Pneumococcal disease
Information about pneumococcal disease, vaccines and recommendations for vaccination from the Australian Immunisation Handbook.
Recently added
This page was added on 11 June 2018.
Updates made
This page was updated on 16 August 2024. View history of updates
The optimal pneumococcal vaccination program for Australia is currently under review. At present Prevenar 13 (13vPCV) and Pneumovax 23 (23vPPV) are the pneumococcal vaccines funded under the National Immunisation Program (NIP) for eligible individuals. Updates to this chapter include interim recommendations for use of extended valency vaccines (Vaxneuvance [15vPCV] and Prevenar 20 [20vPCV]) in the populations for whom they have recently been registered by the Therapeutic Goods Administration; these vaccines are not currently NIP-funded.
Overview
What
Pneumococcal disease is caused by the bacterium Streptococcus pneumoniae. It can cause severe invasive disease, including meningitis, pneumonia and bacteraemia, and non-invasive disease, including otitis media.
Who
Pneumococcal vaccine is recommended for:
- infants and children aged <5 years
- non-Indigenous adults aged ≥70 years
- Aboriginal and Torres Strait Islander adults aged ≥50 years
- children, adolescents and adults with risk conditions for pneumococcal disease
How
There are two types of pneumococcal vaccines registered in Australia:
- Pneumococcal conjugate vaccines: Prevenar 13 - 13vPCV (13-valent pneumococcal conjugate vaccine), Vaxneuvance - 15vPCV (15-valent pneumococcal conjugate vaccine), and Prevenar 20 - 20vPCV (20-valent pneumococcal conjugate vaccine)
- Pneumococcal polysaccharide vaccines: Pneumovax 23 - 23vPPV (23-valent pneumococcal polysaccharide vaccine)
The recommended number and timing of doses, and type of vaccine depend on:
- the person’s age
- their Aboriginal and Torres Strait Islander status
- the state or territory they live in
- whether they have conditions that increase their risk of pneumococcal disease
- whether they have received a pneumococcal conjugate vaccine or 23vPPV before
Why
Infants and elderly people have the highest pneumococcal disease burden. Pneumococcal disease disproportionately affects Aboriginal and Torres Strait Islander children and adults. Pneumococcal disease is more common in people with certain risk conditions.
See
- Infographic. Pneumococcal vaccination for all Australians
- Infographic. Pneumococcal vaccination for children <5 years old
- Infographic. Pneumococcal vaccination for people with risk conditions for pneumococcal disease
- Infographic. Vaccination for healthy ageing
- Infographic. Pneumococcal vaccination recommendations for people who have previously received a pneumococcal vaccine.
Recommendations
Infants and children
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All children are recommended to receive pneumococcal conjugate vaccine in a 3-dose schedule at 2, 4 and 12 months of age. There is no preference for either 13vPCV or 15vPCV. It should be noted that 15vPCV is anticipated to provide benefit against two additional serotypes compared to 13vPCV.
Infants can receive their 1st dose of pneumococcal conjugate vaccine as early as 6 weeks of age. If the 1st dose is given at the age of 6 weeks, infants should still receive their next scheduled dose at 4 months of age.
Some Aboriginal and Torres Strait Islander children, and infants with one or more risk condition for pneumococcal disease need extra doses. See:
- Aboriginal and Torres Strait Islander people
- People with medical risk factors
- Infographic. Pneumococcal vaccination for all Australians
For children aged >12 months who have not completed a full course of pneumococcal conjugate vaccines, the timing and number of further doses for catch-up vaccination depends on:
- the child’s age
- any previous doses they received
For recommendations, see Table. Catch-up schedule for pneumococcal conjugate vaccines 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.
13vPCV (Prevenar 13) is funded through the NIP for all children aged <5 years. For details see the National Immunisation Program Schedule.
View recommendation details
Adults
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A single dose of a pneumococcal conjugate vaccine (13vPCV, 15vPCV or 20vPCV) is recommended for all non-Indigenous adults at 70 years of age. There is no preference for either 13vPCV, 15vPCV or 20vPCV. It should be noted that 15vPCV and 20vPCV are anticipated to provide benefit against additional serotypes compared to 13vPCV.
Non-Indigenous adults aged ≥70 years who did not receive a dose of a pneumococcal conjugate vaccine at 70 years of age are recommended to receive a single catch-up dose of 13vPCV, 15vPCV or 20vPCV as soon as possible. See Infographic. Pneumococcal vaccination recommendations for people who have previously received a pneumococcal vaccine
Non-Indigenous adults aged ≥70 years who have previously received 23vPPV and have not already received a conjugate vaccine are recommended to receive a single dose of 13vPCV, 15vPCV or 20vPCV at least 12 months after their last 23vPPV dose. See Infographic. Pneumococcal vaccination recommendations for people who have previously received a pneumococcal vaccine
Aboriginal and Torres Strait Islander adults aged ≥50 years, and all adults with one or more risk conditions for pneumococcal disease need extra doses. See:
- Aboriginal and Torres Strait Islander people
- People with medical risk factors
- Infographic. Pneumococcal vaccination for all Australians
13vPCV (Prevenar 13) is funded through the NIP for all non-Indigenous adults without risk conditions aged ≥70 years. For details see the National Immunisation Program Schedule.
View recommendation details
Aboriginal and Torres Strait Islander people
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In addition to the 3 doses for all children <5 years of age, Aboriginal and Torres Strait Islander children living in the following states and territories are recommended to receive an additional dose of pneumococcal conjugate vaccine at 6 months of age:
- Northern Territory
- Queensland
- South Australia
- Western Australia
This is because of the higher risk of pneumococcal disease in these children.1
These children are also recommended to receive 2 doses of 23vPPV:
- 1 dose at 4 years of age
- a 2nd dose at least 5 years later
This is because a considerable proportion of pneumococcal disease in these children is caused by serotypes that are present in 23vPPV but not in 13vPCV, 15vPCV or 20vPCV.
For the pneumococcal conjugate vaccine dose, there is no preference for either 13vPCV or 15vPCV. It should be noted that 15vPCV is anticipated to provide benefit against two additional serotypes compared to 13vPCV; however, this difference is diminished after receiving 23vPPV.2
For children aged >12 months who have not completed a full course of pneumococcal conjugate vaccines, the timing and number of further doses for catch-up vaccination depends on:
- the child’s age
- any previous doses they received
For recommendations, see Table. Catch-up schedule for pneumococcal conjugate vaccines for Aboriginal and Torres Strait Islander children living in NT, Qld, SA or WA ONLY, and all children with any risk condition(s) for pneumococcal disease, aged <5 years.
13vPCV (Prevenar 13) and the additional doses of 23vPPV (Pneumovax 23) are both funded through the NIP for Aboriginal and Torres Strait Islander children aged <5 years living in certain states and territories. For details see the National Immunisation Program Schedule.
View recommendation details -
Aboriginal and Torres Strait Islander adults without risk conditions for pneumococcal disease are recommended to receive:
- a dose of a pneumococcal conjugate vaccine (13vPCV, 15vPCV or 20vPCV) at age ≥50 years, and
- a dose of 23vPPV 12 months later, and
- a 2nd dose of 23vPPV at least 5 years later
This is based on:
- the increased risk of pneumococcal disease in Aboriginal and Torres Strait Islander adults, compared with non-Indigenous adults
- the considerable proportion of invasive pneumococcal disease caused by additional serotypes contained only in 23vPPV
Aboriginal and Torres Strait Islander adults aged ≥50 years who have previously received 23vPPV are recommended to receive:
- 1 dose of a conjugate vaccine 12 months after their last 23vPPV dose, if they have not already received a conjugate vaccine, and
- 1 dose of 23vPPV 12 months after their conjugate vaccine dose, or 5 years after their previous 23vPPV dose, whichever is later. If they have already received 2 doses of 23vPPV, no further 23vPPV doses are recommended.
In all these scenarios, the interval between doses of a conjugate vaccine and 23vPPV should be 12 months, but 2–12 months is acceptable. The interval between doses of 23vPPV should be 5 years.
Aboriginal and Torres Strait Islander adults with risk conditions for pneumococcal disease are recommended to receive 1 dose of a conjugate vaccine (13vPCV, 15vPCV or 20vPCV) at diagnosis followed by 2 doses of 23vPPV (see recommendations for people with medical risk factors).
For the pneumococcal conjugate vaccine dose, there is no preference for either 13vPCV, 15vPCV or 20vPCV. It should be noted that 15vPCV is anticipated to provide benefit against two additional serotypes compared to 13vPCV; however, this difference is expected to diminish after receiving 23vPPV.2 20vPCV is anticipated to provide protection against seven additional serotypes, when compared to 13vPCV, but it is uncertain if this difference is maintained after receiving 23vPPV.
13vPCV (Prevenar 13) and the additional doses of 23vPPV (Pneumovax 23) are both funded through the NIP for all Aboriginal and Torres Strait Islander adults without risk conditions aged ≥50 years. For details see the National Immunisation Program Schedule.
View recommendation details
People with medical risk factors
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In addition to the 3 doses of 13vPCV or 15vPCV routinely recommended for healthy non-Indigenous children <5 years of age, children ≤12 months of age with risk conditions for pneumococcal disease (see Table. Risk conditions for pneumococcal vaccination and eligibility for NIP funding) are recommended to receive:
- an additional dose of a pneumococcal conjugate vaccine at 6 months of age
- a dose of 23vPPV at 4 years of age
- a 2nd dose of 23vPPV at least 5 years after the 1st dose of 23vPPV
This is because of the higher disease burden and the possibility of lower antibody responses in these children.3-5
Aboriginal and Torres Strait Islander children diagnosed with risk conditions at ≤12 months of age who live in the Northern Territory, Queensland, South Australia and Western Australia are already recommended to receive these extra doses as part of their routine schedule.
Any child aged 6 to 11 months with a newly identified risk condition who has not received an additional dose of a pneumococcal conjugate vaccine at 6 months of age should receive this dose at diagnosis. The exception is children who have received a haematopoietic stem cell transplant — these children are recommended to receive 3 doses of a pneumococcal conjugate vaccine after transplantation, followed by 2 doses of 23vPPV. See Table. Recommendations for revaccination after haematopoietic stem cell transplant in children and adults.
See Catch-up vaccination for more details, including minimum intervals between doses.
13vPCV (Prevenar 13) and the additional doses of 23vPPV (Pneumovax 23) are both funded through the NIP for people with certain risk conditions. For details see the National Immunisation Program Schedule.
View recommendation details -
All children and adults with newly identified risk conditions (see List. Risk conditions for pneumococcal disease) are recommended to receive:
- 1 dose of a pneumococcal conjugate vaccine (13vPCV, 15vPCV or 20vPCV) at diagnosis (at least 2 months after any previous doses of a pneumococcal conjugate vaccine), and
- 1 dose of 23vPPV 12 months after a pneumococcal conjugate vaccine (13vPCV, 15vPCV or 20vPCV) (2–12 months following the last dose of PCV is acceptable), and
- a 2nd dose of 23vPPV at least 5 years after the 1st dose of 23vPPV
Aboriginal and Torres Strait Islander children <5 years of age with risk conditions who live in the Northern Territory, Queensland, South Australia and Western Australia are already recommended to receive these doses as part of their routine schedule.
Children aged <5 years with risk conditions who have not received all the recommended pneumococcal conjugate vaccine doses should receive doses of a pneumococcal conjugate vaccine according to the catch-up schedule. See Table. Catch-up schedule for pneumococcal conjugate vaccines for Aboriginal and Torres Strait Islander children living in NT, Qld, SA or WA ONLY, and all children with any risk condition(s) for pneumococcal disease, aged <5 years.
All children and adults with existing risk conditions are recommended to receive a pneumococcal conjugate vaccine if they have not previously received this recommended dose. This dose of conjugate vaccine should be followed by 2 doses of 23vPPV.
People who have previously received doses of 23vPPV are recommended to receive an age appropriate pneumococcal conjugate vaccine 12 months after their last 23vPPV dose. If they have already received at least 2 doses of 23vPPV, no further 23vPPV doses are recommended. See Infographic. Pneumococcal vaccination recommendations for people who have previously received a pneumococcal vaccine.
There is no preference for either 13vPCV, 15vPCV or 20vPCV in people aged ≥18 years. For people aged <18 years there is no preference for 13vPCV or 15vPCV.
20vPCV is anticipated to provide benefit against seven additional serotypes, when compared to 13vPCV, but it is uncertain if this difference is maintained after receiving 23vPPV. It should also be noted that 15vPCV is anticipated to provide benefit against two additional serotypes compared to 13vPCV, however this difference is diminished after receiving 23vPPV.2
Aboriginal and Torres Strait Islander adults aged ≥50 years who have already received these doses do not need the doses repeated. The exception is people who have received a haematopoietic stem cell transplant — these people are recommended to receive 3 doses of a pneumococcal conjugate vaccine after transplantation. See Table. Recommendations for revaccination after haematopoietic stem cell transplant in children and adults.
A minimum interval of 2 months between the last dose of an age appropriate pneumococcal conjugate vaccine and 23vPPV is recommended. This is based on a small number of studies in children of different ages with underlying conditions. These studies have shown that 23vPPV elicits a good immune response when given approximately 2 months after a 7vPCV dose6-9 and this is considered also applicable to other pneumococcal conjugate vaccines. A study in adults infected with HIV also found that 23vPPV elicits a good immune response when given 2 months after a 15vPCV dose.10
13vPCV (Prevenar 13) and the additional doses of 23vPPV (Pneumovax 23) are both funded through the NIP for people with certain risk conditions. For details see the National Immunisation Program Schedule.
View recommendation details
Vaccines, dosage and administration
Pneumococcal vaccines available in Australia
The Therapeutic Goods Administration website provides product information for each vaccine.
See also Vaccine information and Variations from product information for more details.
Pneumococcal conjugate vaccines
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Sponsor:Pfizer AustraliaAdministration route:Intramuscular injection
Registered for use in children aged ≥6 weeks and in adults.
13vPCV — 13-valent pneumococcal conjugate vaccine
Each 0.5 mL monodose pre-filled syringe contains:
- 2.2 µg each of pneumococcal capsular polysaccharide of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F
- 4.4 µg of pneumococcal capsular polysaccharide of serotype 6B
- succinic acid
- polysorbate 80
Antigens are conjugated to non-toxic Corynebacterium diphtheriae CRM197 protein and adsorbed onto 0.565 mg aluminium phosphate.
For Product Information and Consumer Medicine Information about Prevenar 13 visit the Therapeutic Goods Administration website.
View vaccine details -
Sponsor:Pfizer AustraliaAdministration route:Intramuscular injection
Registered for use in people aged ≥6 weeks.
20vPCV - 20-valent pneumococcal conjugate vaccine.
Each 0.5 mL dose of vaccine contains:
- 2.0µg each of pneumococcal purified capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F
- 4.4µg of pneumococcal purified capsular polysaccharide serotype 6B
- Succinic acid
- Polysorbate 80
Antigens are conjugated to approximately 51 µg of non-toxic diphtheria CRM197 protein, adsorbed on 125 µg of aluminium (as aluminium phosphate adjuvant).
For Product Information and Consumer Medicine Information about Prevenar 20 visit the Therapeutics Goods Administration website.
View vaccine details -
Sponsor:Merck Sharp & Dohme (Australia)Administration route:Intramuscular injection
Registered for use in people aged ≥6 weeks
15vPCV - 15-valent pneumococcal conjugate vaccine
Each 0.5 mL dose of vaccine contains:
- 2.0 µg each of pneumococcal purified capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F
- 4.0 µg of pneumococcal purified capsular polysaccharide serotype 6B
- Histidine
- Polysorbate 20
Antigens are conjugated to 30 µg of non-toxic diphtheria CRM197 protein, adsorbed on 125 µg of aluminium (as aluminium phosphate adjuvant).
For Product Information and Consumer Medicine Information about Vaxneuvance visit the Therapeutics Goods Administration website.
View vaccine details
Pneumococcal polysaccharide vaccine
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Sponsor:Merck Sharp & Dohme (Australia)Administration route:Intramuscular injection, Subcutaneous injection
Registered for use in children aged ≥2 years and in adults.
23vPPV — 23-valent pneumococcal polysaccharide vaccine
Each 0.5 mL monodose vial contains:
- 25 µg each of pneumococcal capsular polysaccharide of serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F
- 0.25% phenol
For Product Information and Consumer Medicine Information about Pneumovax 23 visit the Therapeutic Goods Administration website.
View vaccine details
Dose and route
13vPCV
The dose of 13vPCV is 0.5 mL, given by intramuscular injection.
15vPCV
The dose of 15vPCV is 0.5 mL, given by intramuscular injection.
20vPCV
The dose of 20vPCV is 0.5 mL, given by intramuscular injection.
23vPPV
The dose of 23vPPV is 0.5 mL, given by either intramuscular or subcutaneous injection.
The intramuscular route is preferred. A 3-fold greater rate of injection site reactions is found following administration of 23vPPV by the subcutaneous route.11 However, a vaccine dose given subcutaneously does not need to be repeated.
Co-administration with other vaccines
Infants can receive 13vPCV, 15vPCV or 20vPCV at the same time as other vaccines in the infant schedule, including inactivated influenza vaccine. However, there is a possible small increased risk of fever if 13vPCV is given at the same time as influenza vaccine. At present, this possible risk has not been observed for 15vPCV, and there is no data available for 20vPCV. Advise parents/carers of infants or children who are recommended to receive both influenza vaccine and 13vPCV of this risk. See Contraindications and precautions.
Adults can receive pneumococcal vaccines (any pneumococcal conjugate vaccine or 23vPPV) with herpes zoster vaccines, seasonal influenza vaccines, RSV vaccines and COVID-19 vaccines at the same time if required. 12-18 See also Herpes zoster and Influenza.
Interchangeability of pneumococcal conjugate vaccines
It is preferable to complete a primary course of pneumococcal conjugate vaccine with the same formulation. However, if a person started their vaccination course with one PCV (for example, 13vPCV), it is acceptable to complete the course with the other (for example, 15vPCV). A study of 900 infants found comparable antibody responses (for shared serotypes) and a similar safety profile when 13vPCV and 15vPCV were used interchangeably.19
Contraindications and precautions
Contraindications
The only absolute contraindications to pneumococcal vaccines are:
- anaphylaxis after a previous dose of any pneumococcal vaccine
- anaphylaxis after any component of a pneumococcal vaccine
Precautions
13vPCV and inactivated influenza vaccine
Children can receive 13vPCV and inactivated influenza vaccine at the same visit if both vaccines are due.
One study found a slightly higher risk of fever and febrile convulsions in children aged 6 months to <5 years (especially those aged 12–24 months) when they received 13vPCV and inactivated influenza vaccine at the same time, compared with receiving the vaccines separately.20
The risk was about 18 excess cases per 100,000 doses in children aged 6 months to <5 years. The highest risk was 45 per 100,000 doses in children aged 16 months. This is a relatively small risk increase.
A later study did not show the same association between febrile seizures and co-administering these 2 vaccines.21
At present, this possible risk has not been observed for 15vPCV.
However, immunisation providers should:
- advise parents of the possible risk
- provide the option of administering these 2 vaccines on separate days, with an interval of at least 3 days
See also Influenza.
Women who are pregnant or breastfeeding
Pneumococcal vaccines are not routinely recommended for pregnant women.
Women of child-bearing age who have a risk condition(s) for pneumococcal disease are normally recommended to receive pneumococcal vaccine either:
- before a planned pregnancy, or
- as soon as practicable after delivery
Data on 13vPCV, 15vPCV, 20vPCV and 23vPPV in pregnant or breastfeeding women are limited.22 However, pregnant women who receive these vaccines are unlikely to have serious adverse effects.
Give special consideration to vaccinating women at the highest increased risk of pneumococcal disease who were not vaccinated before pregnancy but need vaccination before delivery. See List. Risk conditions for pneumococcal disease.
Breastfeeding women can receive 13vPCV, 15vPCV, 20vPCV and 23vPPV.
See Table. Vaccines that are not routinely recommended in pregnancy: inactivated bacterial vaccines in Vaccination for women who are planning pregnancy, pregnant or breastfeeding for more details.
Adverse events
13vPCV
Adverse events in children
Pooled safety analysis from 13 clinical trials showed that 13vPCV is safe in children, and the safety profile is similar to that of 7vPCV.23,24
In young children who received 13vPCV:24
- about 50% had any pain/tenderness and erythema at the injection site
- about 33% had any hardness (induration) or swelling
- about 8% had pain interfering with movement
- about 13% had moderate erythema and induration; this was more common after the dose at 12 months of age than after an infant dose
- about 37% reported fever, and about 5% had fever >39°C;24 fever was more common after the dose at 12 months of age than after the primary doses25
- about 70% had irritability
- about 60% had drowsiness/increased sleep
- about 39% had decreased appetite
Frequencies of each of these adverse events were comparable to those in 7vPCV recipients.24
One post-marketing study in the United States found a higher rate of febrile seizures for children who received inactivated influenza vaccine at the same time as pneumococcal vaccine.20 See Precautions.
Adverse events in adults
Clinical studies of 13vPCV in adults showed it to be safe.26-30 In two clinical studies of 13vPCV and 23vPPV in people aged 60–64 years:26,27
- local reactions were more common after 13vPCV (71–82% of participants) than after a first dose of 23vPPV (62–76%)
- pain was the most common local reaction after 13vPCV
- the frequency of fever of any grade was low (<2%) after either 13vPCV or 23vPPV
Local reactions were more common after a dose of 23vPPV given 1 or 3.5–4 years after a dose of 13vPCV than after either:
- a single dose of either 13vPCV or 23vPPV
- a 2nd dose of 13vPCV (regardless of which vaccine was used as the initial dose)26,28
Systemic reactions such as chills and myalgia have been reported more frequently in adults when pneumococcal vaccine and inactivated influenza vaccine are given at the same time.30 In the same study, there was no significant difference in the prevalence of fever of any grade. See Precautions.
Adverse events in people with risk conditions for pneumococcal disease
Studies have investigated the safety of 13vPCV in people with risk conditions for pneumococcal disease, such as:
- HIV infection
- chronic kidney disease
- haematopoietic stem cell transplant
- kidney transplant
- people who are receiving immunosuppressive therapy for cancers
In these studies:
- local reactions were the most common type of adverse event, and were somewhat higher after 13vPCV than after the first dose of 23vPPV
- pain was the most common local reaction (around 60% of people who received a vaccine)
- local reactions were more common if the person had received 2 previous doses of 23vPPV than if they had received 1 previous dose
- among people who received a haematopoietic stem cell transplant, both local and systemic reactions were higher after a 4th dose than after doses 1 to 3
- there was no substantial difference between safety in children and adults (in the few studies that have data available)
15vPCV
Adverse events in children
Safety data from clinical trials have found that 15vPCV is safe in children and has a similar safety profile to 13vPCV.19,31-37
In infants and children who received 15vPCV:
- the majority of adverse events were mild to moderate in severity
- the most common local reactions were pain (9-55%), erythema (11-22%) and swelling (10-14%)
- the most common systemic reactions were irritability (14–55%), somnolence (8-41%) and decreased appetite (5-19%)
- the frequency of fever ≥40°C was low (<4%)
Adverse events in adults
Evidence from clinical trials found that 15vPCV is safe in adults.10,38,39 In people who receive 15vPCV:
- the majority of adverse events were mild and lasted 1-3 days
- the most common local reactions were pain (54-76%), swelling (13-22%) and erythema (9-15%)
- the most common systemic reactions were fatigue (17-34%), myalgia (15-29%) and headache (12-27%)
- the frequency of fever ≥38°C was low (<2%)
- older adults reported fewer adverse reactions than younger adults
20vPCV
Adverse events in children
Evidence from clinical trials found that 20vPCV is safe in children, and it has a similar safety profile to 13vPCV.18,40
- the majority of adverse events were mild to moderate
- the most common local adverse event was pain, and all local adverse events were comparable between 20vPCV (25%-60%) and 13vPCV (27%-57%)
- the most common systemic adverse event was irritability, and all systemic adverse events were comparable between 20vPCV (55%-86%) and 13vPCV (55%-87%)
Adverse events in adults
Evidence from four trials found that 20vPCV is safe in adults.41-44
- the majority of adverse events were mild to moderate
- the most common local adverse event was pain and all were comparable between 20vPCV (55-79%) and 13vPCV (53-76%)
- the most common systemic adverse event was muscle pain and was slightly higher for those who received 20vPCV (39-77%) and compared to 13vPCV (37-65%)
23vPPV
The proportion of vaccine recipients reporting local and systemic reactions after a primary or a repeat dose of pneumococcal polysaccharide vaccines varies among different study populations, and possibly with age.45-47
In people who receive 23vPPV:545-47
- about 50% or more have some soreness after the 1st dose
- about 20% have swelling and redness
- up to 5% have moderate or severe local adverse events that limit arm movement after the 1st dose
- up to 10% have fever ≥37.5°C, but high fever is uncommon
Transient systemic reactions such as myalgia, fatigue and chills are also common.
Larger and more recent studies indicate that both local and systemic adverse events are more common after a repeat dose of 23vPPV than after the 1st dose in adults. In particular, up to 20% of revaccinated people have more severe local adverse events.45-47 These findings supersede the inconsistent findings from some smaller studies, which were limited by subject numbers and methodology.48-52 These local adverse events are mostly non-serious and self-limiting.
In these studies, the repeat doses were given at least 5 years after the previous dose. Another study used hospitalisations as a proxy measure for very severe local adverse events. The study used hospitalisations coded as cellulitis or abscess of the upper limb within 3 days of pneumococcal vaccination. These adverse events were significantly more likely when a repeat dose was given within 5 years of the 1st dose.53
Severe local reactions are also associated with higher antibody levels.11,46,47,54 This may explain why severe adverse events are associated with shorter intervals between doses. It suggests that such local reactions are associated with more robust immunity.
Nature of the disease
Streptococcus pneumoniae (pneumococcus) is a gram-positive coccus.
The polysaccharide capsule is the most important virulence factor of pneumococci.3,55 There are more than 95 capsular antigenic types (serotypes), with each serotype eliciting type-specific immunity.56
Pathogenesis
The natural reservoir of pneumococci is the mucosal surface of the human upper respiratory tract.3,57 Different pneumococcal serotypes vary in their propensity to cause nasopharyngeal colonisation or disease.
Worldwide, a small number of serotypes cause most cases of pneumococcal disease. The predominant serotypes vary by age group and geographic area.3
Antibiotic resistance in pneumococci is an increasing challenge. In 2012, 10% of Australian invasive pneumococcal disease isolates were non-susceptible to penicillin, and 2% were non-susceptible to ceftriaxone/cefotaxime.58
Transmission
Streptococcus pneumoniae is transmitted from person to person through contact with respiratory droplets of colonised people.
Almost all pneumococcal disease probably begins with nasopharyngeal colonisation.
Clinical features
Invasive pneumococcal disease (IPD) is defined as detection of Streptococcus pneumoniae in a normally sterile site (such as blood, cerebrospinal fluid or pleural fluid) by culture or nucleic acid testing. IPD includes:3,55,57,59
- meningitis
- pneumonia with bacteraemia or empyema
- bacteraemia without focus
Pneumococci may spread from the nasopharynx into adjacent sites to cause non-invasive disease such as:3,55,57,59
- sinusitis
- otitis media
- pneumonia
Pneumococcal disease in children
In children, the most common manifestation is bacteraemia without focus. This accounts for approximately 70% of IPD, followed by pneumonia with bacteraemia.
Meningitis is the least common but most severe category of IPD. Pneumococcal meningitis symptoms include:55,59,60
- stiff neck
- fever
- headache
- photophobia
- confusion
- irritability
- seizures
Acute otitis media is the most common non-invasive manifestation of pneumococcal disease in children. Streptococcus pneumoniae is detected in 28–55% of middle ear aspirates from children with acute otitis media.55,59,60
Pneumococcal disease in adults
In adults, pneumonia with bacteraemia is the most common manifestation of IPD.
Pneumococci may account for:55,61,62
- more than one-third of all community-acquired pneumonia
- up to half of hospitalised pneumonia in adults
However, it is difficult to accurately determine the proportion attributable to pneumococci in cases of non-bacteraemic pneumonia.
Symptoms of pneumonia include:
- fever and chills
- coughing
- difficulty breathing
- chest pain
Groups at risk of IPD
People who are immunocompromised and unable to mount an adequate immune response to pneumococcal capsular antigens have the highest risk of IPD.3,5,55 This includes people with asplenia.
Greater risk and/or severity of IPD is also associated with:
- household crowding
- exposure to cigarette smoke
- childcare attendance
- excessive alcohol consumption
- certain non-immunocompromising chronic medical conditions3,55,63,64
Indigenous populations in developed countries, including Aboriginal and Torres Strait Islander people in Australia, have a disproportionately high burden of IPD.1,3,65
Epidemiology
Young children and elderly people have the highest incidence of invasive pneumococcal disease (IPD).58,59,66 Disease burden is also disproportionately high in Aboriginal and Torres Strait Islander people.1,3
Disease in children
From January 2005, 7vPCV was funded under the National Immunisation Program for all infants in Australia. At this time, IPD incidence was greatest in the primary target group of children <2 years of age and for IPD caused by the 7 serotypes in the 7vPCV vaccine.
After 7vPCV was introduced, the notification rate of IPD due to 7vPCV serotypes decreased overall in all age groups.58,66 However, rates of IPD caused by serotypes that were not contained in 7vPCV increased in Australia and several other countries.67 This is known as serotype replacement. It was particularly evident among non-Indigenous children aged <5 years, in whom non-vaccine serotypes increased by 168%.67
13vPCV was introduced to the National Immunisation Program in 2012. There was a 42% reduction in cases due to 13vPCV-non-7vPCV serotypes (reduced to 1.8 per 100,000) by 2014.66 Serotype 19A caused around 80% of 13vPCV-type disease in children and around 40% in adults before 13vPCV was introduced. The introduction of 13vPCV was followed by a reduction in disease caused by serotype 19A by almost 70% overall.66
In 2018, the National Immunisation Program schedule changed from one that had 3 primary doses only to one with 2 primary doses and a booster dose (i.e. 3+0 schedule to a 2+1 schedule). This was in response to an increased incidence of breakthrough disease in children from 12 months of age in Australia. A similar increase in breakthrough disease was not seen in countries that included a booster dose in their schedule.68
Disease in adults
Vaccination using 23vPPV was introduced in 1999 for all Aboriginal and Torres Strait Islander adults aged ≥50 years, and younger Aboriginal and Torres Strait Islander adults with risk factors. From 2005, 23vPPV was funded under the National Immunisation Program for non-Indigenous adults aged ≥65 years.
In older non-Indigenous adults, the largest disease burden caused by pneumococcus is non-bacteraemic community-acquired pneumonia (CAP). The efficacy of 13vPCV against CAP is higher than that of 23vPPV.69-72 IPD incidence is almost 2-fold higher in non-Indigenous people aged ≥70 years than in those aged 65–69 years, and only a small proportion of cases are due to 23v-non-13v serotypes in people who do not have underlying risk conditions. In non-Indigenous adults, the prevalence of risk factors among those with IPD increases with age. In contrast, Aboriginal and Torres Strait Islander adults have a high prevalence of IPD risk factors at all ages.73,74 The higher burden of disease in Aboriginal and Torres Strait Islander adults also includes a higher proportion of disease (around 26% of IPD cases) caused by 23v-non-13v serotypes.75
The impact of 23vPPV on rates of IPD in Aboriginal and Torres Strait Islander adults has varied in different geographical areas. At a national level, disparities remain in disease rates between Aboriginal and Torres Strait Islander adults and non-Indigenous adults. As is the case for influenza and pneumonia, rates of IPD are highest in older Aboriginal and Torres Strait Islander adults.1 See Vaccination for Aboriginal and Torres Strait Islander people.
Vaccine information
There are 2 types of pneumococcal vaccines:
- pneumococcal conjugate vaccine (PCV)
- pneumococcal polysaccharide vaccine (PPV)
Conjugate vaccine formulations vary in:
- the number of pneumococcal serotypes included
- the conjugating proteins used
Pneumococcal conjugate vaccines are immunogenic in young infants and adults and can induce an immune memory response.
In contrast, 23vPPV is poorly immunogenic for most serotypes in children aged <2 years and does not induce immune memory. However, 23vPPV contains more serotypes.
13vPCV
Immunogenicity in children
As a result of extensive post-marketing analyses of 7vPCV, and the established correlates of protection against invasive pneumococcal disease (IPD) for PCVs in children, the registration of 13vPCV was based on immunogenicity studies showing:
- immune responses at least equivalent to those of 7vPCV
- sufficient antibody response to provide protection against the additional serotypes76-81
Vaccine effectiveness in children
A large retrospective cohort study estimated the vaccine effectiveness of 13vPCV in Australia. The vaccine effectiveness of 3 doses of 13vPCV against IPD due to 13vPCV serotypes was estimated at 86% for non-Indigenous children. These data were similar to those from a previous case–control study, which showed vaccine effectiveness of 87% for 3 doses of 13vPCV.82
Immunogenicity in adults
13vPCV is registered for adults based on immunogenicity data showing equivalent or better antibody responses compared with those provided by 23vPPV for the shared vaccine serotypes.
Vaccine efficacy in adults
A large randomised controlled trial (known as the CAPiTA study – Community Acquired Pneumonia Immunisation Trial in Adults) showed that 13vPCV was protective against pneumococcal disease in vaccine-naive adults aged ≥65 years.69 Efficacy was:
- 46% against a 1st episode of vaccine-type community-acquired pneumonia (CAP)
- 75% against a 1st episode of vaccine-type IPD
Duration of protection in adults
Exploratory analysis of data from the CAPiTA study suggests that immune responses in immunocompetent adults ≥65 years of age persist for 2 years after vaccination with 13vPCV for all 13 serotypes, regardless of comorbidity.83 In people aged ≥80 years, antibody levels remained well above baseline, but were lower than in younger age groups.
Immunogenicity in people with risk conditions
Post-hoc analysis of the CAPiTA study84 assessed the efficacy of 13vPCV in people with certain risk conditions:
- heart disease
- lung disease
- asthma
- diabetes
- liver disease
- smoking
- splenectomy
In these people, the efficacy of 13vPCV against vaccine-type IPD was 77%, and 40% against vaccine-type CAP.84 Although these point estimates were lower than for healthy study participants, the confidence intervals overlapped, indicating a statistically similar response to the vaccine. Vaccine efficacy is expected to be the same or better in younger adults with these risk conditions.
For some risk conditions that involve compromised immunity, immunogenicity data indicate that 13vPCV induces a protective response. These conditions include:
- HIV infection
- cancer therapy
- solid organ transplant
- chronic kidney disease
- haematopoietic stem cell transplant
15vPCV
Immunogenicity in children
The registration of 15vPCV in children is based on immunogenicity studies showing equivalent antibody responses compared with those provided by 13vPCV for the shared vaccine serotypes. For the serotypes unique to 15vPCV (15vPCV-non-13vPCV serotypes 22F and 33F) antibody responses appear to be better compared to 13vPCV.19,31-35,85,86
Immunogenicity in adults
15vPCV is registered for adults based on immunogenicity data showing equivalent antibody responses compared with those provided by 13vPCV for the shared vaccine serotypes. For the serotypes unique to 15vPCV (22F and 33F) antibody responses appear to be better compared to 13vPCV.38,39,87-89
Immunogenicity in people with risk conditions
15vPCV has been assessed in adults living with HIV and in older adults with certain medical factors that increased their risk for pneumococcal disease. These studies found that 15vPCV resulted in similar immunogenicity responses compared to 13vPCV.10,90
20vPCV
Immunogenicity in children
20vPCV is registered in children based on immunogenicity studies showing antibody responses are comparable when compared with 13vPCV for the shared vaccine serotypes. For the seven additional serotypes unique to 20vPCV (20vPCV-non-13vPCV serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) antibody responses appear to be better compared to 13vPCV.18,40
There are currently no immunogenicity studies on 20vPCV followed by 23vPPV.
Immunogenicity in adults
20vPCV is registered for adults based on immunogenicity data showing antibody responses for shared serotypes are likely equivalent when compared to 13vPCV. For the serotypes unique to 20vPCV (8, 10A, 11A, 12F, 15B, 22F and 33F), antibody responses appear to be better compared to 13vPCV.41-44
For six of these seven serotypes that are shared with 23vPPV, antibody responses are equivalent between 20vPCV and 23vPPV; however serotype 8 did not meet the non-inferiority criteria.41,42 This lower immune response is mitigated by those at risk receiving 23vPPV after 20vPCV.91
Immunogenicity in people with risk conditions
20vPCV has been assessed in adults with chronic medical conditions or smoking that increase their risk of developing pneumococcal disease. These studies found that 20vPCV resulted in similar immunogenicity responses compared to 13vPCV.92
There are currently no studies on immunogenicity in children with risk conditions.
23vPPV
23vPPV contains polysaccharides derived from the 23 most frequent or most virulent capsular types of Streptococcus pneumoniae isolated from sterile fluids in the United States in the 1970s and early 1980s. Vaccine development also considered worldwide serotype distribution and potential cross-reactive serotypes.93 12 of these serotypes are also in 13vPCV.
Immunogenicity in children
In children aged <2 years primed with pneumococcal conjugate vaccine, 23vPPV is immunogenic. This boosts the immune response against some of the 12 shared serotypes.94,95
23vPPV is immunogenic in children, and the level of immune response varies by age and serotype.96,97 Studies in children with risk conditions for pneumococcal disease (including cardiac transplant, HIV infection, renal disease and sickle cell disease) show that 23vPPV can elicit an immune response in these populations. However, responses are variable and likely depend on the level of immunosuppression at the time of vaccination.98
Vaccine efficacy and effectiveness in children
Few studies report the efficacy of 23vPPV in children. A study from the United States before conjugate vaccine was introduced showed efficacy of 83% (95% CI: 15–97%) against bacteraemia in children aged 6–15 years. However, this study did not distinguish between immunocompetent and immunocompromised children.99
Immunogenicity in adults
23vPPV induces significant immune responses in immunocompetent adults. Immune responses are similar in older people (aged 70–80 years) and younger people (aged 50–60 years), but poorer in people who are immunocompromised.100
Vaccine efficacy and effectiveness in adults
Estimates of efficacy and effectiveness for 23vPPV are lower and more variable than for 13vPCV, particularly against CAP outcomes:
- Vaccine effectiveness against vaccine-type IPD is estimated at 61.1% (95% CI: 55.1–66.9%), based on data from an Australian observational study, national notification data and adult health surveys.70
- Vaccine effectiveness against CAP outcomes ranges from 27% (95% CI: 3–46%) to 51% (95% CI: 16–71%) from observational studies.71,72
Vaccine efficacy and effectiveness in people with risk conditions
Studies of 23vPPV indicate that this vaccine can be effective in people with risk conditions. In people with HIV and other immunocompromising conditions, vaccine effectiveness against IPD is estimated to be 35–50%.101,102 In people with chronic conditions who are not immunocompromised, vaccine effectiveness against IPD is estimated to be 50–60%.28,101,103
Sequential administration of a dose of PCV and 23vPPV in people with risk conditions is therefore likely to protect these people against 23v-non-PCV serotypes. This is supported by immunogenicity studies that compared sequential administration of 7vPCV, 13vPCV, 15vPCV or 20vPCV and 23vPPV in varying combinations and dose intervals in children and adults.10,26,28,41,42,88,90,104-109
Duration of protection in adults
Data from England and Wales reported 23vPPV vaccine effectiveness of 48% against IPD within 2 years of vaccination for adults aged ≥65 years. But effectiveness waned and became insignificant beyond 5 years. In the subset of adults aged 65–74 years with no risk factors, 23vPPV effectiveness was higher (65% within 2 years) and was maintained for longer.110
Significant and sustained antibody responses after revaccination are seen in adults, including the elderly.45,46,111-113 Evidence of lesser antibody responses to 2nd or subsequent doses of 23vPPV in adults is variable,45,46,106,111,112 but the clinical relevance of this is unknown.
Transporting, storing and handling vaccines
Transport according to National Vaccine Storage Guidelines: Strive for 5.114 Store at +2°C to +8°C. Do not freeze.
Public health management
Invasive pneumococcal disease is a notifiable disease in all states and territories in Australia.
State and territory public health authorities can provide advice about the public health management of invasive pneumococcal disease, including case management.
Variations from product information
Prevenar 13 (13vPCV)
Dosing schedule
The product information for Prevenar 13 recommends:
- 4 doses of 13vPCV for vaccination starting at 6 weeks of age, with further doses at 4 and 6 months of age, and a booster at 12–15 months of age
- 3 doses for vaccination starting between 7 and 11 months of age
- 2 doses for vaccination starting between 12 and 23 months of age
The Australian Technical Advisory Group on Immunisation (ATAGI) recommends that healthy children who do not have an identified risk conditions for pneumococcal disease should receive 1 dose less than that stated in the product information.
ATAGI recommends that the 1st dose be given at 2 months of age, and that this dose can be given as early as 6 weeks of age. The next scheduled dose should be given at 4 months and a booster at 12 months of age.
Preterm infants
The product information for Prevenar 13 recommends a four-dose schedule in children born prior to 37 weeks gestation.
ATAGI recommends a four-dose schedule for infants born less than 28 weeks gestation. Infants and children born ≥28 weeks are recommended to receive a three-dose schedule.
Pneumovax 23 (23vPPV)
The product information for Pneumovax 23 states that Pneumovax 23 and Zostavax should not be given at the same time.
ATAGI recommends that Pneumovax 23 can be given at the same time as Zostavax if both are due.
Vaxneuvance (15vPCV)
Catch-up vaccination
The product information for Vaxneuvance recommends children aged 7 months through 17 years who completed a dosing regimen with lower valency pneumococcal conjugate vaccine should consider a catch-up schedule with Vaxneuvance.
ATAGI recommends that infants and children who receive lower valency pneumococcal conjugate vaccines do not need a catch-up dose of Vaxneuvance. If a child started their vaccination course with 13vPCV (Prevenar 13), it is acceptable to complete the course with 15vPCV (Vaxneuvance).
Preterm infants
The product information for Vaxneuvance recommends a four-dose schedule in children born prior to 37 weeks gestation.
ATAGI recommends a four-dose schedule for infants born less than 28 weeks gestation. Infants and children born ≥28 weeks are recommended to receive a three-dose schedule.
Prevenar 20 (20vPCV)
The product information for Prevenar 20 recommends a four-dose schedule in children born prior to 37 weeks gestation.
ATAGI recommends a four-dose schedule for infants born less than 28 weeks gestation. Infants and children born ≥28 weeks are recommended to receive a three-dose schedule.
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- Australian Institute of Health and Welfare (AIHW). The health and welfare of Australia’s Aboriginal and Torres Strait Islander peoples: 2015. Canberra: AIHW; 2015. https://www.aihw.gov.au/reports/indigenous-health-welfare/indigenous-health-welfare-2015/contents/table-of-contents
- Jayasinghe S. Pneumococcal disease epidemiology in the elderly. ISG annual scientific meeting, 5-6 Feb 2017, Melbourne; 2017. (Accessed 10 February 2020). https://www.immunisationcoalition.org.au/events/2017-isg-annual-scientific-meeting/
- Gadzinowski J, Albrecht P, Hasiec B, et al. Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine. Vaccine 2011;29:2947-55.
- Snape MD, Klinger CL, Daniels ED, et al. Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial. Pediatric Infectious Disease Journal 2010;29:e80-90.
- Esposito S, Tansey S, Thompson A, et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine compared to those of a 7-valent pneumococcal conjugate vaccine given as a three-dose series with routine vaccines in healthy infants and toddlers. Clinical and Vaccine Immunology: CVI 2010;17:1017-26.
- Yeh SH, Gurtman A, Hurley DC, et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics 2010;126:e493-505.
- Kieninger DM, Kueper K, Steul K, et al. Safety, tolerability, and immunologic noninferiority of a 13-valent pneumococcal conjugate vaccine compared to a 7-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in Germany. Vaccine 2010;28:4192-203.
- Bryant KA, Block SL, Baker SA, et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics 2010;125:866-75.
- Jayasinghe S, Chiu C, Quinn H, et al. Effectiveness of 7- and 13-valent pneumococcal conjugate vaccines in a schedule without a booster dose: a 10-year observational study. Clinical Infectious Diseases 2018: [Epub ahead of print] doi:10.1093/cid/ciy129.
- van Deursen AM, van Houten MA, Webber C, et al. Immunogenicity of the 13-valent pneumococcal conjugate vaccine in older adults with and without comorbidities in the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA). Clinical Infectious Diseases 2017;65:787-95.
- Suaya JA, Jiang Q, Scott DA, et al. Post hoc analysis of the efficacy of the 13-valent pneumococcal conjugate vaccine against vaccine-type community-acquired pneumonia in at-risk older adults. Vaccine 2018;36:1477-83.
- Benfield T, Rämet M, Valentini P, et al. Safety, tolerability, and immunogenicity of V114 pneumococcal vaccine compared with PCV13 in a 2+1 regimen in healthy infants: a phase III study (PNEU-PED-EU-2). Vaccine 2023;41:2456-65.
- National Institutes of Health. A study to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants (V114-031/PNEU-LINK). United States: National Institutes of Health; 2023. (Accessed 19 July 2023). https://classic.clinicaltrials.gov/ct2/show/NCT03692871
- Simon JK, Staerke NB, Hemming-Harlo M, et al. Lot-to-lot consistency, safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in healthy adults aged ≥50 years: A randomized phase 3 trial (PNEU-TRUE). Vaccine 2022;40:1342-51.
- Song JY, Chang CJ, Andrews C, et al. Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged ≥50 years: A randomized phase III trial (PNEU-PATH). Vaccine 2021;39:6422-36.
- Stacey HL, Rosen J, Peterson JT, et al. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV-15) compared to PCV-13 in healthy older adults. Human Vaccines and Immunotherapeutics 2019;15:530-9.
- Hammitt LL, Quinn D, Janczewska E, et al. Immunogenicity, safety, and tolerability of V114, a 15-valent pneumococcal conjugate vaccine, in immunocompetent adults aged 18-49 years with or without risk factors for pneumococcal disease: A randomized phase 3 trial (PNEU-DAY). Open Forum Infectious Diseases 2022;9:ofab605.
- Cannon K, Elder C, Young M, et al. A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination. Vaccine 2021;39:7494-502.
- Sabharwal C, Sundaraiyer V, Peng Y, et al. Immunogenicity of a 20-valent pneumococcal conjugate vaccine in adults 18 to 64 years old with medical conditions and other factors that increase risk of pneumococcal disease. Human Vaccines and Immunotherapeutics 2022;18:2126253.
- Robbins JB, Austrian R, Lee CJ, et al. Considerations for formulating the second-generation pneumococcal capsular polysaccharide vaccine with emphasis on the cross-reactive types within groups. Journal of Infectious Diseases 1983;148:1136-59.
- Pomat WS, van den Biggelaar AH, Phuanukoonnon S, et al. Safety and immunogenicity of neonatal pneumococcal conjugate vaccination in Papua New Guinean children: a randomised controlled trial. PLoS One 2013;8(2):e56698.
- Thisyakorn U, Chokephaibulkit K, Kosalaraksa P, et al. Immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine as a booster dose in 12- to 18-month-old children primed with 3 doses of 7-valent pneumococcal conjugate vaccine. Human Vaccines and Immunotherapeutics 2014;10:1859-65.
- Laferriere C. The immunogenicity of pneumococcal polysaccharides in infants and children: a meta-regression. Vaccine 2011;29:6838-47.
- Balloch A, Licciardi PV, Russell FM, Mulholland EK, Tang ML. Infants aged 12 months can mount adequate serotype-specific IgG responses to pneumococcal polysaccharide vaccine. Journal of Allergy and Clinical Immunology 2010;126:395-7.
- Borrow R, Heath PT, Siegrist CA. Use of pneumococcal polysaccharide vaccine in children: what is the evidence? Current Opinion in Infectious Diseases 2012;25:292-303.
- Bolan G, Broome CV, Facklam RR, et al. Pneumococcal vaccine efficacy in selected populations in the United States. Annals of Internal Medicine 1986;104:1-6.
- Grabenstein JD, Musher DM. Pneumococcal polysaccharide vaccines. In: Plotkin SA, Orenstein WA, Offit PA, Edwards KM, eds. Plotkin's vaccines. 7th ed. Philadelphia, PA: Elsevier; 2018.
- Rudnick W, Liu Z, Shigayeva A, et al. Pneumococcal vaccination programs and the burden of invasive pneumococcal disease in Ontario, Canada, 1995-2011. Vaccine 2013;31:5863-71.
- Breiman RF, Keller DW, Phelan MA, et al. Evaluation of effectiveness of the 23-valent pneumococcal capsular polysaccharide vaccine for HIV-infected patients. Archives of Internal Medicine 2000;160:2633-8.
- Shapiro ED, Berg AT, Austrian R, et al. The protective efficacy of polyvalent pneumococcal polysaccharide vaccine. New England Journal of Medicine 1991;325:1453-60.
- Musher DM, Rueda AM, Nahm MH, Graviss EA, Rodriguez-Barradas MC. Initial and subsequent response to pneumococcal polysaccharide and protein-conjugate vaccines administered sequentially to adults who have recovered from pneumococcal pneumonia. Journal of Infectious Diseases 2008;198:1019-27.
- Goldblatt D, Southern J, Andrews N, et al. The immunogenicity of 7-valent pneumococcal conjugate vaccine versus 23-valent polysaccharide vaccine in adults aged 50-80 years. Clinical Infectious Diseases 2009;49:1318-25.
- de Roux A, Schmöle-Thoma B, Siber GR, et al. Comparison of pneumococcal conjugate polysaccharide and free polysaccharide vaccines in elderly adults: conjugate vaccine elicits improved antibacterial immune responses and immunological memory. Clinical Infectious Diseases 2008;46:1015-23.
- Miernyk KM, Butler JC, Bulkow LR, et al. Immunogenicity and reactogenicity of pneumococcal polysaccharide and conjugate vaccines in alaska native adults 55-70 years of age. Clinical Infectious Diseases 2009;49:241-8.
- Macintyre CR, Ridda I, Gao Z, et al. A randomized clinical trial of the immunogenicity of 7-valent pneumococcal conjugate vaccine compared to 23-valent polysaccharide vaccine in frail, hospitalized elderly. PLoS One 2014;9:e94578.
- Wilck M, Barnabas S, Chokephaibulkit K, et al. A phase 3 study of safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine, in children with HIV. AIDS 2023;37:1227–37.
- Andrews NJ, Waight PA, George RC, Slack MP, Miller E. Impact and effectiveness of 23-valent pneumococcal polysaccharide vaccine against invasive pneumococcal disease in the elderly in England and Wales. Vaccine 2012;30:6802-8.
- Manoff SB, Liss C, Caulfield MJ, et al. Revaccination with a 23-valent pneumococcal polysaccharide vaccine induces elevated and persistent functional antibody responses in adults aged ≥65 years. Journal of Infectious Diseases 2010;201:525-33.
- Musher DM, Manoff SB, McFetridge RD, et al. Antibody persistence ten years after first and second doses of 23-valent pneumococcal polysaccharide vaccine, and immunogenicity and safety of second and third doses in older adults. Human Vaccines 2011;7:919-28.
- Grabenstein JD, Manoff SB. Pneumococcal polysaccharide 23-valent vaccine: long-term persistence of circulating antibody and immunogenicity and safety after revaccination in adults. Vaccine 2012;30:4435-44.
- National vaccine storage guidelines: Strive for 5. 3rd ed. Canberra: Australian Government Department of Health and Aged Care; 2020. https://www.health.gov.au/resources/publications/national-vaccine-storage-guidelines-strive-for-5
Page history
Updates throughout the chapter to reflect the availability of Prevenar 20 (20vPCV) in infants and children from 6 weeks of age. Editorial changes to the list of risk conditions for pneumococcal for clarity. A new resource on recommendations for pneumococcal vaccination for people who have previously received a pneumococcal vaccine is now available. Funding statements have also been added to recommendations.
Updates to clinical guidance throughout the chapter to reflect the amended indications for Vaxneuvance (15vPCV) now also for use in children.
Updates to clinical guidance throughout the chapter to include interim recommendations for extended valency vaccines (Vaxneuvance [15vPCV] and Prevenar 20 [20vPCV]) in adults for whom they have recently been registered by the TGA but are not currently funded under the National Immunisation Program.
Updates to clinical guidance through the chapter to provide information regarding 15-valent pneumococcal conjugate vaccine (15vPCV).
Guidance on co-administration with other vaccines has been amended to remove guidance on co-administration with MenACWY vaccines.
Guidance for doses of 23vPPV required after a haematopoietic stem cell transplant updated.
Recommendations have changed for people with risk conditions, Aboriginal and Torres Strait Islander people, and older adults.
The following changes have been made to recommendations for people with risk conditions:
- Category A and Category B conditions have been consolidated into a single list of risk conditions for pneumococcal disease.
- The recommended vaccines and number of doses — 1 extra dose of 13vPCV and 2 doses of 23vPPV — are now the same for all people with risk conditions.
- The number of lifetime doses of 23vPPV recommended for people with risk conditions is now limited to 2 doses.
The following changes have been made to recommendations for Aboriginal and Torres Strait Islander people:
- Aboriginal and Torres Strait Islander children in the Northern Territory, Queensland, South Australia and Western Australia are now recommended to receive 2 doses of 23vPPV in addition to the 4 doses of 13vPCV.
- Aboriginal and Torres Strait Islander adults without risk conditions for pneumococcal disease are now recommended to receive 1 dose of 13vPCV and 2 doses of 23vPPV at age ≥50 years.
- Aboriginal and Torres Strait Islander adults <50 years with risk conditions for pnuemococcal disease are to receive vaccines as per recommendations for people with risk conditions.
The following changes have been made to recommendations for healthy non-Indigenous adults:
- Healthy non-Indigenous adults are now recommended to receive a single dose of 13vPCV at age ≥70 years. Healthy non-Indigenous adults who do not have risk conditions for pneumococcal disease are no longer recommended to receive 23vPPV.
Editorial changes to the recommendations for people with medical risk factors and guidance for co-administration with other vaccines.
Recommendations for people with medical risk factors updated to provide greater clarity on the number and timing of 23vPPV doses.
Guidance under Co-administration with other vaccines updated.
The pneumococcal vaccination schedule has changed for:
- all children aged <5 years living in the Australian Capital Territory, New South Wales, Tasmania and Victoria
- all non-Indigenous children aged <5 years living in the Northern Territory, Queensland, South Australia and Western Australia without underlying medical conditions associated with an increased risk of invasive pneumococcal disease
These children now receive a 2+1 schedule:
- 2 primary doses of 13vPCV (13-valent pneumococcal conjugate vaccine) at 2 and 4 months of age
- a booster dose at 12 months of age
The previous schedule was 3 primary doses at 2, 4 and 6 months of age (3+0 schedule).
The pneumococcal vaccination schedule has changed for:
- all Aboriginal and Torres Strait Islander children living in the Northern Territory, Queensland, South Australia and Western Australia
- all children with underlying medical conditions associated with an increased risk of invasive pneumococcal disease
The booster dose previously recommended for these children at 12–18 months of age is now recommended at 12 months of age. This means that these children should continue to receive 4 doses of 13vPCV at 2, 4, 6 and 12 months of age (3+1 schedule).
These changes have also changed the catch-up schedules for pneumococcal vaccination. See Catch-up vaccination for more details.
Recommendations
The following replaces the existing Recommendations for infant pneumococcal vaccination schedule listed in Chapter 4.6 Pneumococcal disease:
- All children, except those specified in (b) below, should receive three doses of 13vPCV at 2, 4 and 12 months of age (called ‘2+1’ schedule) instead of the current schedule with doses at 2, 4 and 6 months of age (called ‘3+0’ schedule).
- The following population groups at increased risk of pneumococcal infection should continue to receive four doses of 13vPCV at 2, 4, 6 and 12 months^ of age (called ‘3+1’ schedule):
- Aboriginal and Torres Strait Islander children living in the NT, QLD, SA and WA
- Children with underlying medical conditions associated with an increased risk of IPD.
^ Note the preferred schedule point for the fourth (last) 13vPCV dose is age 12 months rather than 18 months.
Table 1: Comparison of current and proposed ATAGI recommendations for 13vPCV schedules in children
Cohort |
Schedule in previous recommendation* |
Schedule in current recommendation |
|
Children without underlying medical conditions associated with increased risk of IPD |
All children in ACT, NSW, TAS or VIC |
3+0 (2, 4 and 6 months) |
2+1 (2, 4 and 12 months) |
Non-Indigenous children in NT, QLD, SA or WA |
|||
Aboriginal and Torres Strait Islander children in NT, QLD, SA or WA |
3+1 (2, 4, 6 and 12–18 months) |
3+1 (2, 4, 6 and 12 months) |
|
All children with underlying medical conditions associated with increased risk of IPD (Attachment A) |
3+1 (2, 4, 6 and 12 months) |
3+1 (2, 4, 6 and 12 months) |
* Refer to The Australian Immunisation Handbook Chapter 4.13 Pneumococcal disease, section 4.13.7 ‘Recommendations’.
Schedules for catch-up doses of 13vPCV for children aged <5 years who have not received any pneumococcal conjugate vaccine (PCV) doses or who have only received incomplete courses of PCVs are covered in Tables 2 (for all children with medical condition(s) increasing IPD risk and Aboriginal and Torres Strait Islander children in NT, QLD, SA or WA) and 3 (for all other children).
Table 2: Catch-up schedule for 13vPCV for Aboriginal and Torres Strait Islander children living in NT, QLD, SA or WA ONLY, and all children with any medical condition(s)* associated with an increased risk of invasive pneumococcal disease (IPD), aged <5 years
Number of doses given previously |
Age at presentation |
Age when previous dose of any PCV† was given |
Recommendations‡ |
||
1st dose |
2nd dose |
3rd dose |
Number of further dose(s) required |
||
No previous doses |
<12 months |
– |
– |
– |
4§ |
12–59 months |
– |
– |
– |
2 |
|
1 previous dose |
<12 months |
Any age |
– |
– |
3§ |
12–59 months |
<12 months |
– |
– |
2§ |
|
≥12 months |
– |
– |
1 |
||
2 previous doses |
<12 months |
Any age |
Any age |
– |
2§ |
12–59 months |
<12 months |
<12 months |
– |
2§ |
|
≥12 months |
– |
1 |
|||
≥12 months |
≥12 months |
– |
None |
||
3 previous doses |
<12 months |
Any age |
Any age |
Any age |
1§ |
12–59 months |
<12 months |
<12 months |
Any age |
1 |
|
≥12 months |
≥12 months |
None |
* Recommendations for vaccination of haematopoietic stem cell transplant (HSCT) recipients differ: a separate table for revaccination following HSCT in children and adults will be included in upcoming updates to The Australian Immunisation Handbook.
† Prior PCV doses may have been given as 7vPCV (e.g. from overseas), 10vPCV or 13vPCV. Use 13vPCV as the vaccine formulation for catch-up doses, regardless of which formulation of PCV the child received previously.
‡ Where possible, align doses with the standard schedule points at 2, 4 and 6 months of age for infants. The minimum interval between dose(s) is 1 month if aged <12 months, and 2 months if aged ≥12 months.
§ The last dose should be given after the child reaches 12 months of age (as a booster dose) with a minimum interval of 2 months after the previous dose of PCV.
Table 3: Catch-up schedule for 13vPCV for all other children aged <5 years (not covered in Table 2a)
Number of doses given previously |
Age at presentation |
Age when previous dose of any PCV* was given |
Recommendation† |
||
1st dose |
2nd dose |
3rd dose |
Number of further dose(s) required |
||
No previous doses |
<12 months |
– |
– |
– |
3‡ |
12–59 months |
– |
– |
– |
1 |
|
1 previous dose |
<12 months |
<12 months |
– |
– |
2‡ |
12–59 months |
<12 months |
– |
– |
1 |
|
≥12 months |
– |
– |
None |
||
2 previous doses |
<12 months |
<12 months |
<12 months |
– |
1‡ |
12–59 months |
<12 months |
<12 months |
– |
1 |
|
≥12 months |
– |
None |
|||
3 previous doses |
<12 months |
<12 months |
<12 months |
<12 months |
1‡ |
12–59 months |
Any age |
Any age |
≥12 months |
None |
* Prior PCV doses may have been given as 7vPCV (e.g. from overseas), 10vPCV or 13vPCV. Use 13vPCV as the vaccine formulation for catch-up doses, regardless of which formulation of PCV the child received previously.
† Where possible, align doses with the standard schedule points at 2 months and 4 months of age for infants aged <5 months. The minimum interval between dose(s) is 1 month if aged <12 months, and 2 months if aged ≥12 months.
‡ The last dose should be given after the child reaches 12 months of age (as a booster dose) with a minimum interval of 2 months after the previous dose of 13vPCV.
Updates throughout the chapter to reflect the availability of Prevenar 20 (20vPCV) in infants and children from 6 weeks of age. Editorial changes to the list of risk conditions for pneumococcal for clarity. A new resource on recommendations for pneumococcal vaccination for people who have previously received a pneumococcal vaccine is now available. Funding statements have also been added to recommendations.
Updates to clinical guidance throughout the chapter to reflect the amended indications for Vaxneuvance (15vPCV) now also for use in children.
Updates to clinical guidance throughout the chapter to include interim recommendations for extended valency vaccines (Vaxneuvance [15vPCV] and Prevenar 20 [20vPCV]) in adults for whom they have recently been registered by the TGA but are not currently funded under the National Immunisation Program.
Updates to clinical guidance through the chapter to provide information regarding 15-valent pneumococcal conjugate vaccine (15vPCV).
Guidance on co-administration with other vaccines has been amended to remove guidance on co-administration with MenACWY vaccines.
Guidance for doses of 23vPPV required after a haematopoietic stem cell transplant updated.
Recommendations have changed for people with risk conditions, Aboriginal and Torres Strait Islander people, and older adults.
The following changes have been made to recommendations for people with risk conditions:
- Category A and Category B conditions have been consolidated into a single list of risk conditions for pneumococcal disease.
- The recommended vaccines and number of doses — 1 extra dose of 13vPCV and 2 doses of 23vPPV — are now the same for all people with risk conditions.
- The number of lifetime doses of 23vPPV recommended for people with risk conditions is now limited to 2 doses.
The following changes have been made to recommendations for Aboriginal and Torres Strait Islander people:
- Aboriginal and Torres Strait Islander children in the Northern Territory, Queensland, South Australia and Western Australia are now recommended to receive 2 doses of 23vPPV in addition to the 4 doses of 13vPCV.
- Aboriginal and Torres Strait Islander adults without risk conditions for pneumococcal disease are now recommended to receive 1 dose of 13vPCV and 2 doses of 23vPPV at age ≥50 years.
- Aboriginal and Torres Strait Islander adults <50 years with risk conditions for pnuemococcal disease are to receive vaccines as per recommendations for people with risk conditions.
The following changes have been made to recommendations for healthy non-Indigenous adults:
- Healthy non-Indigenous adults are now recommended to receive a single dose of 13vPCV at age ≥70 years. Healthy non-Indigenous adults who do not have risk conditions for pneumococcal disease are no longer recommended to receive 23vPPV.
Editorial changes to the recommendations for people with medical risk factors and guidance for co-administration with other vaccines.
Recommendations for people with medical risk factors updated to provide greater clarity on the number and timing of 23vPPV doses.
Guidance under Co-administration with other vaccines updated.
The pneumococcal vaccination schedule has changed for:
- all children aged <5 years living in the Australian Capital Territory, New South Wales, Tasmania and Victoria
- all non-Indigenous children aged <5 years living in the Northern Territory, Queensland, South Australia and Western Australia without underlying medical conditions associated with an increased risk of invasive pneumococcal disease
These children now receive a 2+1 schedule:
- 2 primary doses of 13vPCV (13-valent pneumococcal conjugate vaccine) at 2 and 4 months of age
- a booster dose at 12 months of age
The previous schedule was 3 primary doses at 2, 4 and 6 months of age (3+0 schedule).
The pneumococcal vaccination schedule has changed for:
- all Aboriginal and Torres Strait Islander children living in the Northern Territory, Queensland, South Australia and Western Australia
- all children with underlying medical conditions associated with an increased risk of invasive pneumococcal disease
The booster dose previously recommended for these children at 12–18 months of age is now recommended at 12 months of age. This means that these children should continue to receive 4 doses of 13vPCV at 2, 4, 6 and 12 months of age (3+1 schedule).
These changes have also changed the catch-up schedules for pneumococcal vaccination. See Catch-up vaccination for more details.
Recommendations
The following replaces the existing Recommendations for infant pneumococcal vaccination schedule listed in Chapter 4.6 Pneumococcal disease:
- All children, except those specified in (b) below, should receive three doses of 13vPCV at 2, 4 and 12 months of age (called ‘2+1’ schedule) instead of the current schedule with doses at 2, 4 and 6 months of age (called ‘3+0’ schedule).
- The following population groups at increased risk of pneumococcal infection should continue to receive four doses of 13vPCV at 2, 4, 6 and 12 months^ of age (called ‘3+1’ schedule):
- Aboriginal and Torres Strait Islander children living in the NT, QLD, SA and WA
- Children with underlying medical conditions associated with an increased risk of IPD.
^ Note the preferred schedule point for the fourth (last) 13vPCV dose is age 12 months rather than 18 months.
Table 1: Comparison of current and proposed ATAGI recommendations for 13vPCV schedules in children
Cohort |
Schedule in previous recommendation* |
Schedule in current recommendation |
|
Children without underlying medical conditions associated with increased risk of IPD |
All children in ACT, NSW, TAS or VIC |
3+0 (2, 4 and 6 months) |
2+1 (2, 4 and 12 months) |
Non-Indigenous children in NT, QLD, SA or WA |
|||
Aboriginal and Torres Strait Islander children in NT, QLD, SA or WA |
3+1 (2, 4, 6 and 12–18 months) |
3+1 (2, 4, 6 and 12 months) |
|
All children with underlying medical conditions associated with increased risk of IPD (Attachment A) |
3+1 (2, 4, 6 and 12 months) |
3+1 (2, 4, 6 and 12 months) |
* Refer to The Australian Immunisation Handbook Chapter 4.13 Pneumococcal disease, section 4.13.7 ‘Recommendations’.
Schedules for catch-up doses of 13vPCV for children aged <5 years who have not received any pneumococcal conjugate vaccine (PCV) doses or who have only received incomplete courses of PCVs are covered in Tables 2 (for all children with medical condition(s) increasing IPD risk and Aboriginal and Torres Strait Islander children in NT, QLD, SA or WA) and 3 (for all other children).
Table 2: Catch-up schedule for 13vPCV for Aboriginal and Torres Strait Islander children living in NT, QLD, SA or WA ONLY, and all children with any medical condition(s)* associated with an increased risk of invasive pneumococcal disease (IPD), aged <5 years
Number of doses given previously |
Age at presentation |
Age when previous dose of any PCV† was given |
Recommendations‡ |
||
1st dose |
2nd dose |
3rd dose |
Number of further dose(s) required |
||
No previous doses |
<12 months |
– |
– |
– |
4§ |
12–59 months |
– |
– |
– |
2 |
|
1 previous dose |
<12 months |
Any age |
– |
– |
3§ |
12–59 months |
<12 months |
– |
– |
2§ |
|
≥12 months |
– |
– |
1 |
||
2 previous doses |
<12 months |
Any age |
Any age |
– |
2§ |
12–59 months |
<12 months |
<12 months |
– |
2§ |
|
≥12 months |
– |
1 |
|||
≥12 months |
≥12 months |
– |
None |
||
3 previous doses |
<12 months |
Any age |
Any age |
Any age |
1§ |
12–59 months |
<12 months |
<12 months |
Any age |
1 |
|
≥12 months |
≥12 months |
None |
* Recommendations for vaccination of haematopoietic stem cell transplant (HSCT) recipients differ: a separate table for revaccination following HSCT in children and adults will be included in upcoming updates to The Australian Immunisation Handbook.
† Prior PCV doses may have been given as 7vPCV (e.g. from overseas), 10vPCV or 13vPCV. Use 13vPCV as the vaccine formulation for catch-up doses, regardless of which formulation of PCV the child received previously.
‡ Where possible, align doses with the standard schedule points at 2, 4 and 6 months of age for infants. The minimum interval between dose(s) is 1 month if aged <12 months, and 2 months if aged ≥12 months.
§ The last dose should be given after the child reaches 12 months of age (as a booster dose) with a minimum interval of 2 months after the previous dose of PCV.
Table 3: Catch-up schedule for 13vPCV for all other children aged <5 years (not covered in Table 2a)
Number of doses given previously |
Age at presentation |
Age when previous dose of any PCV* was given |
Recommendation† |
||
1st dose |
2nd dose |
3rd dose |
Number of further dose(s) required |
||
No previous doses |
<12 months |
– |
– |
– |
3‡ |
12–59 months |
– |
– |
– |
1 |
|
1 previous dose |
<12 months |
<12 months |
– |
– |
2‡ |
12–59 months |
<12 months |
– |
– |
1 |
|
≥12 months |
– |
– |
None |
||
2 previous doses |
<12 months |
<12 months |
<12 months |
– |
1‡ |
12–59 months |
<12 months |
<12 months |
– |
1 |
|
≥12 months |
– |
None |
|||
3 previous doses |
<12 months |
<12 months |
<12 months |
<12 months |
1‡ |
12–59 months |
Any age |
Any age |
≥12 months |
None |
* Prior PCV doses may have been given as 7vPCV (e.g. from overseas), 10vPCV or 13vPCV. Use 13vPCV as the vaccine formulation for catch-up doses, regardless of which formulation of PCV the child received previously.
† Where possible, align doses with the standard schedule points at 2 months and 4 months of age for infants aged <5 months. The minimum interval between dose(s) is 1 month if aged <12 months, and 2 months if aged ≥12 months.
‡ The last dose should be given after the child reaches 12 months of age (as a booster dose) with a minimum interval of 2 months after the previous dose of 13vPCV.