No drug or vaccine is “safe”. All have potentially serious and/or fatal effects. Yet the Australian Therapeutic Goods Administration (TGA) declared the “COVID-19 vaccines”, more appropriately described as “COVID gene-based spike injections”, to be “safe” without any qualification based, as we now know, on troublesome animal and clinical safety data. Such reckless advice had no equivalent in the history of the pharmaceutical industry. Furthermore, the TGA released these experimental gene-based injections for use in the entire population including healthy individuals, children, infants and in pregnancy knowing full well that important safety data was lacking.

After two and a half years of use, these COVID gene-based Spike injections (they are not really “vaccines” because they do not prevent infection nor do they prevent transmission of the virus) have been reported to be associated with the highest incidence of serious adverse events and death of any drug ever released according to multiple vaccine adverse event reporting systems, including the Vaccine Adverse Event Reporting System (VAERS) of the US Center for Disease Control (CDC)[1]. The latest VAERS report [1] through 4 August 2023 reports 35,821 associated deaths and 207,715 hospitalisations. The true incidence of deaths due to serious adverse events in this US reporting system, following application of the widely acknowledged under reporting factor of about 50x is 1.8 million[2],[3]. These reported vaccine iatrogenic deaths exceed the number of declared US COVID deaths[4]. 

Even when compared to conventional vaccines the COVID so-called “vaccines” have been reported to be cause more than 10 times the reported incidence of death according to VAERS.
However, as of this time, the reported incidence of death in Australia caused by the COVID gene-based Spike injections according to the TGA stands at 14[5] . The TGA say: “The 14 deaths likely to be related to vaccination occurred in people aged 21–81 years old. There have been no deaths in children or adolescents determined to be linked to COVID-19 vaccination.”  
So, why is there such a discrepancy between the overseas adverse event data and our TGA adverse event data?

The answer lies in the design of the voluntary adverse event reporting systems and the way these systems are administered. Gross under reporting may be a result of a lack of adequate staff to service the system and analyse the data in a timely fashion. However, other factors include: complex or cumbersome design which discourages reporting/searching, computer coding and/or definition anomalies which makes reporting or searching the database difficult.  Failure to follow up important missing data in relation to deaths and other serious adverse events is another problem[6].
Misclassification or deletion of records have been reported in relation to adverse drug reporting systems and important safety signals from these systems have been ignored[7],[8] . In addition, health professionals are loath to report adverse drug reactions due to the COVID injections because they fear being labelling as “anti-vaxxers” or being seen as undermining the prevailing vaccine narrative promoted by the health regulators and they fear being disciplined or even suspended for reporting[9].[3]
Post-marketing adverse drug reporting systems have served a very important role in the past. This is because during the research and development of any new drug, depending on circumstances, usually only a few thousand people are studied in maybe 10-30 clinical trials over 7-10 years.

While these clinical studies are highly monitored for adverse effects, the limited number of studied subjects in these R& D programs means that those adverse effects which occur, maybe one in a hundred or one in a thousand, will be difficult to identify as being caused by the drug tested rather than occurring by chance. For this reason, post-marketing surveillance in pharmacovigilance systems play an important and indispensable role. A total of 462 medicinal products have been withdrawn from the market between 1950 and 2013 using post-marketing surveillance[10].

Post-marketing surveillance of adverse drug reactions is of particular importance when the safety and efficacy data for any drug under research is limited by the number of clinical trials conducted or limited by the types of patients studied. In the case of Provisional Approval in Australia or Emergency Use Authorisation in the U.S. or Conditional Approval of the “COVID vaccines” in the European Union, all these limitations applied. 
In order to have a reliable estimate of safety for drug released under conditional approval where insufficient safety and efficacy data exists for full approval, it is necessary to have a transparent, efficient and dependable adverse drug reporting system to identify safety signals should they arise. Given the discrepancy between the large numbers of adverse events reported in relation to the “COVID vaccines” overseas compared to Australia, it appears that Australia does not have a reliable and transparent adverse drug event reporting system to identify important safety signals and neither does the U.S. Food and Drug Administration (FDA)[11].

For example, up to the writing this paper, a reported total of 9 children have died in relation to the administration of the COVID so-called vaccines[12] in the Australian TGA Drug Adverse Event Notification (DAEN) system. There is insufficient transparency to provide confidence to conclude these deaths are notrelated to the COVID vaccine. Indeed, there is considerable suspicion that the TGA may be under reporting and misclassifying deaths[13],[14]. The full ADR records are not made publicly available to provide any level of assurance.

Reanalysis of the risk of serious adverse drug events which occurred in the Pfizer and Moderna “COVID vaccine” clinical trials showed that about 1 in 800 individuals had a chance of a serious adverse event[15]representing a 16% higher risk of serious adverse events compared to placebo and far more than 1-2 for each million reported for vaccines in general[16]. The official reported TGA DAEN incidence for serious adverse events for “COVID vaccines” fails to even come close to this statistic.
A practical example of the unreliability of adverse drug event reporting systems is provided by the discrepancy between the official TGA reported incidence of myocarditis and the incidence of myocarditis reported in clinical practice. 

According to the TGA: “Myocarditis is a known but very rare side effect of the Pfizer and Moderna so-called “vaccines”. It is usually temporary, with most people getting better within a few days. Myocarditis is reported in around 1-2 in every 100,000 people who receive Comirnaty (Pfizer) and around 2 in every 100,000 of those who receive Spikevax (Moderna)”[17]. 
However, in a rare admission, one prominent Australian cardiologist revealed that he has seen about a hundred cases of myocarditis since the COVID so-called “vaccines” were rolled out[18]. Given that there are about 1200 cardiologists in Australia, this means there may have been 120,000 cases of symptomatic myocarditis….not around 500 cases as estimated by the TGA. This degree of discrepancy is unacceptable.  

The problem is that insufficient safety data was generated prior to the release of the COVID so-called vaccines and the population is entirely dependent upon an unreliable adverse drug event reporting system to prove safety. One cannot have an expedited drug approval system which depends on very limited evidence of safety and, at the same time, have an unreliable and non-transparent adverse drug event reporting system which fails to identify and report important safety signals. If safety signals such as cardiac arrest, pulmonary embolism, stroke, sudden death, cancer, diabetes and neurological disease such as dementia occur significantly above baseline values and are not duly recognised, there is no point in having an adverse drug event reporting system.

There are other clues that our adverse drug event reporting systems are under reporting the real incidence of death associated with the so-called COVID vaccines. Life insurance companies around the world are reporting record numbers of unexpected deaths. These are not statistical fluctuations. For example, Lincoln National, the fifth largest insurance company in the U.S. reported a 153% increase in life insurance claims in 2021[19].  
It is becoming increasingly obvious that we cannot rely upon the various adverse drug reaction reporting systems in order to assess the safety of the so-called COVID vaccines. 

However, from time to time there is a significant clue to the true and exceptionally high incidence of adverse events associated with the Covid vaccines. One such clue was provided by Adverse Event Following Immunisation statistics released by the West Australian government for 2021. This data shows in relative terms the skyrocketing numbers of adverse events reported for Covid vaccines. Twice as many Covid “vaccines” were injected as compared to all other vaccines – but 40x the number of adverse drug reactions were reported [20].

But dangerous drugs can be identified in another way apart from adverse drug reporting systems. Most countries accurately measure a statistic termed the “All-Cause Mortality” and a statistic called “Excess Deaths”.   The All-Cause Mortality is the number of deaths each year from all causes and Excess Deaths are the number of deaths from all causes above that normally expected based usually on recent previous years.  The Australian government publishes this data on a regular basis as Provisional Mortality Statistics[21]. 

In Australia and around the world these All-Cause Mortality statistics have shown a disturbing trend of about 16-20% Excess Deaths since the rollout of the “COVID-vaccines” in 2021 but not in 2020 when there were no “COVID vaccines” and the SARS-CoV-2 virus was at its most virulent.  The majority of these Excess Deaths in 2021 and 2022 were non-COVID-19 deaths and include heart attacks, strokes, diabetes, dementia and other neurological conditions.
 
So, what caused most of the Excess Deaths if it wasn’t COVID-19?
There is now evidence to show that an analysis of COVID vaccine use is strongly correlated with All-Cause Mortality over 31 European Union member states and Norway, Iceland, Liechtenstein and Switzerland[22]. The report shows that the more a country engages in COVID vaccination, the higher is the overall mortality from all causes.  A Bradford Hill analysis of Excess Mortality in relation to the “COVID vaccines” showed mass vaccination was strongly correlated with Excess Deaths[23].

There appears to be a growing body of opinion that the “COVID vaccines” are doing more harm than good[24]and they should be withdrawn.

Additional evidence that the “COVID vaccines” are responsible for the majority of the Excess Deaths comes from a report by Rancourt et al[25].  

The excess All-Cause Mortality following the COVID-19 vaccine rollout (31,000 deaths, mid-April 2021 through August 2022) is more than twice the total number of Australian deaths registered as being from or with COVID-19 (14,014 deaths, 1 January 2020 through 29 August 2022).
The Australian Government is currently attempting to minimise the number of Excess Deaths Reported by the Australian Bureau of Statistics in their latest All-Cause Mortality statistics for 2022 first by ignoring the low number of Excess Deaths in 2020 used as a baseline and more recently by adjusting the number of Excess Deaths downwards by 12,000 using a mysterious statistical model[26] rather than actual Excess Death numbers. In reality, for 2022, there were about 10,000 COVID-19 deaths (as determined by PCR testing) and 20,000 unexplained non-COVID excess deaths.

This is reprehensible. This needs investigation. This needs explaining.
The Australian government continues to insist that the so-called COVID vaccines are “safe and effective” but evidence to support this claim is lacking. In addition, there is no credible or supportable explanation for dramatic rise in the unexpected non-COVID Excess Deaths which have occurred only after the rollout of the “COVID vaccines”. 
One would have thought, given the magnitude of the COVID tragedy, that it would be of utmost importance to determine what is causing more than 30,000 Australians to die non-COVID deaths above average since the “COVID vaccines” were rolled out. A motion to investigate the possible causes of the unexpected non-COVID deaths was introduced into the Australian Federal Parliament in March 2023 and was defeated.

[1] Openvaers.com (last visited 28 June 2023)
[2] UK All Party Parliamentary Group – Pandemic Response and Recovery Group. 17 July 2023.  https://appgpandemic.org/news/yellow-card
[3] Kirsch, S., Rose, J. and Crawford, M. Estimating the number of COVID vaccine deaths in America.
https://sunfellow.com/wp-content/uploads/2021/09/VAERS-Deaths-Kirsch-Rose-Crawford.pdf
[4] Ourworldindata.org United States confirmed deaths. Last visited 21 Aug. 2023.
[5] Australian Government – Dept. of Health and Aged Care. COVID-19 vaccine safety report 15-12-2022.  https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-15-12-2022. 
[6] Rose, J.: Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. vaccine Adverse Events Reproting System (VAERS) a Functioning Pharmacovigilance System”. Science, Public Health Policy, and the Law. Vol 3:100-129, Oct. 2021. https://www.researchgate.net/publication/370158323_Critical_Appraisal_of_VAERS_Pharmacovigilance_Is_the_US_Vaccine_Adverse_Events_Reporting_System_VAERS_a_Functioning_Pharmacovigilance_System
[7] Josh Guezknow Substack: CDC Finally Released its VAERS Safety Monitoring Analyses for COVID Vaccines via FOIA. 5 Jan. 2023. 
https://open.substack.com/pub/jackanapes/p/cdc-finally-released-its-vaers-safety?r=10pxn5&utm_campaign=post&utm_medium=email
[8] Jessica Rose Substack: 19 June 2023. Scrub-a-dub-dub, is Janssen gettin’ thrown off the sub?  
[9] Australian Health Practitioner Regulatory Agency (AHPRA) Position Statement 9 March 2021. 
[10] Onakpoya, I, J. et al: Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature. DOI 10.1186/s12916-016-0553-2
[11] Demasi, M.: FDA urged o publish follow-up studies on Covid-19 vaccine safety signals.  https://www.bmj.com/content/379/bmj.o2527
[12] Personal communication: Case numbers 616124, 647663, 659048, 719838, 724023, 733723, 734187, 744306 and 762472
[13] Mercola, J.: Epoch Times 21 May 2022. Thousands of Deaths and Adverse Reactions Deleted from VAERS. https://www.theepochtimes.com/thousands-of-deaths-and-adverse-reactions-deleted-from-vaers_4481440.html?utm_source=Health&utm_campaign=health-2022-05-22&utm_medium=email&est=7m17NiFo5EoGT1omDWz1WO3DSAnrvrbqvGJvEw%2BYltfW41BaiwbGVeQQ6zkYgnniTyq%2FL7wEg7MbfdTV3MyrR1w%3D#Print
[14] Mohanoor, A: A review of recent Creutzfeldt-Jakob disease VAERS reports. 17 April 2923.  
[15] Fraiman, J. et al: Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine 40 (2022) 5798–5805.  https://doi.org/10.1016/j.vaccine.2022.08.036
[16] Office of Infectious Disease. HIV/AIDS Policy. Vaccine side effects. 2021. http://www.hhs.gov/immunization/basics/safety/side-effects/index.html
[17] Australian Government – Dept. of Health and Aged Care. COVID-19 vaccine safety report 15-12-2022.  https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-15-12-2022.
[18] Radio Interview of Dr. Ross Walker 6 June 2023: 2HD 1143AM Newcastle.  https://www.2hd.com.au/2023/06/06/dr-ross-walker-explains-the-importance-of-good-muscle-strength/?fbclid=IwAR2xpd22lfXIuQRcHOYpEPU8o1_qzzPg3QDeOGM2zfGaOYIA_RuIONJkGsM_aem_th_AYsku5AtEgbXgSaCfd6mJHWWNlaJbUNkNPjBn9WQ_Jyn0imbMS6CE-1Ia3bCRYf428E
[19] Menge, M.: Crossroads Report. Fifth largest life insurance company in the US paid out 163% more for deaths of working people ages 18-64 in 2021 – total claims/benefits up $6 Billion. 16 June 2022. 
[20] Western Australian Vaccine Safety Surveillance – Annual Report 2021.  https://www.health.wa.gov.au/~/media/Corp/Documents/Health-for/Immunisation/Western-Australia-Vaccine-Safety-Surveillance-Annual-Report-2021.pdf
[21] Australian Bureau of Statistics – Provisional Mortlity Statistics. Release 28.6.23.  https://www.abs.gov.au/statistics/health/causes-death/provisional-mortality-statistics/latest-release
[22] Aarstad, J and Kvitastein, O.A.: Is there a Link between the 2021 COVID-19 vaccination uptake in Europe and 2022 Excess All-Cause Mortality?  https://www.preprints.org/manuscript/202302.0350/v1
[23] Sy, W.: Australian COVID-19 pandemic: A Bradford Hill Analysis of Iatrogenic Excess Mortality. J. Clin. Exp. Immunol. 2023, Vol 8, Issue 2, 542-556. 1 April 2023.  https://www.opastpublishers.com/peer-review/australian-covid19-pandemic-a-bradford-hill-analysis-of-iatrogenic-excess-mortality-5339.html
[24] Classen, J.B.: US COVID-19 Vaccines Proven to Cause More Harm than Good Based on Pivotal Clinical Trial Data Analyzed Using the Proper Scientific Endpoint, “All Cause Severe Morbidity”. Trends int. Med. 2021, Vol 1, issue 1, pp1-6. 
[25] Correlation Research in the Public Interest. Rancourt, D.G. et al. 20 Dec. 2022. https://www.researchgate.net/publication/366445769_Probable_causal_association_between_Australia%27s_new_regime_of_high_all-cause_mortality_and_its_COVID-19_vaccine_rollout
[26] Wilson Sy. Australian Excess Deaths: Moving the Goalposts. In print – Principia Scientific 2023 and phillipaltman.substack.com 24 Aug. 2023.

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