Vaccines and COVID-19

Yes. At the time of publishing there are four COVID-19 vaccines provisionally approved by the Therapeutic Goods Administration (TGA) for use in Australia:

• COMIRNATY¹ – Pfizer
  An mRNA vaccine approved to prevent COVID-19, the disease caused by SARS-CoV-2, in people aged 12 years and older.
• VAXZEVRIA – AstraZeneca
  A viral vector vaccine to prevent COVID-19. The Australian Technical Advisory Group on Immunisation (ATAGI) recommends the AstraZeneca vaccine for people aged 60 and over (aged 18 to 59 in outbreak areas, if there is no immediate access to COMIRNATY or SPIKEVAX). If you are aged 18 to 59, you can choose to get the AstraZeneca vaccine following an assessment by your GP.
• SPIKEVAX (elasomeran) – Moderna Australia
  An mRNA vaccine approved to prevent COVID-19, the disease caused by SARS-CoV-2, in people aged 12 years and older. 
  
• COVID-19 Vaccine Janssen – Janssen-Cilag (note that this vaccine is not included in Australia's vaccine rollout).

You can download the Approved Product Information or the Consumer Medicine Information (CMI) for COMIRNATY, VAXZEVRIA AND SPIKEVAX from the TGA website.

The number of COVID-19 vaccines in development and being trialled is constantly changing. A snapshot of the vaccine landscape is available on the NCIRS website, with a more in depth summary of trials available through the WHO.

Monitoring of potential vaccines continues

The European Medicines Agency (EMA), and members of the Access Consortium – including Australia, Canada, Singapore, Switzerland and the UK – will continue to evaluate the evidence of each potential vaccine as they prepare for regulatory review.²

The TGA continues to actively monitor COVID-19 vaccine development occurring both in Australia and around the world. Find out more about the COVID-19 vaccines undergoing evaluation

Read more about how vaccines are approved on the TGA website COVID-19 vaccine: Information for consumers and health professionals

Read more about provisional determinations on the TGA website.

Ensuring COVID-19 vaccines are safe and effective takes time. Typically, vaccine development takes about 10 years.³ This is because vaccines must pass a series of pre-clinical studies (usually laboratory based), clinical trials in humans, and approval processes before they become available for use.

The steps of the clinical trial process are known as phases. Any vaccine in development must progress through each testing phase to make sure it is safe and effective.⁴

Usually the different phases can take months, years or even longer. But due to the urgency of finding a vaccine to prevent SARS-CoV-2 (the virus that causes COVID-19), this process is being fast-tracked.

What happens in each phase of a clinical trial?

Phase I clinical trials are done to test a medicine – in this case a vaccine – for the first time in a small group of people – usually a few dozen healthy volunteers.

A phase I trial works out if the vaccine is safe by evaluating how the human body reacts to the vaccine and observing for any side effects.

Phase II trials usually involve a few hundred people and provide information about how well the vaccine works (efficacy) as well as further information about the safest dose range.

Phase III trials usually involve a few thousand people, testing the efficacy and safety in a larger group.

Before a clinical trial can move to Phase IV, a government regulatory body examines the Phase III results and decides whether to approve the vaccine for use in the general population. In Australia, approval is given by the Therapeutic Goods Administration (TGA).

Phase IV clinical trials are conducted after the product has been approved and involve gathering information about efficacy and safety in the general population.^5,6

To keep up to date with the latest in vaccine research and development in Australia and across the globe visit:

• National Centre for Immunisation, Research and Surveillance (NCIRS) COVID-19 vaccine development landscape.
• Regulatory Affairs Professionals Society (RAPS) COVID-19 Vaccine tracker.

It is estimated that the cost of vaccinating all 25 million Australians against COVID-19 will be between $125 million and $5 billion a year.¹²

Vaccines stimulate the body’s natural defences to strengthen the immune system response to a condition or illness.¹³

Vaccines use inactivated or severely weakened pathogens such as viruses or bacteria to trick the immune system into producing antibodies. Viral vaccines help your body fight off viruses. After receiving a viral vaccine, the body’s immune system recognises and remembers the virus.¹³

Then, if a person is exposed to the virus later on, their immune system can fight off an infection much more effectively because it has already produced antibodies to that virus.^13,14

Viral vaccines can work in two ways. In some instances, they can prevent infection.

At other times, people can still become infected with the virus, but the antibodies produced as a result of the vaccine can significantly reduce the severity of symptoms and stop people from getting very sick.^13,14

It is important to note that not all vaccines provide long-lasting immunity. Protection against a virus can decrease over time. This is why booster doses are needed in some circumstances, such as with the tetanus vaccine.¹⁵

Based on what is currently been reported for the COVID-19 vaccines under investigation, booster doses may be needed to ensure people keep their immune memory and their immune systems remember how to fight the SARS-CoV-2 virus for as long as possible.¹⁶

Even though COVID-19 vaccines are being developed to guard against the same virus (SARS-CoV-2), they are not all the same.

Different research groups have different methods for researching and developing vaccines.

Some research groups are focusing on the whole SARS-CoV-2 virus, while other groups are concentrating on the proteins that are produced by the virus.¹⁷

There are several methods – also known as technologies or platforms – used to develop viral vaccines.

In the race to develop a COVID-19 vaccine, the commonly used methods include:^15,18-20

• live attenuated vaccines, like the vaccine used for measles-mumps-rubella (MMR)
• inactivated vaccines, like the vaccine used for hepatitis A
• protein subunit vaccines, like the vaccine used for hepatitis B
• virus-like-particles, like the vaccine against human papillomavirus (HPV)
• viral vector and nucleic acid (DNA or RNA, including messenger or mRNA). 

How do mRNA vaccines work?

Traditional vaccines contain either inactivated or weakened viruses, or virus proteins that signal the immune system to recognise the part of the virus that causes disease.^21,22

Messenger RNA (or mRNA) vaccines work differently to traditional vaccines. An mRNA vaccine does not contain viral protein. Instead the vaccine contains key genetic instructions (mRNA) so our body knows how to make a particular viral protein itself.

COVID mRNA vaccines are injected into the muscle of the upper arm. These muscle cells read the instructions and build a part of the SARS-CoV-2 virus known as the ‘spike protein’. Once the protein is made, the instructions are broken down and destroyed. The newly built spike protein is seen by the immune system as not belonging to us, and antibodies to that spike are made. If a person vaccinated with the mRNA vaccine is infected with SARS-CoV-2 in the future, the spike proteins on the live virus will be recognised by their immune system and more antibodies will be made to stop the virus from causing an infection.^21,22

You can find out more about vaccine platforms on the National Centre for Immunisation Research and Surveillance (NCIRS) website.

All vaccines, including COVID-19 vaccines, are rigorously tested in human clinical trials to confirm they are safe and effective before they can be used.²³

When it comes to testing COVID-19 vaccines, it’s important to emphasise that the people who are involved in the clinical trials:

• are mostly healthy volunteers (although some may have other health conditions not related to COVID-19)
• are not intentionally infected with COVID-19 to test if the vaccines work.

Viral vaccines use inactivated or severely weakened viruses, or parts of viruses that trick the immune system into producing antibodies.¹³ In this case, it is expected that the person who is receiving the COVID-19 vaccine will produce antibodies to the SARS-CoV-2 virus.

All volunteers must undergo a thorough health assessment before they can be included in a clinical trial.

As with any medicine, vaccines may cause side effects, and these are closely monitored throughout all phases of the clinical trials.⁵

Vaccines are initially tested in young, healthy adults, before being tested on more vulnerable people, such as children, older adults and pregnant women.

Vaccine trials in children usually occur in a stepwise process referred to as age de-escalation, starting with adolescents and older children, followed by younger children, and finally, babies.

This allows us to gather important age-specific information about the safety and efficacy of a vaccine in different age groups.

Trials in healthy volunteers will give us confidence that the vaccine is safe for use in the larger general population.

Severe allergic reactions (anaphylaxis) to vaccines are very rare.²⁴ Doctors and nurses who administer vaccinations are trained to recognise and manage any immediate, severe reactions.²⁵

If anaphylaxis does occur, it is generally within the first 15 to 20 minutes after receiving a vaccine, so it is important for people to wait at the place they get their vaccination so they can be observed for any reaction.²⁵

Most vaccines do not contain food allergens such as dairy products, peanut, tree nuts, wheat, soy, seeds or seafood.²⁴

Allergic reactions to vaccines are more often caused by vaccine components such as gelatin or egg protein, yeast, or the latex parts of vial lids, or syringe plungers rather than the actual vaccine.²⁶

Before any vaccine is given, a safety checklist is performed with the patient to make sure they do not have any allergies to components of the vaccine.

Generally, side effects from vaccination are usually mild and short lasting and do not need special treatment.

Common reactions to vaccination can include:²⁵

• injection site reactions such as local pain, redness and swelling
• mild temperature or fever
• irritability
• decreased appetite
• sleepiness
• vomiting and diarrhoea
• light headedness or fainting (uncommon, but this can occur before or after vaccination).

Yes. While the influenza vaccination won’t protect you against COVID-19 it will reduce your risk of the flu. Getting the flu vaccine will help to provide greater individual and community health protection throughout the COVID-19 pandemic.²⁷

In Australia, complications from influenza lead to thousands of hospitalisations and many deaths every year.

If a person catches COVID-19 on top of the flu, it is likely they will become severely sick or die, especially if they are elderly or their immune system is weaker.

Having the flu vaccination will help to protect vulnerable people from getting the flu. And reducing hospitalisations from the flu will ease pressure on the health system so health workers can focus on people who present with COVID-19.²⁷

Even though a COVID-19 vaccine is available to the general public, it is unlikely to be the ‘silver bullet’ everyone is hoping it might be.¹²

We don’t know if everyone will respond the same way to a vaccine, whether they will experience side effects or have long lasting immunity to COVID-19.

Physical (social) distancing, regular handwashing, choosing to wear a mask in public and changes to the way we travel may be here for a while longer.¹⁶

Find out more about vaccines

The National Centre for Immunisation Research and Surveillance (NCIRS) is closely monitoring information on COVID-19 vaccine candidates and updates this information weekly. Visit NCIRS COVID-19 vaccine development landscape.

• Australian Prescriber: COVID-19 vaccines – are we there yet? published 1 February 2021
• FAQs for Aboriginal and Torres Strait Islander people about the influenza vaccination during the COVID-19 pandemic
• The Australian Government provides information about COVID-19 vaccines in many community languages
  
• Check out the COVID-19 Vaccine Tracker – a real-time visualisation of the race to develop, approve and manufacture COVID-19 vaccines
• Find out How medicines are approved for use in Australia
• Read more about vaccines and immunisation
• Read What is herd immunity? The science behind vaccination
• Watch the Q&A video with Professor Julie Leask: Vaccinations and COVID-19: What parents need to know

Register for a vaccine trial

If you are healthy and interested in taking part in a vaccine trial you can find out more at NCIRS: Upcoming COVID-19 vaccine trials