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'''OPERATION COVID SHIELD

A PUBLIC INTEREST REPORT'''

Exposing Covid-19 vaccine safety and efficacy concerns, government misinformation, and undisclosed conflicts of interest

Operation COVID Shield: “personal freedoms” leveraged to incentivise vaccine uptake

Upon extensively researching product information and literature published by Australia’s drug regulator, the Therapeutic Goods Administration (TGA), I have become seriously concerned that the Australian public has not been adequately informed about the safety profile, potential risks and efficacy of Covid-19 vaccines. For consent to be legally valid, The Australian Government's Immunisation Handbook says, “It can only be given after the potential risks and benefits of the relevant vaccine, the risks of not having it, and any alternative options have been explained to the person. … It must be given voluntarily in the absence of undue pressure, coercion or manipulation.”

Although the Australian government continues to claim that Covid-19 vaccines will be voluntary, the new operations manual for ‘Operation COVID Shield’, Australia’s mass Covid-19 vaccination rollout, openly acknowledges the government will “leverage key incentives” such as “personal freedoms” to “drive vaccine up-take”, and intends to coordinate the use of these incentives across the public, private and community sectors, and across all levels of government.

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The lifting of Covid-19 restrictions and lockdowns is to be continent upon the achievement of vaccination thresholds. Operation COVID Shield’s aggressive nationwide operation to coerce Australians into receiving a Covid-19 vaccine by leveraging “personal freedoms” is bizarre, given the fact that Australia’s chief health bureaucrats, Australia’s drug regulator, and the vaccine manufacturers themselves admit they do not know if the vaccines are effective or not. The nation-wide rollout of Operation COVID Shield means that if Australian do not take part in what Health Minister Greg Hunt has acknowledged is the world’s largest clinical trial in history, their “personal freedoms” are forfeit.

The two Covid-19 vaccines which have been given provisional approval in Australia by the drug regulator, the Therapeutic Goods Administration (TGA), are manufactured by Pfizer and AstraZeneca. Both manufacturers admit the efficacy and duration of protection of their vaccines is unknown. Efficacy and safety for older people, adolescents, Aboriginal and Torres Strait Islander peoples, and the immunocompromised is unknown; yet Operation COVID Shield has prioritised these demographics in the vaccine roll out. The effects on people with autoimmune or inflammatory disorders, or people with a history of anaphylaxis is unknown. There is inadequate data about the effects on reproduction, fertility or foetal development. The interaction of the vaccines with other drugs and vaccines is unknown. Long term immunity and vaccine induced autoimmune disease were not studied. Pfizer is not planning Australia-specific post-market studies. The TGA acknowledges that there is no established immunological correlate of protection against Covid-19 from the AstraZeneca or Pfizer vaccines. The TGA acknowledges that questions about the vaccines’ efficacy against asymptomatic infection and viral transmission have not been addressed. Despite the fact that Pfizer’s vaccine uses a novel therapeutic mRNA technology which is considered a “gene therapy” in the United States and Europe, and has not been approved for use in humans before, there were no genotoxicity or carcinogenicity studies performed. Importantly, Pfizer admits that there was “no meaningful clinical differences” in overall vaccine efficacy for participants whose comorbidities increased their risk of severe Covid-19.

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As of the 8 August 2021, the United Kingdom’s vaccine reporting system reports 98,432 adverse event reports (275,820 total reactions) and 478 deaths following the Pfizer vaccine; and 225,871 adverse event reports (806,085 total reactions) and 1024 deaths following the AstraZeneca vaccine. In the United States, there have been 203,069 adverse event reports (848,553 total reactions) and 2,012 deaths following the Pfizer vaccine. (There is no specific data for AstraZeneca.)

The Australian government recommends pregnant women, women who are trying to conceive, or are breastfeeding are vaccinated with the Pfizer vaccine. Pregnant women are a “priority group” and should “be routinely offered the Pfizer vaccine at any stage of pregnancy.” However, the TGA acknowledges that women who were pregnant or breastfeeding were not included in Pfizer's clinical trial. The Australian government claims the Pfizer vaccine has been shown to be safe in pregnant women, referencing a study which concludes that it was “unable to evaluate adverse outcomes that might occur in association with exposures earlier in pregnancy, such as congenital anomalies, because no pregnant persons who were vaccinated early in pregnancy have had live births … Continued monitoring is needed to further assess maternal, pregnancy, neonatal, and childhood outcomes associated with maternal Covid-19 vaccination, including in earlier stages of pregnancy and during the preconception period.” The Australian government recommends women in early pregnancy and preconception receive the Pfizer vaccine, despite the absence of safety data and the fact that early pregnancy is the period of highest risk.

The TGA has approved administration of Pfizer’s vaccine to adolescent children aged 12-15 years, and Operation COVID Shield designates this cohort a “priority group” for the vaccination rollout. However, the vaccine’s efficacy against transmission is unknown. The number of adolescents in the study was not sufficient to detect rare adverse events, and long term safety is unknown. The TGA acknowledges that Covid-19 is usually mild in adolescents. Although adolescents with underlying medical conditions are at higher risk of severe Covid-19, adolescents with immunodeficient status or high health risks are were not assessed in Pfizer’s clinical study of vaccine efficacy in adolescents.

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The head of the TGA, John Skerritt, has acknowledged the efficacy of both the Pfizer and AstraZeneca vaccines is unknown, however claimed the “safety evidence is pretty thorough”. This is despite the fact that, for example, the TGA has acknowledged that in the AstraZeneca vaccine “there are significant concerns about the robustness of the data” and that “the study design was not entirely fit for purpose to evaluate efficacy in high risk groups”. The TGA’s 21 May 2021 response to a Freedom of Information request has revealed that the TGA has not seen the raw data from clinical trials, and is essentially ‘taking the manufacturers word for it’. The TGA acknowledges that the decision to approve Covid-19 vaccines was based on information (including safety, efficacy and risk management) which was submitted by the manufacturers. There have been no independent studies on safety and efficacy, as all clinical trials of the vaccines have been conducted by the vaccine manufacturers or developers.

The Australian public will not be privy to any genuine concerns about the Covid-19 vaccines from health practitioners, including those who may have prescribed and administered Covid-19 vaccines, or who have treated patients who have experienced adverse effects from the vaccines. The Australian Health Practitioner Regulation Agency (AHPRA) has threatened health practitioners with regulatory action if they contradict the government’s public health messaging. AHPRA has reminded practitioners in its Covid-19 vaccine position statement that it “it is an offence under the National Law to advertise a regulated health service (including via social media) in a way that is false, misleading or deceptive.” AHPRA has determined that “advertising” will also include “false, misleading or deceptive claims about COVID-19”, which includes "anti-vaccination material”. If health practitioners “advertise” anti-vaccination material on their own social media, this “may result in prosecution by Ahpra”.

AHPRA informed health practitioners that “any promotion of anti-vaccination statements” or health advice which “seeks to actively undermine the national immunisation campaign (including via social media) … may be in breach of the codes of conduct and subject to investigation and possible regulatory action”. AHPRA has directed that health practitioners must make sure their social media activity “does not contradict or counter public health campaigns or messaging, such as the Australian COVID-19 Vaccination Policy”.

The Australian government has not adhered to the February 2020 Australian Health Sector Emergency Response Plan for Novel Coronavirus (COVID-19). Many of the most restricting public health measures implemented in response to Covid-19 were directly contraindicated by the key nationally agreed document for pandemic response, which the Emergency Response Plan was based on.

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This report documents:

Provably false claims state and federal government officials and public health officials have made about Covid-10 vaccine safety, efficacy, and effects on transmission.

The federal government’s disturbing misinformation about the safety of Covid-19 vaccine in adolescents and pregnant women, two groups prioritised for Operation COVID Shield’s vaccine rollout. Alarming errors in key modelling which formed the basis of restrictive public health measures such as lockdowns.

Serious concerns raised about the legal standing of key Covid-19 response decision-makers.

Undisclosed potential conflicts of interest with pharmaceutical companies who have manufactured the provisionally approved Covid-19 vaccines.

Silencing of Australian health practitioners, who have been threatened with prosecution and regulatory action if they do not adhere to the government’s Covid-19 vaccine messaging.

https://www.harrisonpublications.org/operation-covid-shield.html