Cancer immunisation guideline: vaccine recommendations following chemotherapy and haematopoietic stem cell transplant

Background

Individuals undergoing cancer treatments (eg. chemotherapy, immunosuppressive therapies or haematopoietic stem cell transplants (HSCT)) are at a higher risk of contracting infectious diseases due to their malignancy, as well as the immune suppression caused by their treatment. Immune suppression can result in an inability to fight new infections, as well as result in the loss of previous immune memory from past infections and vaccines.

Generally speaking, vaccines are withheld during cancer therapy due to an inability to create an effective immune response. The exception to this would be influenza vaccines and COVID-19 vaccines. Individuals with severe neutropenia should not receive vaccines due to the risk of febrile neutropenia.

Following the completion of treatment, individuals are recommended to either be re-vaccinated completely or receive booster doses of vaccines to ensure effective protection against vaccine preventable diseases. The recommendations for vaccine doses/schedules may vary according to type of cancer treatment received, the age of the recipient and any other co-morbidities.

The recommendations for the vaccination of children ≤ 18 years following cancer treatment (within 2 years of completing treatment) are outlined below.

Timing

Inactivated vaccines following cancer treatment can be administered from 6 months after the completion of treatment and if the underlying illness is in remission. Live-attenuated vaccines should only be given in consultation with the patient’s treating oncologist.

Post-chemotherapy immunisation guideline

  • Inactivated vaccines

  • COVID-19 vaccines

  • Live-attenuated vaccines

Post-HSCT immunisation guideline

  • Inactivated vaccines

  • COVID-19 vaccines

  • Live-attenuated vaccines

Authors: Rachael McGuire (MVEC Education Nurse Coordinator) and Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute)

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator), Francesca Machingaifa (MVEC Education Nurse Coordinator) and Teresa Lazzaro (Consultant Paediatrician, Royal Children’s Hospital)

Date: March 10, 2022

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 vaccines in people with immunocompromise

Background

COVID-19 vaccination is strongly recommended for all age-eligible people. Vaccination is particularly important for those who are immunocompromised due to the increased risk of developing severe disease (hospitalisation/intensive care admission, death) if exposed to SARS-CoV-2. All COVID-19 vaccines in Australia are inactivated (non-live) vaccines and are safe to be administered to immunocompromised individuals.

The following guidance details the vaccination recommendations for individuals with immunocompromise and provides specific considerations for a broad group of immunocompromising conditions and therapies, as well as providing specific recommendations and/or links where available.

Vaccination for immunocompromised individuals

  • Primary schedule

    Real-world evidence has demonstrated no safety concerns relating to the administration of COVID-19 vaccines in immunocompromised individuals however, the level of protection may be suboptimal. It is for this reason that a 3-dose primary course of COVID-19 vaccination is recommended for all individuals aged ≥ 6 months with severe immunocompromise for optimal protection (in contrast to a 2-dose primary schedule for individuals with mild immunocompromise/immunocompetent individuals), with the third dose administered 2 months following the second dose (this interval can be shortened to 4 weeks in exceptional circumstances eg. impending transplant).

    Brand choice for individuals ≥ 18 years

    The preferred vaccine brands for individuals aged ≥ 18 years are Spikevax (Moderna) or Comirnaty (Pfizer). Nuvaxovid (Novavax) can also be administered, however there is minimal efficacy data available on it’s use in this patient group. Those aged ≥ 18 years who received Vaxzevria (AstraZeneca) without any serious adverse event for their first two doses may choose to receive Vaxzevria (AstraZeneca) as their third dose however alternate brands are recommended.

    Brand choice for individuals 12-17 years

    Immunocompromised adolescents aged 12-17 years are recommended to receive Spikevax (Moderna), Comirnaty (Pfizer) or Nuvaxovid (Novavax) brands for their 3-dose primary course.

    (NB: Most studies involving a 3-dose primary course of COVID-19 vaccination for immunocompromised individuals involve mRNA vaccines meaning there is limited data available on the efficacy of Nuvaxovid in immunocompromised individuals)

    NB: Individuals ≥ 12 years receiving Spikevax (Moderna) as their third primary dose should receive a full dose (100µg). This differs from the recommended Spikevax (Moderna) booster dose where only a half dose (50µg) is indicated.

    Brand choice for individuals 5-11 years

    Immunocompromised children aged 5-11 years can receive Paediatric Comirnaty (Pfizer) (10µ) as their 3-dose primary course, or alternatively Spikevax (Moderna) (50µ dose) for those aged 6-11 years.

    Brand choice for individuals aged 6 months-5 years

    Severely immunocompromised children aged 6 months-5 years can receive Spikevax (Moderna) (25µ dose) as their 3-dose primary course.

  • Booster doses

    Following a 3-dose primary course of vaccination, severely immunocompromised individuals ≥ 5 years should receive an initial booster dose (4th dose) ≥ 3 months from completion of the primary course. A 5th dose is then recommended for those ≥ 16 years, ≥ 3 months after receiving a first booster.

    mRNA COVID-19 vaccines (Comirnaty (Pfizer) and Spikevax (Moderna) for those ≥ 18 years, and Comirnaty (Pfizer) only for those < 18 years), are the preferred brands for booster doses. Nuvaxovid (Novavax) may also be used in those ≥ 12 years when no other vaccine brand is deemed suitable.

  • Timing of vaccination

    Vaccination to protect against COVID-19 in immunosuppressed patients should follow the general principles of vaccination and immunosuppression. Vaccine administration should be planned with the treating specialist. In some instances, the timing of immune suppressive therapies may be altered to increase the response to vaccination. In other circumstances, the intervals between vaccine doses may be altered to accommodate treatment regimes.

    There is no direct evidence for the temporary cessation of immunosuppressive therapy before or after COVID-19 vaccination. There are some specific immunosuppressive therapies (eg. B-cell depleting therapies eg. rituximab or ocrelizumab; or medications that block T-cell dependent B-cell dependent memory cells eg. abatacept) that are highly likely to reduce COVID-19 vaccine response, based on evidence extrapolated from responses to other inactivated vaccines such as influenza.

    Current evidence demonstrates that a 2-week period is needed to generate an adequate immune response to the COVID-19 vaccine. Therefore, in general COVID-19 vaccination should preferably be completed at least two weeks prior to the commencement of immunosuppressive therapy, transplant or planned splenectomy. For people who are about to start immunosuppressive therapy or are between courses of treatment, the interval between doses of COVID-19 vaccine doses can be reduced depending on the individual circumstances and the type of vaccine being used. If it is not feasible to complete all doses prior to immunosuppression, then the subsequent doses should still be given as per the recommended schedule, with some protection thought to be better than none.

  • Other measures

    Following vaccination immunocompromised individuals are encouraged to continue the use of other preventative measures such as social distancing, mask wearing and hand hygiene. Vaccination of eligible household contacts is strongly recommended to reduce the potential for transmission.

Considerations for individuals with immunocompromising conditions taking immunomodulatory or immunosuppressive therapies

  • Patients undergoing cancer treatment

    Delaying initiation or interrupting cancer therapy to potentially improve the response to vaccination is not recommended. When considering vaccination during cancer treatment, it is preferable to defer vaccination if severe neutropenia is present (< 0.5 x 109/L) and where possible, to time vaccination between treatment cycles.

  • Solid organ transplant recipients who are on immune suppressive therapy

    Solid organ transplant recipients show reduced COVID-19 vaccine response with reduced rates of seroconversion (15 to 66% following mRNA vaccines).

    Timing of vaccination should be discussed with the treating specialist and the level of immunosuppressive therapy should be considered (ie. considering delaying vaccination for up to 3 months if T cell or B cell depleting therapy is being used in induction).

    For more information refer to ISHLT: COVID-19: Information for Transplant Professionals

  • Haematopoietic Stem Cell Transplant (HSCT) recipients

    Individuals who received vaccination prior to allogenic or autologous HSCT or CAR-T cell therapy require re-vaccination with 3 additional doses of COVID-19 vaccine (ie. new primary course). This is due to the risk of partial or complete loss of protective immunity following HSCT or CAR-T cell therapy. Vaccination or re-vaccination (where applicable) is advised to commence 3-6 months after transplantation due to the risk of reduced vaccine response in the initial 3-6 months. The optimal time to commence vaccination should be guided by the treating specialist. The dosing interval should follow the recommend dosing intervals.

  • Graft-versus-Host Disease (GvHD)

    COVID-19 vaccination is recommended in individuals with stable GvHD on therapy. Immunisation with inactivated vaccines has not been associated with flares of GvHD.

    For more information refer to Clinicians guide to COVID-19 vaccination for patients with cancer.

  • Haematological malignancy

    Patients with haematological cancers (Including leukaemia, lymphoma or myeloma resulting in immunocompromise) have lower vaccine responses after mRNA vaccines (seroconversion rates 39%-85%).

    The impaired vaccine response is likely multifactorial and related to the treatments for these malignancies (anti-B cell therapies, cytotoxic chemotherapy) but is also due to the underlying disease.

  • Non-haematological malignancy

    Patients with solid cancer have been shown to have lower vaccine responses (seroconversion 81-98%). Factors associated with poorer vaccine response included radiotherapy, chemotherapy and hormonal therapy. In general, patients should be vaccinated at the earliest opportunity and upon consultation with their treating specialist.

    For more information refer to MOGA: COVID-19 vaccination in patients with solid tumours

  • Medication specific recommendations

    Medications used in the treatment of cancers Recommendation
    Cyclophosphamide Do not delay/modify medication or adjust vaccine administration timing. Prescribers should anticipate when the peak of neutropaenia will occur and avoid vaccinating at this point.
    Rituximab Do not delay oncology related rituximab treatment. Immunisation whilst on rituximab treatment may vaccine effectiveness.
    Checkpoint inhibitor (eg. anti-PD-L1, PD-1 or CTLA-4) The use of immune checkpoint inhibitors (ICI) is not expected to cause significant immunosuppression and a 3rd primary dose is not currently recommended for patients treated only with ICIs.
    Medication containing polyethylene glycol (PEG) or polysorbate PEG or polysorbate is a known component of COVID-19 vaccine and also some conventional chemotherapeutic drugs. In the event of a previous serious/severe immediate allergic reaction (anaphylaxis), referral for specialist review via the VicSIS is recommended.

Considerations for COVID-19 vaccination in individuals with rheumatological and other disorders taking immunomodulatory or immunosuppressive therapies

  • Chronic inflammatory conditions treated with disease modifying anti-rheumatic drugs (DMARDs) or immune-suppressive or immunomodulatory therapies

    People with chronic inflammatory conditions treated with disease modifying anti-rheumatic drugs (DMARDs) or other immunosuppressive or immunomodulatory therapies may have reduced immune response to COVID-19 vaccines. Specific guidance surrounding the COVID-19 vaccines and commonly used therapies are adapted from Australian clinician guide for the use of immunomodulatory drugs in autoimmune rheumatic diseases at the time of COVID-19 vaccination and summarised in the following table:

    Medications used in the treatment of autoimmune inflammatory rheumatic diseases Recommendation
    Methotrexate (when used as a DMARD) Consider stopping methotrexate for 1 to 2 weeks on an individual basis balancing benefits and risks. eg. delay methotrexate for 1 week after each vaccine dose for those with well-controlled disease.
    Hydroxychloroquine, Sulfasalazine, Leflunomide Do not delay/modify medication or adjust vaccine administration timing. The prolonged elimination half-lives of leflunomide and hydroxychloroquine would make dose interruption for vaccine impractical.
    Cytokine inhibitors (TNF, IL-1, IL-6, IL-12/23, IL-17) Do not delay/modify medication or adjust vaccine administration timing.
    JAK inhibitors Do not delay/modify medication or adjust vaccine administration timing. The interruption of therapy may increase the risk of disease flare without any clear evidence of improvement in vaccine efficacy.
    Abatacept

    SC: Withhold subcutaneous abatacept from one week before to one week after the first COVID-19 vaccine dose only. No interruption is required before or after the second vaccine dose.

    IV: Schedule vaccination so that the first vaccine dose is initiated approximately 4 weeks after the abatacept infusion (ie. the entire dosing interval), and postpone the subsequent abatacept infusion by one week (eg. a 5week gap in total). No interruption is required before or after the second vaccine dose.

    Rituximab

    Where possible, aim to administer COVID-19 vaccines towards the end of a rituximab dosing cycle or before initiation of rituximab therapy. eg. schedule vaccination so that the first vaccine dose is administered approximately 4 weeks prior to the next scheduled rituximab cycle. Delay rituximab 2-4 weeks after the second vaccine dose, if disease activity allows.

    NB: Immunisation whilst on rituximab treatment may limit the protective effect of the vaccine.

    Glucocorticoids  

    *High dose is equivalent >20mg/day of prednisolone for ≥ 14days in a month or treatment with pulse corticosteroid therapy

    Vaccine immunogenicity is influenced by dose, duration of therapy and use in combination with other DMARDs. In cases where reducing the dose is impractical, COVID-19 vaccination should not be delayed. However, in cases where steroid tapering is planned and the risk of COVID-19 can be suitably mitigated (ie. low community transmission), some may elect to defer COVID-19 vaccination until the steroid taper is complete or a stable low dose of glucocorticoids is achieved.
    Mycophenolate Do not delay/modify medication or adjust vaccine administration timing. Most people with AIRD using mycophenolate are at risk of adverse consequences if there were loss of disease control.
    Cyclophosphamide

    IV: Perform vaccination as close as possible to the end of the cyclophosphamide dosing schedule ie. suggest waiting 3-4 weeks after the most recent IV dose and allowing about 1 week before the following dose.

    PO: Do not delay/modify medication or adjust vaccine administration timing. Most people with AIRD using cyclophosphamide are at risk of adverse consequences if there were loss of disease control, interruption of cyclophosphamide therapy is not recommended.

    Apremilast Do not delay/modify medication or adjust vaccine administration timing.
    Belimumab Do not delay/modify medication or adjust vaccine administration timing.

  • Chronic neurological conditions

    There is a paucity of data on the efficacy of COVID-19 vaccines in patients with neurological conditions receiving immunomodulatory or immunosuppressive therapies. Many current recommendations for these patients are extrapolated from studies of immunological response to other vaccines or specific to the therapy being used.

    Further information from the Australian and New Zealand Association of Neurologists (ANZAN) in collaboration with MS Research Australia, regarding COVID-19 vaccination and safety can be found here.

Other conditions and therapies

  • Human Immunodeficiency Virus (HIV)

    People living with well controlled HIV, on anti-retroviral therapy with CD4 counts ≥ 250/µL and low or undetectable viral load, do not require a 3-dose primary course. Studies have shown a similar immune response following COVID-19 vaccination when compared to healthy controls.

    ATAGI currently recommends a 3-dose primary course, followed by a booster dose, for individuals with advanced or untreated HIV with CD4 counts <250/µL or those unable to be established on effective anti-retroviral therapy.

    Foe more information refer to ASCIA: Immunodeficiency, Autoimmunity and COVID-19 Vaccination.

  • Long term haemodialysis or peritoneal dialysis

    Individuals receiving dialysis generally have reduced vaccine responses. Due to concerns regarding poor COVID-19 vaccine response and breakthrough COVID-19 infections in fully vaccinated patients receiving dialysis, a 3-dose primary schedule, followed by a booster dose, is recommended.

    More information can be found at Renal Society of Australasia- COVID-19 updates.

  • Intravenous immunoglobulin (IVIg)

    Where possible, it is recommended to schedule COVID-19 vaccination on a different day from regular infusion treatments. Patients on monthly IVIg may be advised by their specialist to be vaccinated 2 weeks after an IVIg infusion. This avoids confusion about the cause of side effects or allergic reactions if they occur in response to the COVID-19 vaccine or the infusion treatment.

Authors: Jeremy Carr (Paediatric Infectious Diseases Consultant, Monash Health), Shidan Tosif (Paediatrician, Royal Children’s Hospital), Andres Noe (DPhil candidate, The Jenner Institute), Nigel Crawford (SAEFVIC Director, Murdoch Children’s Research Institute), Daryl Cheng (MVEC Medical Lead), Francesca Machingaifa (MVEC Education Nurse Coordinator) and Rachael McGuire (MVEC Education Nurse Coordinator)

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

Date: October 27, 2022

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: TGA recognised vaccines

The Therapeutic Goods Administration (TGA) has assessed the protection offered by COVID-19 vaccines currently in use internationally that are not currently registered for use within Australia. This assessment assists with confirming the vaccination status of incoming travellers who have been immunised overseas. The assessment is based on an evaluation of the current available evidence and may be updated as new information arises.

The advice provided by the TGA contains information on the level of protection offered by COVID-19 vaccines and recommendations based on this (ie. recognised/not recognised vaccine) and can be accessed here.

For TGA-approved or recognised vaccines, travellers are considered fully vaccinated if they have completed a primary course of vaccination with 14 days between dose 1 and 2 (if a 2 dose schedule) at least 7 days prior to arrival. This includes two doses of two different TGA-approved or recognised vaccines.

Table 1. TGA recognised/registered COVID-19 vaccines

Vaccine Registered Recognised
Coronavac (Sinovac) No Yes
Covishield (AstraZeneca/Serum Institute of India) No Yes
BBIBP-CorV (Sinopharm China) No Yes
Covaxin (Bharat Biotech, India) No Yes
Sputnik V (Gamaleya Institute, Russian Federation) No Yes
Convidecia (Cansino) No No
Comirnaty (Pfizer) Yes Yes
Vaxzevria (AstraZeneca) Yes Yes
Spikevax (Moderna) Yes Yes
COVID-19 Vaccine Janssen (Janssen-Cilag) Yes Yes
Nuvaxovid (Novavax) Yes Yes

  • What is the purpose of determining the COVID-19 vaccination status of incoming travellers?

    It is important to identify the COVID-19 vaccination status of incoming travellers to limit COVID-19 transmission in Australia and to prevent the risk of incoming travellers becoming unwell with COVID-19 whilst in Australia and potentially requiring healthcare services.

  • How were the estimates of protection from the various COVID-19 vaccines determined?

    In general, the level of protection offered by COVID-19 vaccines is either directly measured in vaccine efficacy and effectiveness (VE) data from clinical trials or inferred from the protection against ‘severe infection’.  

    There can be difficulties making comparisons between different COVID-19 vaccines because there is often a variation in the vaccine efficacy and effectiveness measures amongst the different vaccines.

  • What is the recommendation for individuals who have received a COVID-19 vaccine(s) overseas that is not recognised in Australia?

    Individuals who have previously received a first dose or a course of COVID-19 vaccine/s using a brand that is not recognised in Australia should be re-vaccinated with a full course using a brand that is recognised by the TGA.

    The minimum interval between receiving the last dose of non-recognised vaccine and receiving the first dose of TGA recognised vaccine should be the same interval that is recommended between doses of the non-recognised vaccine course eg. Sputnik COVID-19 vaccine doses are administered 3 weeks apart, therefore there should be at least 3 weeks between the final dose of a Sputnik COVID-19 vaccine and the administration of a TGA recognised vaccine. A longer interval will be accepted if this is not possible. Once a TGA recognised COVID-19 vaccine course has been commenced the recommended intervals between these doses should be adhered to.

    For further information on COVID-19 vaccines recognised in Australia refer to COVID-19 vaccines not registered in Australia but in current international use – TGA advice on “recognition”.

  • What is the recommendation for individuals who have received dose 1 of a brand of COVID-19 vaccine that is not available in Australia?

    Individuals who have previously received a valid first dose of COVID-19 vaccine that is not available in Australia can receive any available COVID-19 vaccine brand to complete the course. This second dose can be administered 4-12 weeks following the first dose. A longer interval will be accepted if this is not possible.

    For further information refer to ATAGI clinical advice on the use of a different COVID-19 vaccine as the second dose.

Authors: Rachael McGuire (MVEC Education Nurse Coordinator), Francesca Machingaifa (MVEC Education Nurse Coordinator), Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute) and Angie Berkhout (MVEC Immunisation Fellow)

Date: February 2, 2022

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 compensation scheme

As Australia aims to roll out a COVID-19 vaccine to everyone age eligible, it means that a number of individuals may experience a serious adverse event following immunisation (AEFI). Supporting these vaccinees is important and providing compensation to individuals who have experienced a vaccine injury is a strategy that has been used widely, for a long period of time, in countries such as the United States, UK and New Zealand to promote vaccine confidence and maintain vaccination rates. It is not a concept designed to suggest causation or fault, but a scheme to promote trust in vaccination programs as well as provide vaccine manufacturers with the reassurance to produce vaccines without fear of legal action.

An example of a serious AEFI requiring hospitalisation is thrombosis with thrombocytopenia syndrome (TTS) following Vaxzevria (AstraZeneca), with the symptoms experienced resulting in a significant impact on a vaccine recipient.

The No Fault COVID-19 Indemnity Scheme is funded by the Commonwealth government and has been introduced to allow Australians who have been significantly impacted by an adverse event following a COVID-19 vaccine to apply for access to financial assistance. There is currently no compensation scheme within Australia for applications relating to non-COVID-19 vaccines.

What is involved?

The No Fault COVID-19 Indemnity Scheme will run for 2 years and cover the cost of injuries ($1,000 and above) in situations where a serious adverse reaction has been caused by a COVID-19 vaccination. A full list of qualifying conditions as well as harm not covered under the scheme can be found at COVID-19 vaccine claims scheme- Overview.

Any vaccine encounter which has occurred since February 2021 is covered under this scheme. Individuals vaccinated within Australia, as well as those overseas as part of the Australian Government Overseas Network (AGON) COVID-19 vaccine rollout managed by DFAT are eligible.

Which vaccines are covered under this scheme?

All TGA approved COVID-19 vaccines are covered under this scheme. Comirnaty (Pfizer), Spikevax (Moderna), Vaxzevria (AstraZeneca) and Nuvaxovid (Novavax) are currently in use within Australia;. COVID-19 Vaccine Janssen is also approved by the TGA however is not in use in Australia.

How to make a claim

Affected individuals (or an individual acting on their behalf) can submit their interest in making a claim via Register your interest in the COVID-19 Vaccine Claims Scheme.

Each claim is assessed by independent experts for accuracy and legitimacy. Evidence required in a claim includes:

  • details of the injury (including any medical documentation relating to its likely relationship to a COVID-19 vaccination)
  • hospitalisation
  • medical costs
  • lost wages.

Resources

Authors: Rachael McGuire (MVEC Education Nurse Coordinator), Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute) and Francesca Machingaifa (MVEC Education Nurse Coordinator)

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator)

Date: February 1, 2022

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 FAQs: allergies, pre-existing conditions and children

These COVID-19 vaccine FAQs have been designed to address common queries relating to COVID-19 vaccine allergies, pre-existing conditions and children.

Please also see our other COVID-19 FAQs for more information on other COVID-19 related topics:

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 contact us here.

Allergies

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

    None of the COVID-19 vaccines used within Australia contain latex. They can safely be administered to people with latex allergies in routine settings followed by a 15 minute post-vaccination observation period.

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

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

    The only two absolute contraindications to vaccination are anaphylaxis to a previous dose of the same vaccine or anaphylaxis to a component of the vaccine.

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

    Additional precautions are recommended for individuals with possible allergic reactions to a previous dose of a COVID-19 vaccine, allergic reactions to ingredients in the COVID-19 vaccine to be administered (including PEG in Comirnaty (Pfizer) and Spikevax (Moderna) and Polysorbate 80 in Vaxzevria (AstraZeneca) and Nuvaxovid (Novavax)), or a known systemic mast cell activation disorder with raised mast cell tryptase that has required treatment.

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

    Pleaser refer to Australian Government Department of Health: COVID-19 vaccine contraindications and precautions or the ASCIA: Allergy, Immunodeficiency, Autoimmunity and COVID-19 Vaccination Position Statement for more information.

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

    PEG is an ingredient contained in Comirnaty (Pfizer) and Spikevax (Moderna). 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 or Spikevax is contraindicated in people with documented anaphylaxis to PEG.

    To read more refer to Australian Government Department of Health: COVID-19 vaccine contraindications and precautions.

  • 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 both Vaxzevria (AstraZeneca) and Nuvaxovid (Novavax).

    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 either Vaxzevria (AstraZeneca) or Nuvaxovid (Novavax).

    NB: Vaccination with Vaxzevria or Nuvaxovid is contraindicated in people with documented anaphylaxis to Polysorbate 80.

    For further information please refer to ASCIA: Allergy, Immunodeficiency, Autoimmunity and COVID-19 Vaccination Position Statement and Australian Government Department of Health: COVID-19 vaccine contraindications and precautions.

  • Do COVID-19 vaccines contain gelatin?

    The COVID-19 vaccines available in Australia do not contain gelatin and are safe to administer to patients with gelatin allergies. A standard 15-minute observation period following immunisation is recommended.

  • What are the ingredients of COVID-19 vaccines?

    There are currently 4 COVID-19 vaccines with provisional registration in use in Australia.

    Each dose of Comirnaty (Pfizer) contains:

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

    Each dose of Vaxzevria (AstraZeneca) contains:

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

    Each dose of Spikevax (Moderna) contains:

    • 100 μg mRNA encoding the SARS-CoV-2 spike glycoprotein
    • Heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate
    • Cholesterol
    • Distearoylphosphatidylcholine
    • 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000-DMG) – Trometamol
    • Trometamol hydrochloride
    • Acetic acid
    • Sodium acetate trihydrate
    • Sucrose
    • Water for injection

    Each dose of Nuvaxovid (Novavax) contains:

    • 5 micrograms of SARS-CoV-2 spike protein
    • Dibasic sodium phosphate heptahydrate
    • Monobasic sodium phosphate monohydrate
    • Sodium chloride
    • Polysorbate 80
    • Sodium hydroxide (for adjustment of pH)
    • Hydrochloric acid (for adjustment of pH)
    • Water for Injections
    • Adjuvant (Matrix M):
      • Quillaja saponaria saponins fraction A
      • Quillaja saponaria saponins fraction C
      • Cholesterol
      • Phosphatidyl choline
      • Monobasic potassium phosphate
      • Potassium chloride

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

  • What ingredients are NOT in mRNA COVID-19 vaccines?

    The following products are NOT ingredients in mRNA COVID-19 vaccines:

    • Animal products
    • Antibiotics
    • Blood products
    • DNA
    • Egg proteins
    • Foetal material
    • Gluten
    • Microchips
    • Pork products
    • Thiomersal
    • Soy
    • Latex
    • Aluminium

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

  • What ingredients are NOT in Vaxzevria (AstraZeneca)?

    The following products are NOT ingredients in Vaxzevria (AstraZeneca):

    • Animal products
    • Antibiotics
    • Blood products
    • Egg proteins
    • Gluten
    • Microchips
    • Pork products
    • Thiomersal
    • Soy
    • Latex
    • Aluminium

    Further information can be found in the vaccine product information:

  • What ingredients are NOT in Nuvaxovid (Novavax)?

    The following products are NOT ingredients in Vaxzevria (AstraZeneca):

    • Animal products
    • Antibiotics
    • Blood products
    • Egg proteins
    • Gluten
    • Microchips
    • Pork products
    • Thiomersal
    • Soy
    • Latex
    • Aluminium
    • Foetal cells

    Further information can be found in the vaccine product information:

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

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

    Post-licensure surveillance of COVID-19 vaccines show anaphylaxis following administration of Vaxzevria (AstraZeneca) occurring at similar rates to routine vaccines. Anaphylaxis following Spikevax (Moderna) has been shown to occur at a rate of 2.5 cases per million doses and Comirnaty (Pfizer), while still extremely rare, occurs at a slightly higher rate of approximately 4.7 cases per million doses.

    For more information please refer to TGA: AstraZeneca ChAdOx1-S COVID-19 vaccine – Update – Expert review finds no evidence of increased risk of anaphylaxis or MVEC: COVID-19 vaccines and allergy.

  • How should patients experiencing delayed urticaria (hives) following a COVID-19 vaccination be managed?

    Acute urticaria can occur 1-2 weeks following vaccination. The symptoms can last on average 3-4 weeks but may resolve more rapidly. The urticaria can be generalised and intensely itchy. Symptoms can be managed with age-appropriate doses of non-sedating over-the-counter antihistamines (tablets or liquid) up to 4 times per day (such as cetirizine, loratadine, fexofenadine or desloratadine), best given in spaced intervals. This type of urticaria with onset that is delayed after the vaccination is generally not an indication of reproducible allergy to the vaccine and therefore investigations are not indicated. Future vaccinations can be given in a routine environment, with a 15-minute post vaccination observation period. If symptoms develop within 24 hours of vaccination, persist beyond two weeks, or there are additional concerns, then review by an immunisation specialist or allergist could be considered.

Pre-existing conditions

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

    Yes. The COVID-19 vaccines currently in use within Australia are non-live vaccines and therefore can be administered at anytime following a blood transfusion.

    Patients with a past history of COVID-19 infection, who received monoclonal antibodies or convalescent plasma as part of their treatment, should wait a minimum of 3 months before considering vaccination.

    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.

  • When should people who have previously tested positive for COVID-19 disease be vaccinated?

    COVID-19 vaccination should be deferred 3 months following COVID-19 infection in order to optimise protection.

    Recommended COVID-19 vaccine schedules should be completed after this time.

    For further information, refer to the Clinical recommendations for COVID-19 vaccines.

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

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

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

    For more information please refer to Health.com – Swollen Lymph Nodes Under Armpit After COVID-19 Vaccine May Mimic Breast Cancer Symptoms—Here’s What to Know and Peter Mac COVID:19 vaccination: frequently asked questions.

  • Are anthracycline therapies considered a contraindication to COVID-19 vaccination due to the association with myocarditis/pericarditis?

    Children who have been treated with chemotherapeutic agents including anthracyclines as part of their cancer therapy are not considered as higher risk of side effects from vaccination (including the development of myocarditis/pericarditis. Parents/guardians should speak to their treating team regarding COVID-19 vaccination based on current recommendations.

    For further information refer to COVID-19 Vaccination Guidance for children 12 years and older undergoing cancer treatment and children with non-cancerous blood disorders.

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

    Individuals who have previously been diagnosed with GBS can receive COVID-19 vaccines. Ongoing surveillance by the TGA and other international vaccine regulators has shown growing evidence of a possible link between GBS and Vaxzevria (AstraZeneca). Specialist advice from a treating neurologist or immunisation specialist may be considered to discuss the benefits and risks of vaccination.

    For more information please refer to MVEC: Guillain-Barre Syndrome and Victorian COVID-19 vaccination guidelines.

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

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

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

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

    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 MS Australia: COVID-19 vaccination guidance for people with MS and MVEC: COVID-19 vaccines in people with immunocompromise.

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

    Yes, COVID-19 vaccines should be offered to this patient group. True vaccine allergy, or anaphylaxis, is an extremely rare adverse event following immunisation occurring in less than 1 case per million doses administered.

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

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

    For more information refer to Australian Immunisation Handbook: Adverse events following immunisation or MVEC: COVID-19 vaccines and allergy

  • I am over 60 years of age and have a history of deep vein thrmobosis (DVT's). Is it safe for me to receive Vaxzevria (AstraZeneca)?

    There is currently no evidence to suggest that having a history of DVT’s or other general thromboembolic disorders predisposes you to developing thrombosis with thrombocytopenia syndrome (TTS) following receipt of an adenoviral vector vaccine such as Vaxzevria (AstraZeneca). In contrast, there is strong evidence that COVID-19 disease is thrombogenic (promotes clot development) and may cause a variety of thromboembolic events. TTS is a unique condition involving the development of thromboses (blood clots) combined with thrombocytopenia (low platelets).

    Refer to the Joint statement from ATAGI and THANZ on Thrombosis with Thrombocytopenia Syndrome (TTS) and the use of COVID-19 Vaccine AstraZeneca for more information.

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

    There is currently no evidence to suggest that taking certain medications or being prone to developing blood clots puts you at increased risk of developing TTS following receipt of Vaxzevria (AstraZeneca). In contrast, there is strong evidence that COVID-19 disease is thrombogenic (promotes clot development) and may cause a variety of thromboembolic events. TTS is a unique condition involving the development of thromboses (blood clots) combined with thrombocytopenia (low platelets).

    For more information please refer to: Joint statement from ATAGI and THANZ on Thrombosis with Thrombocytopenia Syndrome (TTS) and the use of COVID-19 Vaccine AstraZeneca.

  • I am over 60 years of age and have a history of atrial fibrilation putting me at a higher risk of blood clots. Is it safe for me to have Vaxzevria (AstraZeneca)?

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

    There is currently no evidence to suggest that having a history of atrial fibrillation predisposes you to developing thrombosis with thrombocytopenia syndrome (TTS) following receipt of an adenoviral vector vaccine such as Vaxzevria. In contrast, there is strong evidence that COVID-19 disease is thrombogenic (promotes clot development) and may cause a variety of thromboembolic events. TTS is a unique condition involving the development of thromboses (blood clots) combined with thrombocytopenia (low platelets).

    Refer to the Joint statement from ATAGI and THANZ on Thrombosis with Thrombocytopenia Syndrome (TTS) and the use of COVID-19 Vaccine AstraZeneca for more information.

  • I have a history of capillary leak syndrome. Can I have Vaxzevria (AstraZeneca)?

    An extremely rare relapsing-remitting condition known as capillary leak syndrome has been reported overseas following vaccination with Vaxzevria. The syndrome results in fluid leaking from capillaries (small blood vessels) into surrounding tissue and can lead to severe organ damage or death if left untreated.

    In two of the reported cases there was a previous history of capillary leak syndrome. As triggers for relapse are not well understood, the manufacturer of Vaxzevria has updated the product information advising it is not recommended that the vaccine be administered to people with a history of capillary leak syndrome. Individuals with a history of capillary leak syndrome should be referred to their closest VicSIS clinic for further assessment.

    For further information refer to TGA: COVID-19 weekly safety report.

  • Can people with pre-existing cardiac (heart) conditions safely receive COVID-19 vaccines?

    Individuals with the following cardiac conditions can safely receive COVID-19 vaccines without the need for additional monitoring or precautions:

    • coronary artery disease
    • myocardial infarction
    • stable heart failure
    • arrhythmias
    • rheumatic fever
    • rheumatic heart disease
    • kawasaki disease
    • most congenital heart disease
    • those with implanted cardiac devices
    • congenital heart disease
    • cardiac transplant
    • cardiomyopathy.

    Those with a history of the following conditions can also receive COVID-19 vaccines; however should consult their treating specialist to determine the appropriate timing for vaccination:

    • recent (within 3 months) or current inflammatory cardiac conditions (including myocarditis, pericarditis and endocarditis)
    • acute rheumatic fever or acute rheumatic heart disease
    • acute decompensated heart failure.

  • I am taking certain medications that have myocarditis listed as an uncommon side effect. Am I at greater risk of developing myocarditis/pericarditis after COVID-19 vaccination?

    Taking medications that have myocarditis listed as an uncommon side effect (e.g. antipsychotic drugs and biological chemotherapeutic agents) is not a contraindication to COVID-19 vaccination. Individuals taking these medications can be safely vaccinated in the community with no need for additional precautions or monitoring.

  • Are there impacts of other substances on the development of myocarditis/pericarditis after COVID-19 vaccines?

    The use of recreational stimulants (particularly amphetamines) is discouraged especially in the week following vaccination to limit the potential for developing myocarditis/pericarditis.

  • As myocarditis/pericarditis following COVID-19 vaccination is thought to be immune mediated, would those with pre-existing autoimmune diseases be at an increased risk compared with the general public?

    Myocarditis/pericarditis following mRNA vaccines appears to be idiosyncratic at this stage, with no clear risk factors. Thus, there is no indication of increased risk in those with underlying autoimmune disease.

  • Can COVID-19 vaccines be given to immunosuppressed individuals?

    It is recommended that all age-eligible individuals with immunosuppression receive COVID-19 vaccines. Additional doses are recommended for some individuals identified with severe immune suppression. Having a lowered immune system increases the likelihood of developing severe disease and complications if infected with SARS-CoV-2.

    People with immunocompromise receiving COVID-19 vaccination should be counselled about the possibility of reduced efficacy and the need to continue other preventative measures such as social distancing, mask wearing and hand hygiene. Household contacts should be encouraged to receive the COVID-19 vaccine when it is offered because vaccination has also been shown to reduce transmission.

    Please refer to ATAGI – Provider guide to COVID-19 vaccination of people with immunocompromise for more information.

Children

  • What is the risk for children getting pericarditis/myocarditis following COVID-19 vaccination compared with adults?

    Available safety data from local and international sources suggest there is a lower risk of children developing myocarditis/pericarditis following mRNA COVID-19 vaccination. In the 12-17 year old age group, overseas data shows the risk of developing myocarditis from COVID-19 disease is up to 6.7 times higher than developing it from COVID-19 mRNA vaccines.

    For more information please refer to:

  • Should exercie be limited after receiving COVID-19 vaccines to reduce the chance of developing myocarditis/pericarditis?

    Exercise is not thought to exacerbate the risk of myocarditis/pericarditis following COVID-19 vaccination.  It is therefore not necessary to reduce or avoid exercise in the post-vaccination period.

    However, if patients develop myocarditis/pericarditis post vaccination there is a concern that exercise may be pro-arrhythmic (i.e. will exacerbate the condition).

  • If a parent experiences myocarditis/pericarditis following COVID-19 vaccination is it more likely that their child will also experience this side effect?

    No. There is no current evidence to suggest that there is a hereditary link in developing myocarditis or pericarditis following COVID-19 vaccines.

  • Will vaccination have any impact on puberty or fertility?

    There is no evidence to suggest that COVID-19 vaccines have a detrimental impact on puberty or fertility for boys or girls. This is in direct contrast to COVID-19 disease which has been shown to increase the rate of miscarriage and premature birth and decrease male sperm count.

    In particular, there have been concerns around COVID-19 mRNA vaccines and their impacts on puberty and fertility in children and young adults. Importantly, there is no evidence to suggest that hormone levels involved in puberty are affected by the vaccines.

    There is also no evidence that COVID-19 antigens from the vaccine accumulate in harmful amounts in ovaries, fallopian tubes or testes. During COVID-19 vaccine clinical trials, participants became pregnant at similar rates in both the vaccine groups and placebo groups.

    For more information please refer to:

  • What is the rationale for vaccinating children when the risk of children becoming seriously ill or needing hospitalisation is low?

    COVID-19 vaccines have been shown to prevent serious disease and hospitalisation.

    Although COVID-19 disease is most often milder in children than adults, infection still occurs at a similar rate. With community transmission increasing throughout Australia, the expected rates of children needing hospitalisation with COVID-19 disease is also likely to increase.

    Therefore vaccinating children against COVID-19 where possible will assist in a number of ways:

    • it reduces the overall burden or “load” of COVID-19 disease in the community
    • it helps to reduce transmission or spread of COVID-19 throughout the community, including from children to adults (who are at higher risk of severe disease)
    • it helps to protect other members of the community who cannot be vaccinated (including younger children) or more those in the community that are more vulnerable to severe disease.

  • If a child has experienced serious side effects following other vaccines can they receive COVID-19 vaccines?

    Most side effects experienced following a vaccination are generally mild and short lived. However, there may be some instances where a child has experienced a significant or severe side effect (eg. anaphylaxis). In these circumstances it may be appropriate for this child to be referred to an immunisation specialist for a consultation prior to administering a COVID-19 vaccine.

    For more information please refer to MVEC: Victorian Specialist Immunisation Services (VicSIS).

  • My 12 yo is on the small side. Is it safe for them to receive a full dose/adult dose of the vaccine?

    Vaccine doses are not size dependent but rather they are age dependent. This principle also applies when vaccinating low birth weight babies. They receive the appropriate dose for their age, and it is not modified for prematurity or size.

    A full dose of COVID-19 vaccine is recommended for those aged 12 years and older because this is the dose that was administered in clinical trials and was found to be both effective in preventing severe disease, as well as being safe. Conversely there is no data on the safety of using lower doses > 12 yo children or how effective a lower dose would be in preventing disease for those aged > 12 yo.

    It is reassuring to note that teens are actually reporting fewer side effects following mRNA vaccines than adults are.

    For information on the safety of COVID-19 vaccines in teens in Australia please refer to AusVaxSafety.

  • What is the recommended COVID-19 vaccine schedule for children aged < 12 years?

    There are 2 vaccines registered for use in children:

    6 months-5 years Spikevax (Moderna) 25µ dose (blue cap, magenta vial border)

    *note 100mcg/ml formulation

    Primary schedule 2 doses, 8 weeks apart (can be reduced to 4 weeks in certain circumstances)
    Primary schedule for severely immunocompromised 3 doses, with the 3rd administered 2 months after the second
    5-11 years Comirnaty (Pfizer) 10µ dose (orange cap)
    Primary schedule 2 doses, 8 weeks apart (can be reduced to 3 weeks in certain circumstances)
    Primary schedule for severely immunocompromised 3 doses, with the 3rd dose administered 2 months after the second
    6-11 years Spikevax (Moderna) 50µ dose (blue cap, purple vial border)

    *note 200mcg/ml formulation

    Primary schedule 2 doses, 8 weeks apart (can be reduced to 4 weeks in certain circumstances)
    Primary schedule for severely immunocompromised 3 doses, with the 3rd administered 2 months after the second

    More information can be found at MVEC: COVID-19 vaccination in children and adolescents.

  • Are booster doses recommended in children?

    A single COVID-19 booster dose is recommended for all adolescents (including those who are immunocompromised) aged 16-17 years, and a select group of those aged 5-15 years, ≥ 3 months after the completion of a primary course. A further “winter” booster dose is also recommended for some adolescents (≥ 16 years) with high risk of severe disease ≥ 4 months after the initial booster.

    Comirnaty (Pfizer) is the only brand approved for use as a booster dose in those < 18 years. Whilst Nuvaxovid (Novavax) is not registered for use as a booster dose, ATAGI recommends that it may be used in individuals ≥ 12 years of age where no other vaccine brand is suitable (eg. allergy). Using an alternate brand of vaccine for booster doses compared with the brand used to complete the primary course is acceptable.

    Children and adolescents who received a primary course of COVID-19 vaccination when they were < 5 years of age, can receive a booster dose once they are eligible (by age or risk factors) or more than 3 months has elapsed since completing their primary course (whichever is later).

  • What are the recommendations for children who turn 12 years old prior to receiving their second dose of vaccine?

    Vaccine doses are recommended based on the age of the recipient at the time of vaccination. If a child previously received their first dose of COVID-19 vaccine as a paediatric dose/formulation and turned 12 before they were due for their second dose, the second dose should be the administered as a full adult dose dose/formulation.

    Delaying initial vaccination until a child turns 12 is not recommended.

  • Can children provide their own consent for COVID-19 vaccination?

    Generally speaking, a parent or guardian can provide consent for a child. In Victoria, individuals aged 12-17 are able to provide their own consent if they are deemed to be a “mature minor”.  The individual must demonstrate an understanding the proposed procedure and the effect of the decision to be vaccinated in order to provide their own consent. The laws relating to consent can vary between states and territories and it is important to refer to the individual jurisdiction to determine what laws apply.

    If a child refuses a vaccination after valid consent has been provided, it is important to respect the child’s wishes and withhold vaccination.

    Please refer to the Victorian COVID-19 Vaccination Guidelines for more information.

  • What is the recommended interval between COVID-19 vaccines and the routine school vaccines (eg. Year 7 and Year 10)?

    ATAGI advises that COVID-19 vaccines can be co-administered with all routine high school vaccines

    To read more please refer to Clinical recommendations for COVID-19 vaccines.

  • Is the recommended interval between COVID-19 vaccine doses different for children and adults?

    The intervals between vaccine doses for adults (≥ 18 years) are:

    • Comirnaty (Pfizer) 2 doses (30µ) 3-6 weeks apart
    • Spikevax (Moderna) 2 doses  (100µ) 4-6 weeks apart
    • Vaxzevria (AstraZeneca) 2 doses 6-12 weeks apart
    • Nuvaxovid (Novavax) 2 doses 3 weeks apart.

    The intervals between vaccine doses for adolescents (12-17 years) are:

    • Comirnaty (Pfizer) 2 doses (30µ) 3-6 weeks apart
    • Spikevax (Moderna) (100µ) 2 doses  4-6 weeks apart
    • Nuvaxovid (Novavax) is 8 weeks apart.

    The interval between vaccine doses for children < 12 years are:

    • Children aged 5-11 years– Paediatric Comirnaty (Pfizer) 2 doses (10µ) 3-8 weeks apart
    • Children aged 6-11 years– Spikevax (Moderna) 2 doses (50µ) 4-8 weeks apart.
    • Children aged 6 months-5 years– Spikevax (Moderna) 2 doses (25µ) 4-8 weeks apart

  • Is there a blood test you can have to see if you responded to the first dose and therefore the second dose is not needed?

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

    For more information please refer to Clinical guidance for COVID-19 vaccine providers.

  • How can children with needle phobias be supported to receive vaccines safely?

    It is recommended that children with anxiety, intellectual disabilities and needle phobias avoid attending large scale vaccination sites for immunisation. These sites are loud and busy and can increase distress. Smaller settings such as a GP clinic or pharmacy may be preferred.

    Further information and strategies to assist with needle phobia can be found at MVEC: Needle phobia.

    If all avenues for addressing severe needle phobia have been exhausted, a referral to a specialist immunisation service for COVID-19 vaccination can be considered. Information on which strategies have been trialed should be included in the patient referral.

  • Is it safe for children with heart conditions to receive COVID-19 vaccines?

    Individuals with the following cardiac conditions can safely receive COVID-19 vaccines without the need for additional monitoring or precautions:

    • coronary artery disease
    • myocardial infarction
    • stable heart failure
    • arrhythmias
    • rheumatic fever
    • rheumatic heart disease
    • kawasaki disease
    • most congenital heart disease
    • those with implanted cardiac devices
    • congenital heart disease
    • cardiac transplant
    • cardiomyopathy.

    Those with a history of the following conditions can also receive COVID-19 vaccines; however should consult their treating specialist to determine the appropriate timing for vaccination:

    • recent (within 3 months) or current inflammatory cardiac conditions (including myocarditis, pericarditis and endocarditis)
    • acute rheumatic fever or acute rheumatic heart disease
    • acute decompensated heart failure.

    For more information please refer to MVEC: myocarditis and pericarditis following COVID-19 vaccines.

  • Is it safe for children with eczema, asthma or allergies to receive COVID-19 vaccines?

    COVID-19 vaccines can safely be administered to children who have previously been diagnosed with eczema and asthma. Having a history of severe asthma has been associated with an increased risk of severe COVID-19 disease and therefore vaccination is strongly recommended in this patient group.

    Children with allergies/anaphylaxis to food, drugs, venom or latex can safely receive COVID-19 vaccines without the need for additional precautions or monitoring. Those with a history of allergic reactions or anaphylaxis to a component of a COVID-19 vaccine should be referred to a VicSIS clinic for an individual assessment and plan prior to vaccination. Vaccination is contraindicated for individuals with a history of anaphylaxis to a previous dose of COVID-19 vaccine or anaphylaxis to a component of the COVID-19 vaccine that is to be given.

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

Reviewed by: Francesca Machingaifa (MVEC Education Nurse Coordinator)

Date: October 27, 2022

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 FAQs: mRNA vaccines

These COVID-19 vaccine FAQs have been designed to address common queries relating to mRNA vaccines.

Please also see our other COVID-19 FAQs for more information on other COVID-19 related topics:

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 contact us here.

General

  • How do mRNA vaccines work?

    mRNA and DNA vaccines are genetic vaccines. They allow the genetic material of viral proteins (small parts of a pathogen) to be recreated by human cells as an antigen. Once the antigen has been identified by the immune system, antibodies and memory cells are produced to provide protection against future infection.

    Although DNA and mRNA vaccines had not been licensed prior to the COVID-19 pandemic, they were already under development for other viruses, such as influenza.

  • How long has mRNA technology been available for?

    There has been some concern amongst the public regarding the speed of development of mRNA COVID-19 vaccines. When in fact, researchers have been studying and working with mRNA technology for over 30 years. Since its discovery in 1961, mRNA has been the subject of research for various diseases.

    Further information regarding the timeline of key discoveries and advances in the development of mRNA as a drug technology can also be seen at Nature: mRNA-based therapeutics- developing a new class of drugs.

  • What other diseases do we use mRNA technology for?

    mRNA therapeutics hold great promise in the management of numerous human diseases including infections, cancers and genetic disorders. An overview of mRNA therapeutics in preclinical and clinical stages including their application can be seen here. Clinical experience is predominately in cancer immunotherapy but has expanded rapidly following the global use of the COVID-19 mRNA vaccines. As a result, the excellent tolerability and safety profile that has been demonstrated is limited to their current clinical use.

  • Can mRNA vaccines alter my DNA?

    No. It is not possible to integrate vaccine mRNA into an individual’s own DNA. mRNA from vaccines are unable to enter the nucleus of a human cell (where a person’s genetic material is stored). It is also not possible for vaccine mRNA to revert to DNA. In addition, mRNA from COVID-19 vaccines only provide the code for part of the pathogen (eg. the spike protein on the outer surface of a SARS-CoV-2 virus) and not the whole pathogen.

    For more information refer to CHOP: Can mRNA vaccines alter a persons DNA?

  • Do COVID-19 vaccines cause viral shedding?

    None of the COVID-19 vaccines used within Australia contain live virus and therefore people who are vaccinated cannot shed or transmit the virus to other people.

    COVID-19 disease itself is highly infectious and can be transmitted via respiratory secretions.

  • What ingredients are NOT in mRNA COVID-19 vaccines?

    The following products are NOT ingredients in mRNA COVID-19 vaccines:

    • Animal products
    • Antibiotics
    • Blood products
    • DNA
    • Egg proteins
    • Foetal material
    • Gluten
    • Microchips
    • Pork products
    • Thiomersal
    • Soy
    • Latex
    • Aluminium

    Further information can be found in the vaccine product information:

  • What other diseases do we use mRNA technology for?

    mRNA therapeutics hold great promise in the management of numerous human diseases including infections, cancers, genetic disorders and even allergy desensitisation. To date, clinical experience has been predominately in cancer immunotherapy but this technology has expanded rapidly following the global use of the COVID-19 mRNA vaccines.

Pre-existing conditions

  • Can people with pre-exisiting cardiac (heart) conditions receive COVID-19 vaccines?

    Individuals with the following cardiac conditions can safely receive COVID-19 vaccines without the need for additional monitoring or precautions:

    • coronary artery disease
    • myocardial infarction
    • stable heart failure
    • arrhythmias
    • rheumatic fever
    • rheumatic heart disease
    • kawasaki disease
    • most congenital heart disease
    • those with implanted cardiac devices
    • congenital heart disease
    • cardiac transplant
    • cardiomyopathy.

    Those with a history of the following conditions can also receive COVID-19 vaccines; however should consult their treating specialist to determine the appropriate timing for vaccination:

    • recent (within 3 months) or current inflammatory cardiac conditions (including myocarditis, pericarditis and endocarditis)
    • acute rheumatic fever or acute rheumatic heart disease
    • acute decompensated heart failure.

  • What are the vaccine recommendations for people who have previously been diagnosed with myocarditis or pericarditis?

    Individuals with recent (within 3 months) or current inflammatory cardiac conditions (including myocarditis, pericarditis and endocarditis) can still receive COVID-19 vaccines however should consult their treating specialist before doing so to determine the best time to be immunised.

    For individuals in whom the cause of inflammation is attributed to COVID-19 vaccination, future dose recommendations depend on the diagnosis (myocarditis or pericarditis), a person’s age and the level of certainty of diagnosis.

    Individuals who have experienced myocarditis (the more serious adverse event following immunisation) attributed to a COVID-19 vaccination, a report to SAEFVIC is indicated. A referral to a cardiologist or specialist immunisation service prior to the administration of future doses may also be recommended.

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

    Yes. The COVID-19 vaccines currently in use within Australia are non-live vaccines and therefore can be administered at anytime following a blood transfusion.

    Patients with a past history of COVID-19 infection, who received monoclonal antibodies or convalescent plasma as part of their treatment, should wait a minimum of 3 months before considering vaccination.

    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.

  • When should people who have previously tested positive for COVID-19 disease be vaccinated?

    COVID-19 vaccination should be deferred 3 months following COVID-19 infection in order to optimise protection.

    Recommended COVID-19 vaccine schedules should be completed after this time.

    For further information, refer to the Clinical recommendations for COVID-19 vaccines.

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

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

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

    For more information please refer to Health.com – Swollen Lymph Nodes Under Armpit After COVID-19 Vaccine May Mimic Breast Cancer Symptoms—Here’s What to Know and Peter Mac COVID:19 vaccination: frequently asked questions.

  • Are anthracycline therapies considered a contraindication to mRNA COVID-19 vaccines due to the association with myocarditis/pericarditis?

    Children who have been treated with chemotherapeutic agents including anthracyclines as part of their cancer therapy are not considered as higher risk of side effects from vaccination (including the development of myocarditis/pericarditis. Parents/guardians should speak to their treating team regarding COVID-19 vaccination based on current recommendations.

    For further information refer to COVID-19 Vaccination Guidance for children 12 years and older undergoing cancer treatment and children with non-cancerous blood disorders.

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

    Individuals who have previously been diagnosed with GBS can receive COVID-19 vaccines. Ongoing surveillance by the TGA and other international vaccine regulators has shown growing evidence of a possible link between GBS and Vaxzevria (AstraZeneca). Specialist advice from a treating neurologist or immunisation specialist may be considered to discuss the benefits and risks of vaccination.

    For more information please refer to MVEC: Guillain-Barre Syndrome and Victorian COVID-19 vaccination guidelines.

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

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

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

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

    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 MS Australia: COVID-19 vaccination guidance for people with MS and MVEC: COVID-19 vaccines in people with immunocompromise.

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

    Yes, COVID-19 vaccines should be offered to this patient group. True vaccine allergy, or anaphylaxis, is an extremely rare adverse event following immunisation occurring in less than 1 case per million doses administered.

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

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

    For more information refer to Australian Immunisation Handbook: Adverse events following immunisation or MVEC: COVID-19 vaccines and allergy.

  • Can COVID-19 vaccines be given to immunosuppressed individuals?

    It is recommended that all age-eligible individuals with immunosuppression receive COVID-19 vaccines. Additional doses are recommended for some individuals identified with severe immune suppression. Having a lowered immune system increases the likelihood of developing severe disease and complications if infected with SARS-CoV-2.

    People with immunocompromise receiving COVID-19 vaccination should be counselled about the possibility of reduced efficacy and the need to continue other preventative measures such as social distancing, mask wearing and hand hygiene. Household contacts should be encouraged to receive the COVID-19 vaccine when it is offered because vaccination has also been shown to reduce transmission.

    Please refer to ATAGI recommendations on the use of a third primary dose of COVID-19 vaccine in individuals who are severely immunocompromised for more information.

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

    PEG is an ingredient contained in Comirnaty (Pfizer) and Spikevax (Moderna). 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 or Spikevax is contraindicated in people with documented anaphylaxis to PEG.

    To read more refer to Australian Government Department of Health: COVID-19 vaccine contraindications and precautions.

  • Can I get COVID-19 vaccines if I have dermal fillers?

    It is safe and recommended for people who have previously received dermal fillers to receive COVID-19 vaccines.

    Individuals with a history of dermal filler injections can experience swelling at the site of the filler injection following viral or bacterial infections, dental procedures and some vaccines (ie. influenza and COVID-19 mRNA vaccines). International reports following COVID-19 mRNA vaccines indicate that any symptoms experienced following vaccination are likely to occur within 1-2 days and are temporary.

    As a precaution, an interval of 4-6 weeks between filler injections and vaccination may be considered.

    For more information please refer to Coronavirus vaccine – weekly summary of yellow card reporting.

Authors: Daryl Cheng (Medical Lead, MVEC), Rachael McGuire (MVEC Education Nurse Coordinator) and Francesca Machingaifa (MVEC Education Nurse Coordinator)

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator)

Date: October 6, 2022

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 FAQs: women's health

These COVID-19 vaccine FAQs have been designed to address common queries relating to women’s health.

Please also see our other COVID-19 FAQs for more information on other COVID-19 related topics:

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 contact us here.

Planning pregnancy

  • Can COVID-19 vaccines cause infertility?

    There is currently no evidence to suggest that any vaccine, including COVID-19 vaccines, can result in male or female infertility.

    During COVID-19 vaccine clinical trials, participants became pregnant at similar rates in both the vaccine groups and placebo groups.

    For more information please refer to:

  • Can COVID-19 vaccines be given to women who are planning pregnancy?

    Yes. COVID-19 vaccination of women who are planning pregnancy is safe, effective and strongly recommended. They do not need to avoid becoming pregnant before or after receiving vaccines.

    Pregnant women are at higher risk of severe COVID-19 infection and it’s complications compared with non-pregnant women of the same age. There is also an increased risk of premature delivery and hospitalisation for infant’s of mothers who contract COVID-19 during pregnancy.

    For more information please refer to:

  • Can COVID-19 vaccines negatively affect ovaries?

    There are no concerns that COVID-19 vaccines negatively affect fertility.

    There is no evidence to suggest that COVID-19 vaccination is harmful for ovaries or fallopian tubes. There is also no evidence that COVID-19 mRNA from vaccines build up or accumulate in ovaries to levels that cause detrimental effects to their function. The quality of the eggs produced and ability for an egg to be fertilised is not affected by COVID-19 vaccination.

  • Can people undergoing IVF be vaccinated against COVID-19?

    Evidence from COVID-19 vaccine clinical trials demonstrates that vaccination does not affect the success of IVF.

    There is no evidence to suggest that vaccination has any impact on egg quality, egg number, sperm, or the ability to fertilise an egg. There is no increased risk of miscarriage following vaccination.

    Side effects from COVID-19 vaccines will not have any impact your fertility treatment, therefore individuals can be reassured that they can be vaccinated at any time during their IVF journey.

    The vaccines available in Australia do not contain live virus and therefore are safe for women trying to conceive, with no negative impact on mums or their unborn babies.

    For more information please refer to: RANZCOG urges all practitioners to help pregnant women get vaccinated.

Pregnancy

  • Can COVID-19 vaccines be given during pregnancy?

    Yes. Due to an increased risk of severe outcomes for pregnant women and their unborn babies it is recommended that pregnant women are routinely offered COVID-19 vaccination at any stage of pregnancy.

    Real world surveillance of international data on mRNA COVID-19 vaccine administration in pregnant women has shown no significant safety concerns for either the mother or the baby. Further to this, antibodies have been detected in the cord blood and breastmilk of vaccinated women, suggesting a transfer of protection to the baby.

    Whilst there is no immunogenicity or safety data on the use of Nuvaxovid (Novavax) in pregnant and breastfeeding women, there are no theoretical concerns with it’s administration and ATAGI recommends it’s use.

    For more information please refer to:

  • Is there a preferred stage of pregnancy to receive a COVID-19 vaccine?

    Pregnant women can be offered a COVID-19 vaccine during any stage of pregnancy. Data obtained from international surveillance of large numbers of pregnant women receiving mRNA COVID-19 vaccines has not indicated a preferred gestation for administration, and indicates that vaccination is safe and efficacious during any stage of pregnancy.

  • Is it safe for women who previously received a primary course of COVID-19 vaccines to receive a booster dose if it is due during pregnancy?

    Yes. Due to an increased likelihood of severe symptoms if infected with COVID-19, it is important that pregnant women are optimally protected. This includes administering any booster doses of COVID-19 vaccine during pregnancy if they are due.

  • Are there risks of long term effects to babies we don’t know about yet given the lack of longitudinal data?

    Evidence obtained from international surveillance of pregnant women receiving COVID-19 vaccines has shown no unexpected outcomes (above background rates) for pregnancies or for infants when followed up to 3 months of age. Side effects experienced following vaccination are consistent with the expected side effects reported in non-pregnant vaccine recipients.

    Long term follow-up of pregnant women who receive a COVID-19 vaccine during pregnancy, and their infants, is ongoing.

    For more information refer to:

  • Can pregnant women receive their whooping cough, influenza and COVID-19 vaccines on the same day?

    Yes. COVID-19 vaccines can be co-administered on the same day as other vaccines.

    For more information please refer to Clinical recommendations for COVID-19 vaccines.

    For further information on vaccines recommended in pregnancy, refer to MVEC: Maternal vaccinations in pregnancy.

  • Are pregnant women who are classified as high-risk of thrombosis and on anticoagulant therapy recommended to get a COVID-19 vaccine?

    It is recommended that all pregnant women are offered COVID-19 vaccination due to a higher risk of severe disease if exposed to COVID-19. There is no evidence of thrombosis with thrombocytopenia (TTS) occurring following mRNA vaccines (Spikevax (Moderna) and Comirnaty (Pfizer)) or Nuvaxovid (Novavax).  TTS is not related to the usual risk factors for developing thrombosis.

  • Are COVID-19 vaccines as effective in pregnant women as they are in non-pregnant women?

    Current evidence from international surveillance of COVID-19 vaccination of pregnant women has shown that pregnant women have a similar immune response to COVID-19 vaccines compared with non-pregnant women. Conversely pregnant women are at a greater risk of severe COVID-19 disease compared with non-pregnant women of the same age if exposed to COVID-19.

  • If a pregnant woman is vaccinated with a COVID-19 vaccine, does that provide any protection for the foetus?

    Research has demonstrated that in women who received COVID-19 vaccines during pregnancy, antibodies against COVID-19 disease have been detected in breast milk and cord blood. This may offer some protection via passive immunity to the infant. The extent and duration of this transferred immunity is unknown

    For more information refer to the COVID-19 vaccination decision guide for women who are pregnant, breastfeeding or planning pregnancy.

Breastfeeding

  • Can women who are breastfeeding receive a COVID-19 vaccine?

    Yes. It is safe for women who are breastfeeding to receive COVID-19 vaccines. They do not need to stop breastfeeding before or after being vaccinated.

    Antibodies have been detected in breastmilk and therefore this may also offer some protection to the infant via passive immunity.

  • Can breastfeeding women receive Vaxzevria (AstraZeneca)?

    Yes. Whilst Comirnaty (Pfizer), Spikevax (Moderna) and Nuvaxovid (Novavax) are the preferred brands of COVID-19 vaccine for individuals aged under 60 years due to the potential risk for thrombosis with thrombocytopenia syndrome, breastfeeding women (who have not previously received an alternate brand of COVID-19 vaccine) can still receive Vaxzevria if they make an informed decision to do so. Whilst there is minimal safety data available, there are no theoretical concerns over the administration of non-live vaccines and babies of breastfeeding mothers who are immunised.

  • Can a breastfed infant receive their own vaccines if their mother has recently received a COVID-19 vaccine? Does there need to be an interval between mum's vaccines and the infant's vaccines?

    There is no impact on vaccine safety or efficacy for breastfed infants who are due to be immunised with their own vaccines in circumstances where their mother has recently received a COVID-19 vaccine.

    Breastfeeding women can safely continue to breastfeed their infants following vaccination with any COVID-19 vaccine.

    It is recommended that infants of immunised mothers receive all National Immunisation Program vaccines as scheduled. An interval between the mother’s COVID-19 vaccine and the infant’s vaccines is not required.

Menstruation

  • Can COVID-19 vaccines cause menstrual changes?

    Changes in menstrual patterns commonly occur for a variety of reasons including stress and illness (eg. COVID-19 disease).

    There have been some reports of changes to menstrual patterns by women who have received COVID-19 vaccines (mRNA vaccines and adenoviral vectored vaccines), both within Australia and internationally. Similar temporary symptoms have also been reported following administration of the Human Papillomavirus (HPV) vaccine. Any changes noted in menstrual patterns following COVID-19 vaccination are likely to be short-lived, with those reporting initial changes also reporting menstrual patterns returning to normal the following cycle. Changes in menstrual patterns does not indicate a negative effect on fertility.

    For more information please refer to BMJ: Menstrual changes after COVID-19 vaccination.

  • I developed menorrhagia or amenorrhea following COVID-19 vaccination. Can I still receive dose 2?

    Yes. For optimal protection 2 doses of COVID-19 vaccines is recommended.

    While formal studies on the menstrual patterns of COVID-19 vaccine recipients have not been conducted, changes in menstrual patterns were not reported by participants in initial vaccine clinical trials.

    A small study involving women of child-bearing age with confirmed COVID-19 infections investigated the effects of the illness on ovarian reserve, sex hormones and menstruation. A quarter of women reported changes in the volume of their periods; with 20% of participants reporting lighter periods and a further 19% reporting longer periods during their illness. These changes were shown to be more common in those with multisystem involvement in their illness. Menstrual changes resolved within 1-2 months of disease recovery. Sex hormones were not affected and it was concluded that transient effects of the illness were the likely cause of the changes.

    It is thought that any changes to menstrual cycles noticed by vaccine recipients are likely explained by factors such as stress, increased perceptions/attention to menstrual cycles or concurrent illnesses. Vaccines trigger an immune response and do not have any direct impact on the function of ovaries.

    For more information refer to CHOP- News & views: Reproductive health and COVID-19 vaccines.

Authors: Daryl Cheng (Medical Lead, MVEC), Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute), Rachael McGuire (MVEC Education Nurse Coordinator) and Francesca Machingaifa (MVEC Education Nurse Coordinator).

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator)

Date: August 9, 2022

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 FAQs: Vaxzevria (AstraZeneca)

These COVID-19 vaccine FAQs have been designed to address common queries relating to Vaxzevria (AstraZeneca).

Please also see our other COVID-19 FAQs for more information on other COVID-19 related topics:

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 contact us here.

Thrombosis with thrombocytopenia (TTS)

  • What is thrombosis with thrombocytopenia syndrome?

    Thrombosis with thrombocytopenia syndrome, is a rare and new syndrome which has been reported in people who have received an adenoviral vector COVID-19 vaccine (eg. Johnson & Johnson/Janssen and Vaxzevria (AstraZeneca)).

    The syndrome is distinct from other clotting conditions as it is characterised by thrombosis formation (blood clots) combined with thrombocytopenia (low platelet levels).  Symptoms occur 4-30 days following vaccination. Early recognition can lead to effective treatment.

  • What is the difference between Tier 1 and Tier 2 thrombosis with thrombocytopenia syndrome (TTS)?

    Tier 1 and Tier 2 definitions have been applied to TTS by the CDC (Centers for Disease Control and Prevention) in the United States. The tiers are defined by the following:

    Tier 1:

    • unusual site of thrombosis (e.g neurological – central venous sinus thrombosis [CVST] or gut – eg splanchnic vein, associated with bowel ischaemia and surgery, portal vein or other rare venous and arterial thromboses)
    • Platelet count <150,000 per microliter
    • Positive (+) heparin-P4 ELISA HIT antibody result is supportive, but not required

    Tier 2:

    • Usual sites of thrombosis such as leg or lungs (eg. venous thromboembolism, deep vein thrombosis, pulmonary embolism)
    • Platelet count <150,000 per microliter
    • Positive (+) heparin-P4 ELISA HIT antibody result is required

    Tier 1 is more severe, with higher morbidity and mortality than Tier 2. Evidence is emerging that Tier 1 is more common in younger age groups, hence the preferential recommendation for alternative vaccines (in Australia, Vaxzevria (AstraZeneca) is not the preferred vaccine for people aged < 60 years – see the Joint statement from ATAGI and THANZ on Thrombosis with Thrombocytopenia Syndrome (TTS) and the use of COVID-19 Vaccine AstraZeneca for further information).

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

    There have been no known markers identified that either increase or decrease an individual’s risk of developing TTS. This includes having a past history of clots in the leg (DVT), lungs (pulmonary embolus) or heart (myocardial infarction).

    Evidence thus far indicates there is a higher risk of TTS in the younger population (< 60 years of age), although there has been a small number of cases identified in older adults.

  • When do symptoms of thrombosis with thrombocytopenia syndrome (TTS) occur?

    Symptoms of TTS have been reported to occur in the 4-30 day time period following administration of a COVID-19 adenoviral vector vaccine (eg. Johnson & Johnson/Janssen or Vaxzevria (AstraZeneca)). Current information suggests that the risk of TTS is much lower following receipt of a second dose.

    Symptoms can include

    • Cerebral venous sinus thrombosis (CVST): persistent headaches (unresponsive to simple analgesia), visual changes, focal neurological symptoms (e.g. movement or sensation changes), seizures, coma, secondary intra-cerebral haemorrhage, confusion, encephalopathy
    • Splanchnic vein thrombosis: abdominal pain
    • Pulmonary embolus: chest pain/significant respiratory symptoms or distress, dyspnoea
    • Deep vein thrombosis: leg pain, redness or swelling
    • Arterial ischaemia: pallor and coldness in limb, myocardial ischaemia
    • Thrombocytopenia: acute onset bruising or bleeding, petechial rash

    NB: These symptoms are different from the common or expected side effects following vaccination which usually occur in the first 24-48 hours and last 1-2 days.

  • I am over 60 years of age and have a history of deep vein thrombosis (DVT’s). Is it safe for me to receive the Vaxzevria (AstraZeneca) vaccine?

    There is currently no evidence to suggest that having a history of DVT’s or other general thromboembolic disorders predisposes you to developing thrombosis with thrombocytopenia syndrome (TTS) following receipt of an adenoviral vector vaccine such as Vaxzevria (AstraZeneca). In contrast, there is strong evidence that COVID-19 disease is thrombogenic (promotes clot development) and may cause a variety of thromboembolic events. TTS is a unique condition involving the development of thromboses (blood clots) combined with thrombocytopenia (low platelets).

    Refer to the Joint statement from ATAGI and THANZ on Thrombosis with Thrombocytopenia Syndrome (TTS) and the use of COVID-19 Vaccine AstraZeneca for more information.

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

    There is currently no evidence to suggest that taking certain medications or being prone to developing blood clots puts you at increased risk of developing TTS following receipt of Vaxzevria (AstraZeneca). In contrast, there is strong evidence that COVID-19 disease is thrombogenic (promotes clot development) and may cause a variety of thromboembolic events. TTS is a unique condition involving the development of thromboses (blood clots) combined with thrombocytopenia (low platelets).

    For more information please refer to: Joint statement from ATAGI and THANZ on Thrombosis with Thrombocytopenia Syndrome (TTS) and the use of COVID-19 Vaccine AstraZeneca.

  • I am over 60 years of age and have a history of atrial fibrillation putting me at a higher risk of blood clots. Is it safe for me to have Vaxzevria (AstraZeneca)?

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

    There is currently no evidence to suggest that having a history of atrial fibrillation predisposes you to developing thrombosis with thrombocytopenia syndrome (TTS) following receipt of an adenoviral vector vaccine such as Vaxzevria. In contrast, there is strong evidence that COVID-19 disease is thrombogenic (promotes clot development) and may cause a variety of thromboembolic events. TTS is a unique condition involving the development of thromboses (blood clots) combined with thrombocytopenia (low platelets).

    Refer to the Joint statement from ATAGI and THANZ on Thrombosis with Thrombocytopenia Syndrome (TTS) and the use of COVID-19 Vaccine AstraZeneca for more information.

  • ATAGI have noted that “people of any age without contraindications who have had their first dose of Vaxzevria (AstraZeneca) vaccine without any serious adverse events should receive a second dose of the same vaccine``. What constitutes a serious adverse event?

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

    Anaphylaxis to a previous dose of a vaccine is a contraindication to future doses of that same vaccine.

    As a precaution those with a past history of TTS, cerebral venous sinus thrombosis (CVST), heparin-induced thrombocytopenia (HIT), idiopathic splanchnic (mesenteric, portal and splenic) venous thrombosis, anti-phospholipid syndrome (with thrombosis and/or miscarriage), or capillary leak syndrome are advised not to receive Vaxzevria (AstraZeneca).

    All adverse events should be reported to SAEFVIC. Specialist immunisation advice can be sought by referring patients to the VicSIS.

General questions

  • Can Vaxzevria (AstraZeneca) be used for booster doses?

    Vaxzevria (AstraZeneca) is no longer recommended for use as a booster dose, with mRNA COVID-19 vaccines being the preferred choice (Comirnaty (Pfizer) or Spikevax (Moderna)). Individuals who have already received Vaxzevria (AstraZeneca) as their booster dose do not need a repeat booster dose of an alternate brand.

    Nuvaxovid (Novavax) may be given as a booster in individuals aged 12 years or older in circumstances where there is no other suitable vaccine.

    Using an alternate brand of vaccine for booster doses compared with the brand used to complete the primary course is acceptable.

  • I am under 60 years of age and have had dose 1 of Vaxzevria (AstraZeneca), is it safe to receive dose 2?

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

    For more information refer to ATAGI statement on revised recommendations on the use of COVID-19 Vaccine AstraZeneca.

  • I am under 60 years of age and received Vaxzevria (AstraZeneca) as my first dose, should I/can I have an alternate brand to complete the course?

    Where possible ATAGI recommends that a COVID-19 vaccine course is completed with the same brand. Combined or mixed schedules are not routinely recommended in Australia however there is emerging evidence relating to the safety and efficacy of using alternate brands.

    Current information suggests that thrombosis with thrombocytopenia syndrome (TTS) is rarely reported following receipt of dose 2 of adenoviral vector vaccines. If a person has received the first dose of Vaxzevria (AstraZeneca) without any serious adverse events such as TTS or anaphylaxis, then they can receive the second dose.

  • I am over 60 years of age and have a history of deep vein thrombosis (DVT’s). Is it safe for me to receive Vaxzevria (AstraZeneca) vaccine?

    There is currently no evidence to suggest that having a history of DVT’s or other general thromboembolic disorders predisposes you to developing thrombosis with thrombocytopenia syndrome (TTS) following receipt of an adenoviral vector vaccine such as Vaxzevria (AstraZeneca). In contrast, there is strong evidence that COVID-19 disease is thrombogenic (promotes clot development) and may cause a variety of thromboembolic events. TTS is a unique condition involving the development of thromboses (blood clots) combined with thrombocytopenia (low platelets).

    Refer to the Joint statement from ATAGI and THANZ on Thrombosis with Thrombocytopenia Syndrome (TTS) and the use of COVID-19 Vaccine AstraZeneca for more information.

  • I am under 60 years of age and travelling to an area experiencing a current COVID-19 outbreak. Should I have the Vaxzevria (AstraZeneca) vaccine as I am unable to source an alternative?

    ATAGI recommends that Vaxzevria (AstraZeneca) can be administered in adults aged under 60 years of age where the benefits of protection are likely to outweigh the risks of vaccination for that individual. It is important to discuss your individual circumstances with a health care provider in order to make an informed decision. There may be some differences to this advice depending on the state/jurisdiction you live in, so please check with your local Department of Health.

    To read more refer to ATAGI statement on revised recommendations on the use of COVID-19 Vaccine AstraZeneca and ATAGI statement on use of COVID-19 vaccines in an outbreak setting.

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

    There is currently no evidence to suggest that taking certain medications or being prone to developing blood clots puts you at increased risk of developing TTS following receipt of Vaxzevria (AstraZeneca) vaccine.  In contrast, there is strong evidence that COVID-19 disease is thrombogenic (promotes clot development) and may cause a variety of thromboembolic events. TTS is a unique condition involving the development of thromboses (blood clots) combined with thrombocytopenia (low platelets).

    For more information please refer to: Joint statement from ATAGI and THANZ on Thrombosis with Thrombocytopenia Syndrome (TTS) and the use of COVID-19 Vaccine AstraZeneca.

  • I am over 60 years of age and have a history of atrial fibrillation putting me at a higher risk of blood clots. Is it safe for me to have Vaxzevria (AstraZeneca) vaccine?

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

    There is currently no evidence to suggest that having a history of atrial fibrillation predisposes you to developing thrombosis with thrombocytopenia syndrome (TTS) following receipt of an adenoviral vector vaccine such as Vaxzevria. In contrast, there is strong evidence that COVID-19 disease is thrombogenic (promotes clot development) and may cause a variety of thromboembolic events. TTS is a unique condition involving the development of thromboses (blood clots) combined with thrombocytopenia (low platelets).

    Refer to the Joint statement from ATAGI and THANZ on Thrombosis with Thrombocytopenia Syndrome (TTS) and the use of COVID-19 Vaccine AstraZeneca for more information.

  • I am 61 years of age. Why is Vaxzevria (AstraZeneca) vaccine deemed safe for me to receive?

    Like any arbitrary age cut-off, it is acknowledged that there may be limited difference between an individual at age 60 or 61 years. What we do know is that the risk of intensive care admissions and death increases markedly with age, with each decade of life increasing the risk 3-fold. Conversely, the possibility of thrombosis with thrombocytopenia syndrome (TTS) may be higher in younger people, based on currently available data.

    ATAGI have taken this data, along with safety data analysis from other countries such as the UK, other risks such as prevalence of COVID-19 in the Australian population along with any existing COVID-19 outbreaks, to calculate an age-specific benefit-to-risk balance for the Australian population. This has resulted in a current age cutoff of 60 years old in the current recommendations.

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

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

    Data from clinical trials demonstrated that a 4-12 week interval between 2 doses of Vaxzevria (AstraZeneca) vaccine was needed to provide long-term protection.

  • How much protection do I get from 1 dose of Vaxzevria (AstraZeneca)?

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

    Refer to the COVID-19 AstraZeneca Product Information for more information.

  • ATAGI have noted that “people of any age without contraindications who have had their first dose of Vaxzevria (AstraZeneca) without any serious adverse events should receive a second dose of the same vaccine``. What constitutes a serious adverse event?

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

    Anaphylaxis to a previous dose of a vaccine is a contraindication to future doses of that same vaccine.

    As a precaution those with a past history of TTS, cerebral venous sinus thrombosis (CVST), heparin-induced thrombocytopenia (HIT), idiopathic splanchnic (mesenteric, portal and splenic) venous thrombosis, anti-phospholipid syndrome (with thrombosis and/or miscarriage), or capillary leak syndrome are advised not to receive Vaxzevria (AstraZeneca).

    All adverse events should be reported to SAEFVIC. Specialist immunisation advice can be sought by referring patients to the VicSIS.

  • I have a history of capillary leak syndrome, can I have the Vaxzevria (AstraZeneca)?

    An extremely rare relapsing-remitting condition known as capillary leak syndrome has been reported overseas following vaccination with Vaxzevria (AstraZeneca). The syndrome results in fluid leaking from capillaries (small blood vessels) into surrounding tissue and can lead to severe organ damage or death if left untreated.

    In two of the reported cases there was a previous history of capillary leak syndrome. As triggers for relapse are not well understood, the manufacturer of Vaxzevria has updated the product information advising it is not recommended that the vaccine be administered to people with a history of capillary leak syndrome. Individuals with a history of capillary leak syndrome should be referred to their closest VicSIS clinic for further assessment.

    Further information can be found at TGA: COVID-19 weekly safety report.

  • Is there an association with Vaxzevria (AstraZeneca) and developing myocarditis/pericarditis following vaccination?

    Myocarditis is an inflammatory disease of the heart muscle, whilst pericarditis is an inflammatory disease of the lining of the heart muscle. They are rare conditions, most commonly associated with viral infections (including SARS-CoV-2) but can also be triggered by other factors such as medications and autoimmune conditions.

    Vaxzevria (AstraZeneca) has been associated with a small increased risk of developing myocarditis/pericarditis following COVID-19 vaccination however this risk appears lower than that seen in individuals who have received Spikevax (Moderna) and Comirnaty (Pfizer).

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

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator)

Date: October 6, 2022

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 FAQs: administration technique and vaccine schedules

These COVID-19 vaccine FAQs have been designed to address common queries relating to COVID-19 vaccine administration technique and vaccine schedules.

Please also see our other COVID-19 FAQs for more information on other COVID-19 related topics:

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 contact us here.

Administration technique

  • What do I do if there was leakage of diluent when reconstituting Comirnaty (Pfizer)?

    If you have injected most of the diluent into the vial and there has been no breach in infection control, the vaccine can still be used.

    If there is uncertainty as to how much diluent was lost, you may still use the vial provided if you are able to draw up at least 6 doses from a Paediatric Pfizer vial (orange cap) or 4 doses from a ≥ 12 year old Pfizer vial (purple cap).

    To read more please refer to Australian Government Department of Health: COVID-19 vaccine allocations, storage and handling.

  • Can COVID-19 vaccines be given subcutaneously?

    Vaxzevria (AstraZeneca), Comirnaty (Pfizer), Nuvaxovid (Novavax) and Spikevax (Moderna) should be administered via intramuscular injection. There is no safety or efficacy data relating to subcutaneous administration.

  • 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. If you have given most of the dose, you do not need to give the dose again. Please contact your safety service if there are any concerns/questions.

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

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

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

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

    Please refer to MVEC: Administration of injected vaccines – correct technique or Breastcancernow.org: Can I have coronavirus vaccine if I’ve had breast cancer treatment? for more information.

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

    For most people, COVID-19 vaccines can be co-administered on the same day as other vaccines, including influenza, routine scheduled vaccines and maternal pertussis vaccines.

    There is emerging safety evidence supporting the co-administration of COVID-19 vaccines and influenza vaccines. There is currently limited data on the co-administration of COVID-19 vaccines with other routine vaccines however the benefits of ensuring timely vaccination outweighs potential risks associated with immunogenicity, fever or local side effects.

    Where possible it is preferred that infants and children aged 6 months – 5 years receiving Spikevax (Moderna), allow an interval of 7-14 days between administration of Spikevax (Moderna) and other vaccines to minimise the risk of adverse events such as fever.

    For more information please refer to Australian Government Department of Health: Clinical recommendations for COVID-19 vaccines.

  • What is the recommendation for administering COVID-19 vaccines to individuals with bleeding disorders?

    COVID-19 vaccines should be administered via intramuscular injection only. People who are taking anticoagulant therapy or have a history of a bleeding disorder are at higher risk of haematoma formation following intramuscular injection. Prior to vaccine administration, patients should be advised of this risk.

    The correct needle size and length should be used and firm pressure should be applied to the site (no rubbing) for at least 2 minutes following immunisation.

    Subcutaneous administration is not recommended due to a lack of safety and efficacy data regarding this route of administration.

    For further information please refer to the Australian Immunisation Handbook.

Vaccine schedules

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

    Where possible, it is preferred that a primary course of COVID-19 vaccination is completed with the same brand. However, if there is a specific medical contraindication or precaution, lack of vaccine availability, or brand preference by an individual, then an alternate brand can be used to complete a course.

    When using mixed schedules, the recommended interval between the first and second doses is 4-12 weeks. A longer interval will be accepted if this is not possible.

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

  • What are the recommendations for booster doses of COVID-19 vaccines in Australia?

    A single booster dose is recommended for all individuals ≥ 16 years, and a select group of 5-15 year olds, 3 months after a primary course of COVID-19 vaccination is complete. An additional “winter” booster is recommended for some individuals (≥ 16 years) who are at an increased risk of severe COVID-19 disease. This winter dose can be administered ≥ 3 months after receiving the first booster.

    The preferred vaccine brands for booster doses in adults aged ≥ 18 years are Comirnaty (Pfizer) or Spikevax (Moderna). Comirnaty (Pfizer) is the only vaccine brand registered for use as a booster in individuals < 18 years. Whilst Nuvaxovid (Novavax) is not registered for use as a booster dose, ATAGI recommends that it may be used in individuals ≥ 12 years of age where no other vaccine brand is suitable (eg. allergy).

    Vaxzevria (AstraZeneca) is no longer recommended for use as a booster dose. Individuals who have already received Vaxzevria (AstraZeneca) as their booster dose do not need a repeat booster dose of an alternate brand.

    Children and adolescents who received a primary course of COVID-19 vaccination when they were < 5 years of age, can receive a booster dose once they are eligible (by age or risk factors) or more than 3 months has elapsed since completing their primary course (whichever is later).

  • What is the recommended primary course of COVID-19 vaccines for immunocompromised individuals?

    Severely immunocompromised individuals aged ≥ 6 months are recommended to receive a 3-dose primary course of COVID-19 vaccination with the third dose of vaccine being administered 8 weeks following the second dose.

    Age-appropriate mRNA vaccines (Spikevax (Moderna) or Comirnaty (Pfizer)) are recommended for immunocompromised individuals.

    Nuvaxovid (Novavax) may be used in those aged ≥ 12 years who received Nuvaxovid for their first 2 doses or in those with a contraindication to mRNA vaccination, however there is minimal efficacy data available on it’s use in this patient group. Those aged ≥ 18 years who received Vaxzevria (AstraZeneca) without any serious adverse event for their first two doses may choose to receive Vaxzevria as the third dose of their primary course, however alternate brands are recommended and preferred.

    NB: Individuals ≥ 12 years receiving Spikevax (Moderna) as their third primary dose should receive a full dose (100µg). This differs from the recommended Spikevax (Moderna) booster dose where only a half dose (50µg) is indicated.

    Following a 3-dose primary course of vaccination, severely immunocompromised individuals ≥ 12 years should receive a booster dose (4th dose) ≥ 3 months from completion of the primary course. An additional “winter” booster dose (5th dose) is recommended for those ≥ 16 years ≥ 4 months after receiving the first booster.

  • What is the primary COVID-19 vaccine schedule for children aged < 12 years?

    There are 2 vaccines registered for use in children:

    6 months-5 years Spikevax (Moderna) 25µ dose (blue cap, magenta vial border)

    *note 100mcg/ml formulation

    Primary schedule 2 doses, 8 weeks apart (can be reduced to 4 weeks in certain circumstances)
    Primary schedule for severely immunocompromised 3 doses, with the 3rd administered 2 months after the second
    5-11 years Comirnaty (Pfizer) 10µ dose (orange cap)
    Primary schedule 2 doses, 8 weeks apart (can be reduced to 3 weeks in certain circumstances)
    Primary schedule for severely immunocompromised 3 doses, with the 3rd dose administered 2 months after the second
    6-11 years Spikevax (Moderna) 50µ dose (blue cap, purple vial border)

    *note 200mcg/ml formulation

    Primary schedule 2 doses, 8 weeks apart (can be reduced to 4 weeks in certain circumstances)
    Primary schedule for severely immunocompromised 3 doses, with the 3rd administered 2 months after the second

    More information can be found at MVEC: COVID-19 vaccination in children and adolescents.

  • What are the recommendations for children who turn 12 years old prior to receiving their second dose of vaccine?

    Vaccine doses are recommended based on the age of the recipient at the time of vaccination. If a child previously received their first dose of COVID-19 vaccine as a paediatric dose/formulation and turned 12 before they were due for their second dose, the second dose should be the administered as a full adult dose dose/formulation.

    Delaying initial vaccination until a child turns 12 is not recommended.

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

    ATAGI recommends that the absolute minimum interval between dose 1 and 2 of any COVID-19 vaccine is 14 days. In circumstances where a dose 2 has been administered earlier than 14 days after the first dose, that dose in considered invalid and must be repeated. A repeat dose can be administered 4-12 weeks following the invalid dose to complete the primary course.

    There is no maximum interval in which a primary course must be completed by before a vaccine course must be started again.

    Please refer to Australian Government Department of Health: Clinical recommendations for COVID-19 vaccines for more information.

  • Are COVID-19 vaccine brands that are available overseas recognised within Australia?

    In addition to the five COVID-19 vaccine brands with provisional registration in Australia (Comirnaty (Pfizer), Vaxzevria (AstraZeneca), Spikevax (Moderna), Nuvaxovid (Novavax) and COVID-19 Vaccine Janssen (Janssen-Cilag Pty Ltd)), the TGA also recognises the following COVID-19 vaccine brands as currently in use internationally:

    • Coronavac (Sinovac)
    • Covishield (AstraZeneca/Serum Institute of India).
    • BIBP-CorV (Sinopharm)
    • Covaxin  (Bharat Biotech)
    • Sputnik V (Gamaleya Research Institute).

    When making an assessment on the validity of vaccines, the TGA thoroughly reviews information relating to a vaccine’s efficacy and effectiveness to determine the impact of vaccination on severe disease as well as disease transmission.

    For more information please refer to MVEC: COVID-19- TGA recognised vaccines

  • What is the recommendation for individuals who have received dose 1 of a brand of COVID-19 vaccine that is not available in Australia?

    Individuals who have previously received a TGA-recognised first dose of COVID-19 vaccine that is not available in Australia can complete their vaccine course with any COVID-19 vaccine brand available in Australia. This second dose can be administered 4-12 weeks following the first dose. A longer interval will be accepted if this is not possible.

    A COVID-19 vaccine booster dose is then recommended for all age-eligible individuals ≥3 months following the completion of the primary course.

    For further information in Australia refer to ATAGI clinical advice on the use of a different COVID-19 vaccine as the second dose.

  • What is the recommendation for individuals who have received a COVID-19 vaccine(s) overseas that is not recognised in Australia?

    Individuals who have previously received a first dose or a course of COVID-19 vaccine/s using a brand that is not recognised in Australia should be re-vaccinated with a full course using a brand that is recognised by the TGA.

    The minimum interval between receiving the last dose of non-recognised vaccine and receiving the first dose of TGA recognised vaccine should be the same interval that is recommended between doses of the non-recognised vaccine course (commonly 3-6 weeks depending on the vaccine). A longer interval will be accepted if this is not possible. Once a TGA recognised COVID-19 vaccine course has been commenced, the recommended intervals between these doses should be adhered to.

    For further information on COVID-19 vaccines recognised in Australia refer to COVID-19: TGA recognised vaccines.

  • When should people who have previously tested positive for COVID-19 disease be vaccinated?

    COVID-19 vaccination should be deferred 3 months following COVID-19 infection in order to optimise protection.

    Recommended COVID-19 vaccine schedules should be completed after this time.

    For further information, refer to the Clinical recommendations for COVID-19 vaccines.

  • What are the vaccine recommendations for people who have contracted COVID-19 disease after receiving dose 1 of the vaccine but before dose 2?

    Where an individual has contracted COVID-19 disease between vaccine doses, it is recommended the next scheduled dose is deferred for a period of 3 months following infection.

    Recommended COVID-19 vaccine schedules should be completed after this time.

    For further information, refer to the Clinical recommendations for COVID-19 vaccines.

  • For patients who have tested to positive to COVID-19 disease and received monoclonal antibodies or convalescent plasma as part of their treatment, when is the ideal time for vaccination?

    Patients with a past history of COVID-19 infection, who received monoclonal antibodies or convalescent plasma as part of their treatment, should wait a minimum of 3 months before considering vaccination.

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

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

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

    Generally speaking, COVID-19 vaccines can be co-administered on the same day as any other vaccine (including live-attenuated vaccines). The only exception to this, is the preference to separate COVID-19 vaccines from other vaccines by 7-14 days in children aged 6 months-5 years to limit the risk of adverse events such as fever.

  • Can I get a blood test to check my immune response?

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

  • What is the recommended interval between COVID-19 vaccination and tuberculin skin testing (TST, Mantoux)?

    COVID-19 vaccination and TST can be performed on the same day provided they are administered in separate limbs.

  • Can patients diagnosed with multisystem inflammatory syndrome relating to COVID-19 infection receive COVID-19 vaccines?

    Yes COVID-19 vaccines can be administered in this patient group following a discussion with an immunisation specialist or cardiologist on the optimal timing of vaccination. It is recommended that individuals have complete heart recovery prior to use of COVID-19 mRNA vaccines.   

    Please refer to Victorian COVID-19 vaccination guidelines for more information.

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

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator)

Date: October 27, 2022

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 FAQs: vaccine development, safety, effectiveness & storage

These COVID-19 vaccine FAQs have been designed to address common queries relating to COVID-19 vaccine development, safety, effectiveness and storage.

Please also see our other COVID-19 FAQs for more information on other COVID-19 related topics:

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 contact us here.

Vaccine development process

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

    COVID-19 vaccine development has happened “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.

  • 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 its side effect profile.

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

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

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

    The Therapeutic Goods Administration (TGA) is responsible for approving and regulating all medicines, including vaccines, used within Australia.

    Due to the urgent need for COVID-19 vaccines to prevent morbidity, mortality and disease transmission, vaccine sponsors have been able to apply for ‘provisional registration’ which allows the rollout of a vaccine to occur more quickly. Vaccines can be provisionally approved for use based on preliminary clinical trial data, where the benefits of earlier access to a vaccine have been determined to outweigh potential risks of waiting for additional data. Sponsors may then apply for ‘full registration’ when more clinical data is available.

    Refer to MVEC: Provisional registration of COVID-19 vaccine(s) in Australia and TGA: COVID-19 vaccines for further information.

  • 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, safety, affectiveness and quality continues to be monitored in the post-licensure phase.

  • 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.

Safety

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

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

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

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

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

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

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

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

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

    Minor side effects following COVID-19 vaccination are expected. Common symptoms 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.

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

  • 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.

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

    Reporting adverse events is not mandatory in Victoria, however doing so allows the rapid investigation of any potential vaccine or system problems by Victorian and national health authorities (Therapeutic Goods Administration). This helps to ensure a safe and effective immunisation program and it maintains community confidence in vaccines.

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

    More information on adverse event reporting in Victoria can be found at MVEC: SAEFVIC

  • I experienced side effects from the first dose of the vaccine, should I have the second dose?

    Common side effects that are short lived are not a contraindication to further doses of COVID-19 vaccines.

    If you have experienced any unanticipated side effects following a vaccine, it should be discussed with your GP and reported to SAEFVIC.

Effectiveness

  • How do we know a vaccine is effective?

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

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

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

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

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

    It is recommended that all age-eligible individuals with immunosuppression receive COVID-19 vaccines. Additional doses are recommended for some individuals identified with severe immune suppression. Having a lowered immune system increases the likelihood of developing severe disease and complications if infected with SARS-CoV-2.

    People with immunocompromise receiving COVID-19 vaccination should be counselled about the possibility of reduced efficacy and the need to continue other preventative measures such as social distancing, mask wearing and hand hygiene. Household contacts should be encouraged to receive the COVID-19 vaccine when it is offered because vaccination has also been shown to reduce transmission.

    Please refer to ATAGI recommendations on the use of a third primary dose of COVID-19 vaccine in individuals who are severely immunocompromised for more information.

  • What is herd immunity?

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

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

    Please see more information about herd immunity from the Australian Academy of Science.

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

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

    Please refer to Public health management during COVID-19 for more information.

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

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

  • Are booster doses of COVID-19 vaccines recommended in Australia?

    A single booster dose is recommended for all individuals ≥ 16 years, and a select group of 12-15 year olds, 3 months after a primary course of COVID-19 vaccination is complete.

    An additional “winter” booster is recommended for some individuals ≥ 16 years who are at an increased risk of severe COVID-19 disease. This booster dose can be administered ≥ 3 months after receiving the first booster.

    The preferred vaccine brands for booster doses in adults aged ≥ 18 years are Comirnaty (Pfizer) or Spikevax (Moderna). Comirnaty (Pfizer) is the only vaccine brand registered for use as a booster in adolescents. Whilst Nuvaxovid (Novavax) is not registered for use as a booster dose, ATAGI recommends that it may be used in individuals ≥ 12 years of age where no other vaccine brand is suitable (eg. allergy).

    Vaxzevria (AstraZeneca) is no longer recommended for use as a booster dose. Individuals who have already received Vaxzevria (AstraZeneca) as their booster dose do not need a repeat booster dose of an alternate brand.

    Adolescents who received a primary course of COVID-19 vaccination when they were < 12 years of age, can receive a booster dose once they become age-eligible/more than 3 months has elapsed since completing their primary course (whichever is later).

    Booster doses are not recommended for anyone < 12 years of age.

Storage

  • How should COVID-19 vaccines be stored?

    The storage environments required for the COVID-19 vaccines being used within Australia vary depending on the brand of vaccine.

    mRNA vaccines (Comirnaty (Pfizer) and Spikevax (Moderna)) require ultra-low cold chain storage and transport conditions, resulting in additonal logistical considerations for purpose built freezers and dry ice. Once defrosted they will only remain stable for a limited amount of time.

    Vaxzevria (AstraZeneca) and the Nuvaxovid (Novavax ) can be stored in standard vaccine cold chain temperatures of between 2°C to 8°C.

    For more information on cold chain please refer to MVEC: Cold chain.

  • 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 MVEC: Multi-dose vials.

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

Reviewed by: Francesca Machingaifa (MVEC Education Nurse Coordinator)

Date: October 6, 2022

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.