There are currently numerous COVID-19 vaccines under development, with several already granted emergency use authorisation or provisional approval in some countries. Trials continue around the globe for other vaccine candidates.
COVID-19 Vaccine Updates in Australia
The Australian Government entered into 4 separate agreements for the supply of COVID-19 vaccines, conditional on evaluations undertaken into their safety, quality and efficacy. (CSL announced the closure of trials into the University of Queensland vaccine in early December due to vaccine interference in HIV diagnostic tests). As other pharmaceutical companies provide updates to their vaccine trials, we will add a summary of the information to this page.
Do we have a COVID-19 vaccine in Australia?
ON Jan 25, 2021 the Therapeutics Goods Administration (TGA) granted provisional approval for the Pfizer mRNA vaccine, Comirnaty, for use in individuals 16 years of age and older. Read more. The TGA is continuing to review preliminary data from trials of COVID-19 Vaccine AstraZeneca (formerly AZD1222). It remains important to maintain the recommended precautions needed to prevent spread of the coronavirus: hand washing/ hand sanitiser, physical distancing and the wearing of masks if this is difficult to achieve, cough etiquette and prompt testing of respiratory symptoms.
When are the first vaccinations to commence?
Subject to supply, the federal government is set to roll out vaccinations of the Pfizer vaccine in mid- to late-February, starting with phase 1a, as outlined in the national strategy announced on Jan 7, 2021.
List of COVID-19 Vaccine Companies & Latest Vaccine Trial Updates
- University of Oxford/AstraZeneca vaccine, COVID-19 vaccine AstraZeneca – Nov 23 update on vaccine trial results
- Novavax vaccine – Nov 30 Phase 2/3 trials update
- Pfizer/BioNTech vaccine, Comirnaty – Nov 18 trial results
- University of Queensland/CSL – Dec 11 CSL announces trial abandoned
LATEST UPDATES –
Jan 25, 2021 - The Therapeutic Goods Administration (TGA) has granted provisional approval for the Pfizer mRNA COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia. The approval is for individuals aged 16 years of age and over. (TGA news release)
Jan 19, 2021 - Novavax: 'early data released in December suggests it is likely to offer strong protection against COVID-19' (SMH)
Jan 7, 2021 - Australian COVID-19 vaccine rollout to be brought forward to mid-to-late-February but it's hinged on several important factors, including final TGA approval and the delivery of the vaccines from the suppliers. (ABC News)
Jan 4, 2021 - Therapeutic Goods Administration (Australia) still waiting for 'further data' on AstraZeneca vaccine (SMH)
Jan 2, 2021 - Australia to trial 'backup' COVID-19 vaccines that can be modified to fight virus mutations (ABC News)
Dec 31, 2020 - The WHO has listed the Pfizer/BioNTech COVID-19 mRNA vaccine (non-proprietary name of tozinameran and branded as Comirnaty) for emergency use, making it the the first to receive emergency validation from WHO since the outbreak began a year ago. (WHO news release)
Dec 30, 2020 - Oxford-AstraZeneca vaccine approved for use in UK (BBC News)
Dec 21, 2020 - The European Medicines Agency has recommended the Pfizer/BioNTech vaccine, Comirnaty, receive 'conditional marketing authorisation' ahead of planned vaccination campaigns across the region next week (EMA)
Dec 18, 2020 - FDA grants emergency use authorisation for second COVID-19 vaccine in USA.
Dec 15, 2020 - Australia has secured an extra 20 million Astra Zeneca vaccines for onshore manufacturing and a further 11 million Novavax vaccines (Aust Dept. of Health)
Dec 11, 2020 - UQ/CSL trial abandoned due vaccine interference in the HIV diagnostic test. 'There is no possibility the vaccine causes infection, and routine follow up tests confirmed there is no HIV virus present.' (CSL)
Dec 3, 2020 - Australian government plans to start roll-out of vaccines in March, 2021 (ABC News)
Dec 2, 2020 - PfizerBioNTech vaccine approved for use in the UK for adults aged 16 years and above; also due for consideration by the FDA (USA) for emergency use authorisation approval on Dec 10, with Moderna's application due on Dec 17 (STAT News)
Dec 2, 2020 - TGA statement on UK government emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech
Nov 30, 2020 - Results of Moderna vaccine's Phase 3 trials on 30,000 participants explained in an article from Science.
Nov 23, 2020 -The AstraZeneca vaccine has been shown to be well tolerated in older adults with more results due next month
Nov 18, 2020 - News on the outcome of efficacy trials of the Pfizer/BioNTech vaccine as summarised by STAT News.
Nov 16, 2020 – Press release on the first interim analysis of the Phase 3 study for the Moderna mRNA-1273 vaccine
How Many COVID-19 Vaccines Are Being Developed & Tracked Globally?
The World Health Organization (WHO) is currently tracking the vaccine development of around 170 candidate vaccines globally and they are in various stages of progress – from a pre-clinical phase to large-scale human trials. If a coronavirus vaccine trial results prove successful, the sponsoring company can formally apply to regulatory bodies to have their vaccine approved for use in the general public.
COVID-19 Vaccine Timeline Phases
The pathway to developing a successful vaccine follows several stages - not all may apply: Pre-clinical testing, Phase 1, 2 and 3 trials – sometimes a combination of 2 phases, early approval or emergency use only, approval granted by each country’s regulators, post-approval surveillance, and of course a pause in a trial in response to a concern over a side effect or safety issue.
Research & Testing
Unprecedented international scientific cooperation geared towards a single topic, the SARS Coronavirus-2, has boosted vaccine research which built on work started in response to the SARS outbreak in 2002-3. This has meant a faster vaccine development process than the usual, which can take years or even decades without always resulting in an approved therapeutic. The Australian government is ‘supporting world-leading research activities to speed up the development and manufacture of COVID-19 vaccines and treatments’. Read more from the Australian Dept. of Health and the WHO COVID-19 R&D Blueprint.
Prior to entering into Phase 1 clinical trials, a vaccine first undergoes a pre-clinical assessment or exploratory studies with a fractional dose given to a very limited group of people. Once this stage is successfully passed, a small number of healthy adults are given the vaccine in different dosages (to find a safe dosage range) and subsequently tested for an immune response and checked for any safety issues. Read more
The trial is expanded to a much larger and more diverse group of people – from a wider age range – to test how well it performed under controlled conditions, assessing the immune response to the vaccine, and for further evaluation of what could be any more common side effects, plus any safety issues. Read more
There can be many thousands of people in Phase 3 trials which are undertaken in the community. Volunteers are either given the trial vaccine or a placebo and a successful outcome is hinged on fewer people in the vaccine group becoming infected than the placebo group. During this trial, more uncommon side effects may also become apparent. This phase is followed by each country’s regulatory approval process and post-approval surveillance. Read more
The TGA has been reviewing preliminary data from the various vaccine trials while also working in cooperation with international counterparts to ensure that information on clinical trials, manufacturing and safety is shared, allowing a speedy but safe regulatory process for Australia and our region.
In Australia, the approval of vaccines is undertaken by the TGA from advice provided by the Advisory Committee on Vaccines, an independent committee composed of members with expertise in science, medicine and public health. The TGA also oversees the quality of each batch of vaccine for distribution in Australia. Read more
Facts About COVID-19 Vaccinations
The job of these vaccines is to imitate the SARS-CoV-2 virus (which causes the disease COVID-19), prompting a person’s immune system to produce antibodies which can fight the coronavirus. The most novel of vaccines are the mRNA vaccines, where genetically engineered pieces of the virus mRNA (such as the piece that codes for spike protein) are injected and taken up by muscle cells which then use this genetic material to generate the spike protein, so that our immune system can very rapidly generate an immune response including the production of antibodies. These antibodies will be produced by the body if it ever is threatened by the virus. No mRNA vaccine has yet been licenced for use
COVID-19 Vaccine Composition
Rigorous testing ensures that all components of any vaccine are as safe as possible while also producing the best possible immune response. These include some form of the antigen, adjuvants which enhance the actions of the vaccines to produce antibodies, plus stabilisers and preservatives that ensure vaccine potency from manufacture to when it is finally given to someone. In Australia, the Therapeutic Goods Administration (TGA) will assess and grant approval for any vaccines to be used once their safety, quality and effectiveness is proven. More on vaccine composition from the WHO.
Resistance to Vaccination Treatment
There was some early resistance to the idea of rapidly developed vaccines for COVID-19, at least here in Australia, which mainly centred on whether they would be safe. A poll commissioned by the ABC in late September revealed that of the 2,000+ respondents asked whether they would have a vaccine when it became available, only 12 percent said they were either very or somewhat unlikely to do so. More results emerging from vaccine trials showing high levels of protection with minimal side effects may well prove to be reassuring for most of us and pave the way for protective herd immunity.
Vaccine Distribution Strategy & Plan
On Jan 7, 2021, the federal government published Australia's COVID-19 vaccine national roll-out strategy which provides details on the prioritisation of different groups for vaccination against COVID-19. Quarantine and border workers, frontline health care worker sub-groups, aged care and disability care staff and aged care and disability care residents are those in the first, phase 1a of the roll-out.
Possible Vaccine Side Effects & Reactions
Vaccines are like any medication in that they can cause side effects – the most common are usually mild and include a low-grade fever, headache, fatigue or pain or redness at the injection site which all settle within a few days without treatment. Allergic reactions to vaccines are minimised through pre-vaccination screening while severe or long-lasting side effects are extremely rare. Every vaccine is continually monitored by the TGA to ensure ‘acceptable safety, efficacy/performance and quality for its intended use’.
Types of COVID-19 Vaccines
More on the four types of COVID-19 vaccines (Whole virus, Protein subunit, Nucleic and Viral vector) and how they work from GAVI, the Vaccine Alliance.
The Australian government has agreements for 4 different vaccines, conditional on TGA approval. All are expected to be administered in a 2-dose schedule.
- AstraZeneca/University of Oxford - AZD1222 Viral vector vaccine (COVID-19 VACCINE ASTRAZENECA)
- Pfizer/BioNTech - BNT162b2 mRNA-based vaccine (COMIRNATY)
- Novavax - NVX-CoV2373 Protein vaccine
- (University of Queensland/CSL - V451 Protein subunit vaccine trial halted in Dec 2020 Read more)
Another 7 vaccines are included in the COVAX facility, which is a global effort to support fair access to COVID-19 vaccines for all countries. Aust. Dept. of Health
More will be known about the recommended age groups and any potential side effects as results of human trials are published.
More on the vaccines in development across the world from GAVI.
Frequently Asked Questions (FAQs)
Why do we need a vaccine?
Prevention is always better than cure, particularly as we still lack therapeutics known to effectively treat COVID-19 in all its phases. An effective vaccine will enable international travel to be re-established with significantly reduced risk of disease transmission.
When will a vaccine be released in Australia?
The first COVID-19 vaccine, Pfizer's Comirnaty, was approved in Australia on Jan 25, 2021 with TGA reviews continuing into the remaining vaccine candidates. Read more
How much would vaccines cost?
The Australian government will be providing COVID-19 vaccines free of charge for citizens and eligible residents, with the medical consultation for administration of the AstraZeneca vaccine (once approved) to be provided in a bulk bill visit at participating GP clinics. Read more
How many doses of COVID-19 vaccine will be needed?
Most of the vaccines currently in phase 3 trials require 2 doses of vaccine 3 - 4 weeks apart.
Who will receive vaccination first?
The target populations in the initial phases of vaccine roll-out are those considered at a higher risk of COVID-19 disease or its potential outcomes, such as key workers in border control and quarantine, as well as those in healthcare and aged care. For further information see Australia's COVID-19 vaccine national roll-out strategy.
Would vaccines be effective in protecting everyone?
We must wait for the results of human clinical trials which are underway to know the details of vaccine efficacy across different groups of people.
These vaccines have been developed very quickly so are they safe?
Coronavirus vaccine research had started in response to the SARS outbreak in 2002 and while some progress had been made, once the outbreak ended in 2003 funding slowed and only very limited research continued. Now, unprecedented international scientific cooperation has boosted vaccine development and newer platforms now offer different types of vaccines. Testing of vaccine safety continues throughout the manufacturing process and the bottom line is that the risk of having a severe outcome from COVID-19 far outweighs any theoretical risk of a vaccine.
The vaccines which are being developed have had tens of thousands of people in their trials, world-wide totalling nearly one quarter of a million people, providing researchers with a much larger amount of data than for many other vaccines routinely used.
Can I get a COVID-19 earlier through the private system?
COVID-19 vaccines will be free for all Australian citizens, permanent residents and most visa-holders.
Early supplies are expected to be limited and, as per the Australian Vaccination policy , priority groups will be offered the vaccines first at designated vaccination sites. Where these vaccines may be administered will vary from state/territory but is likely to include hospital-based clinics for hospital staff and other workplaces, including aged care facilities.
Once more supplies become available, vaccines will be available to the broader population through usual immunisation providers, such as general practice clinics and general practice respiratory clinics.
It is possible that some vaccine candidates may eventually become available on the private market, meaning they will not be free of charge such as those which will be provided to eligible Medicare card holders in Australia. More information will be forthcoming as the different vaccines are granted approval and supplies are assured.
Learn More About Coronavirus COVID-19
The Australian Department of Health has developed a number of resources on the coronavirus: how Australia is monitoring and responding to COVID -19, how we can help stop the spread of coronavirus and what to do if we have any symptoms. On the vaccine front, the situation is changing and developments are moving quickly.
Travelvax resources: Coronavirus information
Aust. Dept of Health:
o COVID-19 vaccine hub
o COVID-19 vaccine and treatment strategy
o Australian COVID-19 vaccination policy
o Coronavirus - COVID-19 Vaccines information translated into 60+ languages
Therapeutics Goods Adminstration: COVID-19 vaccines
NCIRS: COVID-19 vaccine development landscape
The Australian Government has agreements for the supply of COVID-19 vaccines, if they are proved to be safe and effective, with:
STAT News: COVID-19 drugs and vaccine tracker
World Health Organisation:
- Vaccine candidates Read more
- Vaccine Q&A Read more
- Vaccine research and development Q&A Read more and blueprint
- How COVID-19 vaccines are able to be developed so fast? Facebook post
Australian Academy of Science:
- What is immunisation? Read more
- What’s in a vaccine? Read more
- How safe are vaccines? Read more plus videos on these topics and more.
GAVI: 5 ways scientists are ensuring safety of COVID-19 vaccines Read more
Glossary of terms
Herd immunity: Protection against a disease either through immunity gained from having the infection (with the inherent risk of severe illness, long-last effects or even mortality) or receiving a vaccine. When the majority of people are immune, it is much less likely that the disease will spread as there are so few susceptible people left to infect. These susceptible people may not be able to have a vaccine either due to their age (too young or too old) and immune deficiencies (i.e. cancer or autoimmune disease).
Efficacy vs effectiveness: Efficacy is measured during a vaccine trial when all conditions are ideal and strictly controlled, whereas effectiveness is determined on how well a vaccine performs when used under normal, real-life situations.
Pandemic vaccines 101: Do you understand the medical terms used to explain COVID-19 vaccines? ABC