Vaccines and COVID-19

We answer some of your questions about COVID-19 vaccine development | Updated 26 October 2021

Vaccines and COVID-19

The development of an effective vaccine for COVID-19 has been a global public health challenge. The race continues to manufacture and distribute vaccines that are effective and safe, and readily available to billions of people.

NPS MedicineWise would like to thank the NCIRS for their review of this content.

UPDATE 14 October 2021

On 9 August 2021, the Therapeutic Goods Administration (TGA) granted provisional approval to Moderna Australia for its mRNA COVID-19 vaccine, SPIKEVAX (elasomeran), for people aged 18 years and over, followed by provisional approval for those aged 12 years and over on 3 September 2021.

Provisional approval means that the vaccine has met the high standards of safety, effectiveness and quality required for use in Australia. This allows for temporary registration and inclusion in the Australian Register of Therapeutic Goods (ARTG) for up to two years with an option to extend provisional registration beyond this initial period.

The Moderna COVID-19 vaccine contains the genetic code for an important part of the SARS-CoV-2 virus called the spike protein. After getting the vaccine, your body makes copies of the spike protein.

The Moderna vaccine is the third COVID-19 vaccine to be included in Australia's national rollout.

UPDATE 17 February 2021

On 16 February 2021, the Therapeutic Goods Administration (TGA) announced it had granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine, ChAdOx1-S [note that, as of August 2021, this vaccine is now called Vaxzevria]. This is the second COVID-19 vaccine to receive regulatory approval in Australia.

Provisional approval means that the vaccine has met the high standards of safety, effectiveness and quality required for use in Australia. This allows for temporary registration and inclusion in the Australian Register of Therapeutic Goods (ARTG) for up to two years with an option to extend provisional registration beyond this initial period.

The Australian Government has advised that rollout of the AstraZeneca COVID-19 vaccine will start in March 2021, subject to availability of supply.

 

UPDATE 25 January 2021

On 25 January 2021, the Therapeutic Goods Administration (TGA) announced they had granted provisional approval to Pfizer Australia for its COVID-19 vaccine, COMIRNATY. This is the first COVID-19 vaccine to receive regulatory approval in Australia.

Provisional approval means that the vaccine has met the high standards of safety, effectiveness and quality required for use in Australia. This allows for temporary registration and inclusion in the Australian Register of Therapeutic Goods (ARTG) for up to two years with an option to extend provisional registration beyond this initial period.

The Australian Government have advised that rollout of the Pfizer vaccine will commence towards the end of February, 2021, subject to availability of supply.

Find out more: Getting vaccinated for COVID-19

 

Is there a vaccine for 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.

 

Why is it taking so long?

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

 

Which are the leading vaccine candidates?

 

How much will it cost to vaccinate everyone?

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

 

Will a vaccine offer immunity to COVID-19?

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

 

Why is there more than one COVID-19 vaccine?

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.

 

Is it safe to test the COVID-19 vaccine on people?

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

 

Will the COVID-19 vaccine be safe for all ages?

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.

 

What if I’m allergic to the COVID-19 vaccine?

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.

 

What are the possible side effects of vaccination?

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).
 

Do I still need to get the flu 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

 

Will a COVID-19 vaccine mean no more physical distancing or handwashing?

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

 

Where can I learn more?

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.

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

 

References

  1. Therapeutic Goods Administration. COVID-19 vaccine: Pfizer Australia - COMIRNATY BNT162b2 (mRNA). Canberra: Australian Government Department of Health, 2021 (accessed 25 January 2021).
  2. Therapeutic Goods Administration. Access Consortium statement on COVID-19 vaccines evidence. Canberra: Australian Government Department of Health, 2020 (accessed 21 December 2020).
  3. Mullard A. COVID-19 vaccines start moving into advanced trials. Nature Reviews Drug Discovery July 2020; 19: 435.
  4. National Centre for Immunisation Research and Surveillance. COVID-19 vaccine development landscape. Westmead, NSW: NCIRS, 2020 (accessed 17 December 2020).
  5. National Health and Medical Research Council, Australian Clinical Trials. Phases of clinical trials. Canberra: Australian Government Department of Industry, Innovation and Science, 2015 (accessed 10 September 2020).
  6. NPS MedicineWise. How medicines are approved for use in Australia. Sydney: NPS MedicineWise, 2019 (accessed 10 September 2020).
  7. University of Queensland. Update on UQ COVID-19 vaccine. UQ News. Brisbane: 11 December 2020. (accessed 17 December 2020).
  8. Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med 2020.
  9. Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet 2020.
  10. Therapeutic Goods Administration. COVID-19 vaccine provisional determinations. Canberra: Australian Government Department of Health, 18 November 2020 (accessed 20 December 2020).
  11. Australian Government Department of Health. Australia's vaccine agreements. Canberra: Australian Government Department of Health, 2020.
  12. Dr Bonny Parkinson. Will a vaccine really solve our COVID-19 woes? Sydney, Australia: Macquarie University, 26 August 2020 (accessed 8 September 2020).
  13. Australian Government Department of Health. How does immunisation work? Canberra: Australian Government Department of Health, 2019 (accessed 8 September 2020).
  14. International Coalition of Medicines Regulatory Authorities. Statement from the International Coalition of Medicines Regulatory Authorities on vaccine confidence. Canberra: Therapeutic Goods Administration, 18 June 2020 (accessed 7 September 2020).
  15. Australian Technical Advisory Group on Immunisation (ATAGI). Australian Immunisation Handbook. Canberra, 2018 (accessed 8 September 2020).
  16. Sarah Pitt. A coronavirus vaccine may require boosters - here's what that means. Parkville, Victoria: The Conversation Media Group 29 July 2020 (accessed 7 September 2020).
  17. Monash Biomedicine Discovery Institute. Melbourne researchers map the structure of a COVID-19 protein. Melbourne: Monash University, 1 April 2020 (accessed 7 September 2020).
  18. World Health Organisation. Vaccine safety basics module 2: Types of vaccine and adverse reactions. Geneva: WHO, 2020 (accessed 8 September 2020).
  19. Roldao A, Mellado MCM, Castilho LR, et al. Virus-like particles in vaccine development. Expert Rev Vaccines 2010;9:1149-76.
  20. National Centre for Immunisation Research and Surveillance. Vaccine platforms. Westmead, NSW: NCIRS, 2020 (accessed 8 September 2020).
  21. Mishra S. How mRNA vaccines from Pfizer and Moderna work, why they’re a breakthrough and why they need to be kept so cold. The Conversation. 2020.
  22. van Riel D, de Wit E. Next-generation vaccine platforms for COVID-19. Nature Materials 2020;19:810-2.
  23. National Centre for Immunisation Research and Surveillance. Vaccine safety. Westmead, NSW: NCIRS, 2020 (accessed 8 September 2020).
  24. Australasian Society of Clinical Immunology and Allergy. ASCIA Guidelines - Vaccination of the egg-allergic individual. 2017
  25. Healthy WA. Possible side effects of vaccination. Government of Western Australia Department of Health, 2020 (accessed 8 September 2020).
  26. Jo Ann Faber. Patients with vaccine allergy may be safely vaccinated following new guidelines. Illinois,: American College of Allergy Asthma & Immunology, 2020 Accessed 9 September 2020).
  27. Australian Medical Association (AMA). Early flu vaccine the best protection aginst COVID-19. Canberra: Australian Medical Association Limited, 7 April 2020 (accessed 8 September 2020).