International Network of Special Immunization Services
Background
The International Network of Special Immunization Services (INSIS) is a coordinated international collaboration of vaccine safety surveillance systems. By collaborating on a global scale, rare serious adverse events following immunisation (occurring in < 1 per 10,000 vaccine recipients) are more likely to be identified, thoroughly investigated and better understood. The international leads are Karina Top (Canada) and Bob Chen (United States).
Objectives
INSIS aims to promote confidence in the safety of vaccines. Implementing standardised case definitions and protocols can assist with identifying unique molecular signatures and biomarkers associated with rare adverse events following immunisation (AEFI) and improve our understanding of the genetic basis for adverse events (eg. thrombosis with thrombocytopenia syndrome and myocarditis/pericarditis following COVID-19 vaccines). By determining the causes of AEFI and identifying individual risk factors for experiencing AEFIs, it can develop recommendations for the safest way to immunise individuals with a history of or those identified as at higher risk of experiencing an AEFI. This improved understanding will also help in vaccine safety communication and the development of resources through leading websites such as MVEC.
SAEFVIC, in collaboration with AEFI-CAN, leads Australia’s involvement with INSIS.
Funding
INSIS is funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the Canadian Institutes of Health Research (CIHR) and IWK Health Centre.
Resources
- International Network of Special Immunization Services
- MVEC: SAEFVIC
- MVEC: AusVaxSafety
- MVEC: AEFI-CAN
- MVEC: Adverse event reporting Australia
Authors: Rachael McGuire (MVEC Education Nurse Coordinator) and Nigel Crawford (Director, SAEFVIC, Murdoch Children’s Research Institute)
Date: March 9, 2023
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.
Immune thrombocytopenia (ITP)
Background
Immune thrombocytopenia, also previously known as idiopathic thrombocytopenia purpura (ITP), is an uncommon autoimmune condition in which the body’s own immune system attacks platelets (the cells found in the blood which normally help the blood to clot). In ITP, the body produces antibodies which attack and destroy platelets, which decreases their number and can cause symptoms such as bruising, pin-point red spots (petechiae) on the skin or bleeding (e.g. nose bleeds or bleeding from the gums). Some people have no symptoms at all.
ITP is most often triggered by a viral illness, occurring in the weeks prior to symptoms developing. ITP can be acute (lasting less than 6 months) or chronic (lasting longer than 6 months), with acute ITP far more common in children and chronic ITP far more common in adults. The symptoms of acute and chronic ITP are the same. Approximately one in every 10,000 child will be affected by ITP.
Some cases of ITP are discovered by chance. In some instances, ITP may go away without any treatment. However, when platelets are very low or there are symptoms of bleeding treatment may be needed. Corticosteroids and intravenous immunoglobulin are the most common forms of initial treatment.
ITP and measles, mumps and rubella vaccines (MMR)
MMR vaccines have been associated with ITP, with the risk estimated at approximately 1 in 25,000 vaccinations. However, the risk of ITP following MMR vaccine is much lower than the risk seen with natural measles or rubella infections. Patients with a history of ITP are still recommended to receive the MMR vaccine in line with the National Immunisation Program (NIP) as although there is a small risk of relapse, this risk is still present with the viruses themselves, and it is important that people are protected against these viruses which can cause significant morbidity and mortality.
ITP and COVID-19 vaccines
A link between COVID-19 vaccines and ITP is currently being investigated. This is because of the known link between MMR vaccine and ITP, and also because ITP can be triggered by COVID-19 infection. A study in Scotland reported a link between Vaxzevria (AstraZeneca) and ITP, with rates seen post vaccination higher than background rates of ITP in the community . To date, there has been no association found between mRNA COVID-19 vaccines (Comirnaty or Spikevax) and ITP. Monitoring and investigations are and underway in Australia.
Should patients with a history of ITP receive COVID-19 vaccines?
Yes. The effect of COVID-19 vaccination on pre-existing ITP (acute and chronic) has not been well characterised. Limited and early data indicates that vaccination may worsen thrombocytopenia in approximately 10% of patients with chronic ITP post vaccination. However, it is important to note that ITP is most often triggered by a virus, and that the risk of relapse or worsening of ITP is likely higher if these patients contract COVID-19 than the risk following vaccination itself. Patients with a history of ITP are therefore recommended to proceed with vaccination, however, if clinical symptoms worsen post vaccination (days to weeks) then monitoring of platelets and escalation of therapy may be required.
Can patients who develop ITP following a dose of COVID-19 vaccine receive future doses?
Yes. Patients who develop ITP following receipt of a COVID-19 vaccine can receive future doses (including booster doses) once they are advised that it is safe to do so. Vaccination should be deferred until platelets are stable (>50 x 109/L and off any ITP treatment for >3 months). If a patient remains on immunosuppression (eg. corticosteroids) they should discuss with a heamatologist whether to proceed.
If a patient (> 18 years) has ITP following a dose of Vaxzevria (AstraZeneca), they should receive an mRNA vaccine (eg. Comirnaty or Spikevax) or Nuvaxovid (Novavax) for their subsequent doses. If a patient has ITP following the first dose of an mRNA vaccine or Nuvaxovid they should proceed with the second dose of the same vaccine, as no association has been found between these vaccines and ITP to date. There remains a risk of relapse regardless of vaccine brand, however this risk of relapse is higher with COVID-19 disease itself. Close monitoring should occur following vaccination with dose 2 to ensure that there is no further drop in platelets.
ITP and other vaccines
There are some small studies or case reports which suggest a possible increased risk of ITP and other vaccines, such as influenza, HPV, polio and pneumococcal vaccines. However, to date, no vaccines have been proven to be associated with ITP other than the MMR and Vaxzevria (AstraZeneca) vaccines described above. People with a history of ITP are safe to receive all routine NIP and travel vaccines as required.
Resources
- Miller E, Waight P, Farrington CP, Andrews N, Stowe J, Taylor B. Idiopathic thrombocytopenic purpura and MMR vaccine. Arch Dis Child. 2001;84(3):227-9
- Black C, Kaye JA, Jick H. MMR vaccine and idiopathic thrombocytopaenic purpura. Br J Clin Pharmacol. 2003;55(1):107-11
- Bhattacharjee S, Banerjee M. Immune Thrombocytopenia Secondary to COVID-19: a Systematic Review. SN Compr Clin Med. 2020:1-11
- Simpson CR, Shi T, Vasileiou E, Katikireddi SV, Kerr S, Moore E, et al. First-dose ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland. Nat Med. 2021;27(7):1290-7
- Rinaldi M, Perricone C, Ortega-Hernandez OD, Perricone R, Shoenfeld Y. Immune thrombocytopaenic purpura: an autoimmune cross-link between infections and vaccines. Lupus. 2014;23(6):554-67
- Garbe E, Andersohn F, Bronder E, Salama A, Klimpel A, Thomae M, et al. Drug-induced immune thrombocytopaenia: results from the Berlin Case-Control Surveillance Study. Eur J Clin Pharmacol. 2012;68(5):821-32
Authors: Sally Gordon (VicSIS Manager, Department of Health), Paul Monagle (Clinical Haematologist, Royal Children’s Hospital), Francesca Machingaifa (MVEC Education Nurse Coordinator), Rachael McGuire (MVEC Education Nurse Coordinator) and Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute)
Reviewed by: Paul Monagle (Clinical Haematologist, Royal Children’s Hospital), Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute) and Rachael McGuire (MVEC Education Nurse Coordinator)
Date: July 21, 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.
Influenza
What is it?
Influenza viruses are single stranded RNA orthomyxoviruses which can cause acute viral infections of the respiratory tract. Infections are often classified according to the type of influenza virus responsible for the infection, typically A, B, or C. Influenza types A and B are more commonly responsible for causing severe disease. Influenza A can be further subtyped based on the differences in surface antigens.
What to look for
The incubation period of influenza disease is 1-4 days with typical symptoms including fever, headache, myalgia (muscle aches), lethargy (tiredness), coryza (runny nose), sore throat and cough. Gastrointestinal symptoms such as nausea, vomiting and diarrhoea can also occur. Children with influenza will often present with symptoms of croup.
Most influenza infections will resolve within 2-7 days. However, complications including otitis media (ear infections), secondary bacterial pneumonia (lung infections) and encephalitis (brain inflammation) can prolong the illness and disease outcomes.
How is it transmitted
Influenza is highly contagious. Transmission is via respiratory droplets, aerosol or through direct contact with the respiratory secretions of an infected person.
Epidemiology
Influenza disease can occur as sporadic cases, as an epidemic, or as a pandemic. Whilst outbreaks more commonly occur in the winter months in temperate climates, there is a greater variation seen in the timing of cases in the tropics.
Aged care facilities, health care facilities and child care centres are well recognised as high-risk areas for influenza outbreaks.
Pregnant women, children < 5 years of age, those aged > 65 years, people with underlying medical conditions, and Aboriginal and Torres Strait Islander peoples carry the highest rates of morbidity and mortality within Australia.
Prevention
Influenza vaccination is available and recommended for anyone ≥ 6 months of age who wish to be protected against influenza disease and its complications. Due to the circulating strains of influenza virus changing each year, vaccination is recommended annually to provide the most effective protection against disease.
Influenza vaccines are provided for free on the National Immunisation Program (NIP) for high-risk groups, including:
- children aged 6 months to < 5years
- people aged ≥ 6 months of age with certain medical risk factors
- all adults ≥ 65 years of age
- pregnant women (at any stage of pregnancy)
- all Aboriginal & Torres Strait Islander people ≥ 6 months of age.
Those aged 5 years and over who do not qualify for funded vaccines can purchase vaccines privately through some councils, GPs and pharmacies.
Vaccine platform
The influenza vaccines available in Australia are inactivated, meaning that they cannot replicate and cause influenza disease. They can be cell-based or egg-based depending on how they are manufactured.
Traditional influenza vaccines are made by cultivating influenza viruses in chicken eggs. Cell-based influenza vaccines are made by growing influenza viruses in animal cells lines (canine kidney). By using a cell-based platform, influenza vaccines have the potential to provide protection against influenza strains that are more closely matched to the circulating influenza strains in the community.
Cell-based influenza vaccines have been used internationally since 2012 and in 2021 a cell-based influenza was registered for use within Australia for the first time. Flucelvax quad® is available for private purchase for immunisation of those aged ≥ 2 years.
In 2023 the influenza virus strains included in the seasonal influenza vaccines are the same for both cell-based and egg-based vaccines:
- A/Sydney/5/2021 (H1N1) pdm09-like virus
- A/Darwin/9/2021 (H3N2)-like virus
- B/Austria/1359417/2019-like (B/Victoria lineage)-like virus
- B/Phuket/3073/2013-like (B/Yamagata lineage)-like virus
Adjuvanted vaccines
Due to a gradual decline in effectiveness of the immune system of older people (a process known as immunosenescence) immunity following vaccination with standard influenza vaccines can be suboptimal. In addition, those aged ≥ 65 years have the highest rates of influenza disease burden and associated complications including pneumonia and death. Therefore, adjuvanted influenza vaccines are the preferred vaccine type for the older population.
There are two adjuvanted influenza vaccines registered for use in Australia:
- Fluad® Quad- registered for use in adults ≥ 65 years and funded under the NIP
- Fluzone High-Dose Quad- registered for use in individuals aged ≥ 60 years and privately available on prescription.
Table 1: The 2023 influenza vaccine brand recommendations according to age
Age Group | Vaccine brand and dose | |||||||
Vaxigrip Tetra® (0.5 ml) | Fluarix® Tetra (0.5 ml) | Afluria® Quad (0.5 ml) | FluQuadri® (0.5ml) | Influvac® Tetra (0.5ml) | Flucelvax® Quad (0.5ml) | Fluad® Quad (0.5ml) | Fluzone High-Dose Quad (0.7ml) | |
< 6 months | ||||||||
6 months - < 2 years | ✓*^ | ✓*^ | ✓*^ | ✓*^ | ||||
≥ 2 - < 5 years | ✓*^ | ✓*^ | ✓*^ | ✓*^ | ✓*^ | |||
≥ 5 - < 60 years | ✓*^ | ✓*^ | ✓*^ | ✓*^ | ✓*^ | ✓*^ | ||
≥ 60 - < 65 years | ✓^ | ✓^ | ✓^ | ✓^ | ✓^ | ✓^ | ✓# | |
≥ 65 years | ✓β^# | ✓β^# | ✓β^# | ✓β^# | ✓β^# | ✓β^# | ✓# | ✓# |
* 2 doses, minimum of 4-weeks apart should be given to children < 9 years of age in the first year of receiving the influenza vaccine, a single dose is recommended in subsequent years.
#Adjuvanted quadrivalent influenza vaccines are preferentially recommended for people adults ≥ 65 years.
βFluarix-tetra®/FluQuadri®/Afluria Quad®/Vaxigrip tetra®/Influvac tetra®/ Flucelvax Quad® are registered for use in those aged ≥ 65 years however adjuvanted vaccines are the preferred vaccines for this age group.
^2 doses are recommended in the first year following SOT/HSCT regardless of history of influenza vaccination due to immunosuppression. The exception to this is in individuals receiving an adjuvanted influenza vaccine where only 1 dose is recommended.
shaded boxes indicate vaccines funded under the NIP for eligible individuals.
shaded boxes not registered for use in this age group.
shaded boxes indicate adjuvanted vaccines.
Expected side effects
Common side effects following vaccination include pain, redness and swelling at the injection site as well as fever, malaise and myalgia. Symptoms usually occur within the first 24-48 hours following immunisation.
Cell-based influenza vaccines have a similar side-effect profile to traditional egg-based influenza vaccines. Side effects may occur slightly more commonly following immunisation with adjuvanted quadrivalent formulations than with standard influenza vaccine formulations.
Commonly asked questions
When is the ideal time to be immunised against the flu?
Annual vaccination before the onset of influenza season is recommended for all individuals ≥ 6 months of age. The peak period of circulating influenza disease in Australia is typically June to September. However, out of season cases can and do occur. Optimal protection against influenza occurs within the first 3-4 months following vaccination. It is never too late in the season to vaccinate.
Pregnant women can safely receive the influenza vaccine during any stage of pregnancy. Where a pregnancy crosses over seasons, some pregnant women may be recommended to receive 2 influenza vaccines, one from each year.
Do healthy people need to be immunised against influenza?
Influenza can be a very serious disease resulting in hospitalisation and death. Even in cases where disease and its complications are not severe, it can cause a great inconvenience for the individual, including the cost of GP visits and medications, as well as time off work for themselves or to care for their sick child.
In some cases, a person may not get severe disease but infection can be spread to other people. This can be significant when it is spread to those who are too young to be immunised or are at higher risk of complications of disease.
If an individual has had confirmed influenza disease this year, are they still recommended to receive an influenza vaccine and when should they receive it?
The influenza vaccine would still be recommended for someone with a history of confirmed influenza infection as the vaccine protects against multiple strains of influenza disease. The influenza vaccine can be administered as soon as the patient has recovered from their illness.
Can the influenza vaccine be given at the same time as other vaccines?
Generally speaking, yes, influenza vaccines may be co-administered with most other vaccines on the same day. This includes live-attenuated vaccines (eg. measles and varicella) and the pertussis vaccine in pregnancy.
COVID-19 vaccines can safely be co-administered with influenza vaccines. However, in children aged 6 months – 5 years of age, an interval of 7-14 days is preferred to minimise adverse events such as fever.
If a patient received a 2022 influenza vaccine at the end of the season in early 2023, do they still need a 2023 influenza vaccine?
Yes. A 2023 influenza vaccine is still recommended in order to provide protection against this year’s circulating strains. A minimum interval of 4 weeks is recommended.
In children < 9 years of age who received the influenza vaccine for the first time last year but only received 1 dose, how many doses are required this year?
Only 1 dose is required in this instance. 2 doses of the influenza vaccine are recommended for children < 9 years of age in the first year of receiving the vaccine. However, if the second dose was inadvertently missed, it does not require catch up and only 1 dose is required in future years.
Are influenza vaccines safe for people with allergies?
Based on prospective and retrospective studies of influenza vaccination in those with and without egg allergy (including egg anaphylaxis), the presence of egg allergy does not increase the risk of allergic reactions to the influenza vaccine. Egg-based influenza vaccines can be administered in community vaccination clinics (which may or may not have direct medical practitioner supervision), General Practitioner surgeries or immunisation clinics as a single dose followed by the recommended 15 minute observation period. It is not necessary to preferentially administer cell-based influenza vaccines in this patient group.
All influenza vaccines available under the NIP in 2023 are latex free meaning that people with a latex allergy can safely be vaccinated.
For further queries on influenza vaccination, please contact us via our immunisation support.
Resources
- ATAGI advice on seasonal influenza vaccines in 2023
- TGA: AIVC recommendation for the composition of influenza vaccine for Australia in 2023
- Department of Health: Seasonal influenza vaccine
- Australian Immunisation Handbook: Influenza
- Australasian Society of Clinical Immunology and Allergy: Vaccination of the egg allergic individual
- MVEC: Maternal vaccination during pregnancy
Authors: A/Prof Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute), Rachael McGuire (Research Nurse SAEFVIC, Murdoch Children’s Research Institute), Georgina Lewis (Clinical Manager SAEFVIC, Murdoch Children’s Research Institute) and Mel Addison (Research Nurse SAEFVIC, Murdoch Children’s Research Institute).
Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator).
Date: October 29, 2023
Materials in this section are updated as new information becomes available. The Melbourne Vaccine Education Centre (MVEC) staff regularly review 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.
Immunisation recommendations for the older population
There are a variety of factors that need to be considered in relation to the vaccination of the older population. A gradual decline of the immune system occurs as people age (known as immunosenescence), impacting how the immune system responds to new infections, as well as the effectiveness of long-term immune memory. It is for this reason that some vaccines are specifically designed for the older population and aim to enhance the immune response by using higher immunogenicity formulations or by containing adjuvants. Providing optimal protection can also be complicated due to the increasing prevalence of multiple co-morbidities in the ageing population. Specific medical conditions or targeted therapies (eg. chronic renal conditions, chemotherapy for cancers etc) can also cause older adults to be more vulnerable to infections and their complications. Further to this, relying on patient recall, as well as a lack of awareness for the recommended vaccines for the older population, can result in either missed vaccines or additional unnecessary doses being administered.
There are multiple vaccines recommended for the older population as outlined below.
Herpes zoster (Shingles) vaccines
Shingles is caused by a reactivation of the varicella virus and will occur in approximately 20-30% of people in their lifetime. Older people (> 70 years of age) are more likely to suffer post-herpetic neuralgia (PHN) following a shingles infection than younger people. PHN is a chronic neuropathic pain which can affect 1 in 4 cases of shingles diagnosed in those > 80 years. It can persist for months to years with pain control being difficult to manage, impacting quality of life.
There are currently 2 vaccines available in Australia for the prevention of shingles:
- Zostavax®- a live-attenuated vaccine
- Shingrix®- an adjuvanted recombinant varicella zoster virus glycoprotein E (gE) subunit (non-live) vaccine
Zostavax®
Zostavax® has been shown to reduce the incidence of developing shingles by up to 50%, as well as the incidence of PHN in those ≥ 60 years of age by 66%. It is currently funded under the National Immunisation Program (NIP) for persons aged 70 years, with a catch-up program for those aged 71–79 years also funded (until October 2023). As it is a live-attenuated vaccine, it is contraindicated for use in those who are immunosuppressed, or on immunosuppressive medications (eg; Rituximab, Azathioprine, Prednisolone, chemotherapy etc). Prior to administering Zostavax® it is important to take a thorough patient history to determine suitability for immunisation.
Shingrix®
Shingrix® is preferred over Zostavax® for the prevention of shingles due to a higher efficacy, particularly in the older population. In those aged ≥ 50 years, Shingrix® provided 97% protection against shingles in immunocompetent individuals and 91% protection in those aged > 70 years. Clinical trials have demonstrated high efficacy up to 4 years following vaccination with immunogenicity data indicating this is likely to persist beyond 10 years.
Shingrix® is registered for use in adults aged ≥ 50 years. It is only available through private prescription and supplies are currently limited. It is a non-live vaccine and as such can safely be administered to immunocompromised individuals. ATAGI recommends a 7 day interval between the administration of COVID-19 vaccines and Shingrix®, and prefers that FluadQuad and Shingrix® are not co-administered on the same day.
Further guidance can be provided by reviewing the Australian Immunisation Handbook: Table. Live shingles vaccine (Zostavax) screening for contraindications or by contacting SAEFVIC prior to immunisation.
Pneumococcal vaccines
Invasive pneumococcal disease (IPD) can manifest as meningitis, pneumonia and bacteremia, with severe disease requiring hospitalisation, causing significant morbidity and even death. The elderly (along with infants) are at the highest risk of developing IPD. Recommendations for pneumococcal vaccines in adults vary according to age and medical condition [refer to ATAGI clinical advice on vaccination recommendations for people with risk conditions from 1 July 2020]. Pneumococcal vaccines are currently provided for free on the NIP for the following people:
- Aboriginal and Torres Strait Islander adults with NO risk condition – 1 dose of Prevenar 13® at 50 years of age, followed 8 weeks later by 2 doses of Pneumovax® 23, given 5 years apart
- Non-indigenous adults with NO risk condition – 1 dose of Prevenar 13® at >70 years
- Non-indigenous adolescents/adults diagnosed with a risk condition – 1 dose of Prevenar 13® at diagnosis, followed by 2 doses of Pneumovax® 23, given 5 years apart
In adults, injection site reactions may occur > 3 days following the Prevenar 13® dose given at > 70 years, particularly in those who have previously received Pneumovax®23. A history of large local injection site reactions following previous pneumococcal vaccines is not a contraindication to further doses.
Refer to MVEC: Pneumococcal for more information.
Influenza vaccines
For older adults, and those with certain medical conditions (eg. chronic lung disease, cardiac disease, immunosuppression), influenza disease can cause serious morbidity and mortality. Annual influenza vaccination is strongly encouraged and it is available for free on the NIP for those ≥ 65 years of age and/or adults with certain medical conditions. Due to a reduced immune response to routine influenza vaccines, those aged ≥ 65 years should receive higher-immunogenicity influenza vaccines.
Refer to MVEC: Influenza for specific information on brands and dosing.
COVID-19 vaccines
Older people and those with comorbidities (eg. hypertension, diabetes, chronic lung disease etc) are much more likely to suffer from severe COVID-19 disease if infected. Of those who are > 80 years of age and have COVID-19 disease, approximately 1 in 3 will die from it.
COVID-19 vaccination requires a 2-dose primary course for immunocompetent individuals, or a 3 -dose primary course for those with immunocompromise. A primary course shoulod be followed by a booster dose ≥ 3 months later, and a further “winter booster” dose ≥ 3 months after that for select individuals.
For more information on COVID-19 vaccination for older people please refer to COVID-19 vaccination – COVID-19 vaccination decision guide for frail older people, including those in residential aged care facilities.
Considerations for residents of residential aged care facilities (RACF)
Whilst every effort should be made to immunise residents of RACF at risk of vaccine preventable diseases like COVID-19 and influenza, it is important to monitor for adverse events following immunisation (AEFIs). Due to a high incidence of cognitive impairment, elderly residents may not have capacity to self-report any side effects. Any AEFIs experienced within 5 days of vaccination should be reported to SAEFVIC. It is important to monitor for non-specific symptoms seen in the elderly population when unwell such as falls, delirium, functional decline, decrease/loss of appetite or changes in mood/behaviour.
For further information on additional cares that may be required and management of symptoms following vaccination in residents of RACF refer to Guidance for vaccination care of residents of Victorian Residential Aged Care Facilities.
Reporting to the Australian Immunisation Register (AIR)
The AIR provides a record of all vaccine doses given, the date of administration as well as the specific brands used. Since 2016 vaccines administered to Australians of any age have been recorded onto the AIR. Patient recall, particularly in the older population, is not reliable and as such it important that immunisation records are accurately maintained and reviewed regularly.
From March 2021, new legislation came into effect making reporting vaccines to AIR mandatory. This includes all COVID-19 vaccines, influenza vaccines and all National Immunisation Program vaccines.
Resources
- Australian Government Department of Health: Immunisation for Seniors
- MVEC: Influenza
- MVEC: Zoster
- MVEC: Pneumococcal disease and vaccines
- MVEC: COVID-19 vaccines: Frequently asked questions
- MVEC: Australian Immunisation Register
- COVID-19 vaccination – COVID-19 vaccination decision guide for frail older people, including those in residential aged care facilities
- Guidance for vaccination care of residents of Victorian Residential Aged Care Facilities
- Aw D. Silva B. and Palmer D. Immunosenescence: emerging challenges for an ageing population Immunology 2007 Apr; 120(4): 435–446
- Gustafson C. Kim C. Weyand C. Goronzy J Influence of immune aging on vaccine responses Journal of Allergy and Clinical Immunology 2020 May; 145(5): 1309–1321
Authors: Daryl Cheng (Paediatrician, The Royal Children’s Hospital), Francesca Machingaifa (MVEC Education Nurse Coordinator) and Rachael McGuire (MVEC Education Nurse Coordinator)
Reviewed by: Francesca Machingaifa (MVEC Education Nurse Coordinator)
Date: August 5, 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.
Identifying AEFI in diverse skin colour
Background
The assessment of skin for clinical signs and symptoms is important when identifying adverse events following immunisation (AEFI). Most dermatological assessment guidelines commonly refer to the presentation of symptoms in patients with light skin tones.
The skin is one of the most complex organs in the body. It consists of 3 layers, with each layer performing different roles. The colour of a person’s skin is influenced by the amount of melanin (natural pigment) which is produced by the melanocytes located in the epidermis (outer layer of the skin), with darker toned skin having more melanin present than lighter toned skin. The amount of melanin will affect the appearance of AEFI on a patient’s skin and therefore AEFI, such as pallor, cyanosis, erythema and urticaria, may appear differently in varied skin tones. This can pose a challenge for immunisation providers to identify symptoms of AEFI in a timely manner.
Pallor
Pallor refers to the pale appearance of the skin, nail beds and mucous membranes. Pallor is not always a symptom of disease.
Pallor may be difficult to detect in dark toned skin and may present as ashen or grey. In brown toned skin the skin will present more yellowish in colour. An alternative method for identifying pallor in darker skin tones can be assessing the palmer surface which can appear paler.
Following immunisation, pallor can be noted in events such as vasovagal syncope (fainting) and hypotonic hypo-responsive episodes (HHE).
Cyanosis
Cyanosis is a symptom of decreased oxygen in the bloodstream. There are 2 types of cyanosis:
- Peripheral cyanosis, which is observed in the extremities including hands, fingertips and feet.
- Central cyanosis, which is detected in central parts of the body including head, torso and mucous membranes and is often more serious.
In those with light skin tones, cyanosis will present as a bluish/purple hue. In patients with naturally yellow toned skin, cyanosis may cause a grayish-greenish appearance. In those with darker skin tones, cyanosis may be trickier to assess and may be observed as grey or white.
Following immunisation, cyanosis may occur in the setting of a HHE, apnoea, breath holding episode or high fever.
Erythema
Erythema describes a red appearance of skin caused by the dilation of superficial blood vessels and increased blood flow. It often occurs with skin trauma, inflammation, infection or rash.
Erythema is clearly visible on light toned skin. It may appear red or cause a purplish discoloration on some darker toned skins however it is difficult to see on very dark skin. Assessing the affected site or area for other signs including warmth, swelling or induration can assist in clinical assessment and diagnosis of erythema.
Following immunisation, erythema can be widespread or localised at the injection site.
Urticaria
Urticaria, or hives, occur when the mast cells that lie within the skin release histamine that irritates nerve endings and causes local blood vessels to dilate and leak fluid. They can appear anywhere on the body and can be transient in nature. The cause is often not known however, they may be associated with infections or allergy.
On light toned skin, hives appear as itchy, raised red welts. They often have a white center or wheal which looks like a mosquito bite and are surrounded by an erythematous ring. In darker toned skin, hives appear as raised lumps however the colour changes to the skin may not be as obvious.
Following immunisation, hives can occur anywhere on the body and may occur in the setting of an allergic reaction.
Resources
Images
Other resources
- DermNetNZ: Ethnic dermatology
- Australasian Society of Clinical Immunology and Allergy: Urticaria
- Ortonne, J. Normal and abnormal skin colour, Annales de Dermatologie et de Venereologie December 2021 (139):S125-S129
- Sommers, M. Color Awareness: A must for patient assessment, American Nurse, January 2011
- The Dermatologist: Identifying erythema in skin of colour
Authors: Georgina Lewis (Clinical Manager SAEFVIC, Murdoch Children’s Research Institute), Mel Addison (SAEFVIC Research Nurse, Murdoch Children’s Research Institute), Francesca Machingaifa (SAEFVIC Research Nurse, Murdoch Children’s Research Institute) and Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute)
Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator)
Date: May 31, 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.
Injection site nodules
The development of a nodule at the injection site is a known but rare adverse event following immunisation (AEFI). Nodules are defined as the presence of a palpable, firm, discrete or well-demarcated soft tissue lump at the site of immunisation in the absence of heat, erythema (redness) or signs of abscess.
Nodules can occur following any vaccine. They usually present in the days or weeks following immunisation and are most often reported following vaccines given in infancy or childhood. A nodule can persist for weeks and sometimes months. They are usually asymptomatic but can be tender and/or itchy. They are often reported by parents to feel like a ‘pea’ size lump under the skin. They usually resolve spontaneously without treatment or investigation.
It is unclear what causes a nodule however, vaccine components (e.g. aluminium), local inflammatory reactions or immune-mediated responses have been implicated as possible contributing factors.
Very rarely, a nodule may persist and become symptomatic for the vaccinee (see rare or persisting subcutaneous nodules below).
Implications and considerations for future vaccines
It is recommended that future vaccines continue to be given according to the immunisation schedule. The history of, or presence of, a nodule is not a contraindication to future vaccines.
Ensure correct vaccine administration for both intramuscular and subcutaneous vaccines. Deep intramuscular (IM) injection for IM vaccines should be considered to minimise the risk of potential recurrence of a nodule. Where possible, avoid vaccination at a site of an existing nodule.
Rare or persisting subcutaneous nodules
Some nodules can become symptomatic and last for months or even years and are referred to as persisting subcutaneous nodules. Pruritus (itch) is the most concerning symptom that motivates parents to seek medical attention. Ongoing pruritus can alter the appearance of the skin leading to excoriation, hair growth and pigmentation changes. Intensified itching and a change in size of the nodule has been reported when a child is unwell with a viral infection or even following subsequent vaccinations given at a different anatomical site.
Treatment of persisting subcutaneous nodules
A conservative approach to treatment is recommended and is usually to provide symptomatic relief of pruritus. Any treatments would need to be provided following medical review and can include topical corticosteroids or dressings to protect the area from rigorous scratching. Referral to a Specialist Immunisation Clinic should be considered for specialist consultation.
Any AEFI should be reported to the vaccine safety service in your state. In Victoria reports can be made to SAEFVIC.
Resources
- Rothstein. E, et al Nodule at injection site as an adverse event following immunization: case definition and guidelines for data collection, analysis and presentation, Vaccine 2004 (22): 575-585
- Silcock, R. et al Subcutaneous nodules following immunization in children; in Victoria, Australia from 2007 to 2016, Vaccine 2020 (38): 3169-3177
- Silcock, R. et al Subcutaneous nodules: an important adverse event following immunization, Expert Review of Vaccines 2019 (18): 405-410
- Bergfors, E. Lundmark, K. Kronander, U. A child with a long-standing, intensely itching subcutaneous nodule on a thigh: an uncommon (?) reaction to commonly used vaccines, BMJ Case Reports 2013:bcr2012007779
- MVEC: Injection site reactions
Authors: Mel Addison (SAEFVIC Research Nurse, Murdoch Children’s Research Institute), Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute) and Georgina Lewis (Clinical Manager, SAEFVIC, Murdoch Children’s Research Institute)
Reviewed by: Mel Addison (SAEFVICResearch Nurse, Murdoch Children’s Research Institute)
Date: October 18, 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.
Immunosuppression and vaccines
Background
Immunosuppression (also known as immunocompromise) occurs when a person’s immune system is weakened, resulting in a decreased ability to fight infections. Causes of immunosuppression may include having certain medical conditions (e.g., autoimmune disease, cancer, transplants, functional or anatomical asplenia, advancing age and HIV) or taking specific medications (e.g., corticosteroids, disease-modifying antirheumatic drugs [DMARDs] or cancer therapies).
Vaccination is particularly important for those who are immunosuppressed due to the increased risk of developing severe disease (hospitalisation/intensive care admission, death) if exposed to vaccine-preventable diseases. Protection from vaccines can be suboptimal in this patient group and therefore additional doses of vaccines may be recommended. Conversely, some vaccines (live-attenuated vaccines) may be contraindicated due to the potential risk of vaccine-related disease.
Taking a thorough patient history prior to vaccination is recommended to determine an individual’s degree of immunosuppression and to formulate their individual vaccination strategy.
Vaccination timing
Vaccination may need to be planned with the treating specialist. In some instances, the timing of immunosuppressive therapies may be altered to increase the response to vaccines. In other circumstances, the intervals between vaccine doses may be altered to accommodate treatment regimes.
In some instances, vaccines can be given pre-emptively to people who anticipate immunosuppression in the future (e.g., a patient undergoing a planned splenectomy should be immunised prior to surgery).
Recommended vaccines
Inactivated vaccines are safe to administer to the immunocompromised individual but efficacy may be reduced.
Influenza
Annual influenza vaccination is recommended for all immunosuppressed patients.
Those < 9 years of age are recommended to receive 2 doses of influenza vaccine, administered a minimum of 4 weeks apart, in the first year of receiving an influenza vaccine. Transplant recipients (solid organ or haematopoietic stem cell) should also receive 2 doses of influenza vaccine, a minimum of 4 weeks apart, in the first year following their transplant. This is regardless of age or previous influenza vaccine history.
Where a major shift in the circulating influenza virus occurs, such as in an influenza pandemic situation, 2 doses a minimum of 4 weeks apart, could be considered regardless of patient age or immunisation history to ensure optimal immune response.
Pneumococcal
The timing of vaccination, the number of doses recommended, and the type of vaccine (conjugate or polysaccharide) depends on a person’s age and underlying risk for invasive pneumococcal disease (IPD).
Meningococcal
Those taking certain therapies or with specific medical conditions (particularly those with asplenia) are recommended to receive a primary course of meningococcal B and ACWY vaccines. Following this, booster doses are recommended for some individuals with specified medical conditions or treatment that increase their risk of invasive meningococcal disease (IMD).
COVID-19
COVID-19 vaccination is strongly recommended for all immunosuppressed individuals aged 6 months and over due to an increased risk of developing severe disease. A 3-dose primary course is recommended for optimal protection (compared with a 2-dose course for those who are immune competent). Following a primary course, booster doses are also recommended in those aged ≥ 18 years. Children and adolescents aged 5-17 years of age with comorbidities that increase their risk of severe COVID-19 disease (including immunosuppression) should also consider a booster dose.
Contraindicated vaccines
Live-attenuated vaccines are contraindicated for most immunosuppressed individuals due to the risk of adverse events or vaccine-related disease. In some instances, an alternate inactivated vaccine may be available for use (see table 1).
Table 1: Contraindicated vaccines in immunosuppressed patients and alternative options to consider
Disease | Contraindicated vaccine brands (live-attenuated vaccines) | Alternate vaccine brands (inactivated vaccines) |
Japanese encephalitis¥ | Imojev® | JEspect® |
MMR (measles-mumps-rubella)^ | Priorix®, M-M-R II® | N/A |
MMRV (measles-mumps-rubella-varicella)^ | Priorix-tetra®, ProQuad® | N/A |
Mpox¥ | ACAM2000™ | JYNNEOS |
Rotavirus^ | Rotarix® | N/A |
Tuberculosis#¥ | BCG (varying brands) | N/A |
Typhoid¥ | Vivotif® | Typhim®, Vivaxim® (in combination with hepatitis A) |
Varicella¥ | Varivax®, Varilrix® | N/A |
Yellow fever¥ | Stamaril® | N/A |
Zoster^ | Zostavax® | Shingrix®§ |
^routinely administered on the National Immunisation Program (NIP)
#recommended vaccine for select patient group only
¥available vaccine for those at higher risk of infection (eg. travel)
§not on NIP but available at cost
N/A no alternate vaccine available
Inadvertent administration of a live-attenuated vaccine
If an immunosuppressed patient is inadvertently administered a live-attenuated vaccine prompt action is required. Medical review by an infectious diseases specialist or immunisation expert must be facilitated and the appropriate management commenced (e.g., anti-viral therapy, monitoring etc.).
The patient must be informed of the incident and have a clear understanding of its implications, including any signs and symptoms to monitor for [refer to resources for guidance]. The error must also be reported to the relevant authority to ensure appropriate follow up and support can be provided. In Victoria, this service is SAEFVIC.
If the error occurs out of hours, seek specialist advice from the patient’s treating specialist or an infectious diseases specialist at your local tertiary hospital.
Precautions
Mothers who are receiving immunosuppressive therapy and breastfeeding (or those who received immunosuppressive medication during pregnancy) should seek advice from a Specialist Immunisation Clinic around the safety of live-attenuated vaccines for their child (e.g., oral rotavirus vaccine or BCG).
Household contacts
Household contacts of immunosuppressed individuals should be up to date with all vaccines and are recommended to receive annual influenza vaccination as well as COVID-19 vaccines.
It is safe for household contacts to receive live-attenuated vaccines (including rotavirus and varicella). Thorough hand hygiene should always be performed when handling soiled nappies of rotavirus vaccine recipients to minimise the risk of vaccine-virus transmission. Any varicella-like blisters that occur on the vaccinee following varicella vaccination should be covered until they crust over.
Resources
- MVEC: Asplenia
- MVEC: Zoster
- MVEC: Solid organ transplant recipient: pre-transplant immunisation recommendations
- MVEC Cancer immunisation guideline: vaccine recommendations following chemotherapy and haematopoietic stem cell transplant
- MVEC: Immunisation recommendations for the older population
- Australian Immunisation Handbook: Vaccination for people who are immunocompromised
- MVEC eLearning course: Vaccine errors: Prevention, management and open disclosure [for providers]
Authors: Georgina Lewis (Clinical Manager, SAEFVIC, Murdoch Children’s Research Institute), Francesca Machingaifa (MVEC Education Nurse Coordinator) and Rachael McGuire (MVEC Education Nurse Coordinator)
Reviewed: Rachael McGuire (MVEC Education Nurse Coordinator) and Georgina Lewis (Clinical Manager, SAEFVIC, Murdoch Children’s Research Institute)
Date: May 3, 2023
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.
Injection site reactions
Background
Swelling, redness (erythema), pain and itch at the site of injection can be a common side effect from any vaccine. Symptoms are usually mild and localised to the site of vaccination, with onset commonly occurring within the first 48 hours of vaccination and symptoms lasting 1-2 days. In some cases however, injection site reactions (ISRs) can be more significant, last up to a week, or have delayed onset.
Severe injection site reactions
Severe ISRs can present with pain, erythema and induration (hard, tight swelling) which extends from “joint to joint” (e.g., from the shoulder joint to the elbow joint) or “crossing joints” (e.g., swelling that passes over at least one joint). Localised itch is also often reported. Resolution of these symptoms usually occur within 5-7 days with no long-term sequelae. Most affected individuals do not experience a high grade fever and remain systemically well.


Delayed injection site reactions following COVID-19 vaccines
Delayed ISRs have been reported to occur following COVID-19 vaccination. Symptoms commonly present within 4-11 days of vaccination, with a median onset of 8 days and can last 4-5 days.


Injection site reactions following pneumococcal vaccines
Pneumococcal vaccines are administered to both children and adults via the National Immunisation Program (NIP). In children, ISRs are more commonly reported as occurring within 24-48 hours following immunisation. In adults, ISRs may occur >3 days following the 13vPCV dose given at >70years.
Treatment of injection site reactions
ISRs can generally be managed at home with symptomatic relief such as oral analgesia and a cold compress. Immobilising the affected limb should be avoided as movement will enhance lymphatic drainage. Antibiotics and antihistamines are generally not required.
Implications for future doses
In any age group, previous experience of an ISR is not a contraindication to future doses of vaccines and vaccine recipients are encouraged to complete the recommended vaccine schedules. Recurrence of symptoms following future vaccination may occur in some individuals but severity is not likely to be worsened.
Any event felt to be significant following vaccination, including any symptoms which have not gone away after a few days should be reported to SAEFVIC. Providing a photograph of the ISR can assist with SAEFVIC management and advice.
Resources
- MVEC: Adverse Event Reporting Australia
- MVEC: SAEFVIC
- MVEC: Injection site nodules
- Australian Immunisation Handbook: Common AEFIs and how to manage them
Author: Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute)
Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator)
Date: May 30, 2023
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.