COVID-19 vaccines: frequently asked questions

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

  • 1. 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.

  • 2. 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.

  • 3. 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.

  • 4. 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.

  • 5. 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.

Australian vaccine agreements

The Australian Government has entered into four agreements for the supply of COVID-19 vaccines, if they prove safe, effective and are licensed for use in Australia. More than $3.3 billion has been invested in the following agreements:

  1. Comirnaty® (Pfizer/BioNTech COVID-19 vaccine)- provisional registration granted on January 25, 2021
  2. COVID-19 AstraZenca® (University of Oxford/AstraZeneca vaccine COVID-19 vaccine)- provisional registration granted on February 16, 2021
  3. Novavax COVID-19 vaccine candidate
  4. COVAX Facility

The University of Queensland COVID-19 vaccine candidate previously had an agreement with the Australian government, however will no longer be proceeding to Phase 3 trials.

Priority groups

  • 1. Why will the vaccine only be offered to some groups initially?

    There is significant demand for COVID-19 vaccines globally, meaning that the initial vaccine doses and access will be limited. Hence, the initial rollout will be made available to the highest risk priority groups first before subsequent vaccination of the general population.

  • 2. Who will be offered a COVID-19 vaccine first?

    The Australian Technical Advisory Group on Immunisation (ATAGI) has provided initial advice to the Australian Government on which groups should be prioritised for the first doses. The ATAGI’s expert advice recommends the initial priority groups for COVID-19 immunisation should be:

    1. Those who have an increased risk of developing severe disease
    2. Those at risk of exposure, being infected with and transmitting the virus
    3. Those working in services critical to society functioning.

    Priority groups are chosen taking into account current public health, medical and epidemiological evidence on groups likely to be most adversely impacted if they contracted COVID-19. For example, health and aged care workers are a priority group because they are at high risk of both contracting COVID-19 and transmitting the virus to vulnerable people.

    Further information about these priority groups and who is most at risk of severe disease and exposure, please see the Australian Government Department of Health COVID-19 Vaccines website and Australia’s COVID-19 vaccine national roll-out strategy.

  • 3. Will there be enough vaccines to immunise all Australians?

    Over time, there will be adequate supplies of multiple COVID-19 vaccines for the entire Australian population. However, these supplies will not all be available upfront but will be accessible in a staged format.

    For example, Australia has currently secured a total of 53.8 million doses of the University of Oxford/AstraZeneca vaccine. 3.8 million doses will be delivered to Australia in early 2021 (from overseas) and 50 million doses will be manufactured locally in Australia in monthly batches. This will be enough to vaccinate the entire population once over (utilising a two-dose regime).

    The Australian Government also has agreements with Pfizer/BioNTech for 20 million doses (available from February 2021) and with Novavax for 51 million doses, which will be made available in Australia during 2021 (subject to approval).

Effectiveness

  • 1. 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.

  • 2. 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® (University of Oxford/AstraZeneca COVID-19 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.

  • 3. 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® (University of Oxford/AstraZeneca COVID-19 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.

  • 4. 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.

  • 5. 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:

  • 6. 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.

  • 7. 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 as post-exposure prophylaxis.

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

Storage

  • 1. 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® (Oxford/AstraZeneca COVID-19 vaccine).

  • 2. 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

  • 1. Where can I access a COVID-19 vaccine?

    Significant efforts are currently underway to plan and rollout the COVID-19 vaccine across Australia. Vaccinations will be available via a phased strategy comprising various priority groups,. Phase 1a vaccinations will begin with the rollout of Comirnaty® (Pfizer/BioNTech COVID-19 vaccine) on 22 February, 2021.

    Due to its additional storage requirements (storage at –70°C) Comirnaty® (Pfizer/BioNTech COVID-19) will be restricted to hospital based “hubs” located across urban and rural Australia. In Victoria, these hubs will be managed by Western Health, Austin Health, Monash Health, Barwon Health, Goulburn Valley Health, Latrobe Health, Bendigo Health, Ballarat Health and Albury-Wodonga Health.

    Following this, further vaccination sites will be expanded to incorporate the rollout of COVID-19 AstraZeneca® (Oxford/AstraZeneca COVID-19 vaccine) (due to begin March 2021). These locations have not yet been finalised, however planning and discussions are underway to consider using General Practices, state vaccination clinics, Aboriginal controlled community health services and pharmacies. Please see the following State and Federal government websites for the latest information:

  • 3. How and where will the vaccine administration be registered/recorded?

    It is mandatory for every COVID-19 vaccine administered within Australia to be recorded on the Australian Immunisation Register (AIR). The AIR records any vaccine doses administered, the date of administration and the specific brands given.  It also identifies any vaccines that are due or overdue according to the National Immunisation Program (NIP). Immunisation history statements (IHS) can also be generated from AIR.

  • 4. 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.

  • 5. Can different COVID-19 vaccines be used interchangeably (for example different vaccines between 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.

  • 6. 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.

  • 7. 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® (University of Oxford/AstraZeneca) 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.

  • 8. 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® (University of Oxford/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:

  • 9. 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.

  • 10. 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 Oxford/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.

  • 11. 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.

  • 12. I am interested in being part of the Victorian COVID-19 workforce and delivering COVID-19 vaccines, how do I apply?

    You can apply directly to the vaccination hubs or via Torrens Health. The links below are to the careers pages of the health services operating COVID-19 vaccination hubs:

    For further information refer to the Department of Health and Human Services Coronavirus (COVID-19) health workforce response page or the ANMF COVID workforce FAQ’s.

  • 13. 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 Allergy, Immunodeficiency, Autoimmunity and COVID-19 Vaccination Position Statement.

  • 14. 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 includes anaphylaxis to a previous dose of the same vaccine and anaphylaxis to a component of the vaccine. For specific advice please contact your specialist immunisation service.

    For patients with a history of anaphylaxis to any antigen (including food, insect stings, medicine) and those who have been prescribed an Epipen®, it is recommended that individuals be observed for a period of 30 minutes following COVID-19 vaccination.

    For patients without a history of anaphylaxis, standard precautions with a post-vaccination observation period of 15 minutes apply.

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

  • 15. 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.

  • 16. 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® vaccine.

    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 the COVID-19 AstraZeneca® vaccine.

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

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

  • 17. 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.

  • 18. 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.

    19. 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.

  • 19. 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.

  • 20. 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.

Safety

  • 1. 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.

  • 2. 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-marketing surveillance.

  • 3. 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 COVID-19 vaccination- ATAGI clinical guidance on COVID-19 vaccine in Australia in 2021.

  • 4. 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).

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

    For more information refer to the following:

  • 5. 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:

  • 6. 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.

  • 7. 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.

  • 8. 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.

  • 9. 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

  • 10. 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 Allergy, Immunodeficiency, Autoimmunity and COVID-19 Vaccination Position Statement.

  • 11. 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 includes anaphylaxis to a previous dose of the same vaccine and anaphylaxis to a component of the vaccine. For specific advice please contact your specialist immunisation service.

    For patients with a history of anaphylaxis to any antigen (including food, insect stings, medicine) and those who have been prescribed an Epipen®, it is recommended that individuals be observed for a period of 30 minutes following COVID-19 vaccination.

    For patients without a history of anaphylaxis, standard precautions with a post-vaccination observation period of 15 minutes apply.

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

  • 12. 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.

  • 13. 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® vaccine.

    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 the COVID-19 AstraZeneca® vaccine.

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

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

  • 14. 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.

  • 15. 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.

  • 16. 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.

Authors: Daniela Say (MVEC Immunisation Fellow), Daryl Cheng (Paediatrician, The Royal Children’s Hospital), Georgina Lewis (SAEFVIC Clinical Manager, Murdoch Children’s Research Institute) and Rachael McGuire (MVEC Education Nurse Coordinator)

Date: January 2021

Reviewed: Rachael McGuire (MVEC Education Nurse Coordinator) February 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.


University of Oxford/AstraZeneca COVID-19 vaccine

Name: COVID-19 Vaccine AstraZeneca (AZD1222 or ChAdOx1 nCoV-19)

Type: Viral vector vaccine (chimpanzee adenovirus vector)

Developer: Astra Zeneca

Recommended doses/interval: 2 doses, administered 12 weeks apart (noting a minimum interval of 4 weeks is acceptable)

Doses for Australia: 53.8 million doses, 3.8 million doses will be delivered to Australia in early 2021

Manufacturing: 50 million doses will be manufactured in Parkville, Australia in monthly batches by the local biotechnology company, CSL

Storage: Can be stored, transported and handled at standard refrigerator temperatures (2-8°C)

Background

The University of Oxford/AstraZeneca COVID-19 vaccine (ChAdOx1 nCoV-19) utilises a chimpanzee adenovirus (ChAdOx1) vector; which is unable to cause disease in humans. This viral vector has been tested for safety in other vaccines for Ebola, Middle East respiratory syndrome (MERS) and influenza. This vaccine utilises the full length SARS-CoV-2 spike protein DNA inserted into the viral vector.

On 16 February 2021, the University of Oxford/AstraZeneca COVID-19 vaccine (COVID-19 Vaccine AstraZeneca) was granted provisional registration in Australia by the Therapeutic Goods Administration for use in those ≥18-years of age for the prevention of COVID-19 disease caused by SARS-CoV-2.

Clinical trials

Pre-clinical (animal) trials were conducted in rhesus macaques, mice and ferrets. These trials showed that there were no adverse safety events, no evidence of immune enhanced inflammatory disease and a balanced immune response was induced. In animals, the vaccine appeared to reduce disease severity, but did not prevent infection or transmission (nasal shedding of the virus still occurred).

Phase 1/2 clinical trials were conducted in UK and recruited over one thousand participants in April and May 2020. Phase 2/3 clinical trials will be conducted in 50,000 participants globally (UK, USA, Brazil, South Africa and Kenya), with recruitment starting in July 2020. Interim results of Phase 3 studies, from over 10,000 participants, were published in the Lancet on 8 December 2020.

Safety profile

The Phase 1/2 results showed that the vaccine was safe but had higher reactogenicity than the control vaccine. Symptoms mainly occurred in the day following vaccination and self-resolved. Pain and tenderness at the injection site (83%), fatigue (68%) and headache (70%) were the most common symptoms in participants receiving the ChAdOx1 nCoV-19 vaccine. Fever occurred in 18% and flu-like symptoms of malaise (61%) and muscle ache (60%) were also common.

Phase 2/3 results showed similar reactions to those seen in Phase 1/2 trials but reactions were less common in older adults (aged over 55 years) and after the second dose. Most of the reported local and systemic adverse events were mild to moderate in severity.

Of the nearly 24,000 trial volunteers, only three of the 175 reported serious adverse events were possibly related to the vaccine and more than half of these events occurred in the control arm.

There have been two trial pauses due to initially unexplained illnesses; these were reviewed by independent experts before restarting the trials. One case of transverse myelitis was reported two weeks after ChAdOx1 nCoV-19 booster vaccination and was possibly related to vaccination. There were two additional cases of transverse myelitis that were determined to be unlikely to be related to vaccination by an independent committee of neurological experts. One case was due to pre-existing, but previously unrecognised, multiple sclerosis and the second case occurred in the control arm.

These Phase 3 trials were open to people with many underlying health conditions, however immunocompromised and pregnant people were excluded. Data is currently unavailable for children; they will be recruited in the later stages of Phase 3 trials, once extensive safety data is available from adult studies.

Immunogenicity

The ChAdOx1 nCoV-19 vaccine induced a specific antibody response to the SARS-CoV-2 spike protein after a single dose; this response was boosted after the second dose. Similar immune responses were seen across all age groups, including those aged 70 years and older. Regardless of age or vaccine dose, similar patterns were also observed with neutralising antibody responses and spike-specific T-cell responses.

Vaccine efficacy

Interim analysis of the Phase 3 trials was published on 8 December 2020. There were 11,636 participants (7,548 in the UK and 4,088 in Brazil) included in the interim primary efficacy analysis.

In participants who received two standard doses (5 × 1010 viral particles), vaccine efficacy was 62.1%. A subset in the UK trial received a half dose as their first dose and a standard dose as their second dose; in this cohort vaccine efficacy was 90.0%.

Overall vaccine efficacy across both groups was 70.4%. Further Phase 3 testing is underway to verify these results.

Vaccine efficacy in older age groups (over 55 years of age) could not be assessed in the interim analysis, but will be determined in future analyses once more data is accrued. This will be important data to review given the increasing morbidity and mortality seen with increasing age. Noting immunogenicity studies showed older adults do develop a robust immune response, similar to those seen in younger volunteers.

Resources

Authors: Daniela Say (MVEC Immunisation Fellow) and Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute)

Date: January 2021

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator)

Updated: February 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.

 

 

 

 

 

 

 


Pfizer/BioNTech COVID-19 vaccine

Name: BNT162b2

Type: Genetic vaccine (messenger RNA/mRNA)

Developer: Pfizer/BioNTech

Likely doses/timing: 2 doses (21 days apart)

Doses for Australia: 10 million doses will be available from early 2021

Manufacturing: Doses for Australia will be manufactured overseas

Storage: Must be stored at -70°C, transported on dry ice and will only last 5 days at standard refrigerator temperatures (2-8°C).

Preparation and Injection: Each multi-dose vial of the vaccine contains 5 doses of 0.3ml. The vaccine must be thawed before injection and diluted with the recommended diluent. After dilution the vial must be used within six hours. The vaccine is administered intramuscularly (IM).

Background

Pfizer/BioNTech’s COVID-19 vaccine (BNT162b2) has been issued Emergency Use Authorization (EUA) and even full approval in several counties. Of note, the UK and USA have both issued an EUA, on 2 December and 11 December 2020, respectively. The first injections under a country-wide program began in the UK on 8th  December 2020.

Pfizer’s BNT162b2 vaccine contains messenger RNA (mRNA) which codes for the SARS-CoV-2 full-length spike protein. Although mRNA vaccines have never been licensed before, they had already been studied for more than a decade. mRNA vaccines were already under development for other viruses, such as influenza, and have been tested and shown to be safe in previous clinical trials.

On 25 January 2021, the Pfizer/BioNTech COVID-19 vaccine (Comirnaty) was the first COVID-19 vaccine to be granted provisional registration in Australia.

Clinical trials

Pre-clinical trials were conducted in non-human primates (rhesus macaques) and mice. In animal models, the vaccine induced a strong immune response and prevented lung infection. Vaccinated primates, who were challenged with SARS-CoV-2 virus, had no virus detected in the lower respiratory tract and clearance of virus in the nose within three days. These results indicated the vaccine may reduce both infection and transmission.

Phase 1/2 clinical trials were conducted in Germany and USA. The US Phase 1 trial also included older participants (up to 85 years old) and compared placebo to one of two vaccine candidates (BNT162b1, which encoded the SARS-CoV-2 receptor-binding domain; or BNT162b2, which encodes the SARS-CoV-2 full-length spike). This trial supported the selection of BNT162b2 for advancement to Phase 2/3 trials.

Phase 2/3 clinical trials of BNT162b2 were conducted across USA, Germany, Argentina, Brazil, South Africa and Turkey, and started in July 2020. Initial results of the Phase 3 trial from 43,448 participants, aged 16 years or older, were published in the New England Journal of Medicine on 10 December 2020.

Safety profile

The reactogenicity of BNT162b2 was generally mild or moderate, reactions were generally short-term and were less common and milder in older adults, compared to younger adults. Systemic reactions were more common and severe after the second dose. The incidence of serious adverse events was low and similar in both the vaccine and placebo groups. Phase 3 trial results were consistent with earlier clinical studies and provided results from a median follow-up time of two months after the second dose.

Mild-to-moderate pain at the injection site within seven days after an injection was the most commonly reported local reaction (66-83% depending on age group or first versus second dose). Pain resolved within 1-2 days, there was no increase in reported local reactions after the second dose and no reactions required emergency department visit or hospitalisation.

The most commonly reported systemic events were fatigue (59%), headache (52%) and muscle aches (37%), after the second dose among younger vaccine recipients. These proportions were lower in older vaccine recipients; 51% with fatigue, 39% with headache and 29% with muscle aches after the second done. Severe systemic events were reported in less than 2% of vaccine recipients after either dose, except for fatigue (in 3.8%) and headache (in 2%) after the second dose.

In younger vaccine recipients, fever (≥ 38°C) was reported in 4% after the first dose and 16% after the second dose. In older recipients, fever was reported in 1% and 11%; after first and second dose respectively. Systemic events including fever and chills were observed within the first 1-2 days after vaccination and resolved shortly thereafter.

Serious adverse events were rare; only four were reported among BNT162b2 recipients (shoulder injury related to vaccine administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paraesthesia). No stopping rules (trial pauses) were met during the reporting period. Safety monitoring for this vaccine will continue for 2 years after administration of the second dose of vaccine.

Since public vaccinations began in December 2020, anaphylactic reactions in people receiving the Pfizer/BioNTech COVID-19 vaccine have been reported in the United Kingdom and United States. Clear guidance regarding allergy management will be provided once the Pfizer/BioNTech vaccine has regulatory approval from the TGA. Some guidance from the CDC is included in the following links:

  1. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020
  2. Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States
  3. Lab Tests to Collect Shortly After Severe Allergic Reaction/Anaphylaxis Following COVID-19 Vaccination.

Immunogenicity

Two doses of BNT162b2 elicited high SARS-CoV-2 neutralising antibody titres and robust spike protein-specific T-cell responses. These neutralising antibody responses were greater than the responses measured in people recovered from natural COVID-19 infection; in both younger and older adults. The duration of protection is currently unknown, with booster doses not recommended at this stage.

Vaccine efficacy

The Pfizer/BioNTech vaccine was the first to present interim data of their Phase 3 trial, indicating the vaccine had 95% vaccine efficacy. Similar vaccine efficacy (generally 90 to 100%) was observed across all subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of co-existing conditions. Older adults, 65 years and over, also had the same vaccine efficacy as younger adults.

In among 36,523 participants who had no evidence of existing or prior SARS-CoV-2 infection, there were only 8 cases of COVID-19 (with onset at least seven days after the second dose) in those vaccinated with BNT162b2, compared to 162 cases of COVID-19 among those who received placebo. This corresponded to 95% vaccine efficacy. When combined with participants who did have evidence of past SARS-CoV-2 infection, the vaccine efficacy was still similar (94.6%).

The vaccine appears likely to provide individual protection and prevent severe disease; among 10 cases of severe COVID-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient.

Less than two weeks after the first dose, the vaccine started protecting participants, and the second dose three weeks later, boosted their immune response. The study was not designed to assess the efficacy of a single-dose regimen, however, in the interval between the first and second doses, the observed vaccine efficacy against COVID-19 was 52%, reaching full efficacy at least seven days after the second dose.

Ongoing research

Phase 3 trials are still ongoing and safety monitoring for this vaccine will continue for two years after administration of the second dose of vaccine. Safety monitoring will also continue in the post-licensure phase through surveillance of adverse events following immunisation reporting systems.

Further Phase 3 trials are underway or planned in children (underway for adolescents 12 years and older and planned for younger children), pregnant women and special risk groups, such as immunocompromised people.

Ongoing data collection is required to assess whether the vaccine prevents transmission and asymptomatic cases, as well as assessing how long immune memory may last and whether booster doses are required.

This vaccine has not yet been assessed in clinical trials when co-administered with other vaccines; hence the vaccine should be administered alone. The USA’s CDC recommends a minimum interval of 14 days before or after administration with any other vaccines, including seasonal influenza. ATAGI recommends a 14 day minimum interval between the administration of influenza and COVID-19 vaccines [refer to: ATAGI advice on influenza and COVID-19 vaccines].

Resources

Authors: Daniela Say (MVEC Immunisation Fellow) and Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute)

Date: January 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.

 

 


Novavax COVID-19 vaccine

Name: NVX-CoV2373

Type: Protein vaccine (nanoparticle-based vaccine)

Developer: Novavax

Likely doses/timing: 2 doses (21 days apart)

Doses for Australia: 51 million doses will be made available in Australia during 2021

Manufacturing: Doses for Australia will be manufactured in several locations across Europe and Asia

Storage: Can be stored, transported and handled at standard refrigerator temperatures (2-8°C)

Background

The Novavax COVID-19 vaccine (NVX-CoV2373) was created using Novavax’ recombinant nanoparticle technology which contains the full length SARS-CoV-2 spike protein and Novavax’ patented Matrix-M1 adjuvant (an additional vaccine component that boosts the immune response).

Novavax is a biotechnology company from the USA. Their nanoparticle and Matrix-M1 technology has been previously studied in Phase 3 trials of their quadrivalent influenza vaccine, NanoFlu.

Clinical trials

Pre-clinical trials were conducted in baboons and mice. In animal models, the vaccine induced high levels of anti-spike antibodies and neutralising antibodies, which exceeded the responses measured in humans recovered from natural COVID-19 infection.

Phase 1 clinical trials were conducted in 131 healthy adults, beginning in May 2020. Early clinical trials were performed in Melbourne and Brisbane, Australia, as well as in the USA. Phase 1 results were released in September 2020. This study assessed the safety and immunogenicity of two doses (5-μg and 25-μg) with or without Matrix-M1 adjuvant in healthy adults aged 18 to 59 years, compared to placebo. The phase 2 clinical trials expanded the age of participants to include those aged 60-84 years and results are still pending.

Phase 3 trials are underway in the UK and enrolment of 15,000 participants was completed in November 2020. Interim data is expected in the first quarter of 2021. More large-scale clinical trials are underway or planned for other countries in late 2020 and early 2021, including South Africa, USA and Mexico. These Phase 3 trials will include 30,000 participants overall.

Safety profile

No serious adverse events or adverse events of special interest were reported in Phase 1 trials. Overall reactogenicity was largely absent or mild and the average duration was two days or less for both doses. After first vaccination, local reactions only occurred in 4-16% of participants that received NVX-CoV2373 (the rate of reaction varied for each subgroup; depending on dose given or whether adjuvant was given). Systemic reactions occurred in 4-32% of participants, depending on the subgroup. Common side effects included headache, fatigue and myalgia. After the second vaccination, local and systemic reactogenicity were absent or mild in the majority of participants in all subgroups.

Immunogenicity

Phase 1 results showed NVX-CoV2373 elicited robust antibody responses which were greater than the responses measured in people recovered from natural COVID-19 infection. All participants developed antibodies after a single dose. All participants developed neutralizing antibodies after the second dose. The Matrix-M1 adjuvant was dose sparing; in those receiving NVX-CoV2373 with the Matrix-M1 adjuvant, immunogenicity results were comparable in both low and high dose groups. The Matrix-M1 adjuvant also induced robust polyfunctional CD4+ T-cell responses.

Vaccine efficacy

Interim data regarding vaccine efficacy from the UK’s Phase 3 trials are expected in the first quarter of 2021, noting the high rates of COVID-19  being seen globally may lead to early completion of these event driven trials.

Resources

Authors: Daniela Say (MVEC Immunisation Fellow) and Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute)

Date: January 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.

 

 

 

 

 

 

 


COVAX Facility

The Australian Government has joined the COVAX Facility as part of a global effort to support fair and equitable access to COVID-19 vaccines. This participation and investment means that Australia is able to purchase vaccine doses as they become available from a diverse portfolio of potential COVID-19 vaccines.

The Australian government has invested $123.2 billion to allow the purchase of 25 million doses of COVID-19 vaccines for the Australian population. Australia has committed a further $80 million to support vaccines for 94 lower-income countries. The Department of Foreign Affairs and Trading (DFAT) also announced a $500 million commitment over 3-years to support COVID19 vaccination in Pacific Islander Countries (SICs) and South-east Asia via the Regional Vaccine Access and Health Security Initiative.

Background

COVAX is coordinated by Gavi (the Vaccine Alliance), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization. It brings together governments of over 180 countries, global health organisations, private sector, scientists and manufacturers, in order to provide innovative and equitable access to COVID-19 diagnostics, treatments and vaccines.

COVAX pools funding to support research, development and manufacturing of a wide range of COVID-19 vaccine candidates. All participating countries, regardless of income levels, will have equitable access to these vaccines once they are developed.

COVAX has the world’s largest and most diverse portfolio of COVID-19 vaccines. The initial aim is to have 2 billion doses available by the end of 2021, which should be enough to protect high risk and vulnerable people, as well as frontline healthcare workers.

The COVAX portfolio includes:

Vaccine name Vaccine platform Current stage of clinical trials
University of Oxford/AstraZeneca Viral vector Phase 3
Novavax, USA Protein (nanoparticle) Phase 3
Moderna, USA mRNA Phase 3
CureVac, Germany mRNA Phase 2B/3
Inovio, USA DNA Phase 2
Institut Pasteur/Merck/Themis, France/USA/Austria Viral vector Phase 1
Clover Biopharmaceuticals Protein Phase 1
SK bioscience, South Korea Protein (nanoparticle) Preclinical
University of Hong Kong Viral vector Preclinical

Additional agreements have been made with:

  • Johnson & Johnson/Janssen for 500 million doses of their vaccine candidate, via a memorandum of understanding
  • Sanofi/GSK for 200 million doses of their vaccine candidate, via a statement of intent between Gavi, Sanofi and GSK

Resources

Authors: Daniela Say (MVEC Immunisation Fellow) and Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute) 

Date: January 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.

 


COVID-19 vaccine platforms

Vaccines have been in production for hundreds of years and all of the different forms of technology or so called ‘platforms’ have been applied to the worldwide efforts to produce a SARS-CoV-2 or COVID-19 vaccine. No approach is off the table as researchers and pharmaceutical companies combine efforts to limit the pandemic through immunisation. Hence, there are multiple vaccine approaches utilised by the over 200 COVID-19 vaccines currently in the pipeline. In particular, there are several newer and novel approaches that have shown great promise in advanced (Phase 3) clinical trials. If these newer approaches prove effective, we are likely to see them widely used in the future.

Most of these vaccines build on already existing vaccine technology, many of which have already been shown to be safe in tens of thousands of people. Results from early clinical trials and the interim results from Phase 3 trials of a number of candidates show that the majority of these vaccines are safe, immunogenic and likely to be effective in both preventing COVID-19 infection, as well as severe COVID-19 disease.

This article provides a summary of the different approaches and the most advanced COVID-19 vaccines utilising these different platforms. The majority of the vaccines in advanced trials, require two doses to provide clinical protection against the SARS-CoV-2 virus.

Traditional vaccine approaches

Inactivated virus vaccines

Inactivated vaccines are created by killing or deactivating the virus so that it is unable to replicate. The whole virus or a subunit of the virus can be used. This approach has been used for decades, such as with hepatitis A and inactivated polio vaccines.

These vaccines are generally safer than live vaccines as they can be given to everyone, including immunocompromised people. However, the immune response induced by this mechanism alone may not be as strong or long-lasting and booster doses or an adjuvant may be required (additional vaccine components that boost the immune response).

There are currently four inactivated COVID-19 vaccines in Phase 3 trials. Three are developed by Chinese companies (Wuhan Institute of Biological Products/Sinopharm, Beijing Institute of Biological Products/Sinopharm and Sinovac Biotech) and one is being developed by the Indian company Bharat Biotech. There are several more in pre-clinical and early clinical trials.

Protein-based vaccines

Part of the pathogen that induces an immune response is used to make the vaccine; this part may be a whole protein or fragments of the protein. These vaccines are safe, relatively simple to make and are cheaper to produce. However, multiple doses or an adjuvant is often required to induce an adequate immune response. This method is used to make hepatitis B vaccines.

This is the most common approach for COVID-19 vaccines, with dozens in pre-clinical and clinical trials. There are two in advanced Phase 3 clinical trials, developed by US-based Novavax and Canadian-based Medicago. The most common component of the SARS-CoV-2 virus used to make these vaccines is the spike protein. Spike proteins play a key role in pathogenesis; allowing entry into human host cells and hence subsequent infection.

One disadvantage of using whole protein vaccines is that they have an unstable structure that may lead to loss of immunogenicity. Novel technologies, such as the molecular clamp technique used in the University of Queensland COVID-19 vaccine, have been developed to stabilise the spike protein. This vaccine previously had an agreement with the Australian government, however will no longer be proceeding to Phase 3 trials.

Two other protein-based vaccines are being developed or tested in Australia. Flinders University and an Australia biotech company, Vaxine, are developing a vaccine based on the company’s earlier severe acute respiratory syndrome (SARS) vaccine which was effective in animal studies. Early trials were conducted in Adelaide and Phase 3 trials are due to begin overseas by the end of 2020. The other is a vaccine developed by Chinese-based Clover Biopharmaceuticals which started Phase 1 trials in Perth in June 2020.

Novel vaccine approaches

In the past few decades, vaccine technology has a made significant advances particularly in relation to genetic technology. These newer vaccines pave the way for more efficient and timely vaccine production as soon as the genetic sequence of a new pathogen is known.

Nanoparticle-based and virus-like particles vaccines

Nanoparticle-based vaccines have received increasing interest in recent years due to their good safety profile and high immunogenic potential. Nanoparticle vaccines are constructed by attaching selected key components of a pathogen (such as the COVID-19 spike protein or viral DNA) to an engineered nanoparticle (nanocarrier). This nanoparticle is commonly an engineered virus-like particle (a molecule that mimics the virus but is not infectious). These nanoparticles are highly stable and less prone to degradation than traditional protein vaccines. The human papillomavirus (HPV) vaccine is an example of this approach.

The Novavax COVID-19 vaccine is a nanoparticle vaccine which contains pieces of the spike protein; hence, it can also be listed as a protein-based vaccine. Early clinical trials were performed in Melbourne and Brisbane. Phase 3 trials are underway in the UK. Novavax has signed an agreement with the Australian government to provide 40 million doses during 2021, if the vaccine is successful.

Genetic vaccines

Genetic vaccines deliver one or more of the pathogen’s genes to provoke an immune response. There are two types, DNA and messenger RNA (mRNA) vaccines. DNA is the original genetic sequence which codes for all components of the virus. Firstly, DNA is converted into mRNA and then, mRNA is converted into viral proteins. The immune response is triggered by the production of these viral proteins.

These vaccines can be produced faster than traditional vaccines as development can begin as soon as the genetic sequence of a new pathogen is available. Although DNA and mRNA vaccines have never been licensed before, they have already been under development for other viruses, such as influenza, and have been tested and shown to be safe in Phase 1 and 2 clinical trials.

Due to the instability of DNA and mRNA, these vaccines will be more difficult to transport and store. The majority of other vaccine candidates can be managed using standard cold chain systems, at 2-8°C. The Pfizer COVID-19 vaccine will need storage at -70°C, shipment on dry ice and will only last 24hrs when refrigerated. The Moderna COVID-19 vaccine is be more stable and can be transported at -20°C and stored in a standard vaccine fridge (2-8°C) for 5-days. Australia does not currently have the capacity to make these mRNA vaccines locally.

DNA vaccines may need to be delivered differently from routine injections. Inovio’s COVID-19 DNA vaccine needs to be given intradermally by a device that releases a small electric current to allow entry of the vaccine through the skin. DNA vaccines have not worked as well historically, because it is difficult to get enough DNA introduced to make a strong immune response. Inovio started Phase 2/3 trials in November 2020.

There are theoretical concerns about potential integration into the host’s (vaccine recipient’s) DNA, although the risk of this is extremely very low. The DNA in the vaccine will only enter a small proportion of muscle cells, which cannot replicate, and hence cannot spread to cause mutation or genetic changes in other cells. For mRNA vaccines, this would be impossible. mRNA from a vaccine is only capable of producing proteins and cannot be reversed back into DNA and hence is unable to modify the host DNA. mRNA vaccines have been shown to create a strong immune response, especially compared to DNA vaccines, have the potential for low cost manufacture and a good safety profile.

Moderna was the first company to put a COVID-19 vaccine into human trials in March 2020 and they were also second to release interim results from their Phase 3 trial. These results indicated that their mRNA vaccine had 94.1% vaccine efficacy in preventing COVID-19 disease and also appeared to protect people from severe disease.

The Pfizer/BioNTech mRNA vaccine was the first to present interim data of their Phase 3 trial, indicating it also had 95% vaccine efficacy. On 2 December 2020, the United Kingdom gave emergency authorization to this vaccine. Pfizer/BioNTech has signed an agreement with the Australian government to provide 10 million doses from early 2021, if the vaccine is successful. These doses will be manufactured offshore.

Viral vector vaccines

A virus (viral vector), which doesn’t cause disease in humans, is used to carry part of the pathogen’s DNA into human cells. Some viral vector vaccines enter cells and cause them to make viral proteins (non-replicating viral vectors). Other viral vectors slowly replicate, carrying SARS-CoV-2 proteins on their surface (replicating viral vectors). Replicating viral vectors best mimic natural infection and hence produce a strong immune response and can be used in lower doses.

Human adenoviruses, viruses which cause the common cold, are a commonly used viral vectors for COVID-19 vaccine development. Most encode the spike protein. While adenovirus vectors are well tolerated and highly immunogenic in most people, pre-existing immunity to the viral vector may hamper the immune response to the vaccine. Animal adenoviruses can be used to overcome this; this is utilised by the Oxford University vaccine.

One of the most advanced non-replicating viral vector vaccines is the Oxford University/Astra Zeneca COVID-19 vaccine (AZD1222), which uses a chimpanzee adenovirus vector. This adenovirus vector is unable to cause disease in humans and has been tested for safety in other vaccines for Ebola, Middle East respiratory syndrome (MERS) and influenza. Preliminary analysis of their Phase 3 trial revealed the vaccine had 90% vaccine efficacy, depending on the dosage. Further Phase 3 testing is underway to verify these results. Oxford University/Astra Zeneca have signed an agreement with the Australian government to provide 3.8 million doses from early 2021, if the vaccine is successful. These doses will be manufactured in Australia by CSL.

Another advanced non-replicating viral vector vaccine is the Johnson & Johnson COVID-19 vaccine which utilises an existing human adenovirus vector platform that was used in their Ebola vaccine; which is already approved for use in the general population and has proven to be safe and effective in tens of thousands of people already.

There are two other non-replicating viral vectors in Phase 3 trials, developed by China’s CanSino Biologics and Russia’s Gamaleya Research Institute. There is only one replicating viral vector vaccine candidate in Phase 1 clinical trials, developed by the Institute Pasteur in France. There are over a dozen more in pre-clinical stages which utilise multiple viruses including influenza and measles virus-based vectors.

Other traditional vaccine approaches

Live-attenuated virus vaccines

Live vaccines contain a weakened (attenuated) form of the pathogen that is less capable of replication and is less virulent. Live vaccines induce a strong immune response and provide long-lasting immunity. This method has been used to protect against multiple viruses and is currently used to make the measles, mumps, rubella, chickenpox (varicella) and one rotavirus vaccine. The main disadvantage is that they cannot be given to people who are immunocompromised or pregnant. In addition, they take longer and are more difficult to mass produce because these viruses need to be grown under enhanced biosafety protocols in specialised laboratories.

Due to vaccine safety concerns and the timeline to produce vaccines on this platform, there is currently only one live attenuated COVID-19 vaccine registered to start Phase 1 human trials (developed by New York-based company, Codagenix) and two are in pre-clinical (animal) trials.

The information on this page was updated on 9 December 2020.

Resources

Authors: Daniela Say (MVEC Immunisation Fellow) and Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute) 

Date: December 2020

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.

 


Cold chain

The cold chain describes the system of transporting and storing vaccines within the temperature range of +2°C to +8°C from the place of manufacture to the point of administration. The optimal storage temperature for vaccines is +5°C.

Failure to store and handle vaccines properly can result in reduced vaccine potency and inadequate immune responses in clients as well as poor protection against disease. To ensure that clients receive effective and potent vaccines, immunisation providers should follow the principles of safe vaccine storage management and adhere to, the National Vaccine Storage Guidelines: Strive for 5.

Purpose-built vaccine refrigerators are preferred for storing vaccines because they are designed and constructed specifically for vaccine storage at temperatures between +2°C and +8°C. Domestic refrigerators are not suitable for vaccine storage.

Community pharmacy–acquired vaccines

The cold chain needs to be maintained, not only for vaccines provided as part of the National Immunisation Program but also for vaccines that a person buys from a pharmacist with a prescription. Doctors who provide a prescription for a vaccine should advise clients that it is important to only purchase the vaccine from the pharmacy immediately before attending the practice or clinic appointment for vaccine administration. The pharmacist also has a responsibility to advise on the importance of maintaining the cold chain. On arrival to the clinic, the client should notify reception that they have a vaccine to put in the vaccine refrigerator.

If an immunisation service provider has any concern that a vaccine provided by a client may have been stored outside the recommended +2°C to +8°C range, the vaccine should not be administered.

Cold chain breaches

A cold chain breach is exposure of vaccines to temperatures outside the recommended range of 2°C to 8°C. This excludes fluctuations up to 12°C lasting no longer than 15 minutes which may be noted during restocking, cleaning the fridge or stock taking.

Cold chain breaches must be reported to the Department of Health and Human Services (DHHS) as soon as possible using the Cold Chain Breach Report form. The DHHS will advise you on the next steps to take. It is important to report any cold chain breaches so that client(s) can be revaccinated or unused vaccines can be recalled, if required. For privately purchased vaccines, contact the manufacturer/supplier.

Resources

Author: Georgie Lewis (SAEFVIC Clinical Manager, Murdoch Children's Research Institute)

Reviewed by: Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute) 

Date: July 2020

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.


Cystic Fibrosis immunisation recommendations

Background

Cystic Fibrosis (CF) is a genetic disorder, primarily affecting the lungs as well as the pancreas, liver, kidneys and intestines.  In patients with CF, the cells that are responsible for producing mucous, sweat and other fluids are impaired. As a result of this, secretions become thick and sticky, impacting the function of certain organs in the body. 1 in 2500 babies in Australia are born with CF each year.

Symptoms of CF include frequent chest infections, poor weight gain and growth, intestinal obstructions, infertility (commonly in males) and diabetes. Treatment includes intensive daily physiotherapy, enzyme replacement medication, salt and vitamin supplements, exercise and a high calorie diet. Insulin and blood glucose monitoring is required for patients that develop diabetes. Many patients progress to requiring a lung transplant. CF patients are at high risk of infections, including some that are vaccine preventable diseases.

Immunisation recommendations

Patients with CF are recommended to complete the routine immunisation schedule as per the National Immunisation Program (NIP) as well as some additional funded immunisations.

Secondary school vaccines are available on the NIP and should be administered to all children with CF including Year 7 (12-13 years of age): Boostrix® (diphtheria-tetanus-pertussis) and Gardasil 9® (human papillomavirus) and in Year 10 (14-19 years) Nimenrix® (meningococcal ACWY).

Influenza

Patients with CF are funded to receive influenza vaccines annually from 6 months of age. 2 doses of the age-specific vaccine are required in the first year of receiving the vaccine [refer to MVEC: Influenza vaccine recommendations].

Pneumococcal

Prevenar 13® (pneumococcal conjugate) should be given 6-weeks, 4-months, 6-months (additional dose) and 12-months.

A dose of Pneumovax 23® (pneumococcal polysaccharide) should be should be given at 4-years of age. A second dose should then be given at least 5 years later.

Further booster vaccines are required if being worked up for a lung transplant [refer to MVEC: Solid organ transplant recipient]

Other vaccines to consider

Varicella

Currently a single dose of varicella vaccine is funded on the NIP. The combination MMRV (ProQuad®/Priorix tetra®) is scheduled for 18-months of age, however giving 2 doses of the varicella vaccine can enhance protection. A second varicella vaccine dose can be obtained with a private script. As the varicella vaccine is a live-attenuated vaccine, doses should be separated by a minimum of 4 weeks.

Hepatitis A

CF patients are at risk of associated liver disease, so at The Royal Children’s Hospital they are funded to receive Hepatitis A vaccines via approval from our Drug Usage Committee (DUC). Two doses of age appropriate Hepatitis A are required, given 6-months apart. Administration can be commenced from 12 months of age.

Resources

Authors: Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute) Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute) and Nadine Henare (Nurse Coordinator- Immunisation, The Royal Children's Hospital)

Reviewed by: Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute)

Date: July 2020

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.

 

 

 

 


Catch-up immunisations

Where a person’s immunisations are not up to date with the National Immunisation Program (NIP), it is important to arrange a catch up schedule for immunisations to be completed in the shortest and most effective time frame to ensure protection against vaccine preventable diseases.

Prior to commencing a catch up schedule, written documentation of any previous immunisations should be obtained where possible. Documentation could include the Immunisation History Statement (AIH) from AIR, personal immunisation records (ie: green book) or medical records. Overseas records may need translating.

Serology is not routinely recommended prior to catch up immunisation.

All refugee and humanitarian entrants including asylum seekers are eligible for free catch up immunisations [see resources].

Please be aware that some individuals may be recommended to receive additional immunisations due to predisposing conditions or at risk circumstances. For further queries please contact: info.mvec@mcri.edu.au

For individuals <10 years of age

Australian Immunisation Handbook: catch up calculator

For individuals aged 10 years to 19 years

Victorian immunisation catch-up tool

Refugee and asylum seekers

The Victorian DHHS and Health Translations has an excellent resource for catch up mmunisations in refugees and asylum seekers. It has been translated into more than 10 languages (see Catch up immunisation in other languages).

Resources

Authors: Nigel Crawford (Paediatrician, The Royal Children’s Hospital, Melbourne) and Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children's Research Institute)

Reviewed by: Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children's Research Institute)

Date: July 2020

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.


Children with Cardiac Disease

Background

Children with underlying cardiac disease are at increased risk of vaccine preventable diseases when compared to children with no cardiac disease. This includes influenza and invasive pneumococcal disease (IPD). IPD includes pneumonia, meningitis and bacteraemia, with those at highest risk being children with cyanotic heart disease or cardiac failure.

Vaccine recommendations

  • Routine childhood vaccines as per Victorian immunisation schedule
  • If children with cardiac disease are immunocompromised, live vaccines may be contraindicated 
  • If children with cardiac disease have received blood products and/or immunoglobulin, live vaccines may need to be delayed [see resources]
  • If children are also asplenic or have hyposplenism, some additional vaccines are recommended [see resources]
  • Vaccines should be given within recommended timeframes unless contraindicated due to medical treatment, including surgery (discuss with your treating doctor)
  • Recommended time intervals for vaccination before and after surgery
  • Before surgery – 1 week for inactive vaccines; 3 weeks for live vaccines (e.g. MMR, Varicella)
  • After surgery – delay vaccination for 1 week
  • Additional vaccines –
    • Influenza vaccine: all cardiology patients are recommended to receive influenza vaccine annually from 6-months of age. Two doses are required in the first year of vaccination for children < 9-years
    • Pneumococcal vaccine: children with chronic cardiac disease are recommended to have an additional pneumococcal conjugate vaccine (Prevenar 13®) at 6-months of age (or at diagnosis) and pneumococcal polysaccharide vaccine (Pneumovax 23®) at 4-years of age and another dose at least 5 years later
  • If a child with cardiac disease is travelling overseas, particularly to high risk areas for vaccine preventable diseases, they should seek specialist travel advice [see resources]

Any immunisation queries should be directed to the treating doctor and/or contact the Victorian Immunisation services Hotline 1300 882 924.

Resources

Author: Kirsten Mitchell (SAEFVIC Research Nurse, Murdoch Children's Research Institute)

Reviewed by: Georgina Lewis (Clinical Manager SAEFVIC, Murdoch Children's Research Institute)

Date: July 2020

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.