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How long after COVID-19 can senior citizens in nursing homes get an additional booster in Australia?

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  • While vaccination against COVID-19 is our first and best defence, some people are at higher risk of becoming very unwell if they catch COVID-19.

    There are new, lifesaving treatments available for people at high risk of becoming very sick from COVID-19. But timing is critical. They need to be started as soon as possible after developing symptoms.

    For people over 50 and others with certain underlying medical conditions, these treatments can help lessen symptoms and reduce the risk of hospitalisation and severe illness.

    The key advantage is these are tablets or capsules and can be taken at home but eligible people need a prescription from a general practitioner to access them.

    They are available from pharmacies so if you are at risk and you test positive for COVID-19, talk to your doctor as quickly as possible about a prescription. Or plan ahead and talk to your doctor about how to best manage COVID-19 should you catch it.

    For more information on eligibility for COVID-19 treatments visit the Department of Health website.

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How long after COVID-19 can senior citizens in nursing homes get an additional booster in Australia?

We have provided answers to some of the most frequently asked questions about COVID-19 vaccines. We update this page regularly (last updated 20 September 2022).

Refer also to COVID-19 and children: Frequently asked questions for answers to some of the commonly asked questions about COVID-19 in children, vaccines available in Australia, vaccine safety and schooling.

The Australian Government Department of Health website also has answers to commons questions about COVID-19 vaccines, which are available in 63 languages. Access these questions and answers here.

  • What is the difference between the original COVID-19 vaccine and the bivalent COVID-19 vaccine that has been recently approved in Australia? 

    The original COVID-19 vaccines (Pfizer, Moderna, Novavax and AstraZeneca) contain the original (Wuhan) strain of SARS-CoV-2. The Moderna bivalent vaccine that has been recently approved in Australia contains both the original variant and the Omicron variant (BA.1) of the virus. The Moderna bivalent vaccine uses the same mRNA technology as the original mRNA vaccines, but it produces antibodies that target both the original variant and Omicron BA.1 variant. It is expected to be available in Australia in mid-October 2022.

    The original vaccines are very effective in preventing severe disease from COVID-19 caused by pre-Omicron variants; however, they are not as effective in preventing infection against Omicron and their protection does not last as long. While the bivalent vaccine was designed to target the Omicron BA.1 variant, it also provides better protection against Omicron sub-variants, including BA.4/5. Currently, there are no published studies on the effectiveness of the bivalent vaccine, but a clinical trial found that the Moderna bivalent vaccine produced higher antibodies against the Omicron BA.1 and BA.4/5 variants than the original Moderna COVID-19 vaccine. 

    Higher antibodies have been associated in the past with better protection and so it is expected that the Moderna bivalent vaccine will be more protective, last longer and provide broader protection against current and future variants. However, the additional protection from a bivalent vaccine over an original vaccine is small compared to the benefit of getting any booster dose after a primary course of 2 doses. 

  • Which vaccine should I get as a booster dose?

    If you are 18 years old and over and are due for a COVID-19 booster dose, you should receive either the Moderna bivalent vaccine or any of the original vaccines (Pfizer, Moderna or Novavax), whichever vaccine is available to you. Access the Australian Government Department Health and Aged Care resource When to get your COVID-19 vaccination for details. 

    If you are under 18 years, you cannot receive the Moderna bivalent vaccine, as it is not approved for use in this age group. People aged 16–17 years and some aged 12–15 years at increased risk of severe disease can receive a booster dose of the original vaccines. 
     

  • Who is recommended to receive the new bivalent COVID-19 vaccine?

    The new Moderna bivalent vaccine is recommended as another option for a booster dose for people aged 18 years or older who are recommended a booster dose as per the current ATAGI recommendations. It can be used for either the 1st or 2nd booster dose. If you have received two booster doses, you are not required to receive any additional booster doses, including the bivalent vaccine. It is expected to be available in Australia in mid-October 2022.

    The Moderna bivalent vaccine is not recommended as a primary course, for people who have not received a COVID-19 vaccine.

  • I have not had a COVID-19 vaccine. Should I get the bivalent vaccine?

    No, you cannot receive the bivalent vaccine for your primary doses (first 2 doses in most people, or first 3 doses in severely immunocompromised). You can instead receive either the Pfizer, Moderna, Novavax or AstraZeneca original vaccines as a primary series. The Moderna bivalent vaccine has only been approved for use as a booster dose.

    Access the Australian Government Department Health and Aged Care resource called When to get your COVID-19 vaccination for details on what vaccines are available for use. 
     

  • Should I wait for other bivalent vaccines (like the BA.4/5 vaccine) to be available?

    While there are other bivalent vaccines that are being developed, including the Moderna bivalent Omicron BA.4/5 vaccine, the Pfizer bivalent Omicron BA.1 vaccine and the Pfizer bivalent Omicron BA.4/5 vaccine, these have not been approved for use in Australia yet. 

    The main difference between the BA.1 and BA.4/5 vaccines is the Omicron sub-variant that they contain. Although the Moderna bivalent vaccine approved for use in Australia targets the BA.1 sub-variant, it is broadly protective against multiple Omicron sub-variants, including the currently circulating BA.4/5. 

    There are no trials that directly compare the BA.1 bivalent vaccines with the BA.4/5 bivalent vaccines and it is not clear if BA.4/5 vaccines will offer greater protection than the BA.1 vaccine against currently circulating or future variants/sub-variants.

  • I have had a serious adverse event to a previous dose of an mRNA vaccine. Is it safe to get the bivalent vaccine?

    If you have had a serious adverse event (such as anaphylaxis or myocarditis/pericarditis) to a previous dose of an mRNA vaccine, you should not receive the Moderna bivalent vaccine. Both the original and the bivalent mRNA vaccines use the same mRNA technology. Other COVID-19 vaccines are available and may be suitable for you. Please discuss these options with your immunisation provider.

    The side effects after the Moderna bivalent vaccine are similar to those seen after a booster dose of the original Moderna vaccine. Most side effects are mild and resolve within 1 to 2 days.
     

Disability workers providing intensive support to NDIS participants are also required to receive COVID-19 vaccination as a condition of work.

While for all other Australians COVID-19 vaccination currently is not mandatory and individuals may choose not to vaccinate, some states and territory governments have implemented COVID-19 vaccine mandates. Refer to your state or territory for information on vaccine requirements and public health orders.

  • UPDATED - Which COVID-19 vaccines are already in use in other countries?

    As of 17 September 2022, over 12.6 billion doses of a COVID-19 vaccine have been given to people worldwide, common vaccines used to date are:

    • Vaxzevria (AstraZeneca), a viral vector vaccine (185 countries)
    • Comirnaty (Pfizer), an mRNA vaccine (165 countries)
    • Spikevax (Moderna), an mRNA vaccine (111 countries)
    • BBIBP-CorV (Beijing/Sinopharm), an inactivated vaccine (94 countries)
    • Sputnik V (Gamaleya), a viral vector vaccine (67 countries)
    • CoronaVac (Sinovac), an inactivated vaccine (64 countries)
    • Janssen/Johnson & Johnson vaccine (99 countries)
    • Novavax NVX-CoV2373 (32 countries)

    Several other vaccines have been approved and are being used in other countries. More information about vaccine doses administered globally can be found at the London School of Hygiene COVID-19 vaccine tracker and at Our World in Data.

  • How are COVID-19 vaccination encounters recorded?

    It is mandatory to report all COVID-19 vaccines given to the Australian Immunisation Register (AIR). Information for providers about how to record and update immunisation details is available on the Services Australia website. 

  • How do I get a COVID-19 digital certificate or immunisation history statement to show proof of my COVID-19 vaccinations?

    If you are:

    • eligible for Medicare you can access the digital certificate or history statement via the Express Plus Medicare app, via your Medicare online account through myGov or through your My Health Record.
    • not eligible for Medicare, you can access your digital certificate using the Individual Healthcare Identifiers service (IHI service) through myGov. 
       

    Further information and instructions are available on the Services Australia website and the My Health Record website.

    Alternatively you can call the Australian Immunisation Register (AIR) on 1800 653 809 or ask your immunisation provider to print a statement for you.

  • Which COVID-19 vaccines used internationally are recognised in Australia and how can immunisation providers record these on the Australian Immunisation Register?

    The Therapeutic Goods Administration (TGA) has assessed the protection offered by certain COVID-19 vaccines that have been administered in other countries but are not yet registered in Australia. Coronavac (Sinovac), Covishield (AstraZeneca/Serum Institute of India), Covaxin (Bharat Biotech), BBIBP-CorV (Sinopharm) and Sputnik V (Gamaleya Research Institute) are now considered recognised vaccines for incoming international travellers. People who have received two doses of these vaccines at the appropriate intervals will be regarded in Australia as appropriately vaccinated.

    Immunisation providers can now record these vaccines on an individual’s record on the Australian Immunisation Register (AIR) shortly. It is important that country of immunisation and batch number are recorded, as this information is needed to produce the International COVID-19 Digital Certificate.

    The TGA has advised that other vaccines may be recognised in the future as more data become available.  

    A list of all vaccines currently able to be reported to AIR is available on the AIR vaccine code page. This page is updated regularly. COVID-19 vaccines are listed under the Non-standard vaccines section. It is important that provider's organisation is using the latest version of the practice management software to ensure the provider has the ability to record new vaccines as they become available. If lodging immunisation encounters using the AIR Site, the latest vaccines available will be presented for selection from the Vaccine/Brand field. More information about accessing the AIR site is available on How to set up your access to AIR.

    • UPDATED - Why should I get a COVID-19 vaccine?

      COVID-19 is a disease caused by the virus SARS-CoV-2. It can cause severe lung and generalised disease. As of 16 September 2022, it has caused over 6.5 million deaths worldwide, with more than 608 million cases reported.

      Although the elderly and people with underlying medical conditions are at the highest risk, anyone, including healthy young people, can get severe disease and die of COVID-19. In some people, COVID-19 may cause long-term symptoms of fatigue and breathlessness. We are still learning about other long-term complications caused by COVID-19. The virus is also easily spread by people with few or no symptoms; even if you may not become unwell with COVID-19, you may pass the virus on to others without knowing it and they may become very ill.  

      By vaccinating, you are protecting yourself and others from severe COVID-19. It is also likely that once a large proportion of the population is vaccinated, this will decrease the spread of COVID-19 in our community. 

    • Who can get a COVID-19 vaccine, including booster doses?
    • Why should I get a booster vaccine if I have already had 2 doses?

      There is evidence to show that protection from COVID-19 vaccines against infection reduces overtime. To address this decline, a booster dose of the COVID-19 vaccine has been recommended. Having a booster dose will protect you from COVID-19 for longer. If you do not get a booster dose your immunity against the virus may reduce overtime. This means you may be more likely to get infected with the virus and pass it on to others.

      A booster dose can also protect you against emerging variants. Evidence shows a booster dose provides greater protection against the Omicron variant than two primary doses of a COVID-19 vaccine alone. 

      Research is currently underway to determine how long does immunity from COVID-19 vaccines and booster doses last and how well they protect against new variants. As evidence emerges recommendations on booster doses or additional doses after a booster dose may be updated. For more information refer to ‘How effective are COVID-19 booster vaccines?’

    • When am I considered ‘up-to-date’ with my COVID-19 vaccinations?

      All individuals aged 16 years and older and some adolescents aged 12–15 years are recommended to receive a COVID-19 vaccine booster dose to maintain an ‘up-to-date’ status. This booster dose is now recommended from 3 months after the last primary dose. A person aged 16 years and older will be considered ‘overdue’ if a booster has not been received within 6 months of competing their primary schedule. Currently a booster dose is not recommended for children and adolescents aged 5–11 years.

      Severely immunocompromised people aged 6 months and older require a third primary dose and those who are severely immunocompromised and aged 12 years and older are also required to have a booster (fourth dose). Further details are available in the ATAGI statement on defining 'up-to-date' status for COVID-19 vaccination.

    • Do I need a booster vaccine dose if I get COVID-19 after completing the primary course of 2 doses of the COVID-19 vaccine?

      Yes, if you test positive for COVID-19 after 2 doses, it is recommended you still receive a booster dose. However, you should defer COVID-19 vaccination, including a booster dose, for 3 months after your infection because past infection reduces your chance of reinfection for at least this period. Following infection, your immunity against the virus may reduce overtime. This means you may likely get reinfected with the virus and pass it on to others.

      There is limited evidence on how much protection does previous infection with the Omicron variant provide. With the emergence of new variants, the duration of protection from natural immunity is unclear. It is recommended that you receive a booster dose once you have recovered from acute illness even if you have been infected with COVID-19 to address the uncertainty of protection against new variants and provide you with stronger and longer lasting immunity against infection.

      Residential aged care staff are required to have a third (booster) dose of an approved COVID-19 vaccine as a condition of working in a residential aged care facility.
       

    • What is Comirnaty (Pfizer vaccine) and how does it work?

      Comirnaty, also called BNT162b2, is a COVID-19 vaccine developed by Pfizer and BioNTech. It is an mRNA vaccine that contains the genetic code for an important part of the COVID-19 virus called the ‘spike protein’. After getting the injection, your body reads the genetic code and makes copies of the spike protein. Your immune system then detects these spike proteins and learns how to recognise and fight against COVID-19. The genetic code is quickly broken down and cleared away by the body. 

    • What is Spikevax (Moderna vaccine) and how does it work?

      Spikevax (Moderna vaccine) is a COVID-19 vaccine developed by Moderna. It is the second mRNA vaccine to receive provisional approval in Australia, following the Pfizer vaccine. It contains genetic code, called messenger RNA (mRNA), which instructs our body to make the unique spike protein from the COVID-19 virus. This trains our immune system to fight against COVID-19. Like the Pfizer vaccine, the mRNA from the Moderna vaccine does not change or interact with our DNA. 

    • What is Vaxzevria (AstraZeneca vaccine) and how does it work?

      Vaxzevria (AstraZeneca vaccine) is a COVID-19 vaccine developed by The University of Oxford and AstraZeneca. It contains the genetic code for an important part of the SARS-CoV-2 virus called the spike protein that is carried into your cells by a harmless common cold ‘carrier’ virus (an adenovirus). Your body then makes and uses the spike protein to learn to recognise and fight against SARS-CoV-2. The carrier adenovirus has been modified so that it cannot spread to other cells and cause infection. For this reason, the AstraZeneca vaccine does not behave like a ‘live vaccine’.

    • What is Novavax and how does it work?

      Novavax, also called Nuvaxovid or NVX-CoV2373, is a COVID-19 vaccine developed by Novavax. It is an adjuvant protein subunit vaccine. It uses a version of the spike protein on the COVID-19 virus and adjuvants within the vaccine that mimic the way the real virus would activate your immune system to boost your immune system and provide protection.

      The adjuvants are based on a natural product known as saponin, an extract from tree bark. The spike proteins resemble the structure of the COVID-19 virus; however, once injected they cannot replicate and give you COVID-19. It does not contain any live component of the virus. 

    • What are the differences between the COVID-19 vaccines available in Australia?

      The Pfizer and Moderna vaccines are mRNA vaccines and the AstraZeneca vaccine is a viral vector vaccine. The Australian Government Department of Health has produced a COVID-19 vaccine comparison poster which highlights the key differences between each COVID-19 vaccine approved for use in Australia as per the ATAGI guidelines.

      Further information about each vaccine, including ingredients, is available on the Australian Government Department  of Health website.  

    • What happens if the second dose is given early, late or is missed?

      If the second dose of any COVID-19 vaccine is given early (less than 14 days after the first dose), the dose is considered invalid. It is recommended that a replacement dose is given. The replacement dose can be given 4–12 weeks after the invalid dose. The interval is flexible and should be considered together with the risks and benefits of the individual. Refer to the ATAGI clinical guidance on COVID-19 vaccine in Australia and ATAGI clinical advice on use of a different COVID-19 vaccine as the second dose for more information.

      If the second dose of either COVID-19 vaccine is overdue (i.e. past the recommended interval), it should be given as soon as possible. A single dose likely only gives provide short-term protection. The second dose will be effective regardless of how late it is given. Even if the second dose is late, no vaccine doses need to be repeated.

    • Can COVID-19 vaccines be co-administered with other vaccines (e.g. influenza vaccine)?

      A COVID-19 vaccine can be co-administered (i.e. given on the same day) with other vaccines, including an influenza vaccine and routine childhood and adolescent vaccines, if required. ATAGI advises that there are no minimum intervals between COVID-19 vaccination and other routine vaccination (i.e. HPV, dTpa or MenACWY vaccines) on the basis that the benefits of ensuring timely vaccination and maintaining high vaccine uptake outweigh any potential risks associated with immunogenicity, local adverse reactions or fever. 

      As there is currently limited evidence on the co-administration of a COVID-19 vaccine and other vaccines, providers need to advise patients that when vaccines are co-administered, there is the potential for an increase in mild to moderate adverse events. If co-administration or administration within a few days does occur, it could make it more difficult to attribute any adverse event that may arise. When co-administering a COVID-19 vaccine and another vaccine, including an influenza vaccine, it is recommended to administer the vaccine in different limbs. 

      If you do not want the COVID-19 vaccine co-administered with another vaccine you can receive the second vaccine at any time interval after the other. It is noted that the most common side effects for the COVID-19 vaccines and influenza vaccines appear in the first 1-2 days following vaccination. 

      For more information on the co-administration of COVID-19 vaccines and influenza vaccines, refer to ATAGI advice on seasonal influenza vaccines in 2022. 
       

    • What activities can I do after vaccination?

      All regular daily activities can be performed after vaccination, including showering. If you feel well after vaccination, you can continue your usual exercise. If you feel unwell after vaccination (e.g. fever, body aches), you should take rest and seek medical attention for any symptoms you are worried about. For more information on some common side effects refer to the question "What are the likely side effects from COVID-19 vaccines".

    • How effective are COVID-19 vaccines?

      In clinical trials COVID-19 vaccines have been shown to provide excellent protection from getting sick with COVID-19. In these trials, after two doses the Pfizer vaccine was about 95% effective, the Moderna vaccine was 94% effective, the AstraZeneca vaccine was at least 62–70% effective and the Novavax vaccine was 90% effective in preventing people from getting sick with COVID-19. 

      There are ‘real world' studies (also called observational or post-market vaccine effectiveness studies) from vaccination programs in countries like the USA, the UK and Denmark that show strong protection for both vaccines. These studies were conducted at the time the Delta and Omicron variants were dominant.

      The vaccines appear to have lower effectiveness against the Omicron variant than against Delta. A study from the USA found that two doses of the Pfizer or Moderna vaccine were 94% effective in preventing COVID-19 hospitalisation during the Delta predominant period, which declined to 71% effectiveness during the Omicron period. A study from Denmark found that the Pfizer and Moderna vaccines were 87% and 88% effective in preventing infection from the Delta variant and 55% and 37% effective in preventing infection from the Omicron variant, respectively. A study from the UK found that vaccine effectiveness for the AstraZeneca vaccine against symptomatic infection decreased from 83% against the Delta variant to 49% against the Omicron variant. 

      Booster doses have been found to restore vaccine effectiveness and further increase your protection against disease from the Omicron variant. Refer to 'How effective are COVID-19 booster vaccines'.

    • How effective are COVID-19 vaccines in older adults?

      Studies from the UK, Canada and the USA show slightly reduced vaccine effectiveness (VE) against symptomatic infection and hospitalisation or death in older age groups, especially during the period when Omicron dominant period.

      Data from the UK have found that 2 doses of the either the Pfizer, Moderna or AstraZeneca vaccine is 78% effective at preventing hospitalisation in adults aged 65 years and older. A booster dose increased this protection to 92%. 

      A study from the US found that a booster dose of either the Pfizer or Moderna vaccine was 50% effective at preventing infection in adults aged over 65 years and 60% effective in adults aged less than 65 years, compared to people with who received 2 doses of the vaccine.

    • How effective are COVID-19 booster vaccines?

      There are ‘real world’ studies (also called observational or post-marketing vaccine effectiveness studies) from vaccination programs in countries including the UK and the USA that show strong protection from a booster dose of the Pfizer and Moderna vaccines. These studies estimate the vaccine effectiveness in people who have received a booster dose compared with people who received 2 doses in the primary course more than 5 to 6 months ago and did not receive a booster dose.

      A study from the USA found that a booster dose of the Moderna vaccine was 96% effective in preventing infection from the Delta variant and 64% effective in preventing infection from the Omicron variant. Another study from the USA found that the Pfizer booster vaccine was 93% and 89% effective at preventing hospitalisation from the Delta variant and Omicron variant, respectively. In both of these studies the vaccine effectiveness of 2 doses after 6 months had reduced and increased after receiving a booster dose.

      A study from Finland found that in people who received 2 doses of the AstraZeneca vaccine followed by a booster dose of the Pfizer vaccine, the booster vaccine was 98% effective in preventing hospitalisation from the Omicron variant. 
       

    • Will the COVID-19 vaccines be effective on new variants of the virus?

      Certain viruses, including the novel coronavirus, SARS-CoV-2, naturally mutate over time. Often these mutations don’t impact how viruses affect us. However, some recent variants of SARS-CoV-2 are more easily spread and appear to be associated with increased numbers of cases in some countries.

      Current evidence from clinical trials indicates that the antibodies induced from COVID-19 vaccines are likely to provide protection to a variety of mutations and minor changes. However, in some cases there may be an impact on how antibody developed from vaccines based on the original strain can ‘neutralise’ the virus. 

      There have been five variants of concern (VoC) since the start of the global COVID-19 pandemic. The WHO has classified them as Alpha, Beta, Gamma, Delta and Omicron. The Omicron variant was announced as a new VoC by WHO on 26 November 2021.  WHO also monitors Variants of Interest (VoI) and Alerts for Further Monitoring. 

      Currently approved vaccines have been shown to be effective to provide at least some protection against new variants as these vaccines work to create a broad immune response. The mutations causing these variants should not make the vaccines ineffective. Refer to 'How effective are COVID-19 vaccines?' for more information.

      Bivalent vaccines target two different strains of the virus. The Moderna bivalent vaccine approved for use in Australia contains the original/ancestral (Wuhan) variant and the Omicron BA.1 variant. It generates a better immune response against the Omicron strain and a similar respone against the original strain of COVID-19 compared with the original Moderna vaccine. It also provides provides greater immunity against the BA.4/5 variant than the original Modern vaccine. It is expected to be available in Australia in mid-October 2022.

    • How long will protection from the COVID-19 vaccine last?

      There is emerging evidence from real-world studies that suggests that protection from COVID-19 vaccines against infection reduces overtime, possibly from 6 months onwards. However, protection against severe disease, such as hospitalisation and death, has been shown to remain high 6 months after vaccination in many studies. COVID-19 booster vaccines have been recommended to address the reduction in protection over time. For more information, refer to 'How effective are COVID-19 booster vaccines'.

    • Do the vaccines reduce the risk of transmission of SARS-CoV-2 to others?

      The Omicron variant appears to be more transmissible compared to the Delta variant. Data from the UK and Europe show that vaccination still provides protection against transmission of the Omicron variant to a degree.

      Three studies from Norway and Denmark looked at how many people became infected in a household if the original case had Omicron compared to if they had Delta. All three studies found an increased risk for those who were in a household with an Omicron case. The risk ranged from 1.17 to 1.52 times greater for Omicron cases compared to Delta cases. 

      Studies from Norway, Denmark and the UK also looked at the risk if the original case was vaccinated compared to if they were not vaccinated or vaccinated with fewer vaccine doses (e.g. two doses compared to three doses). These studies found that the rate in which household members became infected, if the case infected with Omicron, did not change if the case was unvaccinated or vaccinated with one or more doses. 

      However, the study from Norway found that if the household contact had received two doses and were in a household with an Omicron case, the vaccine was 27% effective at preventing an infection, and if they had received three doses the vaccine was 45% effective. 

    • What is ‘long COVID?’ Does the COVID-19 vaccine protect against ‘long COVID?’

      ‘Long COVID’ is a condition where people with COVID-19 experience persistent symptoms, usually 3 months from the onset of COVID-19, that continue for at least 2 months. Common symptoms include fatigue, shortness of breath, cognitive dysfunction (‘brain fog’) and others. These symptoms generally affect the person’s everyday functioning. Symptoms can fluctuate or relapse over time. The World Health Organization has developed a case definition for this condition, also called ‘post COVID-19 condition’. ‘Long COVID’ can affect both children and adults. It is not yet known how long symptoms of long COVID last. A study from the UK found that at least 10% of people reported at least one symptom 3 months after their initial infection. 

      Treatment for long COVID depends on symptoms. Talk to your doctor about the care you might need. You may be able to manage your symptoms at home or you can be referred to a specialist or an allied health professional.

      Vaccines are effective at preventing COVID-19 infection and, therefore, reduce the risk of long COVID. A review of studies assessing the effectiveness of vaccination against long COVID found evidence that vaccinated people who are then infected with COVID-19 are less likely to experience long COVID symptom than unvaccinated people. 

    • Can I have a different COVID-19 vaccine for dose 1 and dose 2?

      In Australia, the Pfizer, Moderna and AstraZeneca vaccines require two doses of the same vaccine. ATAGI recommends completing the vaccination course with the same vaccine. There are some special circumstances where a mixed schedule may be is recommended. 

      These include:

      • anaphylaxis to the first dose of a COVID-19 vaccine 
      • thrombosis with thrombocytopenia following the first dose of AstraZeneca vaccine
      • any other serious side effect attributed to the first dose of a COVID-19 vaccine 
      • people who were partially vaccinated overseas with a COVID-19 vaccine not available in Australia.
         

      People who have had a first dose of the AstraZeneca vaccine and have one of the following conditions are recommended to receive the Pfizer or Moderna vaccine for their second dose:

      • history of cerebral venous sinus thrombosis (CVST) 
      • history of heparin-induced thrombocytopenia 
      • history of idiopathic splanchnic (mesenteric, portal, splenic) venous thrombosis 
      • history of anti-phospholipid syndrome (APLS) with thrombosis
      • history of capillary leak syndrome.

      There are emerging data to support the safety and effectiveness of mixed vaccine schedules (i.e. different vaccine brand for dose 1 and dose 2). A different brand can now be used for the second dose for other reasons such as being unable to access or not accepting a second dose of the same brand, although the same brand for dose 2 is preferred. For more information, refer to ATAGI clinical guidance on COVID-19 Vaccine in Australia.

    • Do I need the vaccine if I have already had COVID-19 in the past?

      Yes, COVID-19 vaccines are recommended for people with a past history of COVID-19. If you test positive for COVID-19 it is recommended to defer vaccination for 3 months. All recommended doses should still be received and be given as soon as possible 3 months after infection. For more information, refer to ATAGI clinical guidance on the use of COVID-19 vaccine in Australia.

      People who had an anti-SARS-CoV-2 monoclonal antibody or convalescent plasma treatment for COVID-19 should wait at least 90 days before having a COVID-19 vaccine.

      COVID-19 vaccine clinical trials did include some people previously infected with the virus, although they had not reported it (they had a blood test showing past infection). These people had a good immune response to the vaccine and had similar mild and expected side effects to people who were not previously infected. This and other studies assessing vaccine safety in people who have previously been infected tell us that vaccinating someone after they had COVID-19 infection is safe.

      The healthcare professional can consult with a specialist immunisation service for additional advice if needed. If someone needs a temporary exemption from vaccination for work or other reasons as detailed in the ATAGI Expanded Guidance on temporary medical exemptions for COVID-19 vaccines, this can be obtained from their doctor using Commonwealth health department approved form, for up to 4 months.

    • When can I receive my next scheduled COVID-19 vaccine or other vaccines if I have tested positive for COVID-19?

      If you have tested positive for COVID-19 you can receive your next scheduled dose 3 months after infection. All recommended doses should still be received and be given as soon as possible 3 months after infection. For those who are recommended to receive a second booster (winter dose), it is recommended that this dose is given 3 months after the first booster.

      Evidence from the US suggests that fully vaccinated individuals who get infected with COVID-19 usually experience less severe symptoms than those who are unvaccinated. Vaccination after infection is likely to increase protection against COVID-19. The risk of reinfection with the Omicron variant is very low within the first 3 months after infection. Advice may change if future variants emerge.

      This interval may shortened in some circumstances such as starting an immunosuppressant, prior to overseas travel or in outreach vaccination programs. People who have previously been vaccinating within 3 months of infection do not need to repeat any doses.

    • I’ve recently had COVID-19. Do I need to wait before getting other vaccines?

      You can get non-COVID vaccines, including influenza vaccine, without any minimum interval if you have recently had COVID-19 or have tested positive to COVID-19. If you have a fever or are feeling very unwell, talk to your doctor about the best time to get vaccinated. However if you feel well and have no symptoms or only minor symptoms, you can get other (non-COVID) vaccines at any time. It’s important to be up to date with other vaccines, including influenza vaccine, to minimise your risk of other infections.

    • How do I prepare for COVID-19 vaccination and what to do after COVID-19 vaccination?

      Refer to the preparing for COVID-19 vaccination guide on what to do before your vaccination for what you should do before your COVID-19 vaccination as well as what to expect at your appointment.

      Refer to the after your COVID-19 vaccination guides  for a list of common side effects noted after each vaccine and what to do in the event of a side effect.

    • When preparing the Pfizer vaccine and leakage of diluent occurs, can the vaccine still be used?

      If there is a leakage of diluent from the vial during reconstitution of the Pfizer vaccine, you may use the vaccine if you have injected most of the diluent into the vial.

      Where you are uncertain about how much diluent you have injected, you may use the vaccine if you are able to draw up at least 4 doses. 

      Ensure that there has been no breach of infection control.

    • Can children have a COVID-19 vaccine?

      All children aged 5 years and older and some children aged 6 months to under 5 years can receive a COVID-19 vaccine. A table with information on the recommended number of doses and vaccine brand can be found here.

      Children aged 6 months to under 5 years who have severe immunocompromise, disability and complex and/or multiple health conditions which increase the risk of severe COVID-19 can receive 2 doses of the paediatric Moderna vaccine, 8 weeks apart, shortened to a minimum of 4 weeks in special circumstances. 

      Children aged 6 months to under 5 years who are not in the risk categories specified by ATAGI are not recommended to receive COVID-19 vaccination because of the very low risk of severe illness from COVID-19. This advice may change overtime.

      Children aged 5–11 years are recommended to receive two doses of the paediatric Pfizer vaccine, 8 weeks apart, shortened to a minimum of 3 weeks in special circumstances. A longer dose interval has been recommended in children aged 5–11 years as it may improve immunogenicity and may reduce the risk of myocarditis and pericarditis after vaccination.

      Children aged 6–11 years can also receive two doses of the paediatric Moderna vaccine, 8 weeks apart, shortened to a minimum of 4 weeks in special circumstances, as an alternative to the Pfizer vaccine. The paediatric Pfizer vaccine continues to be the only COVID-19 vaccine approved for children aged 5 years. A longer dose interval has been recommended in children aged 5–11 years as it may improve immunogenicity and may reduce the risk of myocarditis and pericarditis after vaccination.

      Adolescents aged 12–18 years are recommended to receive two doses of the Pfizer vaccine 21–42 days apart or two doses of the Moderna vaccine 28–42 days apart or 2 doses of Novavax 8 weeks apart. 

      Children aged 6 months and older who are severely immunocompromised are recommended to receive a third primary dose of the COVID-19 vaccine, 2 months after their second dose.

      Children and adolescents aged under 18 years cannot have the AstraZeneca vaccine.

      A booster dose of the Pfizer vaccine is recommended for some adolescents aged 12–15 years, including:

      • those who are severely immunocompromised 
      • those who have a disability with significant or complex health needs
      • those who have complex and/or multiple health conditions that increase the risk of severe COVID-19.

      A booster dose is not recommended for all other healthy adolescents aged 12–15 years and children aged less than 12 years. The Moderna vaccine and Novavax vaccine are not licensed for use as a booster dose in this age group.

      Refer to ‘How effective are COVID-19 vaccine in children?’ and ‘How safe are the COVID-19 vaccines in children?’
       

    • How effective are COVID-19 vaccines in children?

      The Pfizer and Moderna vaccines are highly effective in adolescents aged 12–17 years, and the Pfizer vaccine is highly effective in children aged 5–11 years. 

      A clinical trial for the Pfizer vaccine found the vaccine to be 100% effective at preventing COVID-19 infection in adolescents aged 12–15 years. A trial for the Moderna vaccine found the vaccine to be 92% effective in preventing symptomatic COVID-19 infection in adolescents aged 12–17 years. The clinical trial for the paediatric Pfizer vaccine in children aged 5–11 years showed that the vaccine was 91% effective at preventing COVID-19 in children.

      A study from England found that the Pfizer vaccine in adolescents aged 12–16 years was less effective in preventing symptomatic infection caused by Omicron compared with Delta. For the Omicron variant, the study found that the Pfizer vaccine was 83% effective in adolescents aged 12–15 years and 76% effective in adolescents aged 16–17 years. The Pfizer vaccine was found to be 93% effective in preventing symptomatic infection from the Delta variant in adolescents aged 12–15 years. 

      A study from the US found the Pfizer vaccine was 68% and 40% effective at preventing hospitalisation during the Omicron period, in children aged 5-11 years and 12-18 years, respectively. The Pfizer vaccine was 79% effective at preventing critical hospitalisation in children and adolescents aged 5-18 years.

    • Why do children need to get a COVID-19 vaccine?

      It is recommended that all people aged 5 years and older and some at-risk children aged 6 months and older receive a COVID-19 vaccine to protect them from getting severe illness from COVID-19. Although the elderly and people with underlying medical conditions are at the highest risk, anyone, including healthy young people, can get severe disease and this may cause long-term symptoms of fatigue and breathlessness. 

      The virus is also easily spread by people with few or no symptoms.  Vaccinating children is likely to reduce the spread of the virus between themselves and to adults, reduce the risk of complications such as paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS) and reduce disruptions to schooling and other learning.

      For more information on COVID-19 vaccines in children, refer to COVID-19 and children: Frequently asked questions.

    • Can I have a COVID-19 vaccine if I am pregnant, breastfeeding or planning pregnancy?

      Yes, the Pfizer and Moderna vaccines are routinely recommended for pregnant women, and pregnant women are a priority population for vaccination. This is a joint recommendation from the Australian Technical Advisory Group on Immunisation and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. 

      Booster doses are also recommended for pregnant women who received the second dose of their primary vaccination at least 3 months earlier. The Pfizer and Moderna vaccines are the preferred vaccines for pregnant women.

      People aged 50 years and older are recommended to receive a second booster dose, 3 months after the first booster dose. People aged 30 to 49 years, including pregnant women, can also receive a second booster dose at any stage of pregnancy; however, benefit of this dose for people in this age group is less certain because the risk of severe disease appears very low. Pregnant women aged under 30 years are not currently recommended to receive a second booster dose on the basis of the low likelihood of severe disease, if they do not have a disability or chronic medical condition for which a second booster dose is indicated. 

      For more information, refer to the ATAGI clinical guidance. 

      The recommendation to use the Pfizer vaccine or the Moderna vaccine is based on the availability of more safety data for these vaccines in pregnant women, whereas there is very limited evidence using the AstraZeneca vaccine during pregnancy. However, if the Pfizer vaccine or Moderna vaccine is not available, the AstraZeneca vaccine can be considered by pregnant women if the benefits of vaccination outweigh the risks for the individual, such as in outbreak settings. 

      Women who are breastfeeding do not need to stop breastfeeding after vaccination. Women who are planning pregnancy do not need to avoid becoming pregnant after vaccination. Research has shown that pregnant women have a higher risk of severe illness from COVID-19, and compared with non-pregnant women with COVID-19 they are more likely to need admission to an intensive care unit and mechanical ventilation. They are also more likely to deliver their babies early, and their babies are more likely to require admission to a newborn intensive care unit. 

      There is now real-world evidence from countries such as the USA showing that mRNA vaccines (such as the Pfizer vaccine and the Moderna vaccine) are safe in pregnant women, and the side effects they report are similar to those in non-pregnant women. 

      Women who received their first dose of the AstraZeneca vaccine and are pregnant can receive dose 2 of either the AstraZeneca vaccine or the Pfizer or Moderna vaccine, although an mRNA vaccine (Pfizer or Moderna) is preferred. See also 'I had dose one of the AstraZeneca vaccine and am now pregnant. What is the advice for dose 2?'

      More information is available in the COVID-19 vaccination decision guide for women who are pregnant, breastfeeding or planning pregnancy and the World Health Organization Questions and answers: COVID-19 vaccine and pregnancy.

    • I had dose one of the AstraZeneca vaccine and am now pregnant. What is the advice for dose 2?

      Women who received their first dose of the AstraZeneca vaccine and are pregnant can receive dose two of either the AstraZeneca vaccine, or Pfizer or Moderna vaccine, although an mRNA vaccine (Pfizer or Moderna) is preferred. Pregnant women should speak with their healthcare provider about the best choice for them.

      Providers and consumers may wish to consider:

      • there is a growing body of evidence supporting the safety of mRNA vaccines in pregnancy
      • there are still very limited data on the safety of viral vector vaccines (such as the AstraZeneca vaccine) in pregnancy
      • there are comparatively less data on the safety and efficacy of mixed vaccine schedules than completing the series with the same vaccine.
         

    • Can my baby have the live rotavirus vaccine (Rotarix) if I received a COVID-19 monoclonal antibody during pregnancy?

      Yes. All vaccines recommended for children, including live vaccines like Rotarix, can be given to babies whose mothers received a COVID-19 monoclonal antibody during pregnancy, such as sotrovimab. This is because sotrovimab and other COVID-19 specific antibodies do not suppress the immune system.

    • Can I have a COVID-19 vaccine if I am immunocompromised?

      Being immunocompromised means you have a weakened immune system, either from an underlying medical condition or from medical treatment that weakens your immune system. 

      If you are immunocompromised, you are strongly recommended to receive a COVID-19 vaccine currently approved in Australia – the Pfizer, Moderna or the AstraZeneca vaccine. The ATAGI clinical guidance on COVID-19 Vaccine in Australia provides a list of medical conditions associated with increased risk of severe COVID-19 illness.

      In addition, a third primary dose is now recommended for people aged 6 months and older who are severely immunocompromised. This differs from a booster dose which is required when the vaccine effectiveness wanes overtime. A booster dose (i.e. fourth dose) is recommended for people aged 12 years and older who are severely immunocompromised and have received a third primary dose,  three months after completion of the third dose. For more information, refer to 'Who is currently recommended to receive a third dose of a COVID-19 vaccine?' and 'Who is recommended to receive a booster dose of the COVID-19 vaccine?'

      All of these vaccines are considered to be safe in immunocompromised people. However, they may be less effective in immunocompromised people, because the vaccines rely on your immune system to build a response. This means that it’s important to continue other protective measures against COVID-19, even if you are vaccinated. 

      The Pfizer, Moderna and Novavax vaccines are not live vaccines. The AstraZeneca vaccine contains a virus that is non-replicating and is also not considered to be a live vaccine, meaning that it cannot cause infection even in an immunocompromised person.

      If you are taking an immune-weakening treatment (immunosuppressant/immunomodulator), including chemotherapy, you should discuss the best timing of vaccination with your treating doctor. 

      For more information, refer to the COVID-19 vaccination – Shared decision making guide for people with immunocompromise.

    • Could the vaccine react with other medications? Do other medications need to be stopped to have a COVID-19 vaccine?

      No, in most cases medication should not be stopped before having a vaccine. There are a few situations in which people might be advised to either delay vaccination or delay a particular medication:

      • Some people taking blood thinners (anticoagulants) may be advised to delay vaccination if there is a high risk of bleeding after the vaccine is injected. Most people on a stable dose of blood thinner will be able to receive the vaccine without any change to their medication.
      • People taking immune-weakening treatments (immunosuppressants), including chemotherapy, should discuss the best timing of vaccination with their treating doctor. 
         

      People taking other medications should continue their regular treatment before and after vaccination. 
       

    • I have heard that there are treatments for COVID-19 such as sotrovimab. What are these treatments and when can they be used?

      Vaccination is the safest and most important way to be protected from COVID-19. For people who become infected with COVID-19 and are at risk of severe disease, the TGA has granted provisional approval for the use of eight treatments:

      These treatments require confirmed infection either through a PCR test or RAT test, witnessed or performed by a practitioner. 

      For more information on the contraindications, interactions with other medicines and effects of the oral treatments, refer to the Product Information for the individual treatments in the links above.

      Two oral treatments (Lageviro and Paxlovid) are funded by the government. Eligibility for these treatments was expanded on 11 July 2022 to include:

      • people 50 years and older at high risk of severe disease
      • moderately to severely immunocompromised people aged 18 years and older, irrespective of vaccination status
      • Aboriginal and Torres Strait Islander people aged 30 years and older at high risk of developing severe disease.

      Refer to the Australian Government Department of Health resources for more information and criteria for prescribing on COVID-19 treatments and COVID-19 oral treatments. For people who have difficulty taking medication, please speak to your pharmacist. Further information can be found here.

    • Can I have a COVID-19 vaccine if I have been given COVID-19 medication or treatment?

      If you have had COVID-19 you should generally wait 3 months before having your next COVID-19 vaccine dose (in exceptional cases, vaccination may be required earlier). However, COVID-19 antiviral medications, including nirmatrelvir/ritonavir (Paxlovid), remdesivir, molnupiravir, will not affect your response to COVID-19 vaccines nor will antiviral medications for other infections. This is because the currently available COVID-19 vaccines are not live vaccines. 

    • What should I do if I test positive for COVID-19 on a rapid antigen test?

      If you test positive for COVID-19 on a rapid antigen test (RAT) you must isolate immediately and let your local health authorities know. If you test positive on a polymerase chain reaction (PCR or RT-PCR) your local health department will contact you.

    • Can I receive a COVID-19 vaccine if I am feeling unwell (have a fever or a cold)?

      If you are feeling unwell, talk to your doctor about the best time to get vaccinated. If you have mild symptoms and no fever, you may be able to receive a COVID-19 vaccine. It’s important to be up to date with other vaccines, including influenza vaccine, to minimise your risk of infections. 

    • What is hybrid immunity?

      Hybrid immunity refers to the combined immune response of a person after they have been both infected by and vaccinated against a pathogen, such as the COVID-19 virus. The World Health Organization (WHO) provides a detailed explanation of COVID-19 hybrid immunity here. 

      Evidence suggests that hybrid immunity against COVID-19 generates higher antibody levels that take longer to wane than either infection or vaccination alone. This probably means that people with hybrid immunity are less likely to become infected with the currently known COVID-19 variants, but this can still occur.

      Protection against death, severe disease and hospitalisation is probably similar whether immune responses are generated from vaccination alone or hybrid immunity. For these outcomes, infection alone provides less protection. It is unclear whether hybrid immunity will be more protective against new variants than vaccination or infection alone.

      This WHO statement provides further details about studies that compared protection in persons who were vaccinated with and without prior infection.

    • Can you get COVID-19 from a COVID-19 vaccine?

      No, you cannot get COVID-19 from a COVID-19 vaccine. 

      To get COVID-19, a live virus that can multiply in your body has to infect you. No vaccine supplied currently in the world contains live SARS-CoV-2 virus. 

      The vaccines available in Australia and elsewhere contain a genetic material that codes for the spike protein (eg, Pfizer, Moderna and AstraZeneca), the spike protein itself (eg, Novavax) or an inactivated (or killed) form of the virus (in vaccines manufactured in China). They do not contain any live SARS-CoV-2 virus. 

    • What are the likely side effects from COVID-19 vaccines?

      All vaccines can cause side effects. Usually these are mild and temporary. Clinical trials of COVID-19 vaccines have reported side effects such as pain at the injection site, fever or muscle aches starting on the day or day after vaccination and go away without treatment.  

      The most common side effects for both vaccines include pain at the injection site, tiredness, headache, muscle pain, chills, joint pain and fever. These side effects are temporary and go away without treatment in 1–2 days. Sometimes these flu-like side effects can mean people don’t carry out their usual activities for a day or so. 

      For more detailed information about the side effects of each vaccine, refer to:

      AusVaxSafety is actively monitoring the side effects reported after COVID-19 vaccines in Australia. The surveillance data report is updated weekly.

    • What should I do if I have side effects after a COVID-19 vaccine?

      Common side effects include pain, redness or swelling at the site of your injection, as well as tiredness, headache or fever. You can take paracetamol or ibuprofen to help with side effects like pain, headache or fever. 

      These short-term side effects are expected and reflect a developing immune response to vaccination. If you have significant side effects (such as fever, tiredness or muscle aches) which are preventing you from carrying out your usual activities, you may need to take extra rest until you feel better. 

      You should seek urgent medical assistance (e.g. by calling 000) if you think you are having a severe allergic reaction, such as if you are experiencing difficulty breathing, hives, lip swelling or feeling faint.

      You should seek advice from your usual healthcare provider (e.g. GP) if you have any side effects that you are concerned about, or if your side effects have not gone away after a few days. 

      Be aware of the very rare possibility of serious symptoms after AstraZeneca vaccine caused by TTS. These symptoms may include new onset severe headache or abdominal pain starting in the 4-42 days after vaccination. Be sure to seek medical attention if you have any concerns (refer also to the question Where can individuals find information about AstraZeneca vaccine and thrombosis with thrombocytopenia syndrome [TTS])?

      You can report potential side effects after vaccination to your state or territory health authority, or directly to the Therapeutic Goods Administration (TGA). Your healthcare provider can make the report for you if you wish. This will help the TGA collect information about adverse effects that occur after COVID-19 vaccination and detect any possible unexpected safety signals.

    • If I have side effects after the first dose of a COVID-19 vaccine, can I still have the second dose?

      Yes, almost always. Side effects such as pain at the injection site, fever, chills, tiredness, headache and muscle aches occur commonly after the first dose of a COVID-19. You should have the second dose even if you experienced these side effects.

      These side effects are caused by your immune system responding appropriately to the vaccine. Although they cause discomfort and inconvenience, they are usually brief and go away within a few days. Some people may need to take paracetamol or ibuprofen to help reduce the discomfort. You may also need to take extra rest in the day or so after vaccination, until you feel better.

      Having the second dose is important to ensure you get the best possible protection against COVID-19.  

      If you have had a severe allergic reaction to your first dose, or any other severe symptoms that you are worried about or have been diagnosed with TTS after the AstraZeneca vaccine, discuss these with your healthcare provider before having the second dose.

    • How can I report a potential side effect after immunisation?

      If you have any side effects that are unexpected, severe, or which you are concerned about, you can report them to your state or territory health authority, or directly to the Therapeutic Goods Administration (TGA). Your healthcare provider can make the report for you if you wish. This will help the TGA collect information about adverse effects that occur after COVID-19 vaccination and detect any possible unexpected safety signals. 

      For information on how to make the report, refer to the TGA webpage Reporting suspected side effects associated with a COVID-19 vaccine. 
       

    • How safe are the COVID-19 vaccines for children?

      Clinical trials have shown that the Pfizer, Moderna and Novavax vaccines are safe for adolescents and children aged 6 months and older. 

      In the clinical trials of the Pfizer, Moderna and Novavax vaccines, adverse events following COVID-19 vaccination in children aged 12-17 years were mild and generally resolved within 1 to 2 days. Pain or tenderness at the injection site was the most common side effect in children aged 12–17 years for the three vaccines. Side effects such as fatigue, fever, headache and chills were more common after the second dose than the first dose of the vaccine. Overall the frequency and types of side effects were similar to those seen in adults.  

      A clinical trial of the Pfizer vaccine in over 4,000 children aged 5–11 years and a clinical trial of the Moderna vaccine (interim data) in over 3,000 children aged 6–11 years both found the vaccine to be safe for children in this age group. Most side effects were mild and resolved within 1–2 days. There were no vaccine-related serious side effects.

      A clinical trial of the Moderna vaccine in children aged 6 months to 5 years found that the side effects were similar to those found in other age groups receiving the Moderna vaccine. Most side effects were mild and resolved within 1–2 days. Side effects were more common after the 2nd dose. 

      These side effects are expected and reflect a developing immune response to vaccination. For more information refer to ‘What should I do if I have side effects after a COVID-19 vaccine?’

      A risk of myocarditis and pericarditis has been seen in people who have had mRNA vaccines (including the Pfizer vaccine and the Moderna vaccine) overseas. These cases have been reported more commonly in people aged under 30 years, including in adolescents. For more information refer to ‘What is myocarditis and pericarditis?' and 'Can the Pfizer and Moderna vaccine lead to myocarditis and pericarditis?’

    • Are COVID-19 vaccines safe for people with a disability?

      All three COVID-19 vaccines available in Australia are safe for people with a disability, including people with autism. People with a disability are at risk of severe SAR-COV-2 infection and are encouraged to receive COVID-19 vaccination. Vaccination will not only prevent people with a disability from getting sick from COVID-19 but will also protect others from getting infected by preventing the spread of the virus.

      A list of vaccination hubs for people with a disability and more information can be found here.

    • Do COVID-19 vaccines used in Australia contain pork gelatine?

      None of the COVID-19 vaccines currently used in Australia contain pork gelatine. 

      A list of ingredients for the Pfizer vaccine, the Moderna vaccine, the AstraZeneca vaccine and the Novavax vaccine has been published. Once other vaccines are approved for use in Australia, their list of ingredients will be available.

      The Australian National Imams Council and the Muslim Health Professional Australia both have endorsed the COVID-19 vaccines in Australia. They confirmed that the COVID-19 vaccines do not contain any prohibited substances and are considered safe.

      The NSW Jewish Board of Deputies also encourages the Jewish community to receive COVID-19 vaccination. 

    • Do COVID-19 vaccines used in Australia contain material from aborted fetuses?

      There are no cells from aborted tissue in any COVID-19 vaccine. The AstraZeneca vaccine is manufactured using material originally sourced from a human embryo (Human Embryonic Kidney cells: HEK293). Fetal cell lines were not used in the development or manufacturing of the Pfizer and Moderna vaccines, but they were used during the testing stages of the vaccine. 

    • Is the mRNA in some COVID-19 vaccines harmful?

      Some COVID-19 vaccines, including the Pfizer vaccine and the Moderna vaccine, contain mRNA, a form of genetic code. This mRNA contains the code for an important part of the SARS-CoV-2 virus called the ‘spike protein’. After vaccination, our cells make some copies of the spike protein, and this trains our immune system to recognise and fight against SARS-CoV-2. mRNA is very fragile and gets broken down and removed very quickly and easily by our body. 

      mRNA vaccines such as the Pfizer vaccine and the Moderna vaccine have been given to tens of millions of people around the world, and have been safe and well tolerated. 

      The only serious side effect that has been confirmed to be caused by an mRNA vaccine is anaphylaxis, a type of serious allergic reaction, which can occur after any vaccine or medicine, and which is treatable.

      Anaphylaxis after an mRNA vaccine is still very rare. The rate of anaphylaxis after the Pfizer vaccine in the USA as of December 2020 was 11.1 cases per million people and the rate after the Moderna vaccine as of January 2021 was 2.5 cases per million people. 

    • Does the AstraZeneca vaccine contain a live virus?

      No. The AstraZeneca vaccine contains a harmless ‘common cold’ virus (an adenovirus) that carries the piece of genetic code for the SARS-CoV-2 spike protein into your cells. This adenovirus has been modified so that it can only enter your cells once, and it cannot replicate and spread to other cells. It therefore cannot cause infection, and does not behave like a ‘live vaccine’. It is considered safe for people who cannot have live vaccines, such as people with immunocompromise (weakened immune systems). 

    • How is vaccine safety monitored after a vaccine is approved for use?

      After any vaccine is registered and it starts to be given to people, vaccination experts and regulators continue to monitor vaccine safety in several ways. People can report side effects or adverse events directly to the regulatory body, the TGA. This is called passive surveillance because it waits for people to report. As a further check, the TGA assesses the quality of every batch of vaccine before it can be supplied in Australia.

      Weekly TGA reports on COVID-19 vaccine safety monitoring are published here.

      There is also active surveillance where researchers or regulators actively seek out any side effects in large groups of people given the vaccine. One form of active surveillance is where researchers continue to study the vaccine’s effectiveness and safety (sometimes called ‘phase 4’ trials). Another form is using established systems such as AusVaxSafety, in which clinics send SMS messages to people receiving vaccines (or their parents or carers) to ask if they had any reactions after receiving a vaccine. Independent experts analyse the responses to make sure that any safety issues are detected quickly. AusVaxSafety operates in almost 300 clinics around Australia and cover hundreds of thousands of people, and safety monitoring data are published weekly here.


      The systems described above will be used and expanded to monitor vaccine safety for all licensed COVID-19 vaccines, with experts meeting to review all reported data even more frequently than for usual vaccines.

    • Can COVID-19 vaccines lead to infertility?

      No, there is no evidence that any of the COVID-19 vaccines being used in the Australian COVID-19 vaccination program can lead to infertility. 

      Before human trials, the Pfizer, Moderna and AstraZeneca vaccines were assessed for their effect on fertility in animal studies. These studies found pregnancy rates in animals that received the vaccine were same as for those that did not receive the vaccine.

      Two studies from Israel assessed fertility in women who were undergoing in vitro fertilisation (IVF) or intracytoplasmatic sperm injection (ICSI) and had received the Pfizer vaccine. Two further studies from the United States and Israel assessed people who underwent IVF and received mRNA vaccines (Pfizer or Moderna). These four studies found that mRNA vaccines did not affect the quality and number of eggs women produced, the rate at which eggs were successfully fertilised, the number of embryos resulting from fertilisation that were of good quality, or the pregnancy rate that resulted from treatment. Given that the Pfizer and Moderna vaccines did not affect fertility treatment, this implies that the vaccines do not lead to infertility.

      A study in men receiving either the Pfizer and Moderna vaccine and a second study in men receiving the Pfizer vaccine found that the volume and quality of sperms did not change after they received either mRNA vaccine in healthy men or in men who had decreased fertility.

      Pregnant people are a priority group for COVID-19 vaccination, and the Pfizer vaccine or Moderna vaccine is recommended at any stage of pregnancy, due to age. Women who are breastfeeding or planning pregnancy are also recommended to receive these vaccines and women who are trying to become pregnant do not need to delay vaccination or avoid becoming pregnant after vaccination. The COVID-19 vaccination decision guide for people who are pregnant, breastfeeding or planning pregnancy is available on the Department of Health website.

    • Can I have a COVID-19 vaccine if I have dermal fillers?

      Yes, COVID-19 vaccines are recommended if you have dermal fillers.

      There have been reports of facial swelling following mRNA vaccinations in people with a history of injections with dermal facial fillers. In the clinical trial of the Moderna vaccine, two participants who had dermal facial fillers experienced facial swelling within 2 days of vaccination. Potential swelling of the face in people who had dermal fillers has been added as a side effect to the Moderna product information. The swelling is short-lived and a common side effect of dermal fillers.

      In Europe, the European Medicines Agency (EMA) assessed cases of facial swelling in people with a history of injections with dermal facial fillers after receiving the Pfizer vaccine, Facial swelling has been added as a side effect to the Pfizer vaccine in the European product information. The Therapeutic Goods Administration have also reviewed cases of swelling in people who had received dermal filler injections. The reactions are rare and temporary.

      COVID-19 vaccines are still recommended in people with a history of dermal fillers. If you have any concerns, speak to your treating doctor.

      The AstraZeneca vaccine is not known to be associated with facial swelling in people with a history of dermal fillers. 

    • Why are my lymph nodes/underarm area swollen and sore after a booster dose?

      Swollen or painful lymph nodes (also called lymphadenopathy) is a commonly reported side effect after a booster dose.

      Lymph nodes are small groups of tissue, found throughout the body, that help fight infection. After a COVID-19 vaccine is injected into your body, your lymph nodes can enlarge. This is a sign that your white blood cells are activated and creating memory cells to fight against COVID-19 infection. The closest set of lymph nodes, under the arm the needle was injected, may swell and become painful within a few days of vaccination. This is not serious and normally resolves, without treatment, within a week or so.

    • What is myocarditis and pericarditis and can the Pfizer or Moderna vaccine lead to myocarditis and pericarditis?

      Myocarditis is inflammation of the heart muscle. Pericarditis is inflammation of the outer lining of the heart. Myopericarditis is where these two conditions occur together.

      A risk of myocarditis and pericarditis has been seen in people who have had mRNA vaccines (including the Pfizer and Moderna vaccines). Cases are more commonly reported in males aged under 40 years following the second dose. A study from the UK estimated that the rate of myocarditis after the second dose is 12 per million for males under 40 years for the Pfizer vaccine and 101 per million for the Moderna vaccine.

      In Australia, the Therapeutic Goods Administration (TGA) closely monitors cases of myocarditis and pericarditis. The overall rate after the second dose of the Pfizer vaccine is 37 cases per million in males and 12 cases per million in females. For the Moderna vaccine, the rate is 75 cases per million for males and 11 cases per million for females. Data from the UK and a study suggest there is a risk of myocarditis after the AstraZeneca vaccine; however, the risk is smaller than that for mRNA vaccines. The risk of myocarditis and pericarditis after the Novavax vaccine is not yet known and will continue to be monitored.

      The Australian Technical Advisory Group on Immunisation (ATAGI) has provided guidance on myocarditis and pericarditis after mRNA vaccines. ATAGI emphasises that the benefits of vaccination outweigh the rare risk of myocarditis and pericarditis. 

      Symptoms of myocarditis and pericarditis, linked to mRNA vaccination, appear within 1-5 days of vaccination and are typically mild and recover quickly. Possible symptoms of myocarditis or pericarditis include: 

      • chest pain, pressure or discomfort 
      • palpitations (irregular heartbeat, skipped beats or ‘fluttering’). 
      • syncope (fainting) 
      • shortness of breath 
      •  pain with breathing. 

      If you experience any of these symptoms, you should seek prompt medical attention. It is important to note that there could be other causes for these symptoms that are not related to the vaccine.

    • Can I have the Pfizer or Moderna vaccine if I have a cardiac condition?

      The Pfizer and Moderna vaccines continue to be the recommended vaccines to prevent COVID-19 in people with a history of most chronic cardiovascular conditions, including:

      • myocarditis, pericarditis or endocarditis in the past (i.e. more than 3 months before vaccination)
      • coronary artery disease
      • myocardial infarction (a ‘heart attack’)
      • stable heart failure
      • arrhythmias (rhythm disturbances of the heart)
      • prior rheumatic heart disease (RHD). This includes people who have had rheumatic fever in the past and are taking antibiotics to prevent recurrence.
      • Kawasaki disease
      • congenital heart disease
      • cardiomyopathy
      • heart transplant
      • people with implantable cardiac devices


      No specific precautions are recommended for people in these groups. There are no current data suggesting that their risk of developing myocarditis or pericarditis after vaccination is any higher than that for the general population.

      If you have or have had any of the following heart conditions, you can still have the Pfizer or Moderna vaccines, but you should talk to your doctor first to discuss the best timing of vaccination, and whether any extra precautions are needed:

      • recent (i.e. within the last three months) or current myocarditis or pericarditis
      • acute rheumatic fever or acute rheumatic heart disease
      • severe heart failure. 

      If myocarditis or pericarditis has developed and has been attributed to a COVID-19 vaccine, further doses will depend on the specific diagnosis. Discuss options with your doctor and refer to Guidance on Myocarditis and Pericarditis after mRNA COVID-19 vaccines for more information. 

    • If I have had myocarditis or pericarditis after a COVID-19 vaccine dose, can I have further doses?

      If you have symptoms potentially consistent with myocarditis and/or pericarditis after an mRNA COVID-19 vaccine, you should be referred to a cardiologist for further assessment and management, including to investigate possible causes of symptoms other than vaccination, and for follow-up.

      If you have a confirmed diagnosis of myocarditis linked to an mRNA COVID-19 vaccine, ATAGI currently recommends discussing with a specialist immunisation service and/or cardiologist about subsequent administration of COVID-19 vaccine dose.

      The ATAGI guidance on Myocarditis and Pericarditis after mRNA COVID-19 vaccines (last updated on 29 April 2022) provides information on next steps for those who experience pericarditis after an mRNA vaccines.

      For further advice on mixed schedules, refer to ATAGI clinical advice on use of a different COVID-19 vaccine as the second dose in special circumstances.

    • Can I have a COVID-19 vaccine if I have allergies?

      Almost all people with allergies can have a COVID-19 vaccine. This includes people with food allergies, asthma or hay fever. 

      People who have had anaphylaxis (a type of severe allergic reaction) to a particular COVID-19 vaccine, or to an ingredient of a COVID-19 vaccine, should not have another dose of that vaccine. They may be able to have an alternative brand of COVID-19 vaccine.

      For some people, precautions may be needed before vaccination, such as consulting an allergy specialist, being vaccinated in a facility which has medical staff and being observed for at least 30 minutes after vaccination.

      This applies to people in the following groups:

      • people who have had a suspected allergic reaction after a dose of a COVID-19 vaccine 
      • people who have had an allergic reaction (but not anaphylaxis) to an ingredient of a COVID-19 vaccine
      • people who have had anaphylaxis to other vaccines or to medications (including injectable or oral medications) where there may be common ingredients with a COVID-19 vaccine (such as polyethylene glycol, an ingredient in the Pfizer vaccine or the Moderna vaccine, or polysorbate 80, an ingredient in the AstraZeneca vaccine 
      • people with a history of confirmed mastocytosis (a mast cell disorder) with recurrent anaphylaxis, and who require treatment for this condition.

    • If I have an allergic reaction after a COVID-19 vaccine or to one of its ingredients, can I still have an additional dose?

      If you have had anaphylaxis (a type of severe allergic reaction) to a previous dose of a COVID-19, or to one of its ingredients, you should not have that vaccine again. Your healthcare provider can help to determine whether it will be safe for you to have an alternative COVID-19 vaccine. 

      If you had a suspected allergic reaction which was not anaphylaxis after a COVID-19 vaccine, or to one of its ingredients, you may still be able to have an additional dose of the vaccine, but in some cases precautions are needed such as a longer period of observation after vaccination or referral for allergy testing. 

      Side effects following vaccination are common and expected. For more information refer to the question ‘What are the likely side effects from COVID-19 vaccines?’

      You can find out more about the ingredients in COVID-19 vaccines in the Consumer Medicine Information, which is available on the TGA website.

    • Can I have a COVID-19 vaccine if I have a history of Guillain-Barre Syndrome?

      Yes, if you have a past history of GBS, you can have a COVID-19 vaccine. There have been cases of GBS following vaccination in Australia and overseas. The European Medicines Agency (EMA), the US Advisory Committee on Immunisation Practices (ACIP) and the World Health Organisation Global Advisory Committee on Vaccine Safety (GACVS) have reviewed cases of GBS following COVID-19 vaccination. At this stage, it is not yet clear whether the reports of GBS are linked to vaccination.

      The EMA concluded that a relationship between GBS and AstraZeneca vaccination could be possible; however, ACIP and GAVCS concluded that it was not yet clear whether reports of GBS are linked to vaccination.

      GACVS recommended that individuals receiving the AstraZeneca or Janssen vaccines should seek immediate medical attention if they develop signs and symptoms of GBS. 

      Symptoms may include: 

      • difficulty in walking
      • difficulty with facial movements
      • double vision or inability to move eyes
      • difficulty controlling bladder or bowel functions.

    • What is Bell’s palsy? Can COVID-19 vaccines lead to Bell’s palsy?

      Bell’s palsy causes paralysis (weakness) of one side of the face. The exact cause is not known, but it is thought to often be triggered by a recent viral illness. It is treatable, and most cases resolve fully.

      The evidence to date does not support an association between COVID-19 vaccines and Bell’s palsy. However, cases of Bell’s palsy have been reported after COVID-19 vaccines. There were four cases of Bell’s palsy in the group of >18,000 participants who received the Pfizer vaccine in the phase 3 clinical trial, and there were no cases in the group who received the placebo. Cases of Bell’s palsy have also been reported after COVID-19 vaccines in several countries. 

      It is not yet known whether these reported cases are coincidental, because they have not been reported at a higher rate than what would be expected in the general population. 

    • Can I have a COVID-19 vaccine if I have a past history of Bell’s palsy?

      Yes, if you have a past history of Bell’s palsy, you are recommended to have a COVID-19 vaccine. 

      The evidence to date does not suggest that COVID-19 vaccines can trigger Bell’s palsy. 

    • What is capillary leak syndrome? Can COVID-19 vaccine lead to capillary leak syndrome?

      Capillary leak syndrome is an extremely rare but severe relapsing-remitting condition where fluid from small blood vessels (capillaries) leaks into surrounding tissue.

      Cases of capillary leak syndrome after the AstraZeneca vaccine have been reported overseas. The TGA has received a report of one case of a patient who died from multi-organ failure but had signs of capillary leakage. It is not clear whether this was linked to the AstraZeneca vaccine as other causes could not be ruled out.

      The Pharmacovigilance Risk Assessment Committee (PRAC) in Europe is reviewing reports of capillary leak syndrome. At this stage, it is not yet clear whether the reports of capillary leak syndrome are linked to vaccination. 

    • Can I have a COVID-19 vaccine if I have a past history of capillary leak syndrome?

      A past history of the capillary leak syndrome is a contraindication to  the AstraZeneca vaccine. This means if you have had capillary leak syndrome in the past, you should have an alternative vaccine, such as the Pfizer, Moderna or Novavax vaccine. 

    • What is immune thrombocytopenia (ITP) and can the COVID-19 vaccines lead to ITP?

      Immune thrombocytopenia (ITP) is a rare bleeding disorder. It can occur after the immune system is activated, for example by a viral infection or vaccination. ITP has been reported with other vaccines such as for hepatitis B, measles, mumps, rubella and influenza. Up to a third of people with ITP will have no symptoms at all or have only minor bruising. However, about 5% develop severe bleeding. 

      The risk of ITP associated with the AstraZeneca vaccine is still being investigated and characterised. Early findings from a recent Scottish study estimate the risk of ITP to be about 1 case per 100,000 AstraZeneca doses. This study did not find clear evidence of any association between the Pfizer vaccine and ITP.

      The Therapeutic Goods Administration (TGA) have received 86 reports of suspected ITP following COVID-19 vaccination. There have been no new reports of ITP since 2021.

      The TGA encourages people to seek medical attention if they experience signs and symptoms that could suggest ITP, such as unusual skin bruising or clusters of small red or purple spots that do not lose their colour when pressed. Unusual bleeding is another sign, for example bleeding from the nose or mouth that is hard to stop, or blood in the urine or stools.

    • Does the AstraZeneca vaccine lead to blood clots (thrombosis with thrombocytopenia, or TTS)?

      Yes, but very rarely. The AstraZeneca vaccine is associated with a very rare risk of a new condition called thrombosis with thrombocytopenia syndrome, or TTS.

      TTS involves blood clots (thrombosis) along with low blood platelet levels (thrombocytopenia), and occurs around 4-42 days after vaccination. It is estimated to affect around 2.4 per 100,000 doses in Australia. To date, the great majority of cases were after the first dose of the vaccine. There have been no new reports of TTS since 2021 in Australia. Younger adults (i.e. under 50 years of age) appear to have a higher risk of thrombosis with thrombocytopenia syndrome (TTS) than older adults.

      The Pfizer and Moderna vaccines are not associated with a risk of TTS. 
      Not all clots that occur after having the AstraZeneca vaccine will be due to TTS. Other blood clotting problems occur commonly in the population. Annually, common clots such as deep vein thrombosis or pulmonary embolism (a clot in the lungs) will affect about 1 in a 1,000 people in Australia, unrelated to any vaccine.

      TTS is a unique, new condition that requires certain blood tests to confirm it.
      Further details about TTS and people who should not have AstraZeneca vaccine is available on the Department of Health website. 

    • Who is recommended to receive the AstraZeneca vaccine?

      For people aged under 60 years, Pfizer, Moderna, or Novavax COVID-19 vaccines are preferred over AstraZeneca. AstraZeneca COVID-19 vaccine can be used in adults aged under 60 years if the person has made an informed decision based on an understanding of the risks and benefits. For further information on weighing up the risks and benefits refer to COVID-19 vaccination – Weighing up the potential benefits against risk of harm from COVID-19 Vaccine AstraZeneca document. 

      For people aged 60 years and over there is no brand preference. There are some exceptions for people not to be vaccinated with the AstraZeneca vaccine and these are detailed on the Department of Health website.  See also Primary course: vaccine preference recommendations. 

      AstraZeneca is not preferred to be used as a booster dose however it can be used if there is no alternative. See Booster dose recommendations.

    • Where can providers find information about thrombosis with thrombocytopenia syndrome (TTS)?
    • Where can individuals find information about AstraZeneca vaccine and thrombosis with thrombocytopenia syndrome (TTS)?
    • What types of vaccines have researchers developed?

      Researchers have used and are using a variety of methods to develop COVID-19 vaccines, some of which are well established and some newer.

      Established technologies use either the whole virus or parts of the virus (usually proteins) to train the immune system to recognise it. These technologies include:

      • inactivated vaccines, where the whole virus is inactivated with chemicals or heat so that it cannot replicate
      • subunit vaccines, where only a component of the virus is used, such as a protein
      • live attenuated vaccines, which contain a weakened version of the virus. There are currently no live attenuated COVID-19 vaccines in clinical trials.
         

      Newer technologies used in the development of COVID-19 vaccines use the genetic code for a component of the SARS-CoV-2 virus, usually the spike protein or the part of it called the receptor binding domain. After vaccination, host cells take up the genetic code and manufacture that protein, which then triggers an immune response. These technologies include:

      • DNA and mRNA vaccines, which are molecules that contain genetic information (genes). These technologies have been under development for decades. 
      • viral vector vaccines in which a chemically weakened harmless virus like a common cold adenovirus (the vector) is used to carry the genetic code for the spike protein from SARS-CoV-2. There are currently two licensed viral vector vaccines for humans, both for the Ebola virus. Viral vectors are also used in licensed gene therapy products.

      For further information on COVID-19 vaccine candidates, please visit the NCIRS COVID-19 vaccine development landscape page.

    • How have COVID-19 vaccines been tested?

      Before a vaccine is registered for use, it is tested extensively during development and then in thousands of people. Testing first begins with laboratory research, then animal studies and finally human clinical trials.

      Clinical trials involve testing the vaccine in volunteers, and are conducted in phases:

      • Phase 1 clinical trials usually include a few dozen healthy adult volunteers and focus primarily on assessing safety, and also on demonstrating that the vaccine induces an immune response
      • Phase 2 clinical trials have hundreds of volunteers, and can include groups for whom the new vaccine is intended, for example, older adults, children or people with pre-existing medical conditions. These trials aim to show the vaccine induces an immune response and confirm that it is safe with acceptable side effects.
      • Phase 3 clinical trials include many thousands of participants and aim to show that a vaccine has efficacy (i.e. it is effective) in preventing people from getting the disease – in this case COVID-19. Phase 3 trials also thoroughly assess the vaccine for safety and side effects. In a phase 3 trial, researchers usually compare vaccinated people with people who received a placebo (like a salt water injection). They compare the rate of disease, disease severity and reported side effects between the two groups.
         

      For COVID-19 vaccines, some of these phases have been combined. For example, in phase 1/2 trials, results are analysed after the first few dozen volunteers are studied, then the trial proceeds in hundreds more. Also, some phase 3 studies have started once preliminary data from phase 1/2 trials are available. Having these ‘overlapping’ time frames has helped develop COVID-19 vaccines quickly and help make them available earlier to save lives.

    • Why are clinical trials sometimes paused and restarted?

      COVID-19 vaccine trials, in the same way as other vaccine clinical trials, are supervised by independent Data and Safety Monitoring Boards (also known as DSMBs). DSMBs can advise to pause or stop a trial if there are any safety events, such as a participant experiencing a severe illness or event that needs time to investigate more fully. This standard procedure is one of the important ‘checks and balances’ in clinical trials. Pausing a trial allows researchers to investigate the event and see if it may have been a side effect related to the vaccine or if it is coincidental. Since clinical trials usually include tens of thousands of participants and continue for many months, it is inevitable that some participants will experience unrelated illnesses during the trial.

      If researchers are concerned that the vaccine is causing unacceptable side effects, they can stop the trial. This has not yet happened for any COVID-19 vaccine trials.  

    • What is the process for getting a COVID-19 vaccine approved in Australia?

      The Therapeutic Goods Administration (TGA), part of the Australian Government Department of Health, is the organisation responsible for approving medicines and vaccines for use in Australia. Approved products are listed on the Australian Register of Therapeutic Goods. The TGA receives advice from an independent panel of experts on the Advisory Committee on Vaccines. The approval process involves a rigorous assessment of vaccine effectiveness and safety. Given the urgency of the pandemic, the TGA is prioritising COVID-19 vaccines via a faster pathway which involves the following steps:

      Provisional determination

      Being granted provisional determination means that a vaccine developer is eligible to proceed to apply for provisional registration from the TGA. It does not mean that provisional approval has been granted, but that the vaccine can be assessed by the TGA using the provisional registration pathway.

      As of 21 January 2022, the TGA had granted provisional determination to seven companies for their COVID-19 vaccines:

      • AstraZeneca Pty Ltd, for the University of Oxford vaccine
      • Pfizer Australia Pty Ltd, for the Pfizer/BioNTech vaccine  
      • Janssen Cilag Pty Ltd, for the Janssen vaccine
      • Biocelect Pty Ltd on behalf of Novavax Inc, for Nuvaxovid (NVX-CoV2373) vaccine
      • Moderna Australia Pty Ltd, for the Moderna (Spikevax) vaccine
      • Grand Pacific CRO Australia (on behalf of Medigen Vaccine Biologics Corp) for the MVC-COV1901-S-2P-Protein (MVC-COV1901 Vaccine) vaccine
      • Vaxine Pty Ltd for the Recombinant CoV-2-S-ΔTM protein with Advax-CpG55.2 (active ingredient name and tradename to be confirmed) vaccine.

      Provisional approval

      The provisional approval pathway is a process that allows for temporary registration of promising new medicines and vaccines where the need for early access outweighs any potential risks. The decision to grant provisional registration is based on a number of factors, including:

      • the safety, quality and effectiveness of the vaccine has been satisfactorily established for its intended use
      • the sponsor’s plan to submit comprehensive clinical data before the provisional registration ends.

      After provisional approval, the TGA will continue to closely monitor any new data about the vaccine as it becomes available. Similar processes are used by regulatory authorities in other countries, such as the United States Food and Drug Authority and the European Medicines Agency.

      As of 29 August 2022, the TGA had granted provisional approval to six companies for their COVID-19 vaccines:

      • Pfizer Australia Pty Ltd, for Comirnaty
      • AstraZeneca Pty Ltd, for COVID-19 Vaccine AstraZeneca 
      • Janssen Cilag Pty Ltd, for the Janssen vaccine
      • Moderna Australia Pty Ltd, for the Moderna (Spikevax) vaccine
      • Biocelect Pty Ltd on behalf of Novavax Inc, for Nuvaxovid (NVX-CoV2373) vaccine
      • Moderna Australia Pty Ltd, for the Moderna (Spikevax) Bivalent Original/Omicron vaccine

    • UPDATED - Why are COVID-19 vaccines being developed so quickly?

      As of 16 September 2022, more than 6.5 million people have died from COVID-19 globally, and more are dying each day. In Australia, 14,759 people have died and approximately 10.1 million people have been infected. Hundreds of millions of people are suffering from the ongoing social and economic devastation caused by the pandemic. The urgency of this crisis means that all available resources and efforts are have been directed towards finding effective vaccines.

      Developing and licensing a vaccine has in the past taken a decade or longer, but some COVID-19 vaccines have been registered and used within 12 months of the virus being discovered..

      Some of the reasons behind this rapid progress include:

      • Unprecedented funding and collaboration between vaccine developers and governments around the world. Financial risks have been taken, such as building manufacturing facilities before a vaccine is even available.
      • Technology has evolved to make vaccine development faster than in the past. Previously, viral vaccines could only be developed after growing the virus in a lab, which takes time. Newer technologies build vaccines using the genetic code for the virus, so researchers around the world were able to start their work as soon as the genome for the virus was released in January 2020.
         

      Clinical trials progress more quickly if a disease is widespread, as is the case with COVID-19 in many countries, as a significant difference between the unvaccinated and vaccinated groups can be detected sooner than for a rare disease.

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