COVID-19

• When am I recommended to receive a booster dose?

  A 2023 booster dose is recommended 6 months after receiving your last COVID-19 vaccine dose or confirmed infection, regardless of the number of prior doses received, for:

  • All adults aged 65 years and over
  • Adults aged 18 to 64 years who have medical comorbidities that increase their risk of severe COVID-19, or disability with significant or complex health needs

   

  Adults aged 18 to 64 years without risk factors for severe COVID-19 and children and adolescents aged 5 to 17 years with risk factors for severe COVID-19 can consider a 2023 booster dose based on an individual risk benefit assessment with your immunisation provider.

  Booster doses are not recommended for children and adolescents under the age of 18 who do not have any risk factors for severe COVID-19.

  This 6 month interval replaces previous interval advice recognising that most people have had prior vaccination and infection (hybrid immunity) and are well protected against severe infection during the period.

  More information can be found in the ATAGI 2023 booster advice. A summary of the vaccines available for use in Australia can be found here. 
  

• Will ongoing or annual COVID-19 booster doses be required?

  It is likely that people will need booster doses of COVID-19 vaccines in the future, but the best timing and frequency of COVID-19 vaccine booster doses is not yet known. This will depend on factors such as the epidemiology of SARS-CoV-2, potential emergence of new variants, and the duration of protection against serious illness from existing and new vaccines. The evidence is constantly being reviewed.

  As there is still uncertainty regarding the SARS-CoV-2 virus will evolve the vaccine recommendations may change overtime. Refer to the ATAGI clinical guidance or the poster ATAGI recommended COVID-19 doses and vaccines for details for the current recommended number of doses and vaccine brands.

• UPDATED - How many people in Australia have been vaccinated? 

  As of 8 March 2023, 65.1 million vaccine doses have been administered in Australia. Of those:

  • Over 95% of people over the age of 16 years have received two doses
  • 14.3 million people have received three doses
  • 5.5 million people have received four doses
  • 73.1% of adolescents aged 12 to 15 years have received two doses 
  • 38.6% of children aged 5 to 11 years have had at least two doses.
     

  The number of doses administered is updated regularly and is available on the Australian Government Department of Health website.

• UPDATED - Which COVID-19 vaccines are currently being used in Australia?

  The COVID-19 vaccines currently in use are: 

  • Comirnaty (Pfizer vaccine), an mRNA vaccine. The Pfizer vaccine is registered for use in people aged 12 years and older. The paediatric Pfizer vaccine is registered for use in people aged 6 months and older. The Pfizer bivalent Original/Omicron BA.1 vaccine is registered in people aged 18 years and older. The Pfizer bivalent Original/Omicron BA.4/5 vaccine is registered in people aged 12 years and older.
  • COVID-19 Vaccine AstraZeneca (AstraZeneca vaccine), a viral vector vaccine. The AstraZeneca vaccine is registered for use in people aged 18 years and older.  
  • Spikevax (Moderna), an mRNA vaccine. The paediatric Moderna vaccine is registered in people aged 6 months and older. The Moderna bivalent Original/Omicron BA.1 vaccine is registered in people aged 18 years and older. The Moderna bivalent Original/Omicron BA.4/5 vaccine is registered in people aged 12 years and older.
  • Nuvaxovid (Novavax vaccine), a spike protein–based vaccine. The Novavax vaccine is registered for use in people aged 12 years and older.
     

  A summary of the vaccines available for use in Australia can be found here.

• Where can people access the vaccine, and is it free?

  COVID-19 vaccines are free for everyone aged 6 months and older who are eligible in Australia, as per the Australian COVID-19 Vaccination Policy. 

  You do not need a Medicare card to receive the vaccine. The vaccine is available at general practices, community pharmacies, Commonwealth Vaccination Clinics, Aboriginal and Torres Strait Islander Community Controlled Health Services and state and territory vaccination hubs.

  To find a vaccination provider and book an appointment, visit the COVID-19 Vaccine Clinic Finder. The clinic finder is also available in 15 languages.

• Is the COVID-19 vaccine mandatory?

  The Australian government have not mandated COVID-19 vaccination and some individuals may choose not to vaccinate, however some states and territory governments have implemented COVID-19 vaccine mandates for certain workers. Refer to your state or territory for information on vaccine requirements and public health orders.

  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 6 months.

• Are all COVID-19 vaccination encounters recorded on the Australian Immunisation Register (AIR)?

  Yes, 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.

• UPDATED - 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. 

  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 are COVID-19 vaccination policies and recommendations different across countries?

  Many countries recommend COVID-19 vaccination for many children and all adults. Many countries now recommend 1, 2 or more booster doses. However, there are differences across countries which ensure their recommendations are made taking into account local factors. 

  The many reasons for the differences in vaccine recommendations across countries can include: 

  • Vaccine supply and availability 
  • The number of cases in the community at the time and in the past and the time since recent vaccination: recommendations can change as cases increase or decrease. If there is a rise in cases, vaccine recommendations may change to protect people and reduce the number of hospitalisation due to COVID-19 
  • The level of existing protection in a population, i.e. how many people have been vaccinated or had past infection. In countries like Australia, most eligible people have been vaccinated, and the majority of people have now been infected with SARS-CoV-2. This combination (called hybrid immunity) results in good protection against severe illness from COVID-19, at least for the short term. Future booster doses are likely to be recommended when it is thought that protection against severe illness is waning. 
  • The type of healthcare system: The way in which health services are provided is different in each country. For example, free COVID-19 vaccines and hospital care is available in Australia however this is not the same  in all countries. Various analyses are performed to understand the benefits of vaccinating adults and children in relation to many other factors, including the healthcare system. 
     
• Where can I find credible and reliable COVID-19 information?

  There has been misinformation about COVID-19 and COVID-19 vaccines since the start of the pandemic. Misleading information continues to be circulated. It can be challenging to know how and where to find credible and trustworthy information.  

  When reading through information about vaccines, it is important to check that it comes from a credible source, and to look at when it was last updated as not all information online is correct and current. As you search for information related to vaccines, consider the following sources to guide you to check that the information is credible: 

  • Shout Out UK provides some criteria on how to assess credibility of sources of information on the internet.
  • There are a number of fact-checking websites that may provide information about the vaccine or health topic you are interested in, and that you may have seen on social media platforms or in the media. Websites such as Science feedback/ Health Feedback provide information about why certain science or health claims may or may not be true. 
  • The Immunisation Action Coalition suggests some questions to ask about the health information you read online. 

  
  An additional tip is to check the date the information was published. This can usually be found at the top or bottom of the webpage. The COVID-19 vaccine landscape continues to change, and information that is correct at the time of writing could become outdated quickly. 

  The COVID-19 vaccine recommendations in Australia are developed by experts in vaccines and vaccine preventable diseases. Evidence from all over the world is constantly being gathered and reviewed to make sure the most up-to-date recommendations are made. Some sources of credible COVID-19 information in Australia include: 

  • NCIRS: Content provided on the NCIRS website is researched, written and regularly reviewed by experts in vaccinology, epidemiology, vaccine safety and social sciences. This includes infectious disease physicians, GPs, paediatricians, epidemiologists, social scientists and researchers. The information provided by NCIRS is based on peer-reviewed science and expert knowledge, and incorporates links to other credible sources. NCIRS is also a Vaccine Safety Net member, refer to the site to see more websites that provide reliable information on vaccine safety.  
  • AusVaxSafety and the Therapeutic Goods Administration (TGA) of Australia both provide information about safety of COVID-19 vaccines used in Australia. 
  • The Australian Academy of Science provides answers to some general questions about vaccines and immunisation. 
  • The Australian Government Department of Health and Aged Care provides information about COVID-19 and COVID-19 vaccines. 
• UPDATED - Can COVID-19 vaccines impact my natural immunity?

  COVID-19 vaccines enhance your immunity by producing antibodies that fight against the virus and protect you from getting severely sick with COVID-19. If you have been infected with SARS-CoV-2 (the virus that causes COVID-19) you may also have natural immunity that protects against the virus. There is no evidence to show that the vaccines will reduce your natural immunity from COVID-19. 

  Studies have found that your risk of infection with COVID-19 is lower after having a previous infection and receiving vaccination than being infected alone. A Canadian study found that in adults who were unvaccinated but had a previous infection, the risk of being reinfected with Omicron was reduced by 38%, but protection against Omicron was higher among those who had also received two doses (69%) or three doses (70%) of a Pfizer or Moderna vaccine. 

  A study from the USA in children aged 5–11 years who had received the Pfizer vaccine also found similar results. Protection from Omicron infection was 79% in vaccinated children who had a previous infection and 63% in unvaccinated children who had a previous infection. 

• 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 7 March 2023, it has caused over 6.8 million deaths worldwide, with more than 759 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. 

• UPDATED - Who can get a COVID-19 vaccine, including booster doses?

  COVID-19 vaccine is recommended for all people aged 5 years and older and some children aged 6 months to 4 years who are at increased risk of severe COVID-19. The recommended number of doses and vaccine brand are based on age and other conditions. Access the ATAGI clinical guidance or the poster ATAGI recommended COVID-19 doses and vaccines for details (see page 2 for immunocompromised).  

  The COVID-19 Vaccine Clinic Finder is also available to find out when and where you can receive a COVID-19 vaccine. The Vaccine Clinic Finder provides information on which vaccines are recommended for you on the basis of your age.  

  More information can be found here: 

  • ATAGI 2023 booster advice
  • ATAGI recommendations on use of the Pfizer bivalent (Original/Omicron BA.4/5) COVID-19 vaccine
  • ATAGI recommendations on use of the Moderna bivalent (Original/Omicron BA.4/5) COVID-19 vaccine
  • ATAGI recommendations on the use of a third primary dose of COVID-19 vaccine in individuals who are severely immunocompromised 
  • ATAGI recommendations on COVID-19 vaccine use in children aged 6 months to <5 years 
• Why should I get a booster vaccine if I have already had 2 doses?

  Protection from COVID-19 vaccines against infection reduces overtime. To address this decline, a booster dose of the COVID-19 vaccine has been recommended. 

  For some people who are immunocompromised or of older age, protection from COVID-19 vaccines against severe disease may reduce overtime. An additional booster dose may be needed to provide greater protection against COVID-19.

  As evidence on booster doses or new variants emerges, recommendations on booster doses or additional doses after a booster dose may be updated. For more information refer to ‘Who can get a COVID-19 vaccine, including booster doses?' and ‘How effective are COVID-19 booster vaccines?’

• Do I need a COVID-19 vaccine, including a booster dose, 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 are eligible for a booster dose and 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 6 months after your infection because past infection provides protection against COVID-19 disease for at least this period. Following infection, your immunity against the virus may reduce overtime. A booster dose can provide greater protection against COVID-19. 

  There is evidence to show that protection against COVID-19 disease from a booster dose after being infected with COVID-19 is greater than from previous infection alone. A study from Qatar found that effectiveness against infection with the Omicron BA.2 variant was 55% for people who had received 2 doses of an mRNA vaccine and had been previously infected. The effectiveness against infection increased to 77% in people who had received a booster dose and had a previous infection. As new variants emerge, the duration of protection from natural immunity will be unclear. It is recommended that you receive a booster dose to address the uncertainty of protection against new variants and provide you with stronger and longer lasting immunity against infection. 

  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. 

  For more information, refer to ATAGI clinical guidance on the use of COVID-19 vaccine in Australia. 

• 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.

• 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 is the difference between the original COVID-19 vaccine and the bivalent COVID-19 vaccines that have 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 and Pfizer bivalent vaccines that have been recently approved in Australia contain both the original variant and the Omicron variant of the virus. The 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 or BA.4 and 5 variant.  

  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. Clinical trials found that both the Moderna and Pfizer bivalent vaccines produced higher antibodies against the Omicron BA.1 and BA.4/5 variants than the original COVID-19 vaccines. For more information on the effectiveness of bivalent vaccines, refer to 'How effective are COVID-19 booster vaccines?' 

  Higher antibodies have been associated in the past with better protection and so it is expected that the bivalent vaccines 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.  

  The Moderna bivalent vaccine is presented as a blue-capped multi-dose vial (100 mcg/mL). To minimise the risk of administration errors, providers should preferably prepare and store doses of the Moderna bivalent vaccine separately from other vaccines because of the similar vaccine vial cap colours (such as the Moderna paediatric vaccine 6 months to 5 years formulation). Doses withdrawn in advance of administration should be clearly labelled. 

  The dose volume and whether dilution is required varies amongst each approved vaccine. For more information, refer to the ATAGI clinical guidance.

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

  The new Moderna and Pfizer bivalent vaccines are recommended as another option for a booster dose for people aged 18 years or older (and some people aged 12 to 17 years) who are recommended a booster dose as per the current ATAGI recommendations. Certain bivalent vaccines are registered from 12 to 18 years of age. An age-appropriate vaccine should be selected. A summary of the vaccines available for use as a primary course and as boosters in Australia can be found here.   

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

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

  No, you cannot receive a 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 or  Novavax original vaccines as a primary series. The bivalent vaccines have only been approved for use as a booster dose. Access the poster “ATAGI recommended COVID-19 doses and vaccines” for details on which vaccines are available for use.  

• 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. 
   

• How effective are COVID-19 vaccines?

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

  Later on, there have been ‘real world' studies (also called observational or post-market vaccine effectiveness studies) from vaccination programs in countries like the USA and the UK that show strong protection from the vaccines. These studies were conducted both in the pre-Omicron and the Omicron period.

  Since the Omicron period, the protection from vaccination against mild infection has shortened. A review found that vaccine effectiveness against COVID-19 infection decreased more rapidly from 1 month to 6 months after receiving 2 doses of a COVID-19 vaccine during the Omicron period compared to pre-Omicron. However protection against hospitalisation or death remained higher with slowe waning.

  Booster doses, including the bivalent vaccines, 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 doses.”

  Furthermore, protection from infection and vaccination together offer the strongest protection (so called hybrid immunity). A review of 15 real world studies, during the Omicron period, reported that in people who had previously been infected with COVID-19 and received vaccination, the effectiveness of a COVID-19 vaccine against hospitalisation or severe COVID-19 disease was 97%, 12 months after receiving 2 doses and 95%, 6 months after receiving a booster dose. Prior COVID-19 infection alone in people who were unvaccinated was 75% effective at preventing hospitalisation or severe disease.

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

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

  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.

  Another study from the USA found that compared with unvaccinated people, VE of a bivalent booster dose against COVID-19 associated hospitalisation 84% among adults aged 65 years and over. Compared with people who received 2 or more monovalent Pfizer or Moderna doses, the bivalent booster dose was 73% effective at preventing hospitalisation.

• 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 USA and the UK 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 for the Pfizer vaccine, the effectiveness against hospitalisation for 2 booster doses was 73%, for one booster dose was 64% and for the primary series alone was 36%, compared to being unvaccinated. For Moderna, the effectiveness against hospitalisation was 68% for two booster doses, 65% for one booster dose and 41% for the primary series alone, compared to being unvaccinated.

  Another study conducted in Nordic countries found that a second booster dose of the bivalent vaccines were 81% effective at preventing hospitlisation and the original vaccine was 65% effective.  

• 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 Pfizer and Moderna bivalent vaccines approved for use in Australia contain the original/ancestral (Wuhan) variant and the Omicron 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 vaccines.

• 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 'Who can get a covid-19 vaccine, including booster doses?'

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

  The COVID-19 vaccines are effective in preventing severe disease from COVID-19 but are not as effective in preventing transmission.

  The COVID-19 vaccines were designed to protect individuals from COVID-19 and severe disease. Like most vaccines, they were not designed to reduce transmission.

• 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. The UK Health Security Agency and a systematic review have assessed the the effectiveness of vaccination against long COVID and found evidence that vaccinated people who are then infected with COVID-19 are less likely to experience long COVID symptoms than unvaccinated people. A large UK based cohort study have also found that COVID-19 vaccination can reduce your risk of long COVID. It is not yet known if COVID-19 vaccination impacts existing long COVID. 

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

  In Australia, the primary course of the COVID-19 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.
     

  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.

   

• 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 6 months after infection. All recommended doses should still be received and be given as soon as possible 6 months after infection.

  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 serious COVID-19 is low within the first 6 months after infection. Advice may change if future variants emerge.

  You can receive other non-COVID vaccines without any minimum interval if you have tested positive to COVID-19. If you are feeling very unwell you should defer vaccination until you have recovered.

• 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. The recommended number of doses and type of vaccine varies depending on age and whether an individual has conditions that increase their risk of severe COVID-19. A table with information on the recommended number of doses and vaccine brand can be found here. In addition, a table listing primary course vaccines and booster dose vaccines is available 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 4 years with severe immunocompromise, complex or multiple health conditions, or disability with significant or complex health needs can also receive 3 doses of the paediatric Pfizer vaccine, 8 weeks apart. 

  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. 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 effective in children and adolescents aged 5–17 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. These clinical trials were all performed early on in the pandemic, prior to the Omicron variant.

  A review of studies, during the Omicron period, in children and adolescents aged 2 to 18 years found that 2 doses of the Pfizer or Moderna vaccine was 63% effective at preventing hospitalisation, 76% effective at preventing symptomatic infection and 83% effective at preventing hospitalisation due to COVID-19.

• 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. 

  Vaccinating children is likely to 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.

• UPDATED - 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 aged 18 years or older and some people with certain medical conditions aged 5 to 17 years, who received their last dose at least 6 months earlier. The Pfizer and Moderna vaccines are the preferred vaccines for pregnant women.

  Pregnant women are eligible and can consider the 2023 COVID-19 booster dose based on their age-related risk after an individual risk benefit assessment with their immunisation provider. Pregnant women who have received previous primary vaccination and/or have hybrid immunity appear to have a very low risk of severe COVID-19.

  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 other COVID-19 vaccines (Novavax) during pregnancy. However, if the Pfizer vaccine or Moderna vaccine is not available, the Novavax vaccine can be considered by pregnant women if the benefits of vaccination outweigh the risks for the individual, such as those with underlying risk conditions. 

  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 Novavax or the AstraZeneca vaccine and are pregnant can receive dose 2 of the same 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 and subsequent doses?'

  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 Novavax or the AstraZeneca vaccine and am now pregnant. What is the advice for dose two and subsequent doses?

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

  Providers and consumers may wish to consider the following:

  • 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) and protein sub-unit vaccines (such as the Novavax 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 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 is recommended for people aged 5 years and older who are severely immunocompromised, if it's been 6 months or longer since their dose. For more information, refer to 'Who can get a COVID-19 vaccine, including booster doses?'

  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:

  • casirivimab + imdevimab (RONAPREVE)
  • sotrovimab (XEVUDY)
  • remdesivir (VEKLURY)
  • regdanvimab (REGKIRONA)
  • tocilizumab (ACTEMRA)
  • nirmatrelvir + ritonavir (PAXLOVID)
  • molnupiravir (LAGEVRIO)
  • tixagevimab and cilgavimab (EVUSHELD)

   

  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 6 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. 

• 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. 

• 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. 

  The most common side effects for the COVID-19 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 COVID-19 vaccine safety and side effects. 

  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 and myocarditis/pericarditis following an mRNA vaccine. Refer also to the question Where can individuals find information about AstraZeneca vaccine and thrombosis with thrombocytopenia syndrome [TTS] and the section on Myocarditis and pericarditis for more information.

  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 a COVID-19 vaccine, can I still have an additional 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.

  If you have had a severe allergic reaction to a first dose, or any other severe symptoms that you are worried about or have been diagnosed with TTS after the AstraZeneca vaccine or myocarditis/pericarditis following a COVID-19 vaccine, discuss these with your healthcare provider before having an additional 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 and adolescents?

  Clinical trials and real-world studies have shown that COVID-19 vaccines approved for children (aged 6 months–11 years) and adolescents (aged 12-17 years) are safe. Children and adolescents are likely to experience mild side effects after vaccination, such as fever, fatigue/sleepiness, and injection site pain, but these usually resolve within 48 hours. Infants and children are prone to febrile convulsions most frequently due to viral infection but these can also occur after vaccination.

  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 received COVID-19  vaccines. Myocarditis after a COVID-19 vaccine has been reported most often after dose two of an mRNA vaccine in males under 40, but it can occur at any age, in any gender and after any dose. Data from the USA showed no evidence of an increased risk for myocarditis following mRNA COVID vaccination in children ages 6 months to 5 years. There is currently not enough evidence to indicate that there is an increased risk of myocarditis or pericarditis in children aged 5 to 11 years following COVID-19 vaccination, however cases may occur. For more information refer to ‘What is myocarditis and pericarditis?' and ‘Can the Pfizer and Moderna vaccine lead to myocarditis and pericarditis?’

  The bivalent vaccines are safe to use as a booster dose dose, adverse events are similar to those experienced after a monovalent vaccine.

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

  All of the three COVID-19 vaccines available in Australia are safe for people with a disability, including people with autism. Some people with a disability are at risk of severe SAR-COV-2 infection and are encouraged to receive COVID-19 vaccination. Vaccination can prevent people with a disability from getting severe COVID-19. 

  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 COVID-19 vaccines available in Australia can be found here. 

  The Australian National Imams Council and the Muslim Health Professional Australia both 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. 

• UPDATED - 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). As of 21 March 2023, the AstraZeneca vaccine is no longer available for use in Australia. 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. 

  Anaphylaxis, a type of serious allergic reaction, which can occur after any vaccine or medicine, and which is treatable has been confirmed to occur after having mRNA vaccine.

  Anaphylaxis after an mRNA vaccine is still very rare. The rate of anaphylaxis after the Pfizer vaccine in the USA as of January 2021 was 4.7 cases per million doses administered and 2.5 cases per million doses administered following the Moderna vaccine.

  The occurrence of myocarditis and pericarditis following an mRNA vaccine is also a serious potential side effect. Whilst the rates of these conditions have been highest following mRNA vaccines, they have also been observed following other vaccine types (such as DNA-based vaccines like AstraZeneca and protein-based vaccines like Novavax). For more information refer to ‘What is myocarditis and pericarditis?' and ‘Can COVID-19 vaccines lead to myocarditis and pericarditis?’

• UPDATED - 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). As of 21 March 2023, the AstraZeneca vaccine is no longer available for use in Australia.

• 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 or Pfizer 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 bivalent vaccines are similar to those seen after a booster dose of the original COVID-19 vaccines. Most side effects are mild and resolve within 1 to 2 days

• 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.

• 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 a COVID-19 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.

  Different rates of myocarditis have been reported from many countries as they have different ways of capturing information. 

  For children aged 6months to 11 years, there is currently no clear attributable risk of myocarditis and/or pericarditis from the COVID-19 vaccines.

  For males aged 12–17 years, the rates after dose 2 range from 71 to 136 per million doses for the Pfizer vaccine and 237 per million doses for the Moderna vaccine. For males aged 18–29 years, the rates after dose 2 range from 25 to 94 per million for the Pfizer vaccine and 56–300 per million for the Moderna vaccine.

  For females aged 12-17 years, the rates after dose 2 range from 2 to 28 per million doses for the Pfizer vaccine and 0–28 per million for the Moderna vaccine. For females aged 18–29 years, the rates after dose range from 4 to 27 per million for the Pfizer vaccine and 7 to 69 per million for the Moderna vaccine. 

  Rates of myocarditis following a booster (third) dose have been observed to be lesser than after dose 2 but greater than after dose 1. Data from the USA and Israel suggest the rates in adults following a fourth dose are not above the expected background rates. There are currently no data on rates following a fifth dose or subsequent dose. 

  Early data from the USA and UK suggest there is a risk of myocarditis and pericarditis following the bivalent vaccines.

  A UK study suggests there is a risk of myocarditis after the AstraZeneca vaccine; however, the risk is smaller than that for mRNA vaccines. A risk of myocarditis and pericarditis has been observed following the Novavax vaccine.

  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. 

   

  It is important to note myocarditis and pericarditis following vaccination can present with atypical features, such as the absence of chest pain, or the presence of abdominal pain or other non-specific symptoms.

  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 September 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.

• UPDATED - an 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. 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; or difficulty controlling bladder or bowel functions. As of 21 March 2023, the AstraZeneca vaccine is no longer available for use in Australia.

• 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. 

• UPDATED - 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. As of 21 March 2023, the AstraZeneca vaccine is no longer available for use in Australia.

• UPDATED - 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. As of 21 March 2023, the AstraZeneca vaccine is no longer available for use in Australia.

• UPDATED - 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.

  As of 21 March 2023, the AstraZeneca vaccine is no longer available for use in Australia.

• UPDATED - 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. As of 21 March 2023, the AstraZeneca vaccine is no longer available for use in Australia.

• UPDATED - Where can providers find information about AstraZeneca vaccine and thrombosis with thrombocytopenia syndrome (TTS)?

  Further information about AstraZeneca vaccine and thrombosis with thrombocytopenia syndrome (TTS) can be found at the following sites:

  Australian resources

  • Provider information on AstraZeneca vaccine and TTS
  • Weighing up risks and benefits document 
  • Thrombosis and Haemostasis Society of Australia and New Zealand Guideline

  
  Overseas resources

  • Public Health England: Information for healthcare professionals on blood clotting following COVID-19 vaccination

   

  As of 21 March 2023, the AstraZeneca vaccine is no longer available for use in Australia.

• UPDATED - Where can individuals find information about AstraZeneca vaccine and thrombosis with thrombocytopenia syndrome (TTS)?

  Further information about AstraZeneca vaccine thrombosis with thrombocytopenia syndrome (TTS) can be found at the following sites:

  • COVID-19 vaccination – Information on Vaxzevria (AstraZeneca) COVID-19 vaccine
  • COVID-19 vaccination – After your Vaxzevria (AstraZeneca) vaccine
  • COVID-19 vaccination – Weighing up the potential benefits against risk of harm from COVID-19 Vaccine AstraZeneca

  As of 21 March 2023, the AstraZeneca vaccine is no longer available for use in Australia.

• 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?

  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 4 January 2022 the TGA had granted provisional determination to the following 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 23 January 2023, the TGA had granted provisional approval to the following COVID-19 vaccines:

  • Pfizer Australia Pty Ltd, for Comirnaty
  • AstraZeneca Pty Ltd, for Vaxzebria (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 BA.1 vaccine
  • Pfizer Australia Pty Ltd, for Comirnaty Original/Omicron BA.1 vaccine
  • Pfizer Australia Pty Ltd, for Comirnaty Original/Omicron BA.4/5 vaccine
  • Moderna Australia Pty Ltd, for the Moderna (Spikevax) Bivalent Original/Omicron BA.4/5 vaccine
• UPDATED - Why are COVID-19 vaccines being developed so quickly?

  As of 7 March 2023, more than 6.8 million people have died from COVID-19 globally, and more are dying each day. In Australia, 19,447 people have died and approximately 11.3 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.