Pneumococcal disease and vaccines

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) and live attenuated vaccines (MMR/Varicella/Zostavax®).

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)

Date: February 2021

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

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


Pfizer/BioNTech COVID-19 vaccine

Name: BNT162b2

Type: Genetic vaccine (messenger RNA/mRNA)

Developer: Pfizer/BioNTech

Likely doses/timing: 2 doses (21 days apart)

Doses for Australia: 10 million doses will be available from early 2021

Manufacturing: Doses for Australia will be manufactured overseas

Storage: Must be stored at -70°C, transported on dry ice and will only last 5 days at standard refrigerator temperatures (2-8°C).

Preparation and Injection: Each multi-dose vial of the vaccine contains 5 doses of 0.3ml. The vaccine must be thawed before injection and diluted with the recommended diluent. After dilution the vial must be used within six hours. The vaccine is administered intramuscularly (IM).

Background

Pfizer/BioNTech’s COVID-19 vaccine (BNT162b2) has been issued Emergency Use Authorization (EUA) and even full approval in several counties. Of note, the UK and USA have both issued an EUA, on 2 December and 11 December 2020, respectively. The first injections under a country-wide program began in the UK on 8th  December 2020.

Pfizer’s BNT162b2 vaccine contains messenger RNA (mRNA) which codes for the SARS-CoV-2 full-length spike protein. Although mRNA vaccines have never been licensed before, they had already been studied for more than a decade. mRNA vaccines were already under development for other viruses, such as influenza, and have been tested and shown to be safe in previous clinical trials.

On 25 January 2021, the Pfizer/BioNTech COVID-19 vaccine (Comirnaty) was the first COVID-19 vaccine to be granted provisional registration in Australia.

Clinical trials

Pre-clinical trials were conducted in non-human primates (rhesus macaques) and mice. In animal models, the vaccine induced a strong immune response and prevented lung infection. 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.

Phase 1/2 clinical trials were conducted in Germany and USA. The US Phase 1 trial also included older participants (up to 85 years old) and compared 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). This trial supported the selection of BNT162b2 for advancement to Phase 2/3 trials.

Phase 2/3 clinical trials of BNT162b2 were conducted across USA, Germany, Argentina, Brazil, South Africa and Turkey, and started in July 2020. Initial results of the Phase 3 trial from 43,448 participants, aged 16 years or older, were published in the New England Journal of Medicine on 10 December 2020.

Safety profile

The reactogenicity of BNT162b2 was generally mild or moderate, reactions were generally short-term and were less common and milder in older adults, compared to younger adults. Systemic reactions were more common and severe after the second dose. The incidence of serious adverse events was low and similar in both the vaccine and placebo groups. Phase 3 trial results were consistent with earlier clinical studies and provided results from a median follow-up time of two months after the second dose.

Mild-to-moderate pain at the injection site within seven days after an injection was the most commonly reported local reaction (66-83% depending on age group or first versus second dose). Pain resolved within 1-2 days, there was no increase in reported local reactions after the second dose and no reactions required emergency department visit or hospitalisation.

The most commonly reported systemic events were fatigue (59%), headache (52%) and muscle aches (37%), after the second dose among younger vaccine recipients. These proportions were lower in older vaccine recipients; 51% with fatigue, 39% with headache and 29% with muscle aches after the second done. Severe systemic events were reported in less than 2% of vaccine recipients after either dose, except for fatigue (in 3.8%) and headache (in 2%) after the second dose.

In younger vaccine recipients, fever (≥ 38°C) was reported in 4% after the first dose and 16% after the second dose. In older recipients, fever was reported in 1% and 11%; after first and second dose respectively. Systemic events including fever and chills were observed within the first 1-2 days after vaccination and resolved shortly thereafter.

Serious adverse events were rare; only four were reported among BNT162b2 recipients (shoulder injury related to vaccine administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paraesthesia). No stopping rules (trial pauses) were met during the reporting period. Safety monitoring for this vaccine will continue for 2 years after administration of the second dose of vaccine.

Since public vaccinations began in December 2020, anaphylactic reactions in people receiving the Pfizer/BioNTech COVID-19 vaccine have been reported in the United Kingdom and United States. Clear guidance regarding allergy management will be provided once the Pfizer/BioNTech vaccine has regulatory approval from the TGA. Some guidance from the CDC is included in the following links:

  1. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020
  2. Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States
  3. Lab Tests to Collect Shortly After Severe Allergic Reaction/Anaphylaxis Following COVID-19 Vaccination.

Immunogenicity

Two doses of BNT162b2 elicited high SARS-CoV-2 neutralising antibody titres and robust spike protein-specific T-cell responses. These neutralising antibody responses were greater than the responses measured in people recovered from natural COVID-19 infection; in both younger and older adults. The duration of protection is currently unknown, with booster doses not recommended at this stage.

Vaccine efficacy

The Pfizer/BioNTech vaccine was the first to present interim data of their Phase 3 trial, indicating the vaccine had 95% vaccine efficacy. Similar vaccine efficacy (generally 90 to 100%) was observed across all subgroups defined by age, 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.

In among 36,523 participants who had no evidence of existing or prior SARS-CoV-2 infection, there were only 8 cases of COVID-19 (with onset at least seven days after the second dose) in those vaccinated with BNT162b2, compared to 162 cases of COVID-19 among those who received placebo. This corresponded to 95% vaccine efficacy. When combined with participants who did have evidence of past SARS-CoV-2 infection, the vaccine efficacy was still similar (94.6%).

The vaccine appears likely to provide individual protection and prevent severe disease; among 10 cases of severe COVID-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient.

Less than two weeks after the first dose, the vaccine started protecting participants, and the second dose three weeks later, boosted their immune 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.

Ongoing research

Phase 3 trials are still ongoing and safety monitoring for this vaccine will continue for two years after administration of the second dose of vaccine. Safety monitoring will also continue in the post-licensure phase through surveillance of adverse events following immunisation reporting systems.

Further Phase 3 trials are underway or planned in children (underway for adolescents 12 years and older and planned for younger children), pregnant women and special risk groups, such as immunocompromised people.

Ongoing data collection is required to assess whether the vaccine prevents transmission and asymptomatic cases, as well as assessing how long immune memory may last and whether booster doses are required.

This vaccine has not yet been assessed in clinical trials when co-administered with other vaccines; hence the vaccine should be administered alone. The USA’s CDC recommends a minimum interval of 14 days before or after administration with any other vaccines, including seasonal influenza. ATAGI recommends a 14 day minimum interval between the administration of influenza and COVID-19 vaccines [refer to: ATAGI advice on influenza and COVID-19 vaccines].

Resources

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

Date: January 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.

 

 


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 Australian Therapeutic Goods Administration (TGA)

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 (TGA)

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 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)

Date: December 2020

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

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

 


Pharmacist immunisers

Pharmacist immunisers are registered pharmacists with additional training that allows them to administer approved vaccines to specified patient groups. In Victoria, pharmacist immunisers are authorised to administer influenza vaccines to patients 10 years and older and pertussis-containing, measles-mumps-rubella and meningococcal ACWY vaccines to people aged 15 years and older (some exclusions apply as per the current Secretary Approval: Pharmacist Immuniser such as vaccination for travel purposes). This improves accessibility for the community which is particularly important for pregnant women to protect themselves and their newborn.

Training programs need to be recognised by the Chief Health Officer. Details of training programs in Victoria are outlined below. The certificate of completion for the pharmacist should be on display in the immunisation area. Pharmacist immunisers must also hold current First Aid and CPR certificates, have professional insurance and participate in professional development in the area of immunisation.

Pharmacist immunisers must adhere to the policies and procedures of their local jurisdiction. In Victoria these include current editions of the following:

The Regulations, Approval and Guidelines outline the following requirements of the pharmacy premises:

  • Pharmacist immunisers must immunise in either a hospital, pharmacy or pharmacy depot or a mobile or outreach of one the aforementioned premises
  • The premises above must meet the guidelines for facilities for immunisation services described in the Victorian Pharmacy Authority Guidelines that are current at the time of administration
  • The premises must be registered with the Department of Health and Human Services (DHHS) and registered as a vaccination provider on the Australian Immunisation Register (AIR)
  • All pharmacists administering Schedule 4 poisons (prescription only medicines) must do so in accordance with the current edition of the Australian Immunisation Handbook and the current National Vaccine Storage Guidelines: Strive for 5
  • Immunisation must occur in a private consultation room that is not visible or audible to other people in the pharmacy, as outlined in the Victorian Pharmacy Authority Guidelines
  • At least one other staff member in the pharmacy must hold current First Aid and CPR and be present during the administration and post-immunisation period
  • Patients must be provided with adequate seating to wait for 15 minutes after immunisation, where they are in the line of sight of the pharmacist or other qualified staff member
  • The pharmacist must have an accessible anaphylaxis response kit and emergency response protocol
  • Pharmacists must verify and document administration of vaccines onto the Australian Immunisation Register

In addition to administration of immunisations, pharmacist immunisers can offer support in:

  • The safety of immunisations in patients with medical conditions or taking particular medications
  • Application of product information
  • Education about additional immunisations that may not be provided on the immunisation schedule
  • Vaccine procurement and management of vaccine shortages

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 (SAEFVIC Research Nurse, Murdoch Children's Research Institute)

Date: March 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.


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 saefvic@mcri.edu.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.


Private vaccine prices at The Royal Children's Hospital

The majority of vaccines administered in Australia are funded under the National Immunisation Program (NIP)

In some circumstances vaccines need to be purchased privately, examples including:

  • Travel vaccines
  • International patients without a Medicare card
  • Influenza vaccine for household contacts who do not qualify for NIP funded vaccine

Some additional vaccines may be funded if a patient has an underlying special risk medical condition, and/or requested by a medical practitioner. If uncertain, please check with your treating doctor.

Resources

If you have any queries, please check with your treating doctor or call the Immunisation Hotline on 1300 882 924 (option 2)

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

Date: September 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.


Maternal vaccination during pregnancy

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 and pertussis 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. This includes COVID-19 vaccines. 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

The administration of COVID-19 vaccines to pregnant women is not routinely recommended however it is not contraindicated. Currently, there is limited data available on the safety of COVID-19 vaccination in pregnancy and on pregnancy outcomes. ATAGI recommends that immunisation during pregnancy could be considered if there are medical risk factors for developing severe disease or if there is a high risk of exposure to the virus (ie: occupational risk factors).

ATAGI recommends that women who are breastfeeding or who are planning pregnancy can receive COVID-19 vaccines. 

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)

Date: February 2021

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

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


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.