POTS (postural tachycardia syndrome) and immunisation

Background

Postural tachycardia syndrome (POTS) is a syndrome where individuals experience a cluster of symptoms including an inappropriate level of tachycardia (rapid heartbeat) upon standing. The condition is more common in females, especially adolescents and young adults. There can be a number of associated symptoms, including dizziness, weakness, vision changes, difficulty concentrating, sleep disturbances or nausea.

Although the pathophysiology of POTS is yet to be fully understood, it is thought to be due to an abnormal autonomic nervous system response. When changing positions from sitting to standing, gravity sends blood to the legs and pelvis activating the sympathetic (fight or flight) nervous system, releasing noradrenaline. This tightens bloods vessels in the lower body so that blood is moved back to the heart, slightly increasing the heart rate, usually all in under a second, keeping blood pressure and bloody supply to the brain stable. In individuals with POTS, this process does not work as well as it should and the brain compensates by increasing the heart rate.

POTS can have an impact on quality of life, with many people experiencing both physical symptoms as well as other effects on mood, cognition and sleep. However, most cases can be successfully managed with lifestyle modifications. Medications are only required in rare circumstances.

POTS and vaccines

A diagnosis of POTS is not a contraindication to receiving vaccinations. In fact, some cases of POTS are thought to occur following an acute infection, some of which are vaccine-preventable. Therefore it is important that any individual who has a diagnosis of, or is concerned about, POTS should receive all recommended vaccinations.

Human papillomavirus (HPV)

There have been concerns previously after a small number of case reports described POTS being diagnosed following human papillomavirus (HPV) vaccination. However, this has been thoroughly assessed by the Centers for Disease Control and Prevention (CDC) and after examining the data from more than 80 million doses of vaccines, no causal link has been established between HPV vaccines and POTS.

COVID-19

There has not been an established link between COVID-19 vaccines and an increased risk of developing POTS. In fact, there have been reports of POTS developing after COVID-19 infection and POTS has been recognised as a post-covid condition (colloquially known as long COVID). Therefore being vaccinated against COVID-19 is recommended for individuals concerned about developing this condition.

Summary 

For individuals with a previous diagnosis of POTS who are concerned for a worsening of their condition after vaccination, it is important to consider that most vaccine side effects are mild and transient. Overall the benefits of vaccination are likely to far outweigh the risks. However, any concerns should be discussed with an individual’s treating healthcare practitioner.

Resources

Author: Julia Smith (RCH Immunisation Fellow)

Date: September 20, 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.


Polio

What is it?

Polio (poliomyelitis) is caused by a gastrointestinal (gut) infection with one of 3 types of polioviruses (serotypes 1, 2 or 3). Polioviruses are RNA enteroviruses from the Picornaviridae family.

Once an individual is infected, the poliovirus replicates in the gut and enters the bloodstream via lymphoid tissue where it can then cause symptoms in the central nervous system.

What to look for

Approximately 70% of polio infections are asymptomatic or present as a non-specific febrile illness. In symptomatic cases an individual may experience fever, headache, gastrointestinal disturbance (nausea and vomiting) or malaise. In severe infections muscle pain and stiffness of the neck and back can occur.

Paralysis typically presents asymmetrically and can be life threatening when the respiratory and swallowing muscles are affected. The extent of paralysis is usually seen within 3-4 days of symptom onset and any existing paralysis present after 60 days is likely to be permanent. It is estimated that flaccid paralysis occurs in less than 1 percent of all polio cases.

A recurrence of muscle weakness in the years after an initial polio infection is known as post-polio syndrome. It is attributed to a progressive loss or dysfunction of motor neurons as opposed to a persistent or reactivated infection.

How is it transmitted?

Wild polio is transmitted through contact with the faeces or saliva of an infected person and is most often associated with conditions of poor sanitation.

The incubation period of polio is 3-35 days, with a person infectious during the 7-10 days prior to the onset of symptoms. Following acute infection, a person can continue to excrete the polio virus for up to 6 weeks in their faeces, or 2 weeks in saliva.

Epidemiology

Polio infection predominantly occurs in children with the greatest burden of disease affecting those less than 5 years of age (80-90% of cases).

Global vaccination programs and high rates of immunisation have shown great success with the near eradication of wild polio worldwide. A total of 350,000 infections were reported in 1988 across 125 countries and in 2021 this was reduced down to 6 reported cases across countries including Pakistan and Afghanistan. The COVID-19 pandemic has greatly impacted these vaccination programs and since 2022 a resurgence of case across many countries (including the United States and the UK) have been reported, largely in pockets of unimmunised communities.

Prevention

Vaccination remains the most effective measure in disease prevention with protection available in Australia through the administration of a course of inactivated vaccines. Polio vaccination is funded on the National Immunisation Program (NIP) as a combination vaccine for children at:

  • 6 weeks, 4 months and 6 months – Infanrix hexa®
  • 4 years – Infanrix® IPV/Quadracel®

Polio vaccines are also available for other individuals requiring catch up who meet certain criteria (eg. refugee and humanitarian entrants).

Completing a primary course of vaccination generally provides life-long protection and booster doses are not routinely indicated for the broader population.

Precautions

The oral live-attenuated polio vaccine is no longer available in Australia due to the potential low risk (1 case per 2.4 million doses) of Vaccine Associated Paralytic Poliomyelitis (VAPP), also known as Vaccine Derived Poliovirus (VDPV). Following receipt of the oral polio vaccine some of the vaccine virus may be shed in a person’s faeces for up to 6 weeks. In areas of low vaccine coverage this has the potential to cause disease in an unvaccinated individual.

Resources

Authors: Rachael McGuire (MVEC Education Nurse Coordinator)

Date: September 20, 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.


Pericarditis and myocarditis following COVID-19 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 COVID-19 vaccines, with the highest rates occuring following administration of COVID-19 mRNA vaccines Comirnaty (Pfizer) and Spikevax (Moderna).

Information specific to myocarditis and pericarditis can be found via the below buttons. In addition, frequently asked questions relating to vaccination are also addressed.

Myocarditis

  • How is myocarditis following COVID-19 vaccination triggered?

    The exact mechanism behind cardiac inflammation temporally associated with COVID-19 vaccines is currently being investigated. Clinical causes from international and local surveillance data suggest an immune-mediated or hypersensitivity trigger. There are ongoing studies examining the role of the SARS-CoV-2 spike protein, impact of certain cardiac biomarkers and genetic predispositions to this adverse event of special interest (AESI).

  • 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 COVID-19 vaccines vary; however, they are above expected background rates for both sexes. The peak risk group for COVID-19 vaccine related myocarditis is young adult males aged 16-17 years, with a smaller increased risk for males aged between 12-24 years.

    International and local vaccine safety surveillance data have found that it is more commonly associated with administration of a second dose of COVID-19 mRNA vaccine. Myocarditis following other COVID-19 vaccines, third doses or booster doses have also been identified, although reported cases have occurred at lower rates than those identified following either dose of a primary course.

    Although myocarditis AESI has been associated with all of the COVID-19 vaccines used in Australia, there is a higher risk of myocarditis following administration of COVID-19 mRNA vaccines compared to non-mRNA vaccines. Surveillance data from multiple countries have also demonstrated a greater risk with Spikevax (Moderna) compared to Comirnaty (Pfizer).

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

    Available safety data from local and international sources suggest there is a significantly lower risk of children developing myocarditis following vaccination. Thus far, data shows that the risk of COVID-19 vaccine myocarditis decreases as age decreases.

    ATAGI recommends an interval of 8 weeks between vaccine doses in a primary course for age-eligible children (≤ 11 years) 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.

    Very few cases of myocarditis in children <6 years of age have been reported in available worldwide surveillance data to date.

    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 COVID-19 vaccination

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

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

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

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

    Patients with ongoing cardiac inflammation should have vaccination deferred. In some instances, vaccination with Vaxzevria (AstraZeneca) or Nuvaxovid (Novavax) may be considered due to the lower associated risk of developing myocarditis.

  • 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  vaccines, symptoms of myocarditis 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 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 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.

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

    For individuals where the cause of inflammation is attributed to COVID-19 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 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 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 uncommon. 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 COVID-19 vaccination is currently being investigated. Clinical causes from international surveillance data suggest an immune-mediated or hypersensitivity trigger.

  • Who is at risk of pericarditis?

    Pericarditis from any cause occurs in similar rates amongst males and females. It is also more likely to affect younger adults.

    Reported rates of pericarditis occurring following administration of a COVID-19 vaccine vary; however, they are above expected background population rates. Available surveillance data suggests the risks for pericarditis after a mRNA vaccine are higher than non-mRNA vaccines.

    International and local data indicate that pericarditis following COVID-19 vaccines is more common in the 18-39 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 significantly lower risk of children developing pericarditis following COVID-19 vaccination.

    ATAGI recommends an interval of 8 weeks between vaccine doses in a primary course for age-eligible children (≤ 11 years) 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 – which in principle may also extend to pericarditis. 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 COVID-19 vaccination

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

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

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

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

    Patients with ongoing cardiac inflammation should have vaccination deferred. In some instances, vaccination with Vaxzevria (AstraZeneca) or Nuvaxovid (Novavax) may be considered due to the lower associated risk of pericarditis.

  • 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 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 vaccination have mild symptoms and recover well.

    In some scenarios, there have been reports of pericarditis causing prolonged and recurrent symptoms but with functionally normal investigations including cardiac imaging. Information on long term sequelae is still being collected.

    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 arrhythmias, 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 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 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 uncommon. Most individuals diagnosed with myocarditis following COVID-19 vaccination have responded well to treatment.

Frequently asked questions

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

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

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

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

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

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

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

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

    Myocarditis/pericarditis following COVID-19 vaccination appears to be idiosyncratic at this stage, with no clear risk factors. Thus, there is no indication of increased risk in those with underlying autoimmune disease.

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: November 30, 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

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: September 15, 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. Completion of further training modules are required prior to administering some vaccines (COVID-19, monkeypox and Japanese encephalitis)

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:

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: Rachael McGuire (MVEC Education Nurse Coordinator)

Date: October 4, 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.