MVEC’s COVID-19 vaccine FAQ’s have been designed to address common queries relating to COVID-19 vaccines. For ease of reference, information has been categorised as per the below themes:

This page will be updated on a regular basis as further information becomes available regarding COVID-19 vaccines.

For questions that have not been addressed on this page or our dedicated COVID-19 resource page, please email info.mvec@mcri.edu.au for further clarification.

Vaccine development process

  • How can the COVID-19 vaccine be safe when it has been developed so quickly?

    COVID-19 vaccine development is happening “faster than usual” because of the global impact of the pandemic and the urgent need for a vaccine(s). Vaccines have traditionally been developed in consecutive sequential stages – with preclinical trials followed by phases I, II and III, often with large gaps of time in-between phases awaiting funding or manufacturing scaleup. With COVID-19, this process has been made more efficient by running one phase while simultaneously also preparing and/or recruiting for the next phase.

    It is important to note that COVID-19 vaccine candidates must pass through the exact same rigor and phases of clinical trials and do not miss any important safety and quality checks or steps. Approval is only given if the vaccine meets the appropriate requirements for safety and efficacy.

    Refer to MVEC: Vaccine development and safety, including “The Road to a COVID-19 Vaccine” animation for more information.

  • What is involved in the phases of clinical trials?

    During vaccine development, initial safety testing of a vaccine candidate occurs in two stages. Stage one involves preclinical assessment both in the laboratory and also animal trials.  Stage two involves the evaluation of the vaccine candidate in three phases of clinical trials in human volunteers.

    Phase I clinical trials: the vaccine candidate is given to small numbers (25–50) of healthy adults with the primary goal of assessing safety.

    Phase II clinical trials: If the vaccine candidate is found to be safe in Phase I, it is then given to hundreds of participants to determine: how effectively it stimulates immune responses; optimal dose regimen; and whether its side effect profile.

    Phase III clinical trials: If the vaccine candidate is found to be effective and safe in both Phase I and II, it is then given to many thousands of participants to test its effect on protecting large populations from the target disease and to determine if there are any uncommon, serious or severe side effects.

    Refer to MVEC: Vaccine development and safety for more information.

  • What does provisional approval mean and how does it differ from normal registration?

    In Australia, the Therapeutic Goods Administration (TGA) is responsible for assessing vaccines and other medicines for use in Australia. A number of sponsors of COVID-19 vaccines have applied to the TGA for registration using the so-called ‘provisional approval pathway’.

    The provisional pathway is only one of a number of pathways that a sponsor may use to apply for the approval of a vaccine. It is very important to note that the TGA evaluation process under the ‘provisional pathway’ still involves a full review of the vaccine and its associated safety data, noting that the TGA does not have a mechanism for emergency use authorisations (EUA) that have been granted in other countries. The provisional approval is for an initial period of 2 years. Sponsors may then apply for ‘full registration’ when there is more clinical data to confirm the safety of the vaccine.

    Refer to MVEC: Provisional registration of COVID-19 vaccine(s) in Australia for more information on provisional approval.

    Refer to TGA: COVID-19 vaccines for further information on the role of the TGA and their internal processes.

  • How can we be sure that the vaccine manufacturing process is safe?

    Like any medication in development, vaccine candidates must undergo rigorous testing procedures and scientific evaluation to prove not only their effect on the targeted disease, but also to determine their safety – before being licensed and registered for use in vaccination programs.

    In all three clinical trial phases, safety is continually assessed as data is gathered and a vaccine must pass all these phases before it can be considered for registration for use by the TGA. By the time a vaccine is registered, safety would have been assessed in tens of thousands of clinical trial participants and this safety data would have been rigorously evaluated by the TGA and other international drug regulatory bodies.

    The quality, sterility, potency and purity of each vaccine batch is also assessed by the TGA prior to being supplied to Australia, as is the quality of selected batches after they have been supplied.

    Once a vaccine is approved, it continues to be tested in a process known as post-licensure surveillance.

  • Who funds a vaccine trial?

    Vaccine research and development is often funded by a range of sources including governments, bilateral and multilateral organisations, non-government organisations and the private sector (including pharmaceutical companies). Never before has one vaccine received so much investment and global collaboration – this is a major reason why there are multiple COVID-19 vaccines that have been able to progress so efficiently with minimal pauses through to the final phase III large clinical trials.

    A prominent funding source for many COVID-19 vaccines is the COVAX Facility. COVAX is coordinated by Gavi (the Vaccine Alliance), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization. COVAX pools funding from over 180 governments, global health organisations, private sector and manufacturers to support research, development and manufacturing of multiple COVID-19 vaccine candidates.

    Refer to MVEC: COVAX Facility for more information about COVAX.

Vaccine rollout

Effectiveness

  • How do we know a vaccine is effective?

    In vaccine clinical trials it is important to understand the difference between efficacy versus effectiveness. Efficacy is calculated from a Phase III clinical trial and effectiveness is the vaccine’s impact in a real world setting once the vaccine is administered in the general public.

    Vaccine clinical trials represent a strictly controlled setting; for example, trial participants are closely monitored and if two vaccine doses are required, the doses will be given with exactly the same interval for everyone. All vaccines that are eventually registered will have proved they have adequate efficacy through large Phase III trials.

    Efficacy is calculated by assessing how many people develop COVID-19 in the group receiving the COVID-19 vaccine compared to the placebo (or control) group. For example, if 100 people develop COVID-19 disease in a trial, and 95 of these were in the placebo group (meaning only 5 people in the vaccine group developed disease), the vaccine efficacy would be calculated at 95%. In other words, the vaccine prevented 95 out of 100 people from contracting COVID-19 disease. Efficacy is usually calculated after the full vaccine course; for most COVID-19 vaccines this is after two doses.

    In a real-world setting, it is expected that there will be lower levels of protection due to multiple variables, such as wider differences amongst people receiving the vaccine (eg. different ethnicities or underlying medical conditions). Hence vaccine effectiveness is expected to be slightly lower than what is reported in initial clinical trial results. Vaccine effectiveness in the real world will continue to be monitored in post-licensure studies.

  • Is vaccine efficacy the same in all ages?

    Each vaccine is tested in multiple age groups because efficacy can vary amongst different ages. Currently, efficacy data is only available for people ≥16 years of age for  Comirnaty™ (Pfizer/BioNTech COVID-19 vaccine) and ≥18 years for the other vaccines. Further Phase III trials are underway or planned in children, starting with adolescents and progressing to younger ages as more safety data becomes available. Until then, COVID-19 vaccines have only been licensed for children above 16 years of age in Australia.

    Depending on the specific vaccine candidate, the vaccine’s efficacy may also be reduced for people over 65 years of age. With aging, the immune system progressively declines, referred to as immunosenescence, and hence there may be a reduced immune response following vaccination in older adults. Clinical trials for COVID-19 AstraZeneca vaccine demonstrated an excellent safety profile and strong immune response in those aged >65 years, however efficacy in this age group could not be conclusively determined due to an insufficient number of participants infected with SARS-CoV-2. As a result, the TGA recommend that immunisation with COVID-19 AstraZeneca in this age group be decided on a case-by-case basis taking into account age, co-morbidities and environmental factors. Further information from ongoing clinical trials is expected in the coming months.

  • Are there certain vaccine brands that are better for people over 65 years of age?

    Some of the COVID-19 vaccines, such as the  Comirnaty™ (Pfizer/BioNTech COVID-19 vaccine), have the same efficacy in older adults, aged 65 years and over, compared with younger adults. Others, such as the COVID-19 AstraZeneca vaccine, are still gathering further data in order to accurately assess vaccine efficacy in older age groups (over 55 years). However, their immunogenicity studies show that older adults develop a robust immune response, similar to those seen in younger volunteers. In time, more efficacy data will be available for older age groups for all vaccines.

  • Will the vaccine be effective in children?

    At this stage, there is no clinical trial data for children younger than 16 years of age and currently, none of the COVID-19 vaccines are recommended in children. Vaccine candidates may conduct phase III clinical trials in children to fully assess safety and efficacy before the vaccine is approved for use in these age groups.

  • Can the vaccine be given to people who are immunosuppressed?

    ATAGI recommends COVID-19 vaccination for all immunosuppressed people due to an increased risk of developing severe disease if infected with SARS-CoV-2. Due to limitations in clinical trials there is currently no data on the safety and efficacy of COVID-19 vaccination in this group, however in principle there are no theoretical risks.

    It is anticipated that the immune response to vaccination may be reduced in this patient group depending on the level of immune suppression. Hence, when vaccinating immunocompromised people, they should also be counselled about this reduced efficacy and the need to continue other prevention measures such as social distancing and mask wearing.

    Please speak to your doctor to discuss individual cases and see the following links for more information:

  • What is herd immunity?

    Herd immunity describes when a certain proportion of the community is immune to a specific pathogen (in this case virus). It can only be induced by vaccination; never in history has any virus infection been eliminated because of immunity by natural infection.

    Herd immunity is achieved when more than 60-70% of people in a population are vaccinated against a particular illness. At this level of population immunity, there are fewer people that the pathogen can infect and hence this self-limits the spread of the pathogen.

    Please see more information about herd immunity on the Children’s Hospital of Philadelphia – Questions and Answers about COVID-19 Vaccines.

  • Can COVID-19 vaccines be used to prevent disease in patients who have already been identified as contacts of a COVID-19 positive case?

    COVID-19 vaccine administration is not recommended for post-exposure prophylaxis.

    Please refer to COVID-19 vaccination – ATAGI clinical guidance on COVID-19 Vaccine in Australia in 2021 for more information.

Storage

  • How should COVID-19 vaccines be stored?

    Cold-chain requirements for the newer genetic (DNA and mRNA) vaccines require additional logistical considerations. Comirnaty™ (Pfizer/BioNTech COVID-19 vaccine) vaccine must be stored at –70°C, be transported on dry ice and will only remain stable for 24 hours when refrigerated (2°-8°C). Once reconstituted, the vaccine must be discarded if it has not been used within 6 hours.

    The Moderna vaccine will need long-term storage and transport at –20°C, but once defrosted will remain stable in a standard vaccine fridge (2°-8°C) for 5 days.

    The majority of other vaccine candidates can be stored and managed using standard cold-chain systems (2°-8°C), this includes COVID-19 AstraZeneca vaccine.

  • Are multi-dose vials safe? Why are they being used?

    Multi-dose vials (MDV) are safe as long as each dose is prepared appropriately using aseptic technique. They should be kept and accessed in a dedicated clean medication preparation area and away from immediate patient treatment areas. This is to prevent inadvertent contamination of the vial and cross contamination between patients.

    MDVs are cheaper to produce and occupy less cold-chain capacity. In the context of the COVID-19 pandemic; improved efficiency of production and storage is vital when millions of doses must be produced quickly.

    To learn how to safely prepare and store multi-dose vials please refer to MVEC’s immunisation reference page Multi-dose vials as well as MVEC’s eLearning package on the Use of multi-dose vials accessible via the education portal.

Administration

  • Can COVID-19 vaccines be co-administered with other vaccines?

    Currently, COVID-19 vaccines have not been assessed in clinical trials when co-administered with other vaccines, hence they should be administered alone.

    The Australian Technical Advisory Group on Immunisation (ATAGI) recommends a minimum 14 day interval between administration of a COVID-19 vaccine and other vaccines (including seasonal influenza vaccine).

    For more information please refer to COVID-19 vaccination- ATAGI clinical guidance on COVID-19 vaccine in Australia in 2021.

  • Can COVID-19 vaccines be used interchangeably (eg. using a different vaccine brand for the first and second dose)?

    There is no clinical trial data assessing the interchangeability of different COVID-19 vaccines and hence the same brand of vaccine should be given for both the first and second dose. There is currently no recommendation for further booster doses of COVID-19 vaccines.

    For more information please refer to COVID-19 vaccination- ATAGI clinical guidance on COVID-19 vaccine in Australia in 2021.

  • Can the COVID-19 vaccine be given to people who have previously or currently have COVID-19 disease (or evidence of SARS-CoV-2 infection)?

    Yes, people with previous COVID-19 disease should still be vaccinated to ensure ongoing protection. However, vaccination should be deferred until the person has fully recovered from the acute COVID-19 illness. Clinical trials indicate that it is safe to give COVID-19 vaccines in people with evidence of prior SARS-CoV-2 infection.

  • How many doses will be required? How long will I be protected and do I need a booster dose?

    The recommended schedule for Comirnaty™ (Pfizer/BioNTech COVID-19 vaccine) is two doses given 21 days apart.

    The recommended schedule for COVID-19 AstraZeneca vaccine is two doses given 12 weeks apart (with a minimum interval of 4 weeks apart accepted in certain circumstances).

    Data regarding the length of protection following vaccination is still being gathered from phase III clinical trials. The length of protection is still unclear and hence the timing and need for a booster has not been established. Currently, no additional doses beyond the first two are recommended at this time.

  • What are the ABSOLUTE minimum and maximum intervals for each COVID-19 vaccine dose?

    Vaccination with COVID-19 AstraZeneca vaccine requires a 2-dose course, with ATAGI recommending an interval of 12 weeks between doses. In certain circumstances (eg. impending chemotherapy, amount of circulating disease etc) an absolute minimum interval of 28 days is acceptable. If the second dose is inadvertently administered with an interval of less than 28 days, repeat doses are not currently recommended. If more than 12 weeks has elapsed, the second dose should be administered as soon as possible with no need to re-start the course again. In clinical trials dose 2 was administered at a range of timepoints (4-26 weeks after the first dose) with the greatest efficacy induced when dose 2 was administered 12 weeks after the first dose.

    Vaccination with Comirnaty™ (Pfizer/BioNTech COVID-19 vaccine) requires a 2-dose course administered 21 days apart. The absolute minimum interval is 19 days and the recommended maximum interval is 6 weeks. If the second dose is inadvertently administered with an interval of less than 19 days, repeat doses are not currently recommended. If more than 6 weeks has elapsed, the second dose should be administered as soon as possible with no need to re-start the course again. Clinical trials for Comirnaty™ assessed efficacy when doses were administered at a range of timepoints with these recommendations reflective of the best results obtained.

  • What happens if the second COVID-19 vaccine dose is given early, late or is missed?

    The recommended interval between two doses of Comirnaty™ (Pfizer/BioNTech COVID-19 vaccine) is 21 days, with a minimum interval of 19 days and a maximum interval of 6 weeks. There is currently no recommendation for repeat doses/recommencing the course if there are variations to this advice.

    The recommended interval between two doses of COVID-19 AstraZeneca is 12 weeks, with a minimum interval of 4 weeks apart accepted in certain circumstances. There is currently no recommendation for repeat doses/recommencing the course if there are variations to this advice.

    For more information on dosing recommendations please refer to the following links:

  • How long will it take to develop immunity once vaccinated?

    There is some evidence that one dose of Comirnaty™ (Pfizer/BioNTech COVID-19 vaccine) will provide partial protection after 12 days however this is likely to be short lived. Generally the time required following vaccination for the body to develop immunity will depend on the vaccine; this usually takes a number of weeks. Completing both doses of the 2 dose course is recommended.

  • Are booster doses of COVID-19 vaccines required? Will the current vaccines protect against new strain variants?

    There is currently no recommendation for booster doses of COVID-19 vaccines in Australia. However, due to the limited data on duration of protection and the emergence of SARS-CoV-2 strain mutations, international advisory committees are considering the possibility that doses with updated vaccines will be required in the future.

    To read more refer to the links below:

     

  • I have had a recent blood transfusion; can I have a COVID-19 vaccine?

    Recommendations for delayed vaccination following transfusion with blood products depends on the vaccine and the blood product. As further information becomes available, this answer will be updated.

    Recommendations following blood transfusion generally apply to live-attenuated vaccines, such as MMR (measles-mumps-rubella) or varicella vaccines. There are currently no live-attenuated COVID-19 vaccines planned for use in Australia. The Pfizer/BioNTech vaccine is an mRNA vaccine and the COVID-19 AstraZeneca vaccine is a non-replicating viral vector vaccine.

    In people who have received monoclonal antibodies or convalescent plasma for treatment of COVID-19, the United States’ CDC recommends deferring COVID-19 vaccination for 90 days. This is a precautionary measure to avoid interference of the antibody treatment with vaccine-induced immune responses.

    For more information please refer to the CDC: COVID-19 Vaccine FAQs for Healthcare Professionals and MVEC: Live-attenuated vaccines and immunoglobulins or blood products.

  • I have had a recent live vaccine; can I have a COVID-19 vaccine?

    Due to a lack of safety data on the co-administration of COVID-19 vaccines, ATAGI recommends a 14 day interval between the administration of COVID-19 vaccines and any other vaccine (including live-attenuated vaccines). Please refer to COVID-19 vaccination- ATAGI clinical guidance on COVID-19 vaccine in Australia in 2021 for more information.

  • When administering a COVID-19 vaccine the syringe disconnected from the needle and I am not sure how much of the dose my patient received, what should I do?

    If the process of administering a vaccine is interrupted and most of the dose has not been given, repeat the whole dose as soon as practicable. Please contact your safety service if there are any concerns/questions.

    To read more please refer to the Australian Immunisation Handbook: Administration of vaccines.

  • Can COVID-19 vaccines be given subcutaneously?

    Both COVID-19 AstraZeneca and Comirnaty™ should be administered via intramuscular injection. There is no safety or efficacy data relating to subcutaneous administration.

  • My patient has a history of a bleeding disorder, what is the recommendation regarding intramuscular administration of COVID-19 vaccines?

    COVID-19 vaccines should be administered intramuscularly. Subcutaneous administration is not recommended due to a lack of safety and efficacy data regarding this route of administration.

    There is no absolute contraindication to COVID-19 vaccination in patients who have history of a bleeding disorder, and who have stable INR or anti-Xa levels. However, prior to administration, patients who have bleeding disorders or who are on anti-coagulant therapy, should be advised of the increased risk of bruising, bleeding and haematoma formation. Ensure that the correct needle size and length is used for administration. Firm pressure should be applied to the site (no rubbing) for at least 2 minutes following immunisation.

    For further information please refer to the Australian Immunisation Handbook.

  • Can women with a history of breast cancer receive COVID-19 vaccines?

    Yes. Having a history of breast cancer is not a contraindication for COVID-19 vaccination.

    ATAGI recommends COVID-19 vaccination for all immunosuppressed people (including those undergoing treatment for cancers) due to an increased risk of developing severe disease if infected with SARS-CoV-2. It is anticipated that the immune response to vaccination may be reduced in this patient group depending on the level of immune suppression.

    Lymphadenopathy has been reported as a side effect following vaccination. Given that changes in size and consistency of lymph nodes can also indicate a spread of breast cancer, the Society of Breast Imaging (SBI) has recommended breast screening take place either prior to COVID-19 vaccination or 4-6 weeks following the second dose of COVID-19 vaccines to avoid anxiety and unnecessary examination and diagnostic testing.

    To read more refer to the links below:

     

  • What is the recommended site for injection for patients who have had axillary lymph nodes removed/have a history of lymphoedema?

    There is no strong evidence to suggest that vaccine administration into the deltoid will increase the likelihood of lymphoedema in patients who have had lymph nodes removed or have a previous history of lymphoedema.

    Vaccine administration into the deltoid of the unaffected arm may be preferred, alternatively intramuscular injection into the vastus lateralis (thigh) can be considered.

    To read more refer to the links below:

  • My patient has a history of Guillain Barre Syndrome (GBS), is it safe to administer COVID-19 vaccines?

    Having a history of GBS is not a contraindication to vaccination with COVID-19 vaccines and as such it is safe to administer COVID-19 vaccines in this patient group.

    For more information please refer to MVEC: Guillain-Barre Syndrome page and CDC: Vaccine Considerations for People with Underlying Medical Conditions.

  • Are there any concerns regarding COVID-19 vaccines and Bell’s Palsy?

    People who have previously been diagnosed with Bell’s Palsy can receive COVID-19 vaccines. Cases of Bell’s Palsy following immunisation have been identified in participants in mRNA COVID-19 vaccine candidate clinical trials. However, as the rate of occurrence was not above the background rate expected in the general population, they are not considered to be caused by vaccination.

    For more information refer to CDC: Vaccine Considerations for People with Underlying Medical Conditions.

  • Is it safe for people with a diagnosis of Multiple Sclerosis (MS) to be immunised against COVID-19 vaccines?

    Yes. Whilst there is minimal data on the safety and efficacy of COVID-19 vaccination in people with MS, there are no theoretical concerns relating to administration in this patient group.

    For more information please refer to COVID-19 and vaccination- Everything you need to know.

  • Can patients who are taking monoamine oxidase inhibitors (MAOI’s) be safely immunised with COVID-19 vaccines given that they should generally avoid adrenaline? What would be the appropriate treatment if they experienced anaphylaxis?

    Yes, COVID-19 vaccines should be offered to this patient group.

    True vaccine allergy, or anaphylaxis, is an extremely rare adverse event following immunisation occurring in less than 1 case per million doses administered. Post-licensure surveillance of COVID-19 vaccines show anaphylaxis following administration of COVID-19 AstraZeneca occurring at similar rates to routine vaccines [refer to TGA: AstraZeneca ChAdOx1-S COVID-19 vaccine]. Anaphylaxis following Comirnaty™ (Pfizer/BioNTech), whilst still extremely rare, occurs at a slightly higher rate of approximately 4.7 cases per million doses.

    Patients who take MAOI’s have a theoretical increased risk of developing hypertensive crisis if administered adrenaline (or other specific medications/foods) due to a potential for drug interaction. In the setting of anaphylaxis, resuscitation with adrenaline remains the most appropriate treatment regardless of medical history. The benefits of treating anaphylaxis effectively far outweighs any potential risk of hypertensive crisis.

    Ensuring the diagnosis of anaphylaxis is accurate is an important step to avoid unnecessary administration of adrenaline when not clinically indicated.

    For more information refer to:

Safety

  • How can a COVID-19 vaccine be safe when it was made so quickly?

    COVID-19 vaccine development is happening “faster than usual” because of the global impact of the pandemic and the urgent need for a vaccine(s). Vaccines have traditionally been developed in consecutive sequential stages – with preclinical trials followed by phases I, II and III, often with large gaps of time in-between phases awaiting funding or manufacturing scaleup. With COVID-19, this process has been made more efficient by running one phase while simultaneously also preparing and/or recruiting for the next phase.

    It is important to note that COVID-19 vaccine candidates must pass through the exact same rigor and phases of clinical trials and do not miss any important safety and quality checks or steps. Approval is only given if the vaccine meets the appropriate requirements for safety and efficacy.

    Refer to MVEC: Vaccine development and safety, including “The Road to a COVID-19 Vaccine” animation for more information.

  • How can we be sure that the manufacturing process is safe?

    Like any medication in development, vaccine candidates must undergo rigorous testing procedures and scientific evaluation to prove not only their effect on the targeted disease, but also to determine their safety – before being licensed and registered for use in vaccination programs.

    In all three clinical trial phases, safety is continually assessed as data is gathered and a vaccine must pass all these phases before it can be considered for registration for use by the TGA. By the time a vaccine is registered, safety would have been assessed in tens of thousands of clinical trial participants and this safety data would have been rigorously evaluated by the TGA and other international drug regulatory bodies.

    The quality, sterility, potency and purity of each vaccine batch is also assessed by the TGA prior to being supplied to Australia, as is the quality of selected batches after they have been supplied.

    Once a vaccine is approved, it continues to be tested in a process known as post-licensure surveillance.

  • What are the expected side effects of a COVID-19 vaccine?

    You may experience minor side effects following COVID-19 vaccination. Common side effects include pain, redness and swelling at the injection site as well as more general side effects such as fever, chills, headache and tiredness.

    Most systemic (general) symptoms are mild to moderate in severity, occur within the first three days of vaccination, and resolve within 1–3 days of onset. These symptoms may be more common and severe following the second dose and among younger people compared to older people.

    Serious reactions like allergic reactions are extremely rare. If you have any concerns about the vaccine, ask your doctor, nurse or health care professional.

    For more information, please refer to the following documents:

  • Can a COVID-19 vaccine be given in pregnancy? When breastfeeding?

    The administration of COVID-19 vaccines to pregnant women is not routinely recommended however it is not contraindicated. Currently, there is limited data available on the safety of COVID-19 vaccination in pregnancy and on pregnancy outcomes. ATAGI recommends that immunisation during pregnancy could be considered if there are medical risk factors for developing severe disease or if there is a high risk of exposure to the virus (ie: occupational risk factors). As further data is made available these recommendations may change.

    A recent study published in the American Journal of Obstetrics and Gynecology has evaluated the immunogenicity and reactivity of COVID-19 vaccines administered to a small number of pregnant and lactating women.  Immune responses following immunisation with the Pfizer BioNTech and Moderna COVID-19 mRNA vaccines were  comparable to the responses of non-pregnant counterparts in the study and were far greater than that seen following natural SARS-CoV-2 infection in pregnancy. Maternal immunity was passively transferred to infants via the placenta and breastmilk.

    ATAGI recommends that women who are breastfeeding or who are planning pregnancy can receive COVID-19 vaccines.

    For more information refer to the following:

  • I have received 1 dose of COVID-19 but have now discovered I am pregnant. What does that mean for completing the course?

    The administration of COVID-19 vaccines to pregnant women is not routinely recommended however it is not contraindicated. Currently, there is limited data available on the safety of COVID-19 vaccination in pregnancy and on pregnancy outcomes. Based on what we know about other vaccines it is likely that administering COVID-19 vaccines during pregnancy is safe and effective, however pregnant women were not included in COVID-19 vaccine clinical trials. When considering vaccination during pregnancy a risk/benefit discussion with a health care professional is recommended, to assess medical risk factors for developing severe disease as well as any risk of exposure to the virus (ie: occupational risk factors).

    If the second dose of vaccine is delayed until after the pregnancy it should be noted that there is no need to restart the course again despite the interval between doses being greater than recommended. The level of efficacy may be impacted due to the altered timing of doses. Protective measures such as maintaining social distancing and mask-wearing remain important in reducing the risks of contracting COVID-19.

    For more information refer to the following:

     

     

  • Can a COVID-19 vaccine be given to those with immunosuppression?

    ATAGI recommends COVID-19 vaccination for all immunosuppressed people due to an increased risk of developing severe disease if infected with SARS-CoV-2. Due to limitations in clinical trials there is currently no data on the safety and efficacy of COVID-19 vaccination in this group, however in principle there are no theoretical risks.

    It is anticipated that the immune response to vaccination may be reduced in this patient group depending on the level of immune suppression. Hence, when vaccinating immunocompromised people, they should also be counselled about this reduced efficacy and the need to continue other prevention measures such as social distancing and mask wearing.

    Household contacts of people with immunosuppression are recommended to receive COVID-19 vaccines. This helps protect people who are immunocompromised, whether they are a child or an adult, by reducing their exposure to disease.

    Please speak to your doctor to discuss individual cases and see the following links for more information:

  • How are vaccines monitored for safety post licensure? What is the role of SAEFVIC/TGA?

    Post-licensure safety monitoring in Australia occurs using a variety of mechanisms. These may include:

    Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC) is the central reporting service in Victoria for any significant AEFI. SAEFVIC collects, analyses and reports data about significant AEFI as part of monitoring vaccine safety in Victoria. All reports are sent to the Therapeutic Goods Administration (TGA) who is responsible for assessing the safety of vaccines and other medicines for use in Australia.

    The role of the TGA is also to determine whether a COVID-19 vaccine candidate meets the strict safety and efficacy requirements for registration before it can be used in Australia.

    For more information refer to the Therapeutic Goods Administration: COVID-19 vaccines.

  • I think I am experiencing some side effects, should I report?

    Any event felt to be significant following immunisation should be reported. You do not need to routinely report common/minor/expected reactions.

    Clinicians must report severe adverse effects through SAEFVIC in Victoria. This should be done whether you think the side effect was related to the vaccine or not.

  • I experienced side effects from the first dose of the vaccine, should I not have the second dose?

    Common side effects that are short lived are not a contraindication to the second dose of COVID-19 vaccine.

    If you have experienced any unanticipated side effects following the first dose COVID-19 vaccine, speak to your healthcare professional about the safety of a second dose.

    If you had an immediate or severe allergic reaction (anaphylaxis) after getting the first dose of a COVID-19 vaccine, you should not get the second dose. Your healthcare provider may refer you an allergy specialist for further advice. Serious reactions like allergic reactions are extremely rare.

  • What is vaccine-associated enhanced disease?

    Vaccine-associated enhanced disease occurs when a more severe presentation of disease develops in an individual who has previously been immunised, compared with when an infection occurs without prior vaccination.

    For more information on VAED please review our reference page MVEC: Vaccine-associated enhanced disease

  • My patient has a history of Guillain Barre Syndrome (GBS), is it safe to administer COVID-19 vaccines?

    Having a history of GBS is not a contraindication to vaccination with COVID-19 vaccines and as such it is safe to administer COVID-19 vaccines in this patient group.

    For more information please refer to MVEC: Guillain-Barre Syndrome page and CDC: Vaccine Considerations for People with Underlying Medical Conditions.

  • Are there any concerns regarding COVID-19 vaccines and Bell’s Palsy?

    People who have previously been diagnosed with Bell’s Palsy can receive COVID-19 vaccines. Cases of Bell’s Palsy following immunisation have been identified in participants in mRNA COVID-19 vaccine candidate clinical trials. However, as the rate of occurrence was not above the background rate expected in the general population, they are not considered to be caused by vaccination.

    For more information refer to CDC: Vaccine Considerations for People with Underlying Medical Conditions.

  • Is it safe for people with a diagnosis of Multiple Sclerosis (MS) to be immunised against COVID-19 vaccines?

    Yes. Whilst there is minimal data on the safety and efficacy of COVID-19 vaccination in people with MS, there are no theoretical concerns relating to administration in this patient group.

    For more information please refer to COVID-19 and vaccination- Everything you need to know.

  • Can patients who are taking monoamine oxidase inhibitors (MAOI’s) be safely immunised with COVID-19 vaccines given that they should generally avoid adrenaline? What would be the appropriate treatment if they experienced anaphylaxis?

    Yes, COVID-19 vaccines should be offered to this patient group.

    True vaccine allergy, or anaphylaxis, is an extremely rare adverse event following immunisation occurring in less than 1 case per million doses administered. Post-licensure surveillance of COVID-19 vaccines show anaphylaxis following administration of COVID-19 AstraZeneca occurring at similar rates to routine vaccines [refer to TGA: AstraZeneca ChAdOx1-S COVID-19 vaccine]. Anaphylaxis following Comirnaty™ (Pfizer/BioNTech), whilst still extremely rare, occurs at a slightly higher rate of approximately 4.7 cases per million doses.

    Patients who take MAOI’s have a theoretical increased risk of developing hypertensive crisis if administered adrenaline (or other specific medications/foods) due to a potential for drug interaction. In the setting of anaphylaxis, resuscitation with adrenaline remains the most appropriate treatment regardless of medical history. The benefits of treating anaphylaxis effectively far outweighs any potential risk of hypertensive crisis.

    Ensuring the diagnosis of anaphylaxis is accurate is an important step to avoid unnecessary administration of adrenaline when not clinically indicated.

    For more information refer to:

Allergies

  • Is it safe to administer COVID-19 vaccines to people with latex allergies?

    The COVID-19 vaccines with provisional registration for use within Australia (Comirnaty™ and COVID-19 AstraZeneca) can both be administered to people with latex allergies following standard precautions, with a 15 minute post-vaccination observation period. Neither Comirnaty™ or COVID-19 AstraZeneca vials contain latex.

    For more information please refer to the ASCIA: Allergy, Immunodeficiency, Autoimmunity and COVID-19 Vaccination Position Statement.

  • My patient has a history of allergies, is it safe to administer a COVID-19 vaccine to them?

    The only two absolute contraindications to vaccination are anaphylaxis to a previous dose of the same vaccine or anaphylaxis to a component of the vaccine. For specific advice please contact your specialist immunisation service.

    For patients with a history of anaphylaxis to food, drugs, venom or latex, it is recommended a routine observation period of 15 minutes following COVID-19 vaccination is observed.

    Additional precautions are recommended for individuals with possible allergic reactions to a previous dose of a COVID-19 vaccine; allergic reactions to ingredients in the COVID-19 vaccine to be administered (including PEG in Comirnaty™ and Polysorbate 80 in COVID-19 AstraZeneca); prior anaphylactic reactions to other vaccines or medications where PEG or Polysorbate 80 may have been the cause; or a known systemic mast cell activation disorder with raised mast cell tryptase that has required treatment.

    In these instances a specialist review by an immunology/allergy/vaccination specialist to undertake a risk/benefit assessment to assess suitability for vaccination should be undertaken.

    Pleaser refer to COVID-19 vaccination – ATAGI clinical guidance on COVID-19 Vaccine in Australia in 2021 or the ASCIA: Allergy, Immunodeficiency, Autoimmunity and COVID-19 Vaccination Position Statement for more information.

  • My patient has a history of allergy to Polyethylene Glycol (PEG), can I administer a COVID-19 vaccine to them?

    PEG is an ingredient contained in Comirnaty™. It is also a commonly used ingredient of other medications, hand sanitisers, cosmetics, bathroom products and colonoscopy preparation products, routinely used within Australia. Whilst it is uncertain whether PEG contained in mRNA vaccines may trigger anaphylaxis, additional precautions are required.

    If your patient has a history of confirmed or suspected allergy to PEG it is recommended that they are referred to an immunology/allergy/vaccination specialist for advice regarding the safety of administering an mRNA COVID-19 vaccine.

    NB: Vaccination with the Comirnaty™ COVID-19 vaccine is contraindicated in people with documented anaphylaxis to PEG.

    To read more refer to COVID-19 vaccination – ATAGI clinical guidance on COVID-19 Vaccine in Australia in 2021.

  • My patient has a history of allergy to Polysorbate 80, can I administer a COVID-19 vaccine to them?

    Polysorbate 80 is chemically related to Polyethylene Glycol (see question above) and is an ingredient in COVID-19 AstraZeneca.

    If your patient has a history of confirmed or suspected allergy to Polysorbate 80 it is recommended that they are referred to an immunology/allergy/vaccination specialist for advice regarding the safety of administering COVID-19 AstraZeneca.

    NB: Vaccination with the COVID-19 AstraZeneca is contraindicated in people with documented anaphylaxis to Polysorbate 80.

    For further information please refer to ASCIA: Allergy, Immunodeficiency, Autoimmunity and COVID-19 Vaccination Position Statement and COVID-19 vaccination – ATAGI clinical guidance on COVID-19 Vaccine in Australia in 2021.

  • Do COVID-19 vaccines contain gelatin?

    Both COVID-19 AstraZeneca and Comirnaty™ are gelatin free and safe to administer to patients who are allergic to gelatin. A standard 15-minute observation period following immunisation is recommended.

  • What are the ingredients of COVID-19 vaccines?

    There are currently 2 COVID-19 vaccine with provisional registration in use in Australia.

    Each dose of Comirnaty™ (Pfizer/ BioNTech COVID-19 vaccine) contains:

    • 30 mcg mRNA encoding the SARS-CoV-2 spike glycoprotein
    • (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2- hexyldecanoate) (ALC-0315)
    • 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC0159)
    • Distearoylphosphatidylcholine (DSPC)
    • Cholesterol
    • Potassium chloride
    • Monobasic potassium phosphate
    • Sodium chloride
    • Dibasic sodium phosphate dihydrate
    • Sucrose
    • Water for injections

    Each dose of COVID-19 AstraZeneca (Oxford/AstraZeneca COVID-19 vaccine) contains:

    • 5×1010 viral particles of ChAdOx1-S
    • Histidine
    • Histidine hydrochloride monohydrate
    • Sodium chloride
    • Magnesium chloride hexahydrate
    • Disodium edetate (EDTA)
    • Sucrose
    • Ethanol absolute
    • Polysorbate 80
    • Water for injection

    Further information can be found in the Product Information for each vaccine:

  • Is there an increased risk of anaphylaxis following COVID-19 vaccines?

    A true vaccine allergy (anaphylaxis), where a person is contraindicated from being immunised with the same vaccine in the future, is rare (in most studies reported as less than 1 case per million doses).

    Post-licensure surveillance of COVID-19 vaccines show anaphylaxis following administration of COVID-19 AstraZeneca occurring at similar rates to routine vaccines. Anaphylaxis following Comirnaty™, while still extremely rare, occurs at a slightly higher rate of approximately 4.7 cases per million doses.

    To read more follow the links below:

     

COVID-19 Astra-Zeneca

  • Are people > 50 years of age receiving an “inferior” vaccine?

    Both Comirnaty™ and COVID-19 AstraZeneca are effective vaccines which protect against severe COVID-19 disease and hospitalisation.

    The recommendation by ATAGI does not mean or indicate that there are questions over the effectiveness of the vaccine in any age group.

  • I am under 50 years of age and have had dose 1 of the AstraZeneca vaccine, is it safe to receive dose 2?

    People who have received their first dose of COVID-19 AstraZeneca without any serious adverse events can receive their second dose. This should be done in the recommended time frame of 4-12 weeks between doses. Current information suggests that thrombosis with thrombocytopenia syndrome is more frequently reported following receipt of dose 1 of COVID-19 AstraZeneca.

    For more information refer to ATAGI statement on AstraZeneca vaccine in response to new vaccine safety concerns.

  • I am under 50 years of age and received COVID-19 AstraZeneca as my first dose, should I/can I have Comirnaty™ as my dose 2 of a COVID-19 vaccine? Or now commence a course of 2 doses of Comirnaty™ and no further doses of AstraZeneca?

    There is no data on the safety and efficacy of using alternate brands to complete a course of COVID-19 vaccination. Current information suggests that thrombosis with thrombocytopenia syndrome (TTS) is more frequently reported following receipt of dose 1 of COVID-19 AstraZeneca. If a person has received the first dose of COVID-19 AstraZeneca without any serious adverse events such as TTS or anaphylaxis, then they can receive the second dose.

    COVID-19 vaccination is not mandatory, however immunisation is strongly recommended for all who are eligible to receive it. It is important to discuss any queries or concerns with an immunisation provider or your treating health care professional.

  • I am over 50 years of age and have a history of deep vein thrombosis (DVT’s). Is it safe for me to receive COVID-19 AstraZeneca?

    The international vaccine regulators such as the EMA, MHRA and TGA have been conducting investigations into the reports of blood clotting conditions following COVID-19 AstraZeneca. There is currently no evidence to suggest that having a history of DVT’s or other general thromboembolic disorders predisposes you to developing TTS following administration of COVID-19 AstraZeneca.

    In contrast, there is strong evidence that COVID-19 disease is thrombogenic (promotes clot development) and may cause a variety of thromboembolic events.

    Refer to Updated ATAGI statement for healthcare providers on a specific clotting condition being reported after COVID-19 vaccination for more information.

  • I am under 50 years of age and travelling to an area experiencing a current COVID-19 outbreak. Should I have the AstraZeneca vaccine as I am unable to source an alternative?

    ATAGI recommends that COVID-19 AstraZeneca can be administered in adults aged under 50 years of age where the benefits of protection are likely to outweigh the risks of vaccination for that individual. It is important to discuss your individual circumstances with a health care provider in order to make an informed decision. There may be some differences to this advice depending on the state/jurisdiction you live in, so please check with your local Department of Health.

    To read more refer to ATAGI statement on AstraZeneca vaccine in response to new vaccine safety concerns.

  • I am under 50 years of age and allergic to Polyethylene Glycol (PEG) which is an ingredient of Comirnaty™. Can I/should I receive COVID-19 AstraZeneca?

    PEG is an ingredient contained in Comirnaty™ and it is therefore recommended that you are referred to an immunology/allergy/vaccination specialist for advice regarding the safety of receiving the Pfizer/BioNTech vaccine.

    Whilst ATAGI advises that Comirnaty™ is the preferred COVID-19 vaccine for those aged under 50 years, it can be administered in this age group where the benefits of protection are likely to outweigh the risks of vaccination for that individual. It is important to discuss your individual circumstances with a health care provider in order to make an informed decision.

    NB: Vaccination with Comirnaty™ is contraindicated in people with documented anaphylaxis to PEG.

    For more information refer to COVID-19 vaccination – ATAGI clinical guidance on COVID-19 vaccine in Australia in 2021

  • I am over 50 years of age and allergic to Polysorbate 80, an ingredient of COVID-19 AstraZeneca. Will I be able to have Comirnaty™?

    Polysorbate 80 is an ingredient contained in COVID-19 AstraZeneca and it is therefore recommended that you are referred to an immunology/allergy/vaccination specialist for advice regarding the safety of receiving the vaccine or whether an alternate brand (currently Comirnaty™) is preferred.

    NB: Vaccination with the COVID-19 AstraZeneca is contraindicated in people with documented anaphylaxis to Polysorbate 80.

    For more information refer to COVID-19 vaccination – ATAGI clinical guidance on COVID-19 vaccine in Australia in 2021

  • I am taking hormone replacement therapy. Am I at an increased risk of thrombosis with thrombocytopenia syndrome (TTS) if I am given COVID-19 AstraZeneca?

    There is currently no evidence to suggest that taking certain medications or being prone to developing blood clots puts you at increased risk of developing TTS following receipt of COVID-19 AstraZeneca.

  • I am over 50 years of age and have a history of atrial fibrillation putting me at a higher risk of blood clots. Is it safe for me to have COVID-19 AstraZeneca?

    There is currently no evidence to suggest that having a medical condition which increases your likelihood of developing blood clots puts you at a greater risk of developing TTS following receipt of COVID-19 AstraZeneca.

  • I am under 50 years of age and I just want to be vaccinated ASAP. Can I have COVID-19 AstraZeneca as it is more readily available?

    Whilst ATAGI preferentially recommends administration of an alternate brand of COVID-19 vaccine (Comirnaty™) in those aged under 50 years, it is not contraindicated. It is important to be informed of common, expected and rarer side effects of vaccination prior to receiving any vaccine. The risk of developing thrombosis with thrombocytopenia syndrome (TTS) following receipt of COVID-19 AstraZeneca is rare with current evidence suggesting a rate of approximately 4-6 cases per 1 million doses of the vaccine administered.

  • What is thrombosis with thrombocytopenia syndrome (TTS)?

    Thrombosis with thrombocytopenia syndrome (TTS), is a rare and new syndrome which has been reported in people who have received COVID-19 AstraZeneca vaccination.

    The estimated risk of developing TTS is approximately 4 to 6 persons per million doses following dose 1 of COVID-19 AstraZeneca. Current information suggests that TTS is more frequently reported following receipt of dose 1 of COVID-19 AstraZeneca.

    The features of TTS are usually seen in days 4-20 after vaccination. They may include symptoms of blood clots in various organs including (but not limited to):

    • Neurological
      • Severe headaches unresponsive to simple analgesia
      • Visual changes (eg. blurred vision)
      • Focal neurological deficits/changes
      • Confusion/encephalopathy
      • Seizures
    • Gastroenterology
      • Abdominal pain
      • Vomitting
    • Respiratory
      • Significant respiratory symptoms/distress

    There is currently no exact mechanism identified to describe how COVID-19 AstraZeneca may trigger TTS. There is some indication that this is an immune-mediated process, with some recent publications using the title vaccine induced immune prothrombotic immune thrombocytopenia (VIPIT), but we will use the term TTS in these MVEC FAQs.

  • Are there any risk factors for developing thrombosis with thrombocytopenia syndrome (TTS)? eg. age, gender etc

    Evidence thus far indicates there is a higher risk of thrombosis with thrombocytopenia syndrome (TTS) in the younger population (< 50 years of age), although there has been a small number of cases identified in older adults. There is some evidence to suggest that the incidence is higher in women compared to men, although this may be because more vaccine doses have been administered to women in vaccine rollouts worldwide, especially those targeting healthcare professionals.

    TTS is an idiosyncratic reaction. There are currently no biological risk factors that have been identified to either increase or decrease your risk of TTS. This includes a past history of clots in the leg (DVT), lungs (pulmonary embolus [PE]) or heart (myocardial infarction).

  • When do symptoms of thrombosis with thrombocytopenia syndrome (TTS) following COVID-19 AstraZeneca occur?

    Symptoms of TTS have been reported to occur in the 4-20 day time period following administration of COVID-19 AstraZeneca. Current information suggests that TTS is more frequently reported following receipt of dose 1 of COVID-19 AstraZeneca.

    The features of TTS may include symptoms of blood clots in various organs including (but not limited to):

    • Severe headaches unresponsive to simple analgesia
    • Abdominal pain
    • Significant respiratory symptoms/distress
    • Visual changes
    • Vomiting
    • Seizures
    • Focal neurological deficits/changes
    • Confusion/encephalopathy
  • I am 51 years of age. Why is COVID-19 AstraZeneca deemed safe for me to receive?

    Like any arbitrary age cut-off, it is acknowledged that there may be limited difference between an individual at age 50 or 51 years. What we do know is that the risk of intensive care admissions and death increases markedly with age, with each decade of life increasing the risk 3-fold. Conversely, the possibility of thrombosis with thrombocytopenia syndrome (TTS) may be higher in younger people, based on currently available data.

    ATAGI have taken this data, along with safety data analysis from other countries such as the UK, other risks such as prevalence of COVID-19 in the Australian population along with any existing COVID-19 outbreaks, to calculate an age-specific benefit-to-risk balance for the Australian population. This has resulted in a current age cutoff of 50 years old in the current recommendations.

  • What is the risk-benefit ratio (also known as benefit-risk-assessment) when weighing up whether to get vaccinated?

    A benefit-risk assessment is important to conduct when recommending any vaccination. This measures the benefits of vaccination (eg. reduction of morbidity and mortality from the disease) to any potential risks. Also known as a benefit-risk ratio or balance, it will vary with other factors such as age, prevalence of outbreaks in a population and potential exposure to the disease in their workplace. This assessment may differ from individual to individual.

    For COVID-19, older people are at an increased risk of severe disease and death if they contract COVID-19. Younger people with some underlying medical conditions are also at an increased risk of severe disease, which affects their benefit-to-risk balance.

    The absence of COVID-19 in the community also affects this benefit-to-risk balance. Current advice would be reconsidered in the context of an outbreak, as the benefit in preventing COVID-19 would outweigh the risk for most adults.

    For more information on weighing up the potential benefits vs risk of harm please refer to Weighing up the potential benefits against risk of harm from COVID-19 AstraZeneca.

    Whilst the current recommendations in Australia are that Comirnaty™ (Pfizer) COVID-19 vaccine is preferred in people under 50, a person in this age group can make an informed decision in conjunction with their healthcare provider to receive a COVID-19 AstraZeneca vaccine based on an understanding of their individual benefit-risk assessment.

  • Can I get a blood test to check my immune response from the first dose and avoid the need for a second dose?

    COVID-19 serology is not routinely available following vaccination and is not able to inform the decision to proceed with a second dose. Due to the novel nature of SARS-CoV-2, a correlate of protection has not yet been established for COVID-19 in humans.

    Data from clinical trials demonstrated that a 12-week interval between doses of COVID-19 AstraZeneca provided a significant increase in the immune response and longer-term protection. COVID-19 AstraZeneca is provisionally licensed by the Therapeutic Goods Administration as a two dose schedule.

    Refer to COVID-19 vaccination- ATAGI clinical guidance on COVID-19 vaccine in Australia in 2021 for more information.

  • How much protection do I get from 1 dose of COVID-19 AstraZeneca?

    The level of protection gained from a single dose of COVID-19 AstraZeneca was assessed during clinical trials in an exploratory analysis that included participants who had received one dose. Protection was 73%, with the 95% CI from 49% and 86%, starting from 3 weeks after the first dose. This analysis reflects the short term efficacy and does not demonstrate the duration of protection. It is important to note that COVID-19 AstraZeneca is provisionally licensed by the Therapeutic Goods Administration as a two dose schedule.

    Refer to COVID-19 vaccination- ATAGI clinical guidance on COVID-19 vaccine in Australia in 2021 or COVID-19 AstraZeneca Product Information for more information.

  • I’m unsure about having COVID-19 AstraZeneca, can I wait for an alternate vaccine brand?

    Then is no certainty regarding when additional alternate vaccine brands will be available in Australia.

    Whilst the Australian government have announced that an additional 20 million doses of Comirnaty™ have been secured, these will not be available until later in 2021.

    There is an advance purchase agreement for the Novavax vaccine candidate which is still in phase III trials. Once trials have been completed, if proven safe and effective, this vaccine would still need to obtain provisional registration prior to any rollout in Australian. Doses of Novavax vaccine will be manufactured overseas and as such availability will be depend on the ability to import doses.

    In making this decision it is important to be aware of the potential for a COVID-19 outbreak. While Australia currently has minimal community transmission of COVID-19, this could change. Factors to consider include winter months approaching, high rates of global transmission, the emergence of new variants of the virus, as well as the potential for future changes to Australia’s border controls.

  • ATAGI have noted that “people who have had their first dose of COVID-19 AstraZeneca without any serious adverse effects can be given a second dose, including those under 50 years”. What constitutes a serious adverse event?

    A serious adverse event following immunisation (AEFI) includes anaphylaxis or thrombosis with thrombocytopenia syndrome (TTS).

    Anaphylaxis to a previous dose of a vaccine is a contraindication to future doses of that same vaccine. Those with a past history of TTS or central venous sinus thrombosis (CVST) are advised not to receive COVID-19 AstraZeneca.

    Specialist immunisation advice can be sought by referring patients to the VicSIS network if further clarification is required. VicSIS has been established to provide specialist immunisation support for those who have experienced AEFI or those who are identified at risk of AEFI.

  • I am over 50 years of age and my GP has recommended that I be immunised with Comirnaty™. What happens now?

    There are a limited range of indications for a person aged 50 years of age and older to require Comirnaty™ rather than COVID-19 AstraZeneca.

    These include:

    • Anaphylaxis after a previous dose of COVID-19 AstraZeneca
    • Anaphylaxis to polysorbate 80 (a component of COVID-19 AstraZeneca)

    At this time, given the reported association of COVID-19 AstraZeneca with a very rare but serious clotting disorder (thrombosis) together with low platelet count (thrombocytopenia), it is also advised that Comirnaty™ (rather than COVID-19 AstraZeneca) be used in people with a past history of:

    • Past history of heparin induced thrombocytopenia (HITS)
    • Past history of central venous sinus thrombosis (CVST)

    If a doctor feels their patient aged 50 years or older has a medical contraindication to receiving COVID-19 AstraZeneca and should be offered Comirnaty™ instead, the doctor can make a referral of their patient to the VicSIS network for management.

Authors: Daniela Say (MVEC Immunisation Fellow), Georgina Lewis (SAEFVIC Clinical Manager, Murdoch Children’s Research Institute), Rachael McGuire (MVEC Education Nurse Coordinator) and Francesca Machingaifa (MVEC Education Nurse Coordinator)

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator) and Francesca Machingaifa (MVEC Education Nurse Coordinator)

Date: April 25, 2021

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.