Adverse events following COVID-19 immunisation

Background

  • Anyone who experiences a significant reaction following immunisation should first seek medical attention from a health professional
  • While no vaccine is entirely free of potential side effects, the benefits of immunisation far outweigh the risks
  • Severe side effects from vaccines are rare and common side effects are usually mild and short lasting

Should all AEFIs (adverse events following immunisation) following COVID-19 vaccines be reported?

You do not need to routinely report:

  • Common/expected reactions
  • These may include pain, redness, swelling and tenderness at the injection site, tiredness, headache, muscle pain, nausea, fever and chills, feeling unwell, joint pain

You should report:

  • Any event felt to be significant following COVID-19 immunisation, regardless of whether you think the side effect was related to the vaccine or not
  • Any expected reactions that have not gone away after a few days
  • Any reaction to a vaccine which requires assessment by a doctor or nurse
  • Suspected shoulder injury related to vaccine administration (SIRVA)
  • Any vaccination administration errors

COVID-19 AstraZeneca side effects

Common side effects following vaccination with COVID-19 AstraZeneca include swelling, redness, pain or itch at the injection site, joint pain and malaise (feeling unwell). Less common side effects include abdominal pain, dizziness, decreased appetite, pain in limb or enlarged lymph nodes. These side effects are experienced in up to two-thirds of people who receive this vaccine, and mostly resolve within 1-2 days. Symptomatic relief is recommended, i.e. a cool compress at the injection site and simple analgesia such as paracetamol or ibuprofen.

Rare side effects include anaphylaxis and a rare clotting condition, thrombosis with thrombocytopenia (TTS). Symptoms of TTS may include a severe, persistent headache that does not settle with analgesia, abdominal pain, significant respiratory problems/distress, visual changes, vomiting, seizures, focal neurological deficits/changes, confusion/encephalopathy and usually occur 4-20 days after vaccination.

Comirnaty™ (Pfizer/BioNTech) side effects

Common side effects following vaccination with Comirnaty™ include swelling or pain at the injection site, fatigue, headache, myalgia (body aches), fever, chills or joint pain.

Less common side effects include redness or itching at the injection site, nausea, enlarged lymph nodes, malaise (feeling unwell), pain in limb or insomnia. These side-effects are usually mild and last 1-2 days and may require time off work. Systemic reactions are more common following the second dose of the vaccine. Symptomatic relief is recommended, eg. a cool compress at the injection site and simple analgesia such as paracetamol or ibuprofen.

Very rarely, anaphylaxis following Comirnaty™ has been reported.

Can a patient be referred to a specialist immunisation clinic after experiencing AEFI?

The VicSIS network will provide specialist vaccination services for people who have experienced an AEFI with a COVID-19 vaccine, or those who are identified as at risk of an AEFI (for example, people with a history of anaphylaxis). Most people are able to proceed with future vaccines following an AEFI. Clinical consults will be offered in which individual recommendations will be developed. VicSIS clinics will have the ability to vaccinate under extended observation.

For more information on how to refer to VicSIS, please refer to MVEC: The VicSIS (Victorian Specialist Immunisation Services) Network.

Resources

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

Date: April 2021

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.

 

 

 

 

 

 

 

 


AstraZeneca COVID-19 vaccine

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

Type: Viral vector vaccine (chimpanzee adenovirus vector)

Developer: AstraZeneca

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

Doses for Australia: 53.8 million doses, 3.8 million doses from overseas scheduled for delivery to Australia

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

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

Background

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

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

UPDATE: On April 8th 2021, following reported cases of thrombosis with thrombocytopaenia syndrome (TTS) after administration of the COVID-19 AstraZeneca, it is no longer the preferred vaccine for those aged < 50-years in Australia.

Clinical trials

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

Phase 1/2 clinical trials were conducted in UK and recruited over one thousand participants in April and May 2020. Phase 2/3 clinical trials are being conducted in 50,000 participants globally (UK, USA, Brazil, South Africa and Kenya), with recruitment starting in July 2020.

Interim results of Phase 3 studies, from over 10,000 participants in the UK, Brazil and South Africa, were published in the Lancet on 8 December 2020. In participants who received two standard doses, vaccine efficacy was 62·1% and in participants who received a low dose followed by a standard dose, efficacy was 90%. Overall vaccine efficacy across both groups was 70·4%.

Primary results from a further phase 3 US trial including 32,449 participants were released by AstraZeneca on 22 March 2021. The vaccine demonstrated efficacy of 76% against symptomatic disease and 100% efficacy against severe or critical disease and hospitalisation. These results were consistent across age groups, with vaccine efficacy of 85% in people aged over 65-years. These results are currently undergoing peer review.

Safety profile

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

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

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

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

Primary results from the Phase 3 US trial showed that the COVID-19 AstraZeneca was well tolerated, and no safety concerns related to the vaccine were identified. The results are currently undergoing peer review.

No increased risk of anaphylaxis

An independent expert review of 7 reported cases in Australia of suspected anaphylaxis following administration of the COVID-19 AstraZeneca vaccine has concluded that there is no increased risk of anaphylaxis associated with the vaccine above the expected rate for any other vaccine. Anaphylaxis is a very rare side effect that can occur with any vaccine.

Thrombosis with thrombocytopenia syndrome (TTS)

A rare but serious clotting disorder known as ‘thrombosis with thrombocytopenia syndrome (TTS)’ has been seen in a very small number of people who have received the COVID-19 AstraZeneca vaccine in Australia, the UK and Europe. The vaccine appears likely to be causally-linked with a risk of this newly recognised syndrome.

Secondary to these cases, and as a ‘highly precautionary measure’, on April 8th 2021 the Australian Government announced that Australians under 50 should preferentially receive other vaccines (such as Pfizer) over the COVID-19 AstraZeneca vaccine. This decision is based on three recommendations from the Australian Technical Advisory Group on Immunisations (ATAGI):

Summary of Recommendations:

  • Pfizer (or other) vaccines preferred over COVID-19 AstraZeneca in those under the age of 50
  • People under 50 who have had their first dose of COVID-19 AstraZeneca vaccine without side effects can have their second dose
  • People over 50 should receive the COVID-19 AstraZeneca vaccine

The full ATAGI statement can be accessed via the link below:

ATAGI: Statement on AstraZeneca vaccine in response to new safety concerns

COVID-19 AstraZeneca is still strongly encouraged for Australians aged 50 and over and is highly effective at preventing severe COVID.

COVID-19 AstraZeneca can be given to people aged under 50 where benefits are likely to outweigh the risks and an individual has made an informed decision based on an understanding of the risks and benefits. The Department of Health have released a document entitled Weighing up the potential benefits against risk of harm from COVID-19 AstraZeneca which provides information to assist individuals in making an informed decision about whether or not to be vaccinated with COVID-19 AstraZeneca.

For more information please refer to our COVID-19 frequently asked questions on COVID-19 AstraZeneca.

Resources

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

Reviewed by: Daryl Cheng (Paediatrician, Royal Children's Hospital), Davina Buntsma (MVEC Immunisation Fellow), Rachael McGuire (MVEC Education Nurse Coordinator) and Francesca Machingaifa (MVEC Education Nurse Coordinator)

Date: 19th April 2021

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.

 

 

 

 

 


AEFI-CAN: Adverse Events Following Immunisation - Clinical Assessment Network

AEFI-CAN (Adverse Events Following Immunisation - Clinical Assessment Network) is a formal collaboration between Australian state and territory-based vaccine safety clinics and their adult and paediatric immunisation/infectious diseases/allergy specialists. It also includes representatives from the Therapeutic Goods Administration (TGA), most state/territory health departments and the immunisation branch of the Australian Government Department of Health (DoH).

As a national network, AEFI-CAN works collaboratively to clinically assess and manage individual patients following serious or unexpected adverse events after immunisation. The network is also involved in:

  • developing a consistent robust national approach to serious and/or severe AEFI with the creation of standardised protocols
  • standardising AEFI and clinical follow up reporting
  • enhancing community and health/vaccine provider knowledge and practice about AEFI
  • providing expert advice to health professionals as required.

AEFI-CAN bridges the important link between surveillance and clinical assessment and management. As such, AEFI-CAN assists in determining patient outcomes and supports investigation of possible safety signals in a real-time integrated way.

Authors: Adele Harris (SAEFVIC Research Nurse, Murdoch Children’s Research Institute) and Annette Alafaci (SAEFVIC Research Assistant, Murdoch Children's Research Institute)

Reviewed by: Annette Alafaci (SAEFVIC Research Assistant, Murdoch Children's Research Institute)

Date: December 2020

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.


Australian Immunisation Register

In 2016, the previously known Australian Childhood Immunisation Register (ACIR) expanded to an all of life register and became known as the Australian Immunisation Register (AIR). It is a national register recording the immunisations of all Australians of all ages.

Why should vaccines be recorded?

The AIR records any vaccine doses administered, the date of administration and the specific brands given.  It also identifies any vaccines that are due or overdue according to the National Immunisation Program (NIP). Immunisation history statements (IHS) can also be generated from AIR.

For families accessing Family Tax Benefit Part A payments or childcare subsidies, a child’s AIR record needs to show that immunisations are up to date to ensure that payments are not reduced.

In order to confirm enrolment into early childhood education and care services (including childcare and kindergarten), an up to date IHS from AIR must be produced.

A comprehensive reporting of all vaccinations administered, helps to increase vaccination coverage rates and the effectiveness of the NIP.

Who can record immunisations?

Any recognised immunisation provider can record vaccines onto AIR.

What vaccines should be recorded?

All vaccines administered since January 1 1996 can be recorded onto AIR. This includes all vaccines on the NIP, influenza and travel vaccines, as well as any additional vaccines given to an individual (e.g. tetanus vaccines given for tetanus prone wounds, Boostrix® in pregnancy, meningococcal B vaccines etc). Any vaccines given overseas can and should also be recorded.

Please note: From February 2021, a legislation change came into effect mandating AIR reporting. Every COVID-19 vaccine administered within Australia must be reported to AIR. From March 1, 2021 every Influenza vaccine must be included and all other NIP vaccines must be reported from July 1, 2021.

Immunisation exemptions and catch up plans

All approved immunisation exemptions and recognised catch up plans are documented onto AIR to ensure that immunisation records are accurate.

Do patients need to be eligible for medicare in order to have an AIR record?

No. Everyone can have an AIR record. If a person does not have medicare, immunisations can still be recorded based on name, date of birth and address.

Immunisation history statements

An IHS can be used to keep track of vaccines that have been given, that are due or that are overdue. All medical exemptions are noted on an IHS. IHS is the only acceptable form of documentation when enroling into early childhood education and care services.

How do I access my own AIR record?

Statements can be accessed using a Medicare online account through myGov. Alternatively, copies may be obtained from any immunisation provider or the AIR enquiries line.

Resources

Author: Rachael McGuire (MVEC, Education Nurse Coordinator)

Reviewed by and date: Rachael McGuire (MVEC, Education Nurse Coordinator) February 2021

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.


Aboriginal and Torres Strait Islander immunisation recommendations

Background

It is widely recognised that Aboriginal and Torres Strait Islander peoples have higher rates of some vaccine preventable diseases (VPD) than non-Indigenous persons. For this reason, additional vaccines are recommended, some of which are available through the National Immunisation Program (NIP).

The recommendations and funding for additional vaccines for Aboriginal and Torres Strait Islander peoples vary from state to state, based on local disease burden. In addition, individual immunisation providers may have varying approaches to non-NIP vaccines, and this should be clarified with the local health service.

Aboriginal and Torres Strait Islander people have also been identified as a priority population for receiving COVID-19 vaccines. As a result, Aboriginal and Torres Strait Islander people will be offered vaccination as part of phase 1b of the COVID-19 vaccine rollout within Australia.

Accessing immunisations

Routine and additional immunisations can be administered via GP services, councils, hospitals and local Aboriginal Health Services [see Resources].

Additional funded vaccines for Aboriginal and Torres Strait Islander people living in Victoria

Hepatitis B

Rates of hepatitis B infection in Aboriginal and Torres Strait Islander peoples population are up to 3 times higher than the non-Indigenous with notification rates increasing with age.

Hepatitis B vaccination is funded on the NIP with routine doses given at birth, 6-weeks, 4-months and 6-months of age. A booster dose is also given at 12-months of age for those who were born at < 32-weeks gestation and/or < 2000g birth weight.

In addition to this, hepatitis B vaccination is also funded in Victoria for all non-immune Aboriginal and Torres Strait Islander peoples of any age.

Pneumococcal

The risk of invasive pneumococcal disease (IPD) is greatest in young children and older adults. Rates of IPD are 6–7 times higher in Aboriginal and Torres Strait Islander people.

Aboriginal and Torres Strait Islander children living in Australian Capital Territory (ACT), New South Wales (NSW), Tasmania (Tas) or Victoria (Vic) are funded for 1 dose of Prevenar 13® (13vPCV) at ages 6 weeks, 4-months and 12-months (3 doses in total). For those with a risk condition/< 28-weeks gestation an extra dose of 13vPCV is given at 6-months of age (4 doses in total) as well as a dose of Pneumovax 23® (23vPPV) at 4-years of age.

Aboriginal and Torres Strait Islander children in Northern Territory (NT), Queensland (Qld), South Australia (SA) and Western Australia (WA) are funded to receive an extra dose of pneumococcal vaccine at age 6 months followed by two further doses of 23vPPV at age 4-years and at least 5 years later.

All Aboriginal and Torres Strait Islander individuals aged > 12-months with risk conditions are recommended to receive 1 additional dose of 13vPCV unless they have previously received a total of 4 doses of 13vPCV (according to the routine schedule for Aboriginal and Torres Strait Islander infants in NT, Qld, SA and WA) followed by two doses of 23vPPV. These doses are funded for some but not all risk conditions.

All Aboriginal and Torres Strait Islander adults ≥ 50-years of age are eligible for 1 dose of 13vPCV and two doses of 23vPPV.

The maximum number of doses of 23vPPV received in a lifetime is two.

For more information please refer to ATAGI clinical advice on changes to vaccine recommendations and funding for people with risk conditions from 1 July 2020 and ATAGI clinical advice on changes to recommendations for pneumococcal vaccines from 1 July 2020.

Influenza

Aboriginal and Torres Strait Islander people are three times more likely than non-Indigenous people to be admitted to hospital for influenza and pneumonia.

Annual influenza vaccination is funded on the NIP for all Aboriginal and Torres Strait Islander peoples from 6-months of age.

Meningococcal B and ACWY

In 2019, Aboriginal and Torres Strait Islander people had a 10-fold increased incidence of meningococcal disease than non-Indigenous people across some age groups. The most common strains causing infection were types B and W. The recommendation for all Aboriginal and Torres Strait Islander peoples is immunisation against meningococcal disease from 6-weeks of age.

Nimenrix® (meningococcal ACWY) is currently funded on the NIP as a single dose at 12-months of age and an adolescent dose at 14-15 years of age (Year 10 equivalent).

Meningococcal B vaccine (Bexsero®) is free and recommended under the NIP for Aboriginal and Torres Strait Islander infants at 2, 4, and 12-months of age.  An additional dose at 6-months of age is required for Aboriginal and Torres Strait Islander infants with certain medical risk conditions.

Meningococcal B and meningococcal ACWY vaccines are also funded under the NIP for people of all ages with specified medical risk conditions that increase their risk of IMD.

For more information refer to ATAGI clinical advice on changes to recommendations for meningococcal vaccines from 1 July 2020.

COVID-19 vaccines

COVID-19 vaccination is recommended for any Aboriginal and Torres Strait Islander person > 16- years of age, with the initial focus of COVID-19 vaccine rollout being older adults. Aboriginal and Torres Strait Islander people have been identified as a priority population (phase 1b) for immunisation as there is an increased risk of severe COVID-19 disease and death due to a number of factors. This includes a higher prevalence of underlying medical conditions, as well as a greater likelihood of living in communities where other preventative measures (social distancing, mask wearing and hand hygiene) cannot be maintained.

Please refer to COVID-19 vaccination – ATAGI clinical guidance on COVID-19 Vaccine in Australia in 2021 and National Aboriginal Community Controlled Health Organisation: COVID-19 Vaccine Updates and Information for more information.

Funded additional vaccines for Aboriginal Torres Strait Islander peoples living in other states

Vaccine Age group State
BCG (tuberculosis) Neonates NT, QLD, Northern SA (in high incidence TB areas)
Prevenar 13® (13-valent pneumococcal conjugate vaccine) 6-months NT, QLD, SA, WA
Vaqta® Paediatric (hepatitis A - 2 dose course) 18-months and 4-years NT, QLD, SA, WA

SA Health- Aboriginal and Torres Strait Islander people immunisation recommendations QLD Health- Aboriginal and Torres Strait Islander people immunisation recommendations WA Department of Health - Immunisation schedule ATAGI clinical advice on hepatitis A vaccine

Resources

Aboriginal health services

Other resources

Authors: Rachael McGuire (MVEC Education Nurse Coordinator), Nigel Crawford (Director SAEFVIC, Murdoch Children's Research Institute) and Rebecca Feore (Immunisation Nurse, The Royal Children's Hospital)

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator)

Date: February 2021

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.


Administration of injected vaccines- correct technique

Most vaccines on the National Immunisation Program (NIP) are administered via intramuscular or subcutaneous route. Correct injection technique is of paramount importance when administering vaccines to ensure optimal immune response, minimise side effects and to reduce the risk of injury to the patient.

Preparing the site for injection

The skin at the injection site should be visibly clean prior to administering a vaccine. The swabbing of clean skin before giving an injection is not necessary. If the skin is visibly dirty, clean the site with alcohol wash/single use alcohol swab and allow the site to dry completely before administering the injection. If active/infected eczema is present at the recommended site, consider an alternate site to minimise the risk of injection site abscess. If there is no alternate site suitable, consider cleaning the site with an alcohol based wash/single use alcohol swab and allowing the site to dry completely before injecting.

Recommended injection sites by age

Infants < 12-months

The recommended injection site is the middle third of the vastus lateralis (anterolateral thigh).

To locate the correct anatomical site for injection:

  • Ensure the infant’s leg is completely exposed
  • Locate the upper and lower anatomical landmarks- greater trochanter of femur and patella
  • Draw an imaginary line between the 2 landmarks down the front of the thigh
  • Then imagine the thigh is divided into thirds
  • The correct injection site is located in the middle third and on the outer aspect of the imaginary line (see images below)

Where only two vaccines are scheduled it is recommended to give one vaccine into each thigh. If more than two vaccines are recommended at the one visit, two vaccines may be given into each thigh ensuring they are separated by 2.5 cm.

Do not inject into the anterior aspect of the thigh as underlying structures may be damaged.

In some circumstances (eg; congenital limb malformations, active eczema or hip brace placement) alternate sites should be considered. In these scenarios, alternate sites include the deltoid or opposite anterolateral thigh (ensuring that each vaccine has a 2.5cm spacing).

Children ≥ 12-months of age, adolescents and adults

The recommended injection site is the deltoid (upper arm).

To locate the correct anatomical site for injection:

  • Expose the arm completely from the top of the shoulder to the elbow; remove shirt or clothing if needed
  • Locate the upper and lower anatomical landmarks- acromion (shoulder tip) and the muscle insertion of the deltoid (deltoid tuberosity)
  • Draw an imaginary inverted triangle below the shoulder tip, using the identified landmarks (see images below)
  • The site for injection is halfway between the acromion and the deltoid tuberosity, in the middle of the deltoid muscle (triangle)

More than one vaccine can be given into the deltoid muscle ensuring each vaccine is separated by 2.5cm.

For children at 12 and 18 months of age the anterolateral aspect of the thigh may be used as an alternate site when giving more than 2 vaccines [see resources].

Recommended needle size, length and angle for administering vaccines

Age or size of the patient Needle type Angle of needle insertion
Infant, child or adult for IM injection 22 - 25 gauge, 25mm in length
Preterm infant or very small infant for IM injection 23 - 25 gauge, 16mm in length
Very large/obese patient for IM injection 22 - 25 gauge, 38mm in length
Subcutaneous injection in all patients 25 - 27 gauge, 16mm in length

* Table adapted from the Australian Immunisation Handbook

Implications of incorrect injection technique

Injection site reactions are more likely following inadvertent administration into subcutaneous tissue as opposed to the intended muscular tissue.

Shoulder injury related to vaccine administration (SIRVA) is a rare complication of incorrect vaccine administration causing an immune-mediated inflammatory reaction within the shoulder joint. When a vaccine is given into the shoulder joint (too high) it can cause a sudden onset of pain and limited range of movement which can persist for variable lengths of time and require medical investigations and treatment.

Impaired immune response can follow administration of vaccines utilising an incorrect injection technique. Depositing vaccines into the subcutaneous tissue (when muscular tissue was intended) or into the joint can lead to a decreased immune response to the vaccine.

Resources

Authors: Mel Addison (SAEFVIC Research Nurse, Murdoch Children’s Research Institute) and Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute)

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

Date: July 2020

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.


Allergy and immunisation

Hypersensitivity/allergic reactions following immunisation can be classified as:

  • Urticarial- a red, itchy skin rash often referred to as hives, which characteristically has a central raised white wheal surrounded by an area of redness
  • Non-urticarial rash- skin changes that don’t involve hives
  • Angioedema- swelling in the deeper layers of the skin
  • Generalised allergic reaction- involving symptoms like vomiting and diarrhoea
  • Anaphylaxis- a sudden onset and rapid progression of symptoms involving the skin, respiratory and/or cardiovascular systems

Suspected hypersensitivity reactions, particularly non-urticarial skin rashes following immunisation, are common, however true vaccine allergy, where a person is contraindicated from being immunised with the same vaccine in the future, is rare (less than 1 case per million doses).

A true vaccine allergy can only be diagnosed after specialist consultation with a vaccine allergy specialist, often after specific testing is carried out.

For management of immunisation hypersensitivity/allergic reactions, referrals should be made to SAEFVIC for review. SAEFVIC staff may direct the referral to an Immunisation Specialist or alternatively to a Vaccine Allergy Specialist.

Influenza vaccine and egg allergy

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.

The influenza vaccine 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.

MMR vaccine and egg allergy

Although measles and mumps vaccine viruses are cultivated in eggs, these vaccines (MMR or MMR-Varicella vaccines) contain negligible amounts of egg protein/allergen. Therefore individuals with allergy/anaphylaxis to egg can be safely immunised in the community setting without any need for extra monitoring or additional observation.

Yellow Fever vaccine and egg allergy

Currently, many guidelines advise that egg anaphylaxis is a contraindication to receiving a yellow fever vaccine (YFV), with the Australian Immunisation Handbook recommending people requiring the vaccine discuss this with an immunologist or allergist due to the YFV containing egg ovalbumin.

Due to the serious nature of the disease, some countries requiring proof of immunisation as an entry requirement and the widely varying guidelines pertaining to YFV in egg-allergic people; researchers from the National Centre for Immunisation Research and Surveillance (NCIRS), and the Royal Children’s Hospital in Melbourne, have published a case series proposing that skin testing may not be required for patients with mild egg allergy, and that a 2-step graded challenge under medical supervision is a safe alternative.

COVID-19 vaccines and allergy

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™ and Polysorbate 80 in COVID-19 AstraZeneca®); prior anaphylactic reactions to other vaccines or medications where PEG or Polysorbate 80 may have been the cause; 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.

For all other allergies, including those 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.

Resources

Author: Kirsten Perrett (Clinician Scientist Fellow, Murdoch Children's Research Institute)

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator)

Date: March 2021

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.


Adverse events reporting Australia

Vaccines are medications and like any medication, there are possible side effects or adverse events. Serious adverse events from immunisation are extremely rare. If you or your child has experienced an adverse event it should be reported to your local government health authority for follow up and management.

Please see the list below for the appropriate body to report to, according to your state or territory.

It is important to note that these services do not provide emergency care and are reporting services only.

If you require medical assistance please see your GP, local emergency department or dial 000 if immediate support is required.

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

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

Date: December 2020

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.


ATAGI (Australian Technical Advisory Group on Immunisation)

The Australian Technical Advisory Group on Immunisation (ATAGI) provides independent advice to the Minister for Health on the Immunise Australia Program and other related issues [see resources].

In addition to technical experts, ATAGI's membership includes a consumer representative and general practitioners.

The Terms of Reference of the Australian Technical Advisory Group on Immunisation are to:

  • provide technical advice to the Minister for Health on the medical administration of vaccines available in Australia, including those on the National Immunisation Program (NIP)
  • through the department, provide advice to research funding bodies regarding the status of current immunisation research and areas where additional research is required
  • advise the Pharmaceutical Benefits Advisory Committee (PBAC) on matters relating to the ongoing strength of evidence pertaining to existing, new and emerging vaccines in relation to their effectiveness and use in Australian populations
  • produce the Australian Immunisation Handbook for the approval of the National Health and Medical Research Council
  • consult with the National Immunisation Committee (NIC) on the content and format of the Australian Immunisation Handbook and associated implementation strategies
  • consult with the Communicable Diseases Network Australia (CDNA) and the Advisory Committee on Vaccines (ACV) on matters relating to the implementation of immunisation policies, procedures and vaccine safety
  • provide advice on COVID-19 immunisation programs and policies, to improve confidence in COVID-19 vaccines and to ensure equitable access to COVID-19 vaccines as they become available in Australia

ATAGI meets three times a year and provides bulletins detailing the important outcomes from the meeting [see resources]

The vaccine PBAC outcomes are also publicly available on their website [see resources]

Resources

Author: Nigel Crawford (Director, SAEFVIC, Murdoch Children’s Research Institute)

Reviewed by: Daryl Cheng (Senior Research Fellow, Murdoch Children's Research Institute)

Date: October 2020

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.


AusVaxSafety: vaccine safety surveillance in Australia

AusVaxSafety is an active national surveillance system of all vaccines on the National Immunisation Program (NIP), which monitors adverse events following immunisation (AEFI) to detect possible vaccine safety signals. With funding from the Australian Government Department of Health, it commenced in 2014 and is led by the National Centre for Immunisation Research and Surveillance (NCIRS). The Victorian vaccine safety surveillance is coordinated by SAEFVIC, based at the Murdoch Children’s Research Institute (MCRI).

AusVaxSafety monitors de-identified data using three software programs: SmartVaxVaxtracker and NPS Medicine Insight. Information is gathered directly from patients or their carers via SMS or email. It is used across more than 350 sites including general practices, hospital- and community-based immunisation clinics, and Aboriginal medical services spread throughout all Australian states and territories. 

All data is shared with the Therapeutic Goods Administration (TGA), the Australian Government Department of Health and the participating state health departments, all of whom have a shared responsibility for monitoring the safe use of vaccines.

Resources

Author: Annette Alafaci (SAEFVIC Research Assistant, Murdoch Children's Research Institute)

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

Date: July 2020

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.