The New Daily published an article recently criticising Clive Palmer’s COVID-19 vaccine newspaper advertisements that appeared in The Australian and The Western Australian newspapers. The article titled, “Fact-checking Clive Palmer’s ‘dangerous’ vaccine ads”, takes issue with Mr Palmer being “very concerned by the emergency use of this vaccine on the general population”. The author states that “this is an incorrect claim, with Australia’s Therapeutic Goods Administration running a full approval process on both the Pfizer and AstraZeneca – not an emergency use authorisation, as other nations around the world have enacted”.
The article states that the ad “contains factual inaccuracies” and that the “TGA does not have an ‘Emergency Use Authorisation’ pathway for COVID-19 vaccines. Australia has issued a formal regulatory approval for the Pfizer COVID-19 vaccine and AstraZeneca COVID-19 vaccine.”
The author is correct in pointing out that the Therapeutic Goods Administration (TGA) is running an approval process. However, the crucial point to note here, which leads to Mr Palmer’s concerns, is that this approval process is currently ongoing. The TGA have only granted PROVISIONAL approval for both the Pfizer and AstraZeneca vaccines. Full approval has NOT yet been granted.
In their official media release regarding the Pfizer and AstraZeneca vaccines, the TGA states: “Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for (Pfizer and AstraZeneca) to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.”
Granting provisional approval confirms that the safety and efficacy of the vaccines is still under investigation, particularly in the longer term. This reasonably validates Mr Palmer’s concern that the vaccine rollout has been rushed, and that there is the same inherent risk to Australians receiving the jab, as there would be for any patient participating in an ongoing clinical trial. This notion was reaffirmed by Australian Federal Health Minister Greg Hunt, who stated recently in an interview with ABC news that the “world is engaged in the largest clinical trial, the largest global vaccination trial ever”.
Mr Palmer did not claim that the vaccines have been granted ‘emergency use authorisation’, as they have been in the U.S. This would be an incorrect statement, as they have been granted provisional approval. Mr Palmer also states that the “simple fact is that we don’t have one-year safety data, three-year safety data or five-year safety data for the use of the COVID-19 vaccine”. Mr Palmer is correct. We do not have this data. The Australian Public Assessment Report for the Pfizer vaccine states that the long-term safety is “unknown”. Normal vaccine development takes 10-12 years, whilst these vaccines have been rushed to market in 6-12 months. The Pfizer vaccine uses mRNA technology, which has never been used in a vaccine for humans previously. Mr Palmer, along with every other Australian, should be questioning whether these vaccines are indeed safe, not just in the short-term, but also in the long-term.
The article also takes issue with an advertisement Mr Palmer placed specifically in The West Australian newspaper, requesting readers to “ask Mark McGowan” why the government had “provided pharmaceutical companies with an indemnity from injury or death”. The article claims Mr Palmer is “wrong” to request the Western Australian constituency to question their state Premier, because it was the “Federal Government that inked deals with vaccine manufacturers and provided the indemnity”. Surely the question of who inked the indemnity deal is insignificant compared to the fact that pharmaceutical companies are indemnified against liabilities that could result from the use of this experimental treatment that is still currently undergoing clinical trials?
Mr Palmer should be applauded for having the courage to publicly question these rushed-to-market vaccines, and he should be congratulated for requesting long-term safety data before the vaccine is rolled out to the general population. Like Mr Palmer, we should all be demanding long-term safety data before we choose whether or not to receive the vaccine. We should be made aware of the risks of taking the vaccine, and it should be acknowledged that we will not be able to pursue legal action against the pharmaceutical companies should we or a family member suffer from a serious adverse event or death as a result of the vaccine. These ads are far from dangerous. They are merely asking simple questions that the government is unable to answer. Where there is risk, there must be choice.