Investigation into claims that vaccines undergo stringent assessments by TGA

We are told by our government representatives that all vaccines in use in Australia must undergo “stringent” or “rigorous” assessments by the Therapeutic Goods Administration (TGA). However our investigations show that the TGA assessments are somewhat less than “stringent” or “rigorous” by any reasonable measure. Our evidence based findings listed below.

From TGA website:

“The TGA rigorously assesses vaccines for safety, quality and efficacy before they can be used in Australia” [1].

“The TGA regulates therapeutic goods through:

Premarket assessment; post market monitoring and enforcement of standards; licencing of Australian manufacturers and verifying overseas manufacturers’ compliance with the same standards as their Australian counterparts” [2].

So let’s look at this a little deeper.

1. PRE-MARKET ASSESSMENT

The TGA’s “Pre-market assessment” is contained in reports (AusPARs) [3] that provide information about the evaluation of prescription medicines and the considerations that lead the TGA to approve or reject an application.

The TGA misleadingly describes its vaccine assessments: “Before any COVID-19 vaccine is approved for use in Australia it will be subject to the TGA’s stringent assessment and approval processes. The TGA rigorously assesses all vaccines for safety, quality and effectiveness. Vaccine candidates are subject to clinical and non-clinical assessments by technical experts.” [4]

When we reviewed the TGA’s AusPARs for the COVID vaccines, we found that ALL of the clinical trials used for their assessments were by vaccine manufacturers and developers and NONE were independent. For example:

AstraZeneca / Oxford: ChAdOx1-S (9 clinical trials) [5]

- 5 were conducted by the vaccine’s developer; the University of Oxford - 3 were conducted by AstraZeneca - 1 was conducted by vaccine manufacturer Serum Institute of India/Indian Council of Medical Research

Pfizer / BioNTech: Comirnaty BNT162b2 (mRNA) (2 clinical trials) [6]

- 2 were conducted by vaccine developer BioNTech

Note: “Employees of Pfizer may hold stock options from Pfizer to perform neutralisation assays…” [7]


The TGA assessed the data provided by the manufacturers and their associates who conducted the trials. The TGA did NOT conduct its own trials or commission independent trials.

2. POST-MARKET MONITORING | ADVERSE EVENT REPORTING

Post-market monitoring consists of two types of reporting:

  1. Passive (Through TGA’s Database of Adverse Event Notifications (DAEN) website)

  2. Active (through AusVaxSafety);

Some Limitations of the Database of Adverse Event Notifications (DAEN)

The TGA states “It is generally acknowledged that adverse events are under-reported around the world, with estimates that 90-95% of adverse events are not reported to regulators” [8]. e.g. in the USA “fewer than 1% of adverse events are reported" [9]. “Adverse event reports from consumers and health professionals to the TGA are voluntary, so there is under-reporting by these groups of adverse events related to therapeutic goods in Australia.” [10]

  • The TGA’s weekly vaccine safety report on 27th May 2021 states that “the TGA has received 210 reports of death following vaccination for COVID-19” [11]. The TGA claims the statistic to be “misinformation” [12] if causality is attributed to all the deaths.

BUT….

  • The TGA states: “The TGA reviews all deaths reported after vaccination and monitors for safety signals. Part of our analysis includes comparing expected natural death rates to observed death rates following immunisation” [11]. Can the TGA actually gather data on “natural death rates” or are the TGA’s “natural death rates” really those in the repeatedly vaccinated?

  • The TGA then says: “To date, the observed number of deaths reported after vaccination is actually less than the expected number of deaths.” [11]. Of course it is. The TGA has acknowledged (above) most adverse events go unreported. Hence, the “observed and reported deaths” constitute, at best, an uncertain fraction of vaccination associated deaths and, at worst, an underestimate.

  • Furthermore the TGA notes “ … it is possible in frail older people that even relatively mild and expected adverse reactions following the vaccination may contribute to deterioration of an underlying illness” [11]. So could “adverse reactions” and ”adverse events” that are not mild or not expected hasten death? Death that may be wholly attributed to an underlying illness?

To 24th June 2021, there have been 318 reports to the TGA of death following COVID vaccination [13].


Given that there is only limited and preliminary safety data from vaccine trials available, these deaths may constitute significant associations that the population should know about.

Some Limitations of the AusVaxSafety adverse event reporting

Active surveillance for vaccines was implemented in Australia in 2014 to monitor flu vaccination for <5’s [14], but has been extended to vaccines on the National Immunisation Program. It would appear that active surveillance stops a mere three days post-vaccination [15], making it unsuitable for detecting adverse events and other illness with a delayed onset.

Active surveillance of injury and illness associated with COVID vaccination occurs at 3, 8, and 42 days after vaccination [6]. However, this surveillance ONLY includes those vaccinated at a “participating immunisation clinic”. There are only 450 participating clinics in the whole of Australia. None of which include Aged Care facilities or hubs. Are the elderly without mobile phones excluded?

Thus, just a very small fraction of the total vaccinations is monitored and that for only a short time [17].

The TGA has also been quick to dismiss many deaths from being associated with vaccination. The death of Lindsey Day [18], Ashley Epapara [19], Alina Poppy Murtagh [20] and an Adelaide man’s blood clots [21] were quickly dismissed as not being caused by the vaccine. It simply doesn’t make sense that some people, not ill prior to vaccination, can become ill soon after vaccination and die without clear other cause. When no other cause can be found, the vaccine SHOULD be suspected.

3. CONFLICTS OF INTEREST

The funding system the TGA uses is known as Cost Recovery (or User-Pays) and it means that the TGA recovers the full cost of its regulatory activities by charging the sponsors and manufacturers of the products that are regulated [22]. i.e. the pharmaceutical and manufacturing industry funds the TGA’s regulatory activity even though this government body has the dual role of approving drugs for its sponsors and monitoring the safety of drugs and vaccines during their routine use!

The composition of the TGA’s Advisory Committee on Vaccines (ACV) and advisors to Government is such that government advice is heavily weighted towards pharmaceutical solutions rather than “root cause” approaches such as immune enhancement through an improved environment and life style education.

For example, chair of the ACV, Prof Allen Cheng, is Professor (research), Epidemiology and Preventive Medicine Alfred Hospital [23] run by Alfred Health [24], which has received payments from vaccine manufacturers and collaborators, GSK, Merck, Gilead and George Clinical [25].

4. CONCLUSION

Based on our findings so far, the TGA’s regulatory involvement into vaccination assessment is far from independent. Its processes are not adequate, not “stringent” nor “rigorous” as claimed. In fact, such characterisations can be reasonably seen as “mis-information” or even dis-information.

Since the TGA and its advisor, the ACV, relies on vaccine developers and manufacturers for the assessment of effectiveness and safety and the TGA receives ongoing funding from pharmaceutical companies and both approves and monitors vaccines, it has multiple and profound conflicts of interest.

Are the foxes in charge of the henhouse?

In our view, the TGA neither conducts, nor is fit to conduct, “rigorous” practical assessment of vaccine safety or effectiveness, either before or after approval and use.

REFERENCES:

1] https://www.tga.gov.au/vaccines-overview [2] https://www.tga.gov.au/how-tga-regulates [3] https://www.tga.gov.au/australian-public-assessment-reports-prescription-medicines-auspars [4] https://www.health.gov.au/sites/default/files/documents/2021/01/aboriginal-and-torres-strait-islander-advisory-group-on-covid-19-communiques-25-january-2021-communique.pdf [5] https://www.tga.gov.au/auspar/auspar-chadox1-s [6] https://www.tga.gov.au/auspar/auspar-bnt162b2-mrna-comirnaty [7] https://www.biorxiv.org/content/10.1101/2020.09.08.280818v1 [8] https://www.tga.gov.au/media-release/new-web-service-helps-consumer-reporting-side-effects [9] https://web.archive.org/web/20190813160009/https://paleofam.com/wp-content/uploads/2019/02/r18hs017045-lazarus-final-report-2011.pdf [10] https://www.tga.gov.au/about-daen-medicines [11] https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-27-05-2021 [12] https://www.theguardian.com/australia-news/2021/jun/01/australias-drug-regulator-may-refer-anti-vaccination-facebook-posts-to-federal-police [13] https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-24-06-2021 [14] https://www.ausvaxsafety.org.au/about-us/our-history [15] https://www.ausvaxsafety.org.au/about-us/faqs Click on “What timeframe does AusVaxSafety monitor AEFI?” [16] https://www.ausvaxsafety.org.au/sites/default/files/2021-03/AusVaxSafety%E2%80%99s%20ACTIVE%20follow-up.pdf [17] https://www.smartvax.com.au/smartvax-participating-clinics/ [18] https://lindseyday.org/ [19] https://www.abc.net.au/news/2010-09-10/flu-vaccine-cant-be-ruled-out-in-toddlers-death/2256142 [20] http://www.stopmandatoryvaccination.com/parent/vaccine-injury/mmr-vaccine-causes-loss-of-speech-appetite-horrendous-seizures-and-then-her-death/ [21] https://fb.watch/5T9a4xJDON/ [22] https://www.tga.gov.au/fees-and-payments [23] https://research.monash.edu/en/persons/allen-cheng [24] https://www.alfredhealth.org.au/our-hospitals/ [25] https://www.health.gov.au/sites/default/files/atagi-conflict-of-interest-disclosures.pdf


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