Omari Gates
Vaccines are no longer produced or regulated in the countries in which they are used. Most Australian vaccines are made in other countries and licensed in the USA. China and India are major manufacturers of vaccines, and there is no evidence that vaccines used in Australia are not made in these countries. Moderna's COVID-19 vaccine is now available in Australia, and the company will soon establish a manufacturing presence in the country. The Australian government has also invested in the development of an mRNA sector in the country, and a new manufacturing facility will be built in Victoria to produce respiratory mRNA vaccines.
| Characteristics | Values |
|---|---|
| COVID-19 vaccines | AstraZeneca, Moderna, Pfizer |
| mRNA vaccines | Moderna, Pfizer |
| Recombinant adenovirus vaccine | AstraZeneca |
| Protein-base vaccines | AstraZeneca |
| Country of manufacture | Australia, China, India, Sweden, Turkey, USA |
| Funding | $25 million from the Australian government |
| Manufacturing facilities | Victoria |
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What You'll Learn
The Moderna mRNA vaccine
The Moderna mRNA-1273 vaccine is a COVID-19 vaccine that uses nucleoside-modified messenger RNA (mRNA) technology. This technology utilises a PEGylated lipid nanoparticle drug delivery system, where the mRNA is encapsulated within lipid nanoparticles. The vaccine mRNA is dissolved in an aqueous buffer containing tromethamine, tromethamine hydrochloride, sodium acetate, and sucrose.
The first step in the manufacturing process involves the synthesis of DNA plasmids, which are used as a template for mRNA synthesis. This step is handled by a contractor called Aldevron, based in North Dakota. The mRNA-1273 drug delivery system delivers the mRNA compound into a human cell, where it links up with the cell's endoplasmic reticulum. The mRNA then triggers the cell to produce a specific protein using the cell's normal manufacturing process. This protein is a modified version of the SARS-CoV-2 spike protein, containing two stabilising mutations where the original amino acids are replaced with prolines.
Once the protein is expelled from the cell, it is detected by the immune system, which begins generating antibodies. This immune response provides protection against infection by the SARS-CoV-2 virus, preventing COVID-19. The initial course of the vaccine consists of two doses, with the World Health Organization (WHO) recommending an interval of eight weeks between doses.
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The AstraZeneca COVID-19 vaccine
In Australia, the AstraZeneca COVID-19 vaccine (ChAdOx1-S), also known as Vaxzevria, is a recombinant adenovirus vaccine. The Australian Government purchased 50 million doses of the vaccine, which were manufactured by CSL in Victoria, Australia. CSL is a contract manufacturer that worked closely with the Therapeutic Goods Administration (TGA) to ensure that the locally-manufactured vaccine had the same composition, performance, quality, and purity as the overseas-manufactured vaccine.
Initially, in April 2021, ATAGI recommended that the Pfizer vaccine (Comirnaty) was preferred for individuals under 50 years of age due to reported cases of TTS associated with the AstraZeneca vaccine. However, as of June 2021, ATAGI revised its recommendation, suggesting that the benefits of the AstraZeneca vaccine outweighed the risks for individuals aged 50 and above. This decision was based on the ongoing risk of COVID-19 outbreaks, low vaccine coverage, and the increasing rate of severe COVID-19 outcomes in older individuals.
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How vaccines are classified
In Australia, the Australian Technical Advisory Group on Immunisation (ATAGI) develops evidence-based vaccine clinical practice recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. The GRADE methodology is a transparent, systematic and methodical framework for developing and presenting summaries of evidence and its certainty.
The certainty of evidence classification can be categorised as high, moderate, low, or very low. The default classification for evidence certainty obtained from randomised clinical trials (RCTs) is high, but this may be downgraded for reasons such as risk of bias, inconsistency, indirectness or imprecision. Conversely, it can be upgraded due to a large effect magnitude, clear dose-response gradient, or reverse residual confounding. The default classification for evidence certainty obtained from observational studies is low, and this may also be downgraded or upgraded for the same reasons as RCTs.
The Australian Immunisation Register (AIR) is a national register that records all vaccines administered to all people in Australia since 1996. The AIR provides a central record of the vaccination history of every Australian, accessible by immunisation providers to assess a person's vaccination history and plan vaccination needs.
In terms of COVID-19 vaccines, the Therapeutic Goods Administration (TGA) has indicated that approximately 15% of reported adverse events are classified as 'serious'. A class action has been filed in the Federal Court of Australia against the Australian Government, the Department of Health and Aged Care Secretary, and the Deputy Secretary of the Health Products Regulation Group by three lead applicants, on behalf of other COVID-19 vaccination injured parties, to recover compensation for injuries obtained as a result of taking one or more COVID-19 vaccines.
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The international market for vaccines
In Australia, CSL has been manufacturing the AstraZeneca COVID-19 vaccine, with a contract to produce 50 million doses for Australians. Moderna's COVID-19 vaccine is also available in Australia, and the company will soon establish a manufacturing presence in the country, ensuring priority access to vaccines for Australians.
The Australian government is investing in the development of an mRNA sector, with plans to build a new facility in Victoria to produce mRNA vaccines for potential future pandemics and seasonal health issues. This facility will be part of a strategic partnership with Moderna, aiming to increase pandemic preparedness and ensure priority access to vaccines, research, and global supply chains.
On a global scale, the World Health Organization (WHO) emphasizes the importance of effective and equitable distribution of COVID-19 vaccines worldwide. The COVID-19 vaccine rollout has faced challenges, with companies like Novavax seeking full approval from regulators and facing manufacturing and regulatory hurdles.
The international vaccine market is not limited to COVID-19 vaccines. Merck, known as MSD outside the US and Canada, has expanded its vaccine manufacturing capabilities with a new $1 billion facility in North Carolina, focusing on research and development and creating new jobs.
Overall, the international market for vaccines is dynamic and rapidly evolving, with countries and companies working to develop, produce, and distribute vaccines to meet global health needs.
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The future of vaccine manufacturing in Australia
The COVID-19 pandemic has highlighted the need for Australia to improve its sovereign research and manufacturing capabilities in the biotechnology domain. In response, the Australian government has invested in the development of onshore vaccine manufacturing capabilities to prepare for future pandemics.
Prior to the pandemic, most Australian vaccines were imported, which created potential supply chain disruption during the COVID-19 outbreak. To address this issue, the government has partnered with global mRNA company Moderna to establish an mRNA vaccine manufacturing facility at Monash University in Victoria. This facility will produce respiratory vaccines for potential future pandemics and seasonal health issues such as the flu. The deal will also provide Australia with priority access to both pandemic and non-pandemic respiratory mRNA vaccines.
In addition to the partnership with Moderna, the Australian government has also invested in CSL Limited, a leading multinational specialty biotechnology company. CSL has been involved in manufacturing the AstraZeneca COVID-19 vaccine and has plans to produce mRNA vaccines in the future. They have proposed developing onshore mRNA capacity in Australia by constructing a commercial-scale mRNA facility in Victoria. This facility would be able to manufacture more than two doses of an mRNA vaccine for every Australian in 16 weeks, or roughly 50 million doses.
To further promote the development of an mRNA sector in Australia, the government has also committed to investing up to $25 million from 2022-23 in the mRNA Clinical Trials Enabling Infrastructure Grant Opportunity. This funding will support medical research and innovation projects that leverage emerging technologies and infrastructure to conduct clinical trials of mRNA-based vaccines and therapeutics.
Overall, the future of vaccine manufacturing in Australia looks promising, with the development of new manufacturing facilities and partnerships that will increase the country's preparedness for future pandemics and improve access to cutting-edge vaccination science.
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Frequently asked questions
CSL has been manufacturing the AstraZeneca COVID-19 vaccine in Australia. Moderna has also announced plans to build a manufacturing facility in Victoria, Australia, to produce its COVID-19 vaccine.
The AstraZeneca COVID-19 vaccine is a recombinant adenovirus vaccine.
Moderna's COVID-19 vaccine is an mRNA vaccine.
mRNA vaccines do not require the handling of large amounts of live virus, unlike traditional vaccines. Instead, they use a small DNA molecule that can replicate itself and acts as a template to make RNA. The mRNA is then purified and encapsulated into a lipid nanoparticle, mixed with a buffer at a human-friendly pH, and portioned into vials.
Most Australian vaccines are made in other countries, particularly China and India, and licensed in the USA.
