Pneumococcal disease

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
• all adults aged ≥65 years
• Aboriginal and Torres Strait Islander adults aged ≥25 years
• people with risk conditions for pneumococcal disease

How

Two pneumococcal vaccines are recommended for use: 20vPCV for children (i.e. aged <18 years) and 21vPCV for adults.

The recommended schedule for non-Indigenous children without a risk condition is a dose of 20-valent pneumococcal conjugate vaccine (20vPCV) at 2, 4 and 12 months of age.

The recommended schedule for Aboriginal and Torres Strait Islander children and all children aged <12 months with a risk condition is a dose of 20vPCV at 2, 4, 6 and 12 months of age.

The recommended schedule for people aged ≥12months to <18 years with a risk condition is a dose of 20vPCV at diagnosis.

The recommended schedule for non-Indigenous adults without a risk condition is a dose of 21-valent pneumococcal conjugate vaccine (21vPCV) at age ≥65 years.

The recommended schedule for Aboriginal and Torres Strait Islander adults without a risk condition is a dose of 21vPCV at age ≥25 years.

The recommended schedule for people aged ≥18 years with a risk condition is a dose of 21vPCV either at diagnosis or at age 18 years if diagnosed before age 18 years. 

The need for further doses has not yet been established.

Why

The highest pneumococcal disease burden is in infants, Aboriginal and Torres Strait Islander peoples, older adults and people with certain risk conditions. 

See:

• Infographic. Pneumococcal vaccination for all Australians
• Infographic. Pneumococcal vaccination recommendations for people who have previously received a pneumococcal vaccine
• Infographic. Vaccination for Aboriginal and Torres Strait Islander children
• Infographic. Vaccination for Aboriginal and Torres Strait Islander adolescents and adults

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.

Dose and route

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.

21vPCV (Capvaxive)

The dose of 21vPCV is 0.5mL, given by intramuscular injection.

Vaccine administration errors

Advice on the management of a range of possible pneumococcal vaccine administration errors is described below.

Co-administration with other vaccines

Infants and children

Infants can receive PCV at the same time as, or separate to, other vaccines or immunisation products in the infant schedule, including inactivated influenza vaccine and RSV-specific monoclonal antibody.

Older adults

Adults can receive PCV at the same time as, or separate to, other vaccines, such as zoster, seasonal influenza, RSV and COVID-19 vaccines.^6-9 See also Herpes zoster, Influenza, RSV and COVID-19. There are practical advantages of co-administration, including benefits in maximising coverage and ensuring vaccines are received on time.

A co-administration study on 21vPCV and influenza vaccine showed lower antibody responses to most pneumococcal serotypes and influenza subtypes when given at the same time compared with when these vaccines are administered separately.¹⁰ The clinical significance of these decreased antibody responses is uncertain. 

Interchangeability of pneumococcal conjugate vaccines

If a child started their vaccination schedule with 13vPCV or 15vPCV, they are recommended to complete it with 20vPCV. 21vPCV is not registered for use in children.

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

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 15vPCV, 20vPCV and 21vPCV in pregnant or breastfeeding women are limited. 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 15vPCV, 20vPCV and 21vPCV.

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.

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.^11-15 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.^16-18 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.^9,19

• 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.20-23

• 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%)

21vPCV

Adverse events in adults

Evidence from clinical trials found that 21vPCV is safe in adults, and has a similar safety profile comparable to both 20vPCV alone and to 23vPPV given after a prior dose of 15vPCV.^24-26

• the majority of adverse events were mild to moderate
• the most common local adverse event was injection site pain, and all local adverse events were comparable between 21vPCV (47–53%) and 20vPCV (56%). Local adverse events were lower for 21vPCV when compared to 15vPCV followed by a dose 23vPPV (82–84%).
• the most common systemic adverse events were fatigue and headache, and all systemic adverse events were comparable between 21vPCV (42–63%) and 20vPCV (41%). Systemic adverse events were slightly lower for 21vPCV when compared to 15vPCV followed by a dose of 23vPPV (60–69%).

In adults who had previously received a pneumococcal vaccine (13vPCV, 15vPCV or 20vPCV), rates of adverse events following 21vPCV were comparable to those who were pneumococcal vaccine naive.^25,26 
 

Streptococcus pneumoniae (pneumococcus) is a gram-positive coccus.

The polysaccharide capsule is the most important virulence factor of pneumococci.^2,3 There are more than 100 capsular antigenic types (serotypes), with each serotype eliciting type-specific immunity.²⁷ 

Pathogenesis

The natural reservoir of pneumococci is the mucosal surface of the human upper respiratory tract.^2,28 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.² 

Antibiotic resistance in pneumococci is a challenge. According to Antimicrobial Use and Resistance in Australia Surveillance System data, resistance to benzylpenicillin in pneumococcal isolates is low (around 2% in 2024), but overall rates of resistance to macrolides (erythromycin), tetracyclines and trimethoprim– sulfamethoxazole have remained above 17%.²⁹

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.

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, but is not limited to:^2,3,28,30

• 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:^2,3,28,31

• 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:³

• 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.^3,31,32

Pneumococcal disease in adults

In adults, pneumonia with bacteraemia is the most common manifestation of IPD.

Pneumococci may account for about 15–25% of community acquired pneumonia in adults:^33,34

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.^2,3,35 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 conditions^2,3,36,37

Indigenous populations in high-incomes countries, including Aboriginal and Torres Strait Islander people in Australia, have a disproportionately high burden of IPD.^2,38,39

The highest pneumococcal disease burden is in infants, Aboriginal and Torres Strait Islander peoples, older adults and people with certain risk conditions.^1,4,5,40,41

Disease in children

PCV use in children has led to major changes in pneumococcal disease epidemiology in Australia.^42-47 In 2001, 7vPCV was fast-tracked for use in Aboriginal and Torres Strait Islander children and children with underlying medical at-risk conditions due to their high incidence of IPD. The program was extended to all children in 2005 resulting in dramatic reduction in IPD of vaccine serotypes among children together with parallel declines in disease in unvaccinated populations through strong herd impact.^42,43 Certain non-vaccine serotypes however emerged to cause ‘serotype replacement’ disease, partially offsetting the vaccine type declines.⁴⁴ In 2011, 7vPCV was replaced by 13vPCV that covered the predominant serotype replacement serotypes. In 2018, the 13vPCV schedule used for healthy children changed from 3+0 to 2+1 in order to improve persistence of vaccine protection beyond infancy as there was an observed increased incidence of breakthrough IPD cases occurring in toddler years.^46,48 Early assessments showed that following the change there were less breakthrough cases in children who had 2+1 schedule than those who had the previous 3+0 schedule.⁴⁷ The latest PCV change in 2025 was the replacement of 13vPCV with 20vPCV providing protection against seven additional serotypes.

Data from 2023-2024 show the number of residual cases of IPD due to 13vPCV serotypes were small except serotype 3 (22% of cases).⁴⁹ About 27% of IPD cases were due to the additional 7 serotypes included in 20vPCV.^49-51 In 2025 the 4-dose (3+1) PCV schedule for Aboriginal and Torres Strait Islander children was expanded to include children in all states and territories. This was based on the higher incidence of 20vPCV-type IPD in those who were recommended the 3-dose schedule compared to those who were recommended the 4-dose schedule. This was most notable in the border regions of NSW and QLD and VIC and SA. 

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 2020, 13vPCV was recommended and funded for non-Indigenous adults aged ≥70 years and Aboriginal and Torres Strait Islander adults aged ≥50 years. In 2026, 21vPCV replaced 13vPCV as the funded and recommended vaccine under the NIP for non-Indigenous adults ≥65 years and Aboriginal and Torres Strait Islander adults ≥25 years. 

In 2024 there were 2,341 notifications of IPD, 34% of which were in adults who were aged ≥65 years (rate 17.5 per 100,000 in adults ≥65 years). Among Aboriginal and Torres Strait Islander adults aged ≥25 years there were 235 number of cases in 2024 (rate 45.9 per 100,000).  The 21vPCV covers the greatest proportion of vaccine-type IPD cases across these populations, including non-Indigenous adults aged ≥65 years without risk conditions, Aboriginal and Torres Strait Islander adults aged ≥25 years without risk conditions, and adults aged ≥18 years with risk conditions. 

In recent surveillance data among Aboriginal and Torres Strait Islander adults aged ≥25 years only a small number of IPD cases are caused serotypes in 23vPPV that are not in 21vPCV (n=32, 15%).  However these 23v-non-21v types are in the 20vPCV. Strong herd effect from the paediatric 20vPCV program is expected to provide protection against these serotypes in adults. Apart from IPD, pneumococcal vaccines would also prevent other pneumococcal diseases such as non-bacteraemic community acquired pneumonia (CAP) that has a substantially greater burden in adults than IPD. However unlike for IPD, the magnitude of the benefit against non-IPD is less certain due to current data limitations. It is likely that a 21vPCV adult program combined with a 20vPCV paediatric program could result in substantial reductions in vaccine-type non-bacteraemic CAP in adults. 

Pneumococcal vaccines in Australia are  pneumococcal conjugate vaccines (PCV) that vary in the number of pneumococcal serotypes included.

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.^11-13,52,56

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.^{18,57 17,58,59}

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.^16,60

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.^9,19

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.^20-23

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.⁶¹

There are currently no studies on immunogenicity in children with risk conditions.

21vPCV

Immunogenicity in adults

21vPCV is registered for adults based on immunogenicity data showing antibody responses for shared serotypes are equivalent when compared to 20vPCV. For 10 out of the 11 serotypes unique to 21vPCV (9N, 15A, 16F, 17F, 20A, 23A, 23B, 24F, 31, 31B), antibody responses appear to be better compared to 20vPCV; however the response to serotype 15C, did not meet the superiority criteria threshold required to be considered better than 20vPCV, but was considered equivalent.²⁵

For all 13 serotypes that are shared (3, 6A, 7F, 8, 9N, 10,A, 11A, 12F, 17F, 19A, 20/20A, 22F, 33F), antibody responses are equivalent between 21vPCV and 15vPCV followed by a dose of 23vPPV. For the 8 unique serotypes to 21vPCV, antibody responses appear to be better compared to 15vPCV followed by a dose of 23vPPV; however in one study the response to serotype 15C did not meet the superiority criteria, but was still equivalent.²⁵ 

Immunogenicity in people with risk conditions

21vPCV has been assessed in adults living with HIV as well as adults with chronic medical conditions that increase their risk of developing pneumococcal disease. These studies found that 21vPCV resulted in similar immunogenicity responses compared to 15vPCV followed by a single dose of 23vPPV.^24,26 

Transport according to National Vaccine Storage Guidelines: Strive for 5.⁶² Store at +2°C to +8°C. Do not freeze. 

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.

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 children born less than 28 weeks gestation. Children born ≥28 weeks are recommended to receive a three-dose schedule.

Prevenar 20 (20vPCV)

Catch-up vaccination

The product information for Prevenar 20 recommends children aged 15 months to less than 18 years regardless of prior pneumococcal conjugate vaccine vaccination should receive a single dose of Prevenar 20.

ATAGI recommends that infants and children who receive lower valency pneumococcal conjugate vaccines do not need a catch-up dose of Prevenar 20. If a child started their vaccination course with 13vPCV (Prevenar 13) or 15vPCV (Vaxneuvance), it is recommended to complete the course with 20vPCV (Prevenar 20).

Preterm infants

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 children born less than 28 weeks gestation. Children born ≥28 weeks are recommended to receive a three-dose schedule.

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