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.