Allergy, Immunodeficiency, Autoimmunity and COVID-19 Vaccination Position Statement
14 April 2021:
This statement has been developed by ASCIA, the peak professional body of clinical immunology/allergy specialists in Australia and New Zealand as a guide for COVID-19 vaccination in people with allergy, immunodeficiency and autoimmune conditions, and will be updated when new information is available.
Vaccination is an important method to reduce the risk of developing infectious diseases, including COVID-19, caused by infection with the SARS-CoV-2 coronavirus. Immunisation occurs after the vaccine stimulates the immune system to induce antibodies (immunoglobulins) and cellular immunity to protect from severe COVID-19 disease, and possibly reduce the risk of transmission of infection in the community.
Whilst public health measures and restrictions that were implemented by the Australian and New Zealand governments since March 2020 have been successful in controlling the COVID-19 pandemic, vaccination programs are required throughout the world, including Australia and New Zealand.
COVID-19 vaccines to be used in Australia and New Zealand
The COVID-19 vaccines listed below are not live-attenuated vaccines and are safe for people with immune system disorders, including allergy, immunodeficiency and autoimmune conditions.
Allergic reactions to COVID-19 vaccines are rare. However, if there is a high risk of an allergic reaction to one of the vaccines, it may be possible to have another vaccine which does not contain the ingredient, subject to availability and medical advice.
A range of COVID-19 vaccines have been developed using different technologies.
Pfizer/BioNTech COMIRNATY COVID-19 vaccine (mRNA-based) has been provisionally approved by the Therapeutic Goods Administration (TGA), part of the Australian Government Department of Health, and by Medsafe in New Zealand for people 16 years and older. This vaccine is stored at -60 to -90°C, but can be stored at ‑ 20±5°C for up to two weeks (even during transportation) within the six month shelf life.
Vaccine ingredients are listed at https://www.tga.gov.au/apm-summary/comirnaty and details are available at:
- TGA https://www.tga.gov.au/media-release/tga-provisionally-approves-pfizer-covid-19-vaccine
- New Zealand Ministry of Health https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-safety-and-approval
AstraZeneca/Oxford COVID-19 vaccine (viral vector) has been provisionally approved by the TGA for people 18 years or older. This vaccine is being manufactured in Australia by CSL Behring and needs to be stored at 2 to 8 degrees Celsius. For details go to https://www.tga.gov.au/media-release/tga-provisionally-approves-astrazenecas-covid-19-vaccine and refer to the Australian Technical Advisory Group on Immunisation (ATAGI) statement summary below.
Biocelect/Novavax COVID-19 vaccine (protein subunit) has been granted provisional determination by the TGA. This vaccine is not yet available in Australia.
Other COVID-19 vaccines may be assessed by authorities in Australia and New Zealand, subject to government agreements with vaccine suppliers.
The Australian Technical Advisory Group on Immunisation (ATAGI) issued a statement on 8 April 2021 about the AstraZeneca COVID-19 vaccine in response to new vaccine safety concerns. The following is a summary of the ATAGI statement:
- ATAGI notes further evidence of a rare but serious side effect involving thrombosis (clotting) with thrombocytopenia (low blood platelet count) following receipt of AstraZeneca COVID-19 vaccine.
- ATAGI recommends that the Pfizer (Comirnaty) COVID-19 vaccine by is preferred over the AstraZeneca COVID-19 vaccine in adults aged under 50 years. This recommendation is based on the increasing risk of severe outcomes from COVID-19 in older adults (and hence a higher benefit from vaccination) and a potentially increased risk of thrombosis with thrombocytopenia following the AstraZeneca COVID-19 vaccine in people aged under 50 years.
- The AstraZeneca COVID-19 vaccine can be used in adults aged under 50 years where the benefits are likely to outweigh the risks for that individual, and the person has made an informed decision based on an understanding of the risks and benefits.
- People who have had the first dose of the AstraZeneca COVID-19 vaccine without any serious adverse effects can be given the second dose, including adults under 50 years.
Further information from ATAGI is available at www.health.gov.au/news/atagi-statement-on-astrazeneca-vaccine-in-response-to-new-vaccine-safety-concerns
Allergic reactions to COVID-19 vaccines
With new vaccines it is critical to evaluate the safety after the vaccine has been licensed. Post-licensure information on the safety of mRNA vaccines have demonstrated higher rates of severe allergic reactions (anaphylaxis) than expected. However, rates are extremely low, with less than ten cases of anaphylaxis reported per million doses of the Pfizer COVID-19 vaccine.
Polyethylene Glycol (PEG), also known as macrogol, is an ingredient in mRNA vaccines:
- Different forms of PEG are found in tablets, laxatives, hand sanitiser gels, injectable corticosteroids, medications, cosmetics, bathroom products and colonoscopy preparation products.
- PEG can cause contact dermatitis in some people.
- PEG is recognised as a rare hidden allergen that can trigger anaphylaxis to multiple classes of drugs.
It is uncertain whether PEG or another ingredient may trigger COVID-19 vaccine anaphylaxis.
Polysorbate 80 is chemically related to PEG and is an ingredient in the AstraZeneca COVID-19 vaccine.
Widespread use of COVID-19 vaccines suggests that severe allergic reactions to the Pfizer and AstraZeneca vaccines are very rare.
Guide for COVID-19 vaccination in people with allergic conditions
ASCIA has developed the following recommendations, based on the current knowledge regarding allergic reactions to COVID-19 vaccines. These recommendations may change when new information is available.
1. Vaccinate without additional precautions
Vaccinate in the community as per national recommendations, with a post-vaccination observation period of 15 minutes. This includes people with:
- History of allergy, including anaphylaxis to food, drugs, venom, or latex.
- Allergic conditions, including asthma, atopic dermatitis (eczema) or allergic rhinitis (hay fever).
2. Vaccinate with precautions*
- Immediate (within four hours) and generalised symptoms of a possible allergic reaction without anaphylaxis to a previous dose of a COVID-19 vaccine.
- Generalised allergic reaction (without anaphylaxis) to one of the ingredients in the COVID-19 vaccine to be administered (Pfizer-PEG or AstraZeneca-Polysorbate 80).
- Prior history of anaphylaxis to previous vaccines and/or multiple drugs (injectable and/or oral) where ingredients such as PEG or polysorbate 80 may conceivably be the cause.
- A known systemic mast cell activation disorder with raised mast cell tryptase, that requires treatment.
- Review or discussion prior to vaccination by a clinical immunology/allergy or vaccinology specialist, to develop a risk/benefit assessment for each patient.
- Skin testing to the vaccine and/or graded doses should be considered in some cases.
- Vaccination in a medical facility equipped for the management of anaphylaxis (such as a medical clinic with multiple doctors available, or a hospital clinic).
- Post-vaccination observation period should be at least 30 minutes.
- Documented anaphylaxis to one of the ingredients contained in the COVID-19 vaccine to be administered (Pfizer – PEG or AstraZeneca - Polysorbate 80).
- Anaphylaxis to a prior dose of a COVID-19 vaccine.
Anaphylaxis with one type of COVID-19 vaccine may not preclude vaccination with another vaccine, but this should only occur if the precautions listed above are met. If there is a high risk of an allergic reaction to one of the vaccines (such as a known allergy to PEG or Polysorbate 80), it may be possible to have another vaccine which does not contain the ingredient, subject to availability and medical advice.
COVID-19 vaccination and adverse events
Some people will get mild, short-term side effects from vaccination, including injection site reactions, fever, joint pain, muscle aches, fatigue, headaches, or worsened eczema a day after vaccination.
These common side effects indicate the start of an immune response, not an allergic reaction, which are rare. Side effects do not usually require treatment other than paracetamol for fever or discomfort.
Anaphylaxis to vaccines is extremely rare but can be life threatening and should always be treated as a medical emergency, with immediate treatment with adrenaline (epinephrine). Most cases of anaphylaxis to vaccines occur within 20 to 30 minutes of vaccination and respond to one or two doses of adrenaline.
Health professionals administering vaccines in Australia and New Zealand should all be trained in the emergency treatment of anaphylaxis, and adrenaline should be readily available in all vaccination centres.
ASCIA anaphylaxis e-training and action plans are available at www.allergy.org.au/anaphylaxis
All notifications of adverse events following immunisation should be made through the usual reporting mechanisms. Refer also to the Reporting to immunisation registers section of the Australian Immunisation Handbook.
In New Zealand, notifications of adverse events should be reported to the Centre for Adverse Reactions Monitoring (CARM) https://nzphvc.otago.ac.nz/reporting/
Any unexpected or serious event should be reported, regardless of the causal association with the vaccine.
COVID-19 vaccines and allergy
There is no evidence that people with allergic conditions such as asthma, hay fever, food allergy or insect sting allergy are at any greater risk of vaccine allergy compared to the general population.
People with a known PEG allergy or previous anaphylaxis to multiple medications, should see their clinical immunology/allergy specialist to assess and confirm their allergy. The AstraZeneca vaccine may be a suitable alternative to the Pfizer vaccine if PEG allergy is confirmed.
Unlike some other vaccines there is no food, gelatin or latex in the COVID-19 vaccines that are currently available and they are not grown in eggs. If people have had an allergic reaction to another vaccine, this does not mean that they will also be allergic to the COVID-19 vaccine.
Regular medications for allergic rhinitis, atopic dermatitis and asthma should be continued when having the COVID-19 vaccine.
It is recommended that allergen immunotherapy (AIT) or venom immunotherapy (VIT) injections should not be given within 48 hours of the COVID-19 vaccine injection. This avoids confusion about the cause of side effects or allergic reactions, if they occur in response to the COVID-19 vaccine or immunotherapy.
COVID-19 vaccines, immunodeficiency and autoimmune conditions
There is no evidence that people with primary or secondary immunodeficiencies and autoimmune conditions are at any greater risk of vaccine allergy than the general population.
People with certain pre-existing medical conditions have been identified as one of the initial priority groups for COVID-19 vaccines. This includes people with immunodeficiencies and autoimmune conditions.
It is important that treatments for immunodeficiencies and autoimmune conditions are continued, because stopping these treatments can place patients at greater risk from COVID-19.
Vaccination should occur on a different day (if possible) from regular infusion treatments, such as immunoglobulin replacement therapy or immunosuppressant infusions.
For example, people on monthly intravenous immunoglobulin (IVIg) may be advised by their specialist to be vaccinated two 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.
People with immunodeficiencies and autoimmune conditions should follow the usual advice from their clinical immunology/allergy specialist or rheumatologist regarding vaccinations, or ask for specific advice regarding the COVID-19 vaccine.
COVID-19 vaccines, other medical conditions and vaccinations
COVID-19 vaccines have initially been tested in healthy adults, before being tested on more vulnerable people, to provide confidence that the vaccine is safe for use in the general population.
If a patient is being treated for other medical conditions or is in a clinical trial, they should ask their doctor for advice regarding the COVID-19 vaccine.
Surgery guidelines recommend that people do not have major surgery and vaccines within one week of each other. This is because both surgery and the vaccine can cause a fever.
It is recommended not to have the influenza vaccine and a COVID-19 vaccine on the same day. The preferred minimum interval between an influenza vaccine and a COVID-19 vaccine is two weeks.
COVID-19 vaccines and pregnant or breastfeeding women
Based on clinical trials of other similar vaccines, it is unlikely that COVID-19 vaccines pose a risk to a pregnant woman or her baby. However, pregnant and breastfeeding women have not been included in initial COVID-19 trials. If a pregnant woman has a medical condition that may place her at high risk of having serious complications due to COVID-19, she should discuss COVID-19 vaccination with her obstetrician, GP and/or midwife.
The Australian Government has developed a decision aid for COVID-19 vaccination in women who are pregnant, breastfeeding or planning pregnancy:
COVID-19 vaccines for children under 16 years of age
COVID-19 vaccines are generally not recommended for children under 16 for the following reasons:
- Children and young people are at low risk of COVID-19.
- Clinical trials for the vaccines in children have only recently begun.
- COVID-19 vaccines are not yet registered for use in children under 16 years of age.
It is possible that these recommendations may change once clinical trials in children have been completed.
COVID-19 vaccines and new variants of the SARS-CoV-2 coronavirus
Clinical trials have shown that the vaccine stimulates the immune system to make antibodies (immunoglobulins) that are able to respond to a variety of mutations.
Technology used in vaccine development is adaptable to change if mutations occur, in the same way that the influenza vaccine ingredients change each season.
Developments in this area will be closely monitored.
Other measures to prevent COVID-19
It is not yet known how long the antibodies (immunoglobulins) or cellular immunity lasts, which are induced in response to having the COVID-19 vaccine, or after having COVID-19.
There is limited information from COVID-19 vaccine clinical trials regarding whether vaccination reduces the rate of transmission of infection.
Therefore, it is important that the following measures continue to be followed, even if people are vaccinated or have had COVID-19:
- Hand hygiene - Regular, thorough hand washing with soap and water is vital to prevent infections, especially after using the bathroom and before eating. Hand sanitiser may be used if soap and water are unavailable.
- Respiratory hygiene - Physical distancing and covering the mouth and nose with a bent elbow or tissue when coughing or sneezing, then disposing of the used tissue immediately, can prevent infections.
- Stay home if you are unwell -If anyone has a fever or cough, they should stay home, seek medical attention (call in advance), and follow health authority instructions.
- Follow government advice and restrictions - This includes the measures listed above.
ASCIA has also developed a Frequently Asked Questions (FAQ) about Allergy, Immunodeficiency, Autoimmunity and COVID-19 Vaccination, for patients, consumers and carers.
To access the FAQ and further information go to www.allergy.org.au/members/covid-19
© ASCIA 2021
ASCIA is the peak professional body of clinical immunology/allergy specialists in Australia and New Zealand.
ASCIA resources are based on published literature and expert review, however, they are not intended to replace medical advice.
The content of ASCIA resources is not influenced by any commercial organisations.
For more information go to www.allergy.org.au
To donate to allergy and immunology research go to www.allergyimmunology.org.au