Australia is following the UK and US in rolling out COVID-19 vaccines.
Given the enormity of the program, and its wide ranging implications, let’s dig a little into what vaccines are being fast tracked, and how it will roll out.
According to a Department of Health spokesperson, ‘The Government has secured access to COVID-19 vaccines through advanced purchase agreements with AstraZeneca, Novavax and Pfizer’.
They added, ‘Additional COVID-19 vaccine candidates are being evaluated in early stage clinical trials in Australia, including one developed by Flinders University and Adelaide company Vaxine, and four being developed by international companies (SpyBiotech/Serum Institute of India, Novavax, Clover Biopharmaceuticals and Symvivo)’.
All will be assessed by the Therapeutic Goods Administration (TGA), says the spokesperson, ‘after being tested in large clinical trials on thousands of people.
They added, ‘The TGA and the Australian Government won’t be cutting any corners in the regulatory process’.
According to www.health.gov.au, all four are up to Phase III clinical trials, and owing to the fast tracking, ‘some of these phases have been combined’.
Biomedical intervention vaccinations generally pass through four phases during development, which starts with small groups of people, and expands to hundreds, then thousands.
The Department of Health spokesperson told The Echo, ‘Phase IV clinical trials refer to clinical trials that occur after a vaccine is licensed to continue to monitor safety and effectiveness’.
Who is Pfizer?
Pfizer produces Viagra, Xanax and Zoloft and, according to Drug Watch, was the second-largest pharmaceutical company, by revenue, in 2020. The largest is Johnson & Johnson.
Pfizer’s 2019 revenue was US $51.75 billion, according to its financial report.
Headquartered in the US, Pfizer’s largest shareholders are mutual fund managers, the Vanguard Group being the largest, holding 7.6 per cent.
BlackRock Fund Advisors are the third biggest shareholders. BlackRock are the world’s largest asset manager, with around $7 trillion under management.
Like all behemoth corporations, they regularly break the law, defend themselves in court, then pay the fines if they lose. It’s all part of their business model and is factored into profit margins.
In 2009, ABC News reported Pfizer was fined $2.3 billion ‘for illegal marketing in an off-label drug case’, making it the ‘largest health care fraud settlement in history’.
It’s worth considering that, in light of CNN’s report in November 2020: ‘Shares of Pfizer jumped by almost 15 per cent after the company and its partner, BioNTech, said its vaccine was more than 90 per cent effective in preventing COVID-19 among those in the trial without evidence of prior infection’.
A ‘serious’ allergic reactions was recorded from Pfizer’s vaccine, by two UK National Health Service staffers. The UK medicines regulator issued precautionary advice in December that ‘people with a significant history of allergic reactions’ should not be given this vaccine for now.
Pfizer’s vaccine is called Comirnaty COVID-19 mRNA, and according to www.health.gov.au, ‘the vaccine doses purchased by the Australian Government will be manufactured in the United States, Belgium and Germany’.
‘The decision to approve a new vaccine is always made by the TGA on the basis that the benefits outweigh the risks for the intended population’.
Urgency v rigorous assessment
On December 31, 2020, Pfizer’s vaccine was listed as an ‘Emergency Use Listing (EUL) procedure’ by The World Health Organization (WHO).
WHO says, ‘The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality’.
‘The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
‘The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan.
‘These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.
Meanwhile, AstraZeneca makes one of the other vaccines that the government is likely to roll out.
According to www.money.cnn.com, the biggest shareholders in that company appear to be mutual funds such as Wellington Mutual Investors Fund, and Fidelity Contrafund. Interestingly, other companies are listed with similar names, such as Wellington Management and Fidelity Research.
There are accusations emerging on Twitter regarding AstraZeneca insider trading by members of the Morrison government (ie buying stocks in the company before the government contract was publicly announced).
There’s sparse information regarding the National Rollout Strategy, available on www.health.gov.au.
The focus will be on vaccinating ‘hospital, quarantine and border staff and residential aged care and disability residents and staff’.
Will it be mandatory?
No, according to www.health.gov.au. The website adds, ‘There are no mandatory vaccines in Australia’.
Yet this is a misleading statement, given that ‘children who are unvaccinated owing to their parent’s conscientious objection can no longer be enrolled in child care’ (source: www.health.nsw.gov.au).
Meanwhile, a Department of Health spokesperson told The Echo, ‘The Australian New Zealand Clinical Trials Registry (www.anzctr.org.au) publish information about clinical trials being conducted in Australia and New Zealand, including a number of trials related to COVID-19 [vaccines].
‘These sites allow you to search for trials as they become available and contact trial sponsors and coordinators who can provide further information.
‘As these applications are under active review, and owing to the commercial-in-confidence nature of applications for registration of therapeutic goods, the TGA cannot disclose the nature of the clinical trials that have been submitted’.
Further information is available at: www.tga.gov.au/covid-19-vaccines.