Are you interested to know the information the TGA actually reviewed when it came to approving the AstraZeneca jabs?
Now you can!
The Australian Therapeutic Goods Administration (TGA) Freedom of Information (FOI) Disclosure Log can be found here
Here are the direct PDF files for AstraZeneca FOI 2494
Document 1 - TGA DELEGATE'S OVERVIEW
Document 2 - Notice of decisions to provisionally register medicine(s)
Document 3 - Meeting with EMA Rapporteurs/ Co-Rapporteurs
Document 4 - Advisory Committee on Vaccines ACV 19 Minutes
Document 5 - TGA Clinical Evaluation Report
Document 6 - Nonclinical Evaluation Report
Document 7 - Australian Specific Annex to the EU Risk Management Plan for COVID-19 Vaccine AstraZeneca
Here are some of the excerpts from document 1 alone...
EXCERPTS
"The sponsor has submitted an interim analysis of a meta- analysis of 4 clinical studies. Over 23 000 subjects are available for the analysis of safety, around 10 000 are available for the analysis of efficacy. There were a number of changes in the protocol during the clinical study, which has led to significant heterogeneity and potential confounding factors. In addition, there was limited follow up time; high risk populations such as the elderly and those with significant co-morbidities were under-represented in the studies. Dosing interval varied from 3 to 26 weeks. For the dose proposed for registration, the SDSD group, efficacy was 62%. Apart of reactogenicity, there were no significant safety concerns."
EXPERT ADVICE
"The statistician considered it appropriate to exclude the studies where there were < 5 cases of COVID-19. He considered that Poisson models were appropriate, and that there would be very little gained from using Bayesian statistics. The short duration of follow up, and decreasing number of participants followed as duration from the baseline increases, decreases the precision of data with longer duration of follow up. The Kaplan Meier curves were therefore misleading. Statistical analysis of secondary or supportive endpoints should be considered cautiously, with the following factors considers 1) biological rationale for the subgroup; 2) prior evidence or belief that a differential effect in a subgroup is plausible 3) independent confirmation from other factors in the study of the possible differential treatment effect in the subgroup"
TOXICOLOGY
"The sponsor has generally conducted adequate pharmacology studies. As part of a rolling submission limited toxicity studies were provided with AZD1222. A biodistribution study and a main developmental and reproductive toxicity (DART) study in mice are pending."
VIRAL SHEDDING
"When vaccinated rhesus monkeys were exposed to COVID - 19, the clinical disease severity scores in the lungs were reduced, however there was no reduction in viral shedding from the nose."
BIODISTRIBUTION
"Three different mouse studies using three different ChAdOx1 vectors examined the biodistribution.
Two of these showed no evidence of the adenovirus vector beyond the site of administration.
The third show low levels of the ChAdOx1 vector were found in the heart, liver, ovary, testes and lymph nodes."
"No genotoxicity or carcinogenicity studies are performed"
DISCUSSION
"The study was not powered for secondary analysis – thus firm conclusions cannot be drawn from this. However there appeared to be lower number of patients requiring hospitalisation. The COV002 study included active screening for asymptomatic COVID-19. Participants were required to perform and return their own swab. The results are uninterpretable due to low numbers and incomplete compliance. Animal studies have shown reduced viral load in the lower respiratory tract but persistent spreading in the upper respiratory tract. At this stage, efficacy in preventing asymptomatic disease and transmission is unknown."
It is important that the population understand the facts about the efficacy of the vaccine, and limitations of the data, and the need to continue other public health measures to prevent the spread of disease until more information about vaccine efficacy is available.
"One of the major limitations in the study is the short and variable duration of follow up. The duration of follow up, and reasons for missing data in follow up, are important in determining efficacy. Lower duration of follow up may be from drop outs, but may also arise due to sensoring of cases. Longer duration of follow up increases the time of exposure and increases the opportunity for true effectiveness (or non-effectiveness ) to be demonstrated. Variable doses and variable dose intervals arose due to procedural issues in the study. Although the AZD1222 and control groups were equally affected, different subgroups within the meta-analysis were unequally affected. For regulatory purposes, the sponsor is proposing the standard dose of 5 X 1010 vp and a two dose regime, 4-12 weeks apart. This is supported by primary efficacy analysis. And will be confirmed by ongoing studies. The post hoc exploratory subgroup analysis suggested greater efficacy (and immunogenicity) with longer dose intervals, such that the best dose regimen may be 12 weeks between doses. This is supported by adequate protection of a single dose for up to 12 weeks, and adequate protection after 2 doses for after 12 weeks. The optimal dose interval within the 4-12 week interval for the vaccine roll out is best left to the immunisation task force for consideration."
Another limitation to the clinical development program was that those at high risk of COVID -19, including the elderly and those with significant co-morbidities, were excluded or under- represented.
"From a regulatory perspective, under the Therapeutic Goods Act the delegate must be satisfied that ‘quality safety and efficacy have been adequately established for the purpose for which they are to be used’. This is a different assessment to a risk/benefit analysis as the potential risks of vaccination are small, and the potential benefits in this population large. In my opinion as delegate, these populations should not be excluded from the indication as it is reasonable to extrapolate efficacy, and the risks of COVID-19 outweigh potential risks of the vaccine."
But there needs to be adequate warning about the limitations of the data in the PI, and a recommendation to prescribers that the potential risks and benefits to an individual be considered prior to proceeding to vaccinate. Similar limitations apply to the data available for use in pregnancy. However, not only was there insufficient patients in the study but also incomplete pre-clinical studies. The proposed pregnancy category is B2.
"The ACV will be requested to advice on the adequacy of the warning for use in pregnancy."
What is most alarming...this document was NOT written by AstraZeneca, it was written by a Delegate in the Australian TGA!!!
The Australian people have not been tricked by the pharmaceutical companies, this document proves that the Australian TGA were aware of;
1. All of the testing gaps,
2. All of the gaps with age, pregnancy,
immunocompromised,
3. all of the gaps with animal trials,
4. The risk with Adenovirus spreading through the bodies of mice in 1 out of 3 trials,
5. no toxicity testing,
6. no conformity in dosing regimen,
7. Follow up periods were hit and miss,
8. Trial protocols changed numerous times
9. follow up period fluctuated,
10. asymptomatic cases were tracked by people testing themselves,
11. animals challenged with COVID-19 after vaccination still had viral shedding in the nose
And after acknowledging all those limitations, gaps, and discrepancies, the TGA approved ASTRAZENECA anyway!!!
REMEMBER...
THIS IS JUST A FEW SECTIONS FROM 1 OUT OF 7 FOI DOCUMENTS
