Pericarditis and myocarditis following COVID-19 mRNA vaccines

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

Globally, an increased number of cases above an expected population rate of myocarditis and pericarditis have been reported in individuals who have received mRNA COVID-19 vaccines (eg. Comirnaty (Pfizer) and Spikevax (Moderna)).

Myocarditis

  • How is myocarditis following COVID-19 vaccination triggered?

    The exact mechanism behind cardiac inflammation temporally associated with COVID-19 mRNA vaccines is currently being investigated. Clinical causes from international surveillance data suggest an immune-mediated or hypersensitivity trigger. Further safety surveillance continues, including with non-mRNA COVID-19 vaccination, to determine the exact cause.

  • Who is at risk of myocarditis?

    Myocarditis from any cause, occurs more commonly in males than females. It is also more likely to affect younger adults.

    Reported rates of myocarditis occurring following administration of an mRNA COVID-19 vaccine vary; however, they are above expected background rates. The peak risk group is young adult males aged 16-17 years, with a smaller increased risk for males aged between 12-24 years.

    International vaccine safety surveillance data currently suggests that it is more commonly associated with administration of a second dose of a COVID-19 mRNA vaccine.

    Myocarditis following third doses or booster doses have also been identified in a small number of individuals. Reported cases have occurred at significantly lower rates than those identified following either dose of a primary course.

  • Are children more likely to experience myocarditis following COVID-19 vaccination?

    Available safety data from local and international sources suggest there is a lower risk of children developing myocarditis following mRNA COVID-19 vaccination.

    ATAGI recommends an interval of 8 weeks between vaccine doses in a primary course for age-eligible children (5-11 years for Comirnaty (Pfizer) and 6-11 years for Spikevax (Moderna)) for maximum efficacy and safety. This extended interval is based on international data suggesting a longer time interval between dose 1 and 2 may reduce the risk of myocarditis. This extended interval also allows more time to observe international vaccine safety data and identify any signals for rare adverse events.

    For more information on COVID-19 vaccination in individuals < 18 years please refer to COVID-19 vaccination in children and adolescents.

  • Pre-existing cardiac conditions and mRNA vaccination

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

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

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

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

    Patients with ongoing cardiac inflammation should have vaccination deferred. Alternate COVID-19 vaccine brands (eg. Vaxzevria (AstraZeneca) or Nuvaxovid (Novavax)) may be considered.

  • What are the symptoms of myocarditis?

    Myocarditis presents similarly to pericarditis, with a range of symptoms including:

    • chest pain, pressure or discomfort
    • pain with breathing (pleuritic chest pain)
    • shortness of breath
    • palpitations
    • syncope (faint)
    • other non-specific symptoms such as fatigue, dizziness, abdominal pain.

    In individuals who have received COVID-19 mRNA vaccines, symptoms of myocarditis related to COVID-19 mRNA have most commonly been reported within 2-7 days of second dose vaccination.

  • How is myocarditis after COVID-19 vaccination diagnosed and investigated?

    If there is suspicion of myocarditis, particularly in the first week following vaccination, timely medical review is important. Those who appear unwell should be referred to an emergency department for examination and the following primary investigations:

    • blood tests for cardiac biomarkers, such as troponin
    • electrocardiogram (ECG).

    Other tests should be considered if the patient is unwell or the tests above are abnormal:

    • chest X-ray (CXR)
    • other tests related to investigating differential diagnoses such as inflammatory markers (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)
    • bedside or formal ultrasound/echo
    • cardiac MRI.

    Consistent findings of myocarditis may include elevated troponin, ECG changes (ST or T-wave abnormalities, premature atrial or ventricular complexes) as well as abnormal echocardiogram or cardiac MRI.

    Individuals who are investigated for myocarditis following mRNA vaccination should avoid high-intensity exercise until symptoms have resolved is recommended.

    Cardiologist advice and followup is strongly recommended.

  • How is myocarditis after COVID-19 vaccination treated?

    Current data shows that most cases of myocarditis following COVID-19 mRNA vaccination have mild symptoms and recover well. Information on long term sequelae is not yet available.

    Treatment of these conditions is managed by a cardiologist and include in-patient supportive therapies. In the rare severe or complicated cases, specific management for arrythmias, decreased cardiac function or congestive cardiac failure with pharmacological agents such as ACE-inhibitors and beta-blockers or mechanical support may be necessary.

  • I have specific questions around my risk of myocarditis following COVID-19 mRNA vaccines. Help!

    Please refer to our FAQs on COVID-19 mRNA vaccines for further information. This includes answers on:

    • impact of dose intervals between 1st and 2nd dose of mRNA vaccine
    • risk of developing myocarditis from COVID-19 disease vs the vaccine
    • exercise after COVID-19 mRNA vaccines
    • impacts of medications and drugs such as clozapine, stimulants, amphetamines on developing myocarditis.

  • What are the implications for future doses (including third and booster doses)?

    For individuals where the cause of inflammation is attributed to COVID-19 mRNA vaccination, a report to SAEFVIC is indicated and a referral to a cardiologist and/or specialist immunisation service (eg. VicSIS) is recommended.

    Please refer to the below algorithm for recommendations relating to further doses of COVID-19 vaccines in patients who have been diagnosed with myocarditis following COVID-19 vaccination.

    *Brighton Level refers to Brighton Collaboration criteria for classifying myocarditis
    PDF version of the above diagram available here.

    ATAGI currently recommends that individuals diagnosed with myocarditis following mRNA vaccination defer any further doses and are referred to a specialist immunisation clinic.

  • What is the risk/benefit ratio for vaccination for the young adult age group?

    It is important to discuss your individual circumstances with a health care provider in order to make an informed decision.

    The level of COVID-19 community transmission in Australia can change quickly. Factors to consider include age, potential for exposure to the virus (including in the workplace), high rates of global transmission, the emergence of new variants of the virus, as well as the potential for future changes to Australia’s border controls.

    Whilst COVID-19 infection can sometimes result in myocarditis, its incidence following COVID-19 vaccination is comparatively extremely rare. Most individuals diagnosed with myocarditis following COVID-19 vaccination have responded well to treatment.

Pericarditis

  • How is pericarditis following COVID-19 vaccination triggered?

    The exact mechanism behind cardiac sac inflammation temporally associated with a COVID-19 mRNA vaccine is currently being investigated. Clinical causes from international surveillance data suggest an immune-mediated or hypersensitivity trigger.

    Further safety surveillance continues, including with non-mRNA COVID-19 vaccinations to determine the exact cause.

  • Who is at risk of pericarditis?

    Pericarditis from any cause, occurs more commonly in males than females. It is also more likely to affect younger adults.

    Reported rates of pericarditis occurring following administration of an mRNA COVID-19 vaccine vary; however, they are above expected background population rates.

    International and local data suggest that pericarditis following mRNA COVID-19 vaccines is more common in the 25-49 year old age group for both males and females.

    Pericarditis following third doses or booster doses have also been identified in a small number of individuals. Reported cases have occurred at significantly lower rates than those identified following either dose of a primary course.

  • Are children more likely to experience pericarditis following COVID-19 vaccination?

    Available safety data from local and international sources suggest there is a lower risk of children developing myocarditis following mRNA COVID-19 vaccination.

    ATAGI recommends an interval of 8 weeks between vaccine doses in a primary course for age-eligible children (5-11 years for Comirnaty (Pfizer) and 6-11 years for Spikevax (Moderna)) for maximum efficacy and safety. This extended interval is based on international data suggesting a longer time interval between dose 1 and 2 may reduce the risk of myocarditis. This extended interval also allows more time to observe international vaccine safety data and identify any signals for rare adverse events.

    For more information on COVID-19 vaccination in individuals < 18 years please refer to COVID-19 vaccination in children and adolescents.

  • Pre-existing cardiac conditions and mRNA vaccination

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

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

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

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

    Patients with ongoing cardiac inflammation should have vaccination deferred. Alternate COVID-19 vaccine brands (eg. Vaxzevria (AstraZeneca) or Nuvaxovid (Novavax)) may be considered.

  • What are the symptoms of pericarditis?

    Pericarditis presents similarly to myocarditis, with a range of symptoms including:

    • chest pain, pressure or discomfort
    • pain with breathing (pleuritic chest pain)
    • shortness of breath
    • palpitations
    • syncope (faint)
    • other non-specific symptoms such as fatigue, dizziness, abdominal pain.

  • How is pericarditis after COVID-19 vaccination diagnosed and investigated?

    If there is suspicion of either of these conditions, particularly in the first 2-3 weeks following vaccination, timely medical review is important. Those who appear unwell should be referred to an emergency department for the following investigations:

    • blood tests for cardiac biomarkers, such as troponin
    • electrocardiogram (ECG)

    Other tests should be considered if the patient unwell or the tests above are abnormal:

    • chest X-ray (CXR)
    • other tests related to investigating differential diagnoses such as inflammatory markers (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)).

    Consistent findings of pericarditis include a pericardial rub on auscultation, widespread ST-elevation or PR depression on ECG, as well as pericardial effusion on imaging.

    Individuals who are investigated for pericarditis following mRNA vaccination should avoid high-intensity exercise until symptoms have resolved is recommended. Those experiencing ongoing symptoms should return for review in 1-2 days time. Cardiologist advice is recommended if clinical suspicion is high, regardless of normal investigations.

  • How is pericarditis after COVID-19 vaccination treated?

    Current data shows that most cases of pericarditis following COVID-19 mRNA vaccination have mild symptoms and recover well. Information on long term sequelae is not yet available.

    Treatment of these conditions is managed by a cardiologist and include in-patient supportive therapies, often with anti-inflammatory medications or colchicine. In the rare severe or complicated cases, specific management for arrythmias, decreased cardiac function or congestive cardiac failure with pharmacological agents such as ACE-inhibitors and beta-blockers or mechanical support may be necessary.

  • What are the implications for future doses (including third and booster doses)?

    For individuals where the cause of inflammation is attributed to COVID-19 mRNA vaccination a report to SAEFVIC is indicated and a referral to a cardiologist and/or specialist immunisation service (eg. VicSIS) is recommended.

    Please refer to the below algorithm for recommendations relating to further doses of COVID-19 vaccines in patients who have been diagnosed with pericarditis following COVID-19 vaccination.

     

    *Brighton Level refers to Brighton Collaboration criteria for classifying pericarditis
    Access a pdf version of this guide here.

    In particular, the groups which are at lower risk (green in algorithm), could proceed with further doses of COVID-19 vaccination as per above suggested instructions.

  • What is the risk/benefit ratio for vaccination for the young adult age group?

    It is important to discuss your individual circumstances with a health care provider in order to make an informed decision.

    The level of COVID-19 community transmission in Australia can change quickly. Factors to consider include age, potential for exposure to the virus (including in the workplace), high rates of global transmission, the emergence of new variants of the virus, as well as the potential for future changes to Australia’s border controls.

    Whilst COVID-19 infection can sometimes result in pericarditis, its incidence following COVID-19 vaccination is comparatively extremely rare. Most individuals diagnosed with pericarditis following COVID-19 vaccination have responded well to treatment.

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

Reviewed by: Daryl Cheng (MVEC Medical Lead) and Julia Smith (Immunisation Fellow, Royal Children’s Hospital)

Date: March 10, 2022

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

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


Pregnant women: immunisation recommendations

Immunisation assessment is an extremely important aspect of healthcare during pregnancy. When planning a pregnancy, talk to your health care provider about any vaccines you might need beforehand. Live-attenuated vaccines should be given at least a month before conception.

Recommended vaccines

Influenza, pertussis and COVID-19 vaccines are the only vaccines routinely recommended for pregnant women. They are provided for free via the National Immunisation Program (NIP).

Some other vaccines can be administered in special circumstances but are not routinely recommended. Refer to the Australian Immunisation Handbook for further information.

Influenza

Influenza vaccination is safe and strongly recommended for pregnant women to avoid complications from influenza disease. It can be administered at any stage of pregnancy and not only aims to protect the expectant mother from disease, but also to provide passive protection to the infant.

Pregnant women are at greater risk of morbidity and mortality from influenza disease than non-pregnant women. They are more than twice as likely to be hospitalised with influenza disease as other people with influenza.

Babies less than 6-months of age are at greatest risk of disease and death from influenza and maternal vaccination will provide protection to babies for the first few months of life until they can be immunised against influenza from 6-months of age.

Pertussis

Pertussis (whooping cough) immunisation during pregnancy is a safe and effective way to protect the mother and prevent disease of the newborn. It is recommended that a single dose of the vaccine be administered between 20 and 32 weeks of pregnancy, in every pregnancy, including pregnancies that are closely spaced.

Maternal antibodies against pertussis provide protection for babies until they have at least received 2 doses of their own pertussis containing vaccine (given at 6-weeks and 4-months of age). Babies less than 6-months of age are at greatest risk of severe disease and death from pertussis.

COVID-19 vaccines

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

Surveillance of international data on administration of mRNA COVID-19 vaccines (Comirnaty (Pfizer) or Spikevax (Moderna)) to pregnant women has shown no significant safety concerns for either the mother or the baby. Evidence demonstrates antibodies can pass into breastmilk and cord blood which may provide protection to infants via passive immunity.

Nuvaxovid (Novavax) may be administered to pregnant and breastfeeding women however there is no immunogenicity or safety data on it’s use in this patient group.

Pregnant women have been shown to have an increased risk of needing admission to the intensive care unit and requiring mechanical ventilation if they contract COVID-19 compared with non-pregnant women of the same age.

Women who are planning pregnancy or who are breastfeeding can safely receive a COVID-19 vaccine. You do not need to stop breastfeeding before or after vaccination.

For more information refer to the following:

Contraindicated vaccines

All live-attenuated vaccines are contraindicated during pregnancy due to the potential risk to the unborn baby [see Table 1 below]. In most circumstances the risk is hypothetical however, there is insufficient evidence to support vaccination in this patient group. The limited safety data from inadvertent administration of live-attenuated viral vaccines such as the MMR and Varicella vaccines is reassuring.

Table 1: Live-attenuated vaccines contraindicated in pregnancy

Disease Brand name
Rotavirus Rotarix®, Rotateq®
MMR (measles-mumps-rubella) Priorix®, MMR II®
MMRV (measles-mumps-rubella-varicella) Priorix-tetra®, ProQuad®
Varicella (chickenpox) Varilrix®, Varivax®
Zoster (shingles) Zostavax®
Tuberculosis BCG (varying brands)
Yellow fever Stamaril®
Typhoid^ Vivotif®
Japanese encephalitis Imojev®

^Oral vaccine

Resources

Monash Health immunisation resources

MVEC resources

Authors: Michelle Giles (Infectious Diseases Consultant, Monash Health) and Rachael McGuire (MVEC Education Nurse Coordinator)

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

Date: February 7, 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.


Pneumococcal

Background

Pneumococcal disease is caused by Streptococcus Pneumoniae (pneumococcus), a bacteria that can live in the nose and throat (nasopharynx) of healthy people and in most cases does not cause illness or disease. However, in some cases the bacteria may grow and spread to other parts of the body.  Invasive pneumococcal disease (IPD) can manifest as meningitis, pneumonia, sinusitis, otitis media (ear infections), osteomyelitis (bone infection), joint infections and septicaemia (blood infection). The severity of illness can vary, with severe disease requiring hospitalisation, causing significant morbidity and even death. Certain individuals with specific medical conditions (advancing age, identifying as Aboriginal and Torres Strait Islander, Asplenia etc) may be considered at increased risk of IPD and therefore require additional protection.

Pneumococcal vaccines

There are currently two multivalent pneumococcal vaccines available for free on the National Immunisation Program (NIP).

  1. Prevenar 13® (13vPCV) – a conjugate vaccine, providing protection against 13 different serotypes of pneumococcal (1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F). It is available on the NIP for individuals >6 weeks of age.
  2. Pneumovax 23® (23vPPV) – a polysaccharide vaccine, providing protection against 23 serotypes of pneumococcal (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F). It is available on the NIP as an additional recommendation for individuals >4-years of age who are at increased risk of IPD (it is not recommended for those <2 years of age due to poor immunogenicity in this population).

Co-administration with other vaccines

13vPCV and 23vPPV may be co-administered with other vaccines on the NIP, including the quadrivalent influenza vaccine (QIV), live attenuated vaccines (MMR/Varicella/Zostavax®) and COVID-19 vaccines.

Consider where possible, different injection sites when co-administering pneumococcal and QIV in adults due to the increased risk of injection site reactions.

Common side effects of pneumococcal vaccines

  • fever
  • irritability
  • lethargy
  • pain at the injection site
  • injection site reactions (redness, heat, swelling and tenderness)
  • body aches

Note – In children, injection site reactions are more commonly reported as occurring within 24-48 hours following immunisation. In adults, injection site reactions may occur >3 days following the 13vPCV dose given at >70years, particularly in those who have previously received 23vPPV [see resources]. In both age groups a history of large local injection site reactions following previous pneumococcal vaccines is not a contraindication to further doses.

Current pneumococcal recommendations as of July 2020

Specific population groups are at an increased risk of IPD. Updated ATAGI advice relating to these population groups include:

It is important for immunisation providers to familiarise themselves with the pneumococcal vaccine recommendations specific to each patient, recognising the variations to recommendations for different age groups, at-risk medical conditions, and Aboriginal and Torres Strait Islander status.

Table 1: Summary of pneumococcal vaccine recommendations for all age groups and risk-categories

Age and risk category Current age/Age at diagnosis of risk-condition Prevenar 13® (13vPCV) schedule Pneumovax 23® (23vPPV) schedule*
Infants and children with NO medical risk conditions (including Aboriginal and Torres Strait Islander children living in Vic, ACT, Tas and NSW) < 12-months As per NIP (2, 4 & 12-months)^ N/A
Infants and children WITH a medical risk condition (including Aboriginal and Torres Strait Islander children) living in NT, QLD, SA and WA) < 12-months As per NIP (2, 4 & 12-months) + 1 additional dose at 6-months^ (total 4 doses in a lifetime) Dose 1 at 4-years of age
Dose 2 ≥ 5-years following dose 1*
≥ 12-months As per NIP (2, 4 & 12-months) + 1 additional dose at age of diagnosis,^ given a minimum of 2-months after dose 3 (total 4 doses in a lifetime) Dose 1 > 4-years of age (minimum 2- months after 4th dose of 13vPCV)
Dose 2 ≥ 5-years after dose 1*
Aboriginal and Torres Strait Islander adults with NO risk condition Adults > 50-years 1 dose at > 50-years§ 2 doses* at least 5-years apart (minimum of 2-months after dose of 13vPCV)
Non-indigenous adults with NO risk condition Adults > 70-years 1 dose at > 70-years#§

(catch up for all adults > 70-years)

N/A
Non-indigenous adolescents/adults diagnosed with a risk condition Any age 1 dose at age of diagnosis# 2 doses* at least 5-years apart (minimum of 2-months after dose of 13vPCV)

*Maximum amount of 23vPPV in a lifetime is 2 doses
^ Refer to specific pneumococcal catch up advice if commencing immunisations late/delayed including Table. Catch-up schedule for 13vPCV for Aboriginal and Torres Strait Islander children living in NSW, Vic, Tas or ACT, and all children who do not have risk condition(s) for pneumococcal disease, aged <5 years and Table. Catch-up schedule for 13vPCV for Aboriginal and Torres Strait Islander children living in NT, Qld, SA or WA ONLY, and all children with risk condition(s) for pneumococcal disease, aged <5 years
§ For those individuals who have already received a dose 23vPPV, 13vPCV must be given ≥12-months after the 23vPPV
# In July 2020, 13vPCV replaced the 23vPPV that was previously funded at > 65-years. 13vPCV should still be given even if 23vPPV has been administered previously. In scenarios where 23vPPV was administered first, there should be a minimum interval of 12-months before giving 13vPCV

Resources

Authors: Mel Addison (SAEFVIC Research Nurse, Murdoch Children’s Research Institute), Georgina Lewis (Clinical Manager SAEFVIC, Murdoch Children’s Research Institute), Rachael McGuire (MVEC Education Nurse Coordinator), Teresa Lazzaro (Paediatrician, the Royal Children’s Hospital)

Reviewed by: Mel Addison (SAEFVIC Research Nurse, Murdoch Children’s Research Institute)

Date: May 9, 2022

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

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


Pfizer (Comirnaty) COVID-19 vaccine

Name of vaccineComirnaty (generic name BNT162b2) Paediatric Comirnaty (generic name Tozinameran)
Vaccine platformGenetic vaccine (messenger RNA/mRNA)
Developer of vaccinePfizer/BioNTech
RegistrationProvisional registration granted by the TGA on 16 February 2021
For useComirnaty registered for use in individuals aged ≥ 12 years Paediatric Comirnaty registered for use in individuals 5-11 years
DoseComirnaty- 30µ Paediatric Comirnaty- 10µ
Primary course in immunocompetent individualsIndividuals aged ≥ 12 years should receive 2 doses (3-8 weeks apart) Individuals aged 5-11 years should receive 2 doses (3-8 weeks apart)
Primary course in immunocompromised individual3 dose primary schedule of age appropriate vaccine, with the third dose administered 2-6 months post dose 2
Booster dose recommendationsComirnaty may be used as a booster where indicated for individuals from 12 years of age.
ManufacturerDoses for Australia will be manufactured overseas
Storage requirementsMust be stored at ultra-cold temperatures of -90°C to -60°C. Unopened vials can be stored and transported at domestic freezer temperatures (-25°C to -15°C) for up to 2 weeks. Vials held at these temperatures can then be returned to ultra-cold temperatures for longer term storage ensuring that they remain within the manufacturer’s use by date. Unopened vials can be stored for up to one month (31 days) at temperatures of 2°C to 8°C. Once thawed, Comirnaty cannot be refrozen.
Preparation and injectionThe vaccine must be thawed before preparation and should only be diluted with the recommended diluent. After reconstitution the vial must be used within six hours. Each multi-dose vial of Comirnaty contains 6 doses of 0.3ml of vaccine for intramuscular (IM) administration. Each multi-dose vial of Paediatric Comirnaty contains 10 dose of 0.2ml of vaccine for intramuscular administration (IM).

Immunogenecity

Pre-clinical trials were conducted in non-human primates (rhesus macaques) and mice. Vaccinated primates, who were challenged with SARS-CoV-2 virus, had no virus detected in the lower respiratory tract and clearance of virus in the nose within three days. These results indicated the vaccine may reduce both infection and transmission.

The US Phase 1 trial included participants aged 18 – 85 years old and compared a placebo to one of two vaccine candidates (BNT162b1, which encoded the SARS-CoV-2 receptor-binding domain; or BNT162b2, which encodes the SARS-CoV-2 full-length spike protein). This trial supported the selection of BNT162b2 (full length spike protein) for advancement to Phase 2/3 trials.

Two doses of BNT162b2 were shown to elicit high SARS-CoV-2 neutralising antibody titres and robust spike protein-specific T-cell responses.

Safety profile

During clinical trials, symptoms following immunisation with Comirnaty were generally mild to moderate and generally short-term. They were less common and milder in older adults (>55 years), compared to younger adults (<55 years). Local reactions including pain (66-83%) and redness (5-7%) at the injection site were more common after the first dose compared to the second dose. Systemic reactions (including fatigue, headache, muscle ache and headache) were more common and severe following the second dose. The incidence of serious adverse events was low and similar in both the vaccine and placebo groups.

Vaccine efficacy

Phase 3 trial data showed 95% vaccine efficacy. Similar vaccine efficacy (generally 90 to 100%) was observed across all subgroups defined by age (>16 years), sex, race, ethnicity, baseline body-mass index, and the presence of co-existing conditions. Older adults, 65 years and over, also had the same vaccine efficacy as younger adults. An immune response was detected less than two weeks after the first dose, and a second dose three weeks later, boosted that response. The study was not designed to assess the efficacy of a single-dose regimen, however, in the interval between the first and second doses, the observed vaccine efficacy against COVID-19 was 52%, reaching full efficacy at least seven days after the second dose.

Paediatric clinical trials

2,260 adolescents (aged 12 to 15 years) were enrolled in a phase 3 trial in the United States (US). A good safety profile and strong immune response was observed with 100% efficacy 7 days after dose 2 of Comirnaty. 18 cases of COVID-19 infection observed in the placebo group (n=1,129) versus zero cases in the vaccinated group (n=1,131).

2,268 children (aged 5 to 11 years) participated in a phase 2-3 clinical trial. Participants in the vaccine group were administered a 2 dose course of 10 micrograms of Paediatric Comirnaty, 21 days apart. A similar safety profile to that seen in the ≥ 12 year old age group was observed in this younger cohort. A robust immune response was reported with a vaccine efficacy of 90.7% more than 7 days after the second dose. 3 cases of COVID-19 disease were observed in the vaccine group (n=5,157) and 16 cases among the placebo group (n=751).

Post-licensure surveillance

Allergies

A true vaccine allergy (anaphylaxis) is a rare side effect occurring for all vaccines at a rate of approximately 1 case per million vaccine doses administered. Post-licensure surveillance of Comirnaty in the US has shown that it has a slightly higher rate of anaphylaxis with approximately 4.7 cases per million doses administered. Most cases (89%) occurred within 30 minutes of vaccination and 24% had a history of prior anaphylaxis.

Myocarditis/pericarditis

A small number of cases of myocarditis and pericarditis have been reported in individuals vaccinated with COVID-19 mRNA vaccines (eg. Comirnaty and Moderna). Reports have predominantly involved adolescents and young adults, more commonly males, after the second dose of vaccine. Symptom onset has typically been seen within 4 days of vaccination.

Resources

Authors: MVEC Education Team

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

Date: February 10, 2022

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

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


Provisional registration of COVID-19 vaccine(s) in Australia

MVEC supports the authorisation of COVID-19 vaccines that reach the regulatory requirements regarding both vaccine efficacy and safety.

There is lots of interest nationally and internationally regarding the process for regulation of vaccines and concerns that this may be happening ‘too fast’ and steps may be missed. There is also some confusion regarding how these vaccine regulatory processes may vary between countries.

The Therapeutic Goods Administration

The Therapeutic Goods Administration (TGA), is the body in Australia that reviews all the information required to license a vaccine in Australia. This includes a detailed dossier of all available trial information (preclinical and phases 1-3), as well as an extensive pharmacovigilance plan to be activated once the vaccine comes onto the market (phase 4 vaccine safety monitoring).

The TGA has established a COVID-19 hub that includes detailed information on their role and internal processes [refer to TGA: COVID-19 hub].

Provisional registration process

A number of sponsors of COVID-19 vaccines have applied to the TGA for registration using the so-called ‘provisional approval pathway’.

The provisional pathway is only one of a number of pathways that a sponsor may use to apply for the approval of a vaccine. It allows for the temporary registration of promising medicines or vaccines based on early data, where the benefits of early access, outweigh any risks. It is very important to note that the TGA evaluation process under the ‘provisional pathway’ is still a full review of the vaccine and the TGA does not have a mechanism for emergency use authorisations (EUA).

Once the TGA has approved a COVID-19 vaccine for registration, it will be included in the Australian Register of Therapeutic Goods (ARTG) as a provisionally registered medicine and available to be administered by health professionals.

Timeline: The provisional registration is for an initial period of 2-years, with the option to apply for up to two extensions, up to a maximum of 6-years. Sponsors may apply for ‘full registration’ when there is more clinical data to confirm the safety of the vaccine.

The TGA’s provisional approval pathway consists of five steps:

  1. provisional determination
  2. pre-market registration 
  3. provisional registration period 
  4. extension of provisional registration (if required), and  
  5. transition to full registration. 

Emergency Use Authorisation (EUA)

This is a process for vaccine use being utilised in the United States by the FDA [refer to FDA: Emergency Use Authorization]. 

It allows the FDA to approve a vaccine in the setting of a public health emergency, such as the COVID pandemic. The FDA have outlined to vaccine sponsors the thresholds that would need to be met for a COVID-19 vaccine to be considered under this pathway, which can only be activated under specific guidance of section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

The European Medicines Agency have also outlined their guidance for COVID-19 vaccine authorisation in Europe [refer to EMA: Guidance for medicine developers and other stakeholders on COVID-19 . 

International Coalition of Medicines Regulatory Authorities (ICMRA) 

In this MVEC page we have already mentioned three regulators (TGA, FDA and EMA) and like many issues flagged during the pandemic, there has been close collaboration between the regulators and early sharing of information related to the vaccine trials and safety data. 

The International Coalition of Medicines Regulatory Authorities (ICMRA) is acting as a forum to support strategic coordination and international cooperationamong global medicine regulatory authorities. The aim of these international activities is toexpediteand streamline the development, authorisation and availability ofboth COVID-19 treatments and vaccinesworldwide. ICMRA members also work towards increasing the efficiency and effectiveness of regulatory processes and decision-making [refer to ICMRA: COVID-19].

MVEC will continue to provide news items on the regulatory processes being undertaken regarding COVID-19 vaccines, with a focus on some of the safety aspects and phase 4 surveillance activities being undertaken as part of post marketing surveillance. 

To report any adverse event following immunisation in Victoria, go to SAEFVIC.  

Resources

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

Reviewed by: Rachael McGuire (MVEC Education Nurse Coordinator)

Date: August 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.


Pharmacist immunisers

Background

Pharmacist immunisers are registered pharmacists who have completed additional training that allows them to administer approved vaccines to specified patient groups. This improves vaccine accessibility for the community which is particularly important to limit the spread of vaccine preventable diseases.

Pharmacist immuniser requirements

In addition to completing an immunisation program recognised by the Chief Health Officer, pharmacist immunisers are required to display their certificate of completing said training, hold current First Aid and CPR certificates, and ensure that another suitably qualified staff member is on site when immunising in pharmacy settings.

Pharmacist immunisers are bound by the policies and procedures of their local jurisdiction. For more information on requirements of pharmacists in Victoria, refer to the Victorian Pharmacist-Administered Vaccination Program Guidelines.

Which vaccines can pharmacist immunisers administer in Victoria?

In Victoria, pharmacist immunisers are authorised to administer the following vaccines:

The Royal Children’s Hospital immunisation service pharmacist

The RCH Immunisation Service has a pharmacist immuniser as part of their specialist team. If you have any queries regarding a pharmacist’s role in immunisation, please email immunisation.centre@rch.org.au or phone 1300 882 924 (option 2).

Resources

Pharmacist Immuniser Training Programs

Other resources

Authors: Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute), Annie Cobbledick (Immunisation Pharmacist, The Royal Children’s Hospital), Nigel Crawford (Director SAEFVIC, Murdoch Children’s Research Institute), Helen Pitcher (Immunisation Section, Department of Health and Human Services) and Linny Nguy (Immunisation Section, Department of Health and Human Services)

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

Date: April 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.


Porcine gelatin and vaccines

A number of families and health care providers may wonder if immunisations are permitted based on religious beliefs, given the presence of gelatin derived from pork in some vaccines.

Leaders of the Jewish faith have declared that pork derived additives in medicines are permitted for those observant of the Jewish faith. Rabbi Abraham Adler, from the Kashrus and Medicines Information Service in the United Kingdom has advised:
“It should be noted that according to Jewish laws, there is no problem with porcine or other animal derived ingredients in non-oral products. This includes vaccines, injections, suppositories, creams and ointments”

Scholars of the Islamic Organization for Medical Sciences have also determined that the process by which the original pork product is transformed into gluten, alters it enough whereby it is permitted for observers of Muslim faith to receive vaccines. A 2001 letter from the World Health Organization Regional Office for the Eastern Mediterranean reported:
“the gelatin formed as a result of the transformation of the bones, skin, and tendons of a judicially impure animal is pure, and it is judicially permissible to eat”
Grand Mufti of Australia has also released supportive statements noting that the use of vaccines containing gelatin derived from pork is permitted for observant Muslims.

Seventh-Day Adventists are not forbidden to use pork derivatives in medical products.

If there are any queries regarding porcine products in vaccines please contact info.mvec@mcri.edu.au

Resources

Authors: Rachael McGuire (SAEFVIC Research Nurse, Murdoch Children’s Research Institute), Nigel Crawford (Director, SAEFVIC, Murdoch Children’s Research Institute) and Georgie Lewis (SAEFVIC Clinical Manager, Murdoch Children’s Research Institute)

Date: February 2019

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.

 


Preterm infant immunisation

Prematurity, particularly extreme prematurity (< 28-weeks gestation) and low birth weight infants often have associated chronic (special risk) medical conditions. This can be associated with prolonged hospitalisation and frequent clinic visits. These are some of the reasons premature infants are at a greater risk of vaccine preventable diseases (VPDs) and their complications. Preterm infants may also not respond as well to some vaccines (e.g. Hepatitis B).

Immunisation recommendations

Infants should be immunised according to the recommended immunisation schedule based on their chronological age as opposed to their corrected age. This is because it is important to minimise the window preterm infants are not protected from VPDs. Specific special risk medical conditions, as well as birth weight need to be taken into account as extra vaccines may be required .

It should be noted that the Rotavirus immunisation must be given within a strict time frame, with the first dose required before turning 15-weeks (chronological age) and the second dose before 25-weeks of age.

Additional vaccines recommended:

< 28-weeks gestation

Pneumococcal vaccines

  • Infants born at < 28-weeks gestation are recommended to receive 4 doses of 13vPCV and 2 doses of 23vPPV
    • 13vPCV in a 4-dose schedule at 2, 4, 6 and 12-months of age (the first dose may be given as early as 6-weeks of age)
    • 2 doses of 23vPPV; 1 dose at 4-years of age and another dose at least 5 years later

< 32-weeks gestation and/or < 2000g birth weight

Hepatitis B

  • Hepatitis B vaccine should be given at 12-months of age

Additional risk condition vaccine recommendations

  • Influenza vaccine should be given annually from 6 months of age
  • Meningococcal vaccines (MenB and MenACWY) are now funded under the NIP for people of all ages with medical conditions associated with the highest risk of invasive meningococcal disease

Resources:

Household contacts

It is recommended that family members of premature infants be fully up to date with their immunisations including influenza and pertussis boosters. This concept of ‘cocooning’ will help protect vulnerable preterm infants from VPDs.

The whooping cough (pertussis) vaccine is free and recommended for pregnant women and can be given anytime between 20-32 weeks of each pregnancy. It should be given as early as possible (from 20 weeks) to women who have been identified as being at high risk of early delivery to protect baby in the first months of life when they are too young to be vaccinated.

Influenza vaccination in pregnancy is safe and strongly recommended in avoiding complications of influenza disease. It can be administered at any stage of pregnancy and not only aims to protect the expectant mother from disease, but also to provide protection to the infant once born. Babies less than 6-months of age are at greatest risk of disease and death from influenza and maternal vaccination will provide protection to babies for the first few months of life until they can be immunised against influenza from 6-months of age.

Resources

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

Reviewed by: Francesca Machingaifa (SAEFVIC Research Nurse, Murdoch Children’s Research Institute) and Georgina Lewis (Clinical Manager SAEFVIC, 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.


Photographing a severe local reaction

The majority of vaccines on the National Immunisation Program are administered as injections, either into the muscle (intramuscular- IM) or just under the skin (subcutaneous- sc). A common, expected side effect of vaccines is therefore a local reaction. They may occur following any vaccine usually within 24 hours post immunisation The majority of these local reactions are small, do not limit activity and no further action is required. Symptoms usually resolve with minimal intervention. Symptomatic relief may include analgesia and cool compress.

Some Injection Site Reactions (ISR), however, can be more severe: defined as an enlargement or swelling at the injection site that, depending on severity, may extend from joint to joint (e.g. shoulder to elbow) or crossing a joint.  Other features of ISR’s may include redness, pain and tenderness. Symptomatic relief is again all that is usually required (e.g. analgesia and cool compress).

Photography

To confirm the diagnosis of the moderate to severe ISR, it would be helpful to have a photograph of the affected limb.

Here are some simple steps to follow:

  1. Ensure you are standing in a position lit by plenty of natural light (i.e. a window with lots of sunlight or outside).
  2. You will need a ruler to show the length of the reaction against the affected limb.
  3. When photographing the limb, we need to see from above the shoulder to below the elbow. No more and no less. Try and keep identifying features such as the face, out of the picture. Clothing needs to be removed or minimised so as not to cover the area.
  4. The limb needs to be photographed from 2 angles. The first of which should be looking directly onto the limb with the ruler being held up at the side as a reference. See example below.

Injection Site Reaction - 1

5. The next image needs to show the profile of the arm from behind, so we can identify any swelling of the limb. Standing behind the child, photograph the limb from above the shoulder to below the elbow, again holding the ruler against the limb to reference the size of the reaction. See example below.

ISR_1

6. Once images have been taken, please email them together to enquiries@saefvic.org.au using your SAEFVIC report number as a reference in the subject line.

If you have any queries regarding any of the information posted above, please contact SAEFVIC either by email or by calling 1300 882 924 (Option 1).

Resources

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

Date: February 2018

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.


Paediatric Integrated Cancer Service (PICS): Immunisation resources

The Paediatric Integrated Cancer Service (PICS) is a statewide initiative supported by Cancer Australia, with guidelines endorsed by the Australian and New Zealand Childrens Haemotology/Oncology Group (ANZHOG).

The PICS immunisation resources detail vaccines to consider during cancer therapy [e.g. influenza (flu)], as well as highlighting the vaccines that are required after completion of chemotherapy. These resources cross-link with the MVEC Cancer immunisation guidelines (see Resources below).

The PICS Immunisation information sheets have been translated into a number of different languages.

Resources

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

Date: February 2018

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.