The Therapeutic Goods Administration (TGA) recently granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, whilst Prime Minister Scott Morrison has indicated that the vaccine will be rolled out across the country from the end of February. According to the Department of Health, quarantine and border workers, frontline health care workers, and aged care and disability care staff and residents will be amongst the first to receive the vaccine.
In a recent interview, John Skerritt, the head of the Therapeutic Goods Administration, explained that the TGA has “done the same amount of work” in a shorter period of time as they would for the approval of other vaccines. There is no doubt that many people have been working around the clock to develop and approve the COVID-19 vaccine in record time. However, one thing that doesn’t change is the length of time that is required to adequately assess the efficacy and safety of a vaccine. There is no way to speed this process up because it simply takes time.
Mr Skerritt highlighted this point himself. “What we don’t have, which we often have with other vaccines, is an indication of whether the vaccine will last for a year, three years, forever.” According to the TGA’s Australian Public Assessment Report, the “duration of protection is not yet known and is to be assessed in the ongoing trial”. There is currently no data that suggests that the vaccine will provide protection from COVID-19 beyond two months. Mr Skerritt continues by stating that “we also don’t know how well the vaccines prevent transmission.” The ongoing trial is every person that receives the vaccine between now and January 2023 when the trial is due for completion.
The Centres for Disease Control and Prevention (CDC) state that a vaccine is a “product that stimulates a person’s immune system to produce immunity to a specific disease, protecting that person from that disease”. Immunity means that “you can be exposed to it (a disease) without becoming infected”. According to the TGA, the Pfizer vaccine doesn’t provide immunity nor does it stop transmission of the virus. One could argue that the Pfizer vaccine by definition is not actually a vaccine at all. And if it isn’t a vaccine, then exactly what is it?
The idea of herd immunity is that enough people will develop immunity to a particular disease either naturally or through vaccination in order to protect those that are most vulnerable to the disease, and to protect those that are unable to receive a vaccine against the disease. If it is not yet known if the COVID-19 vaccine provides immunity or prevents transmission, how is it possible to protect those that are most vulnerable? According to Mr Skerritt, the “information on how long the vaccine will last will take some years to develop.” In the meantime, we are all expected to take the experimental vaccine without knowing if it will protect us or those around us from COVID-19.
Mr Skerritt continues by explaining that “even the very serious safety effects that arise tend to happen 4-6 weeks after the first shots.” We are seeing a number of very serious reactions to the vaccine in many countries around the world, including a number of deaths within days or weeks of taking the vaccine. Many of these deaths have occurred in aged care facilities, which according to the Federal Government, will be the first in line to receive this experimental vaccine. Why is it then, that when someone has a severe reaction or dies within 2-3 weeks of having the vaccine, governments and pharmaceutical companies state that there is no correlation between the vaccine and the reaction or death, given that Mr Skerritt stated that “serious effects” can occur 4-6 weeks after the vaccine is administered?
The Therapeutic Goods Administration are “expecting a final decision to made during the month of February” regarding approval of the AstraZeneca/Oxford vaccine. According to Mr Skerritt, the Pfizer and AstraZeneca vaccines “appear to be good vaccines, and both are supported by large amounts of data… Both have good data on how effective they are, both have a good safety record… For some things we don’t know, but the safety evidence is pretty thorough.”
The Australian Public Assessment Report, which was compiled by the TGA and is freely available on their website, certainly contradicts these statements. The Australian Public Assessment Report states the following:
“In addition to the unknown longer term safety and unknown duration of vaccine protection, there are other limitations with the submitted data. The following questions have not yet been addressed:
The Pfizer and AstraZeneca vaccines are quite clearly not supported by large amounts of data. The Swiss medical regulator recently announced that they were not approving the AstraZeneca vaccine for use due to a “lack of data to reach conclusions on the efficacy of the COVID-19 vaccine”. This follows other European countries France, Germany, Italy, Sweden and Poland in advising people over a certain age not to take the AstraZeneca vaccine. Will the TGA follow the lead of these European countries by requesting more data before provisionally approving the vaccine?
In his interview, Mr Skerritt was asked what the worst-case scenario would be. One would assume that the worst-case scenario would be severe adverse events or even deaths as a direct result of the vaccine. Mr Skerritt answered this question by saying that the “worst-case scenario will be that there’s very low take up of the vaccines”. Does the government really care about our health or do they simply care about profits?
The government continually reiterates that their draconian measures are in place to protect our health. Does the same apply when it comes to vaccines? Will the TGA remove the provisional approval should the vaccine prove to be ineffective or unsafe? Will they refuse to approve vaccines that lack the required efficacy and safety data? There is already a high level of scepticism when it comes to taking the COVID-19 vaccine, and given the lack of data so far, it is completely justified. We have the right to ask questions and demand answers, especially when it comes to our health and the health of our children.
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