Information about pneumococcal disease, vaccines and recommendations for vaccination from the Australian Immunisation Handbook
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.
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.
Pneumococcal vaccine is recommended for:
- routine vaccination in infants and children
- 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
Pneumococcal vaccines available in Australia are 13vPCV (13-valent pneumococcal conjugate vaccine) and 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 13vPCV or 23vPPV before
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.
Infants and children
Infants and children aged <5 years are recommended to receive 13vPCV
All children are recommended to receive 13vPCV in a 3-dose schedule at 2, 4 and 12 months of age.
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 and children with a risk condition(s) 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 13vPCV for Aboriginal and Torres Strait Islander children living in NSW, Vic, Tas or ACT, and all children who do not have risk condition(s) for pneumococcal disease, aged <5 years.
Non-Indigenous adults without risk conditions for pneumococcal disease are recommended to receive 13vPCV at ≥70 years of age
A single dose of 13vPCV is recommended for all non-Indigenous adults at 70 years of age.
Non-Indigenous adults aged ≥70 years who did not receive a dose of 13vPCV at 70 years of age are recommended to receive a single catch-up dose of 13vPCV as soon as possible.
Non-Indigenous adults aged ≥70 years who have previously received 23vPPV are recommended to receive the dose of 13vPCV at least 12 months after their last 23vPPV dose.
Adults aged ≥70 years with risk conditions for pneumococcal disease are recommended to receive 13vPCV followed by additional doses of 23vPPV, as per the schedule for people with medical risk factors.
Aboriginal and Torres Strait Islander people
Aboriginal and Torres Strait Islander children aged <5 years living in certain states and territories are recommended to receive 13vPCV and 23vPPV
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 13vPCV at 6 months of age:
- Northern Territory
- 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.
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 13vPCV 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.
Aboriginal and Torres Strait Islander adults without risk conditions for pneumococcal disease are recommended to receive 13vPCV and 23vPPV at ≥50 years of age
Aboriginal and Torres Strait Islander adults without risk conditions for pneumococcal disease are recommended to receive:
- a dose of 13vPCV at age ≥50 years
- a dose of 23vPPV 12 months later
- 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 high proportion of invasive pneumococcal disease caused by additional serotypes only in 23vPPV
Aboriginal and Torres Strait Islander adults who have previously received 23vPPV are recommended to receive:
- 1 dose of 13vPCV 12 months after their last 23vPPV dose
- 1 dose of 23vPPV 12 months after their 13vPCV dose, or 5 years after their previous 23vPPV dose, whichever is later. If they have already received at least 2 doses of 23vPPV, no further 23vPPV doses are recommended.
In all these scenarios, the interval between doses of 13vPCV 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 13vPCV at diagnosis followed by 2 doses of 23vPPV (see recommendations for people with medical risk factors).
People with medical risk factors
Infants diagnosed with certain risk conditions at ≤12 months of age are recommended to receive 13vPCV and 23vPPV
In addition to the 3 doses of 13vPCV routinely recommended for healthy non-Indigenous children <5 years of age, children ≤12 months of age with risk conditions for pneumococcal disease (see List. Risk conditions for pneumococcal disease) are recommended to receive:
- An additional dose of 13vPCV 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.2-4
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 already 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 13vPCV 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 13vPCV after transplantation. 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.
People aged >12 months with risk conditions are recommended to receive 13vPCV and 23vPPV
All children and adults with newly identified risk conditions (see List. Risk conditions for pneumococcal disease) are recommended to receive:
- 1 dose of 13vPCV at diagnosis (at least 2 months after any previous doses of 13vPCV)
- 1 dose of 23vPPV 12 months after 13vPCV (2–12 months later is acceptable) or at 4 years of age whichever is later
- a 2nd dose of 23vPPV at least 5 years later
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 already receive these doses as part of their routine schedule.
Children aged ≤5 years with risk conditions who have not received all the recommended 13vPCV doses should receive doses of 13vPCV according to the catch-up schedule. See Table. Catch-up schedule for 13vPCV for Aboriginal and Torres Strait Islander children living in NT, Qld, SA or WA ONLY, and all children with any risk condition(s) for pneumococcal disease, aged <5 years. All children and adults with risk conditions are recommended to receive 13vPCV if they have not previously received this recommended dose. This should be followed by 2 doses of 23vPPV.
People who have previously received doses of 23vPPV are recommended to receive the dose of 13vPCV 12 months after their last 23vPPV dose. If they have already received at least 2 doses of 23vPPV, no further 23vPPV doses are recommended.
Aboriginal and Torres Strait Islander adults aged ≥50 years already receive these doses, and they do not need to be repeated. The exception is people who have received a haematopoietic stem cell transplant — these people are recommended to receive 3 doses of 13vPCV 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 13vPCV 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 dose5-8 and this is considered also applicable to 13vPCV.
Vaccines, dosage and administration
Pneumococcal conjugate vaccine
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.
Pneumococcal polysaccharide vaccine
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
Dose and route
The dose of 13vPCV is 0.5 mL, given by intramuscular injection.
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.9 However, a vaccine dose given subcutaneously does not need to be repeated.
Co-administration with other vaccines
Infants can receive 13vPCV 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. Advise parents/carers of infants or children who are recommended to receive both influenza vaccine and 13vPCV of this risk. See Contraindications and precautions.
Co-administration of 13vPCV with Menactra (quadrivalent MenACWY vaccine) should be avoided. This is because Menactra may interfere with the immune response against some pneumococcal serotypes. Two other brands of MenACWY vaccine, Menveo or Nimenrix, are available and can be co-administered with 13vPCV without such interference. If a person needs to receive 13vPCV and Menactra, the vaccines should be given at separate visits, especially if the person has a medical condition that increases their risk of meningococcal and/or pneumococcal disease. It is preferred that they receive 13vPCV first, followed by Menactra at least 4 weeks later. If 13vPCV and Menactra are inadvertently co-administered, a repeat dose of either vaccine is not needed. If the person has a condition that increases their risk of pneumococcal disease (see List. Risk conditions for pneumococcal disease), 23vPPV should be administered as scheduled.
Interchangeability of 10vPCV and 13vPCV
There are no specific data on the interchangeability of 10vPCV (not used in Australia) and 13vPCV. It is preferable to complete a primary course of pneumococcal conjugate vaccine with the same formulation. However, if a child started their vaccination course with 10vPCV (for example, children born overseas), it is acceptable to complete the course with 13vPCV.
Contraindications and precautions
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
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.13
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.19
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 and 23vPPV in pregnant or breastfeeding women are limited.20 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 and 23vPPV.
Adverse events in children
Pooled safety analysis from 13 clinical trials showed that the safety profile of 13vPCV in young children is similar to that of 7vPCV.16,17
In young children who received 13vPCV:17
- 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;17 fever was more common after the dose at 12 months of age than after the primary doses23
- 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.17
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.13 See Precautions.
Adverse events in adults
There are fewer clinical studies of 13vPCV in adults.19-23 In 2 clinical studies of 13vPCV and 23vPPV in people aged 60–64 years:19,20
- 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)19,21
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.23 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)
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.24-26
In people who receive 23vPPV:24-26
- 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
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.24-26 These findings supersede the inconsistent findings from some smaller studies, which were limited by subject numbers and methodology.27-31 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.32
Severe local reactions are also associated with higher antibody levels.9,25,26,33 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.2,34 There are more than 95 capsular antigenic types (serotypes), with each serotype eliciting type-specific immunity.35
The natural reservoir of pneumococci is the mucosal surface of the human upper respiratory tract.2,36 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 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.37
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 classified 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:2,34,36,38
- pneumonia with bacteraemia
- bacteraemia without focus
Pneumococci may spread from the nasopharynx into adjacent sites to cause non-invasive disease such as:2,34,36,38
- otitis media
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:3,42,43
- stiff neck
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.34,38,39
Pneumococcal disease in adults
In adults, pneumonia with bacteraemia is the most common manifestation of IPD.
Pneumococci may account for:34,40,41
- 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
- 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.2,4,34 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 conditions2,34,42,43
Indigenous populations in developed countries, including Aboriginal and Torres Strait Islander people in Australia, have a disproportionately high burden of IPD.1,2,44
Young children and elderly people have the highest incidence of invasive pneumococcal disease (IPD).37,38,45 Disease burden is also disproportionately high in Aboriginal and Torres Strait Islander people.1,2
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.37,45 However, rates of IPD caused by serotypes that were not contained in 7vPCV increased in Australia and several other countries.46 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%.46
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 2014.45 Serotype 19A caused around 80% of 13vPCV-type disease in children and around 40% in adults before 13vPCV was introduced. Introducing 13vPCV reduced disease caused by serotype 19A by almost 70% overall.45
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.47
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 non-Indigenous adults aged ≥65 years, 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.48-51 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.52,53 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.54
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.
There are 2 types of pneumococcal vaccines:
Conjugate vaccine formulations vary in:
- the number of pneumococcal serotypes included
- the conjugating proteins used
Pneumococcal conjugate vaccines are immunogenic in young infants 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.
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:
- non-inferiority for the 7vPCV serotypes
- sufficient antibody response to provide protection against the additional serotypes55-60
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.61
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 efficacious against pneumococcal disease in vaccine-naive adults aged ≥65 years.48 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.62 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 study63 assessed the efficacy of 13vPCV in people with certain risk conditions:
- heart disease
- lung disease
- liver disease
In these people, the efficacy of 13vPCV against vaccine-type IPD was 77.3%, and 40.3% against vaccine-type CAP.63 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
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.64 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.65,66
23vPPV is immunogenic in children, and the level of immune response varies by age and serotype.67,68 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.69
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.70
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.71
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.49
- Vaccine effectiveness against CAP outcomes ranges from 27% (95% CI: 3–46%) to 51% (95% CI: 16–71%) from observational studies.50,51
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%.72,73 In people with chronic conditions who are not immunocompromised, vaccine effectiveness against IPD is estimated to be 50–60%.21,72,74
Sequential administration of 13vPCV and 23vPPV in people with risk conditions is therefore likely to protect these people against 23v-non-13v serotypes. This is supported by immunogenicity studies that compared sequential administration of 7vPCV or 13vPCV and 23vPPV in varying combinations and dose intervals (2, 6, 12 months, or 3–4 years) in adults from 50 years of age.19,21,75-79
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.80
Significant and sustained antibody responses after revaccination are seen in adults, including the elderly.24,25,81-83 Evidence of lesser antibody responses to 2nd or subsequent doses of 23vPPV in adults is variable,24,25,77,81,82 but the clinical relevance of this is unknown.
Transporting, storing and handling vaccines
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
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.
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.
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- 13-valent pneumococcal conjugate vaccine
- 23-valent pneumococcal polysaccharide vaccine
- Western Australia
- 7-valent pneumococcal conjugate vaccine
- 10-valent pneumococcal conjugate vaccine
- invasive pneumococcal disease
- confidence interval
- Australian Technical Advisory Group on Immunisation
- Japanese encephalitis
- enzyme-linked immunosorbent assay
- World Health Organization
- pertussis toxoid