On the 16th of February 2021, the Therapeutic Goods Administration (TGA) provisionally approved the COVID-19 Vaccine AstraZeneca (ChAdOx1-S) for active immunisation of individuals 18 years and older. This follows the provisional approval of COMIRNATY, the Pfizer vaccine, on the 25th of January 2021 for individuals 16 years and older. The TGA has released the Australian Public Assessment Report and the Australian Product Information for the AstraZeneca vaccine.
Unlike the Pfizer vaccine, which uses mRNA technology, the AstraZeneca vaccine is a more traditional vaccine. It is composed of a “recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike (S) glycoprotein (GP)”. Like other vaccines, it is “manufactured using material originally sourced from a human embryo (Human Embryonic Kidney cells: HEK293)”. HEK293 is a “specific cell line originally derived from human embryonic kidney cells grown in tissue culture taken from an aborted female foetus”. There is much conjecture around whether vaccines use aborted foetal tissue, which raise numerous moral, ethical and religious questions. The AstraZeneca vaccine is manufactured using a cell line from an aborted foetus.
According to the Australian Public Assessment Report (APAR), there are “significant concerns about the robustness of the data. The study design was not entirely fit for purpose to evaluate efficacy in high risk groups, there is insufficient data about dosing, and there were a number of patients lost to efficacy analysis.” The TGA’s own assessment report states that there is insufficient data about dosing. This is highly alarming. If the Australian government is going to roll out a vaccine to the Australian population that has been developed in less than 12 months when normal vaccine development takes 10-12 years, surely one of the first things that we should know is the dosage. The APAR states that the “dosing interval proposed for 4 to 12 weeks is acceptable”. How can you ‘propose’ a time frame? Surely, prior to the provisional approval of the vaccine, this simple fact should have been established. It’s no wonder that Swiss Medical Regulator have decided not to approve the AstraZeneca vaccine for use due to a lack of data.
The Australian Public Assessment Report continues by stating that the following is “missing information”:
The Australian government, along with the TGA, have repeatedly stated that the vaccine is effective and safe, yet the APAR clearly states that there is no long-term safety data. How can one definitively say that the vaccine is safe without this data? European countries France, Germany, Italy, Sweden and Poland have all advised against the use of the vaccine over a certain age. Why has the Australian government not advised against use of the vaccine in individuals over the age of 65, given that there is no data on this demographic of people? This age group often have co-morbidities. There is no data on those with co-morbidities, which is even more dangerous. The alarm bells are ringing loud and clear.
As with the Pfizer vaccine, the “duration of protection has not yet been established”. The TGA have provisionally approved two vaccines for COVID-19, yet we have no idea how long immunity will last. At this stage, it is two months at best. The Australian Product Information (API) states that the “COVID-19 Vaccine AstraZeneca has provisional approval for… Active immunisation of individuals >18 years old for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2”. This API clearly states that the vaccine prevents COVID-19, yet the same report states that the duration of protection is unknown. Which is it? Are we protected or not? One would assume that this would be the basis of any vaccine, and if it is unclear if or how long protection lasts, then surely more studies are required prior to rolling it out to the Australian public.
The Australian Product Information also states that “genotoxicity (mutagenicity)” or “carcinogenicity” studies have not been conducted. Genotoxicity refers to chemical agents that damage the genetic information within a cell causing mutations, which may lead to cancer, whilst carcinogenicity refers to the ability or tendency to produce cancer. Again, one would assume that it would be imperative that these studies are conducted before rolling out a vaccine to the entire population. The consequences could be catastrophic if the vaccine is found to cause either of these issues.
There have been a number of concerning side effects throughout the AstraZeneca vaccine trials. According to the APAR, important potential risks include nervous system disorders, including immune-mediated neurological conditions, vaccine-associated enhanced disease (VAED), including vaccine associated enhanced respiratory disease (VAERD), and anaphylaxis. There were reported cases of transverse myelitis, an inflammatory condition of the spinal cord, in September 2020 in the UK AstraZeneca trial, resulting in the trial being paused. In fact, the trial was suspended temporarily in the US as a result of the adverse reactions in the UK. We are already seeing a large number of adverse reactions to the AstraZeneca vaccine in the UK and around the world.
Although the AstraZeneca vaccine is a more traditional vaccine compared to the Pfizer vaccine, there is no more data available on it. There is no data on how long immunity will last, or if the vaccine will prevent transmission of the virus. There is so little data that it makes one question how the TGA could even approve such a vaccine. They are using “post-market assessment” to determine the efficacy and safety of the vaccine. That means that anyone that takes the vaccine is part of the clinical trials. Ruud Dobber, a member of Astra’s senior executive team, stated that “this is a unique situation where we as a company simply cannot take the risk if in… four years the vaccine is showing side effects”. The point of vaccine trials is to rule out these long-term side effects through clinical trials, not mass population experiments. We are not protected and the pharmaceutical companies are not liable should something go wrong. This is unacceptable, and the Australian public deserve so much better. More and more people are saying no to this experimental and rushed-to-market vaccine for a virus with a 99.7% survival rate. More and more people in Australia and around the world are standing up for medical freedom. Where there is risk, there must be choice.
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