatekeepers' of misinformation has compounded access to reliable objective scientific data. For the avoidance of doubt, we use the term 'objective scientific' data purposefully.

The consent form for Pfizer claims the vaccine is effective in preventing Covid. The Moderna consent form claims the vaccine provided some protection against infection with the Omicron variant. The roll-out for the 5-11-year-olds began on January 10. On January 11 it was reported the CEO of Pfizer said, 'The first two doses provide limited if any protection against omicron.' Omicron was the circulating variant at the time. Further, unlike the consent form claims, both TGA and AusPAR reports state there are no data provided by the sponsor regarding vaccine efficacy against new variants such as Omicron. The reports also state the duration of immune persistence is not known, because of the short follow-up period. The Moderna AusPAR suggests that while it is 'likely' to prevent severe disease there are no clinical data on severe disease endpoints.

It is also worth noting that the Moderna vaccine efficacy was less than 50 per cent and this does not meet the FDA guidelines. Interestingly, both AusPARs use immunogenicity as the primary endpoint for assessing efficacy even though the US FDA states, 'Currently authorised SARS-CoV-2 antibody tests should not be used to evaluate a person's level of immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.'

Nowhere on the consent forms does it say these experimental injections are assessed using inappropriate primary endpoints. Nowhere does it say they were not tested for transmission and have poor efficacy of unknown duration against a variant the CEO says they provide limited, if any protection against. Efficacy claims made to parents on the consent forms appear unscientific, being unreliable and inconsistent with valid consent requirements. Would parents be rightly hesitant had they been provided with appropriate AusPAR information on the consent forms?

Obviously, the vaccines are not particularly effective, but are they safe?

Safety is imperative in determining the risks versus benefits required for valid informed consent. The Department of Health consent forms claim the vaccine is safe and most side effects are mild with no specific safety concerns identified. Both consent forms claim it is safe in children who are immunocompromised. Does the evidence in the AusPARs support these claims?

The AusPAR stated that there were no genotoxicity studies, the safety sample was small, there was missing information on longer-term safety including adverse events of special interest, and there was a lack of safety data for immunocompromised children. The Moderna AusPAR, while recommending the vaccines to high-risk immunocompromised children, indicates that high-risk and immunocompromised children were excluded from the study. The lack of safety data was also outlined in the Feb 2021 European Medicine Agency Assessment Report that showed there were no toxicology data on genotoxicity and carcinogenicity, and also no human reproductive testing. The TGA should also have been aware of the Pfizer 5.3.6 cumulative analysis of post-authorisation adverse event reports that the FDA wanted hidden for 75 years. The report showed within the first 90 days of administration there were 1,223 reported deaths and nine pages of around 1,200-odd adverse events of special interest.