The Australian Government has secured agreements for three COVID-19 vaccines with administration subject to approval from the Therapeutic Goods Administration (TGA).
The TGA rigorously assesses vaccines for safety, quality and efficacy before they can be used in Australia. The TGA is working with international counterparts, monitoring information on vaccine clinical trials, manufacturing and safety. This will ensure a safe and fast regulatory process for the COVID-19 vaccine in Australia.
The TGA will continue to monitor COVID-19 vaccines for safety, after they are supplied in Australia, through ongoing safety monitoring. The TGA will receive adverse event reporting and if it suspected there is an issue with a vaccine an investigation will be undertaken which may include suspending the use of the vaccine under investigation.
Pfizer/BioNTech Vaccine
Further information
If the vaccine is proven to be safe and effective, and is approved for use, it will be available from early 2021. This vaccine is currently being rolled out across the United Kingdom (UK), european Union (EU) and and the United States of America (USA).
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Administration
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2 doses will be required approximately one month apart
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Side effects
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In the trials, the vaccine was generally well-tolerated, and an independent data monitoring committee reported no serious safety concerns. The worst side effects were fatigue and headaches after the second dose. Around four per cent of people reported fatigue and two per cent a headache. Other side effects were pain at the injection site and myalgia.
With the roll out of the vaccine in the UK, there have been reports of two people with a history of allergies who have had serious adverse reactions to the vaccine. These are being investigated to determine causality.
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Storage
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For long-term storage (approximately six months) the vaccine must be kept at -70° C, which requires specialist cooling equipment. Pfizer has a distribution container that keeps the vaccine at that temperature for 10 days if unopened. These containers can be used for temporary storage in a vaccination facility for up to 30 days if they are replenished with dry ice every five days. Once thawed, the vaccine can be stored at 2°C to 8°C for up to five days.
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General comments
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It is still unclear if the vaccine provides immunity for the disease as well as preventing infection.
In the UK, roll out to pregnant women and children is not included due to lack of testing in these groups.
Early data has been provided to the TGA and there be will be an application for provisional approval for use in Australia.
The 10 million doses secured by Australia will be manufactured in the United States of America, Belgium and Germany.
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University of Oxford/AstraZeneca vaccine
Further information
If the vaccine is proven to be safe and effective, and is approved for use, it will be available from early 2021.
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Administration
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Based on current trials it is likely two doses will be required approximately one month apart
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Side effects
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Side effects have been reported as minimal, however, there appears to be limited information on what these side effects are
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Storage
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The vaccine can be stored at temperatures between 2°C to 8°C
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General comments
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Early trials suggest the vaccine may prevent asymptomatic infection, however, more research is required before this can be verified.
Australia has secured the delivery of 3.8 million doses in early 2021 and 30 million doses will be manufactured in Australia by the Commonwealth Serum Laboratories (CSL).
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Novavax vaccine
Further information
If the vaccine is proven to be safe and effective, and is approved for use, it will be available in the first half of 2021.
Phase 3 trials commenced in November 2020 in the UK, with interim data from the trial expected in the first quarter of 2021.