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Pneumococcal vaccination in children

Pneumococcal vaccination in children
Literature review current through: Jan 2024.
This topic last updated: Nov 01, 2023.

INTRODUCTION — Streptococcus pneumoniae (pneumococcus) is a leading cause of serious illnesses in children.

Pneumococcal vaccination for healthy children and children at increased risk of invasive pneumococcal disease will be reviewed here. Pneumococcal vaccination in adults, the microbiology and pathogenesis of pneumococcal disease, and pneumococcal pneumonia in children are discussed separately.

(See "Pneumococcal vaccination in adults".)

(See "Streptococcus pneumoniae: Microbiology and pathogenesis of infection".)

(See "Pneumococcal pneumonia in children".)

PNEUMOCOCCAL VACCINES — The surface capsular polysaccharide of S. pneumoniae determines the serotype and provokes a type-specific protective immune response [1]. More than 102 pneumococcal serotypes have been identified so far. It is not possible to include all serotypes in a pneumococcal vaccine; the serotypes most frequently isolated from patients with invasive disease are included in the available vaccines. (See "Streptococcus pneumoniae: Microbiology and pathogenesis of infection", section on 'Capsule'.)

Conjugate vaccines — Pneumococcal polysaccharide-conjugate vaccines (usually called pneumococcal conjugate vaccines [PCVs]) are inactivated vaccines that consist of type-specific pneumococcal polysaccharides conjugated to a carrier protein or proteins. The carrier protein elicits a T cell-dependent memory response during the first two years of life, which increases the effectiveness of the vaccine (table 1).

PCVs that include 7, 10, 13, 15, and 20 serotypes have been developed (table 2). The 7-valent vaccine (PCV7) is no longer available.

10-valent vaccine – The 10-valent PCV (PCV10) contains polysaccharides from 10 pneumococcal serotypes (table 2) conjugated to protein D, tetanus and diphtheria toxoids, and an aluminum adjuvant. PCV10 is not licensed in the United States but is used in other countries [2].

13-valent vaccine, 15-valent vaccine, and 20-valent vaccine – If neither the 15-valent (PCV15) nor the 20-valent pneumococcal conjugate vaccines (PCV20) are available, the 13-valent pneumococcal conjugate vaccine (PCV13) may be used. All three vaccines contain polysaccharides from the specified pneumococcal serotypes (table 2) conjugated to CRM197 (a nontoxic mutant of diphtheria toxin) and an aluminum adjuvant. None contain thimerosal (table 1) [3-5].

13-valent vaccine PCV13 is licensed to prevent invasive pneumococcal disease (IPD) caused by the 13 vaccine serotypes in children 6 weeks through 17 years of age and to prevent acute otitis media by the seven serotypes in PCV7 (table 2) in children age 6 weeks through 5 years [4]. PCV13 replaced PCV7 in the routine childhood immunization schedule in the United States in 2010 [6].

15-valent vaccine PCV15 contains the 13 serotypes included in PCV13 plus serotypes 22F and 33F. It is licensed to prevent IPD in individuals ≥6 weeks of age [7,8]. It was licensed for children <18 years of age based on randomized trials that demonstrated safety and immunogenicity similar to those with PCV13 for the shared serotypes [9-14].

20-valent vaccine PCV20 contains the 15 serotypes included in PCV15 plus serotypes 8, 10A, 11A, 12F, and 15B. It is licensed to prevent pneumonia and IPD in children 6 weeks through 17 years of age [7,15]. In a randomized trial comparing PCV20 and PCV13 in 460 infants, PCV20 was immunogenic and had a safety profile similar to PCV13 [16].

Polysaccharide vaccine — The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is an inactivated vaccine that contains purified capsular polysaccharide antigens of 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F) (table 2). The 23 serotypes were chosen to represent 85 to 90 percent of the serotypes that cause IPD in the United States. PPSV23 does not contain thimerosal (table 1) [17].

PPSV23 is licensed for use in people ≥2 years of age. Polysaccharide vaccines are poorly immunogenic in children younger than two years of age [18,19]. (See "Assessing antibody function as part of an immunologic evaluation", section on 'Children under two years of age'.)

ROUTINE IMMUNIZATION FOR CHILDREN <5 YEARS — Children <5 years of age, particularly those <2 years of age, are at increased risk for invasive pneumococcal disease (IPD), such as meningitis and bacteremia. Routine immunization with a pneumococcal conjugate vaccine (PCV) is effective in preventing IPD in vaccinated children and providing community ("herd") immunity for people who are not vaccinated. (See 'Efficacy and effectiveness' below.)

The United States Advisory Committee on Immunization Practices and the World Health Organization (WHO) recommend immunization with PCV for all infants [6,8,20].

Schedule and catch-up schedule

In the United States

Routine schedule – In the United States, the routine schedule for PCV (either 15-valent PCV [PCV15] or 20-valent PCV [PCV20]) for all children includes a three-dose primary series and a booster dose [21]. We prefer to administer PCV20 when available. The recommended schedule is as follows:

Age two months (the minimum age for this dose is 6 weeks)

Age four months and ≥4 weeks after the first dose

Age six months and ≥4 weeks after the second dose

Booster dose at age 12 through 15 months and ≥8 weeks after the third dose

If the child has only received PCV13, the series may be completed with PCV15 or PCV20. Restarting the series is not necessary.

In preterm infants, PCV is administered according to chronologic age [6,22-25].

Administration of PCV is discussed below. (See 'Administration of PCV13/PCV15/PCV20 and PPSV23' below.)

The booster dose at ≥12 months is recommended to prevent breakthrough disease due to waning immunity [26,27]. In an observational study from Australia, which used a schedule consisting of three doses at age 2, 4, and 6 months without a booster dose, vaccine effectiveness declined with time since the third dose, particularly beyond 24 months [28].

Catch-up schedule

Healthy children between 2 and <5 years of age who are incompletely immunized with PCV should receive a single dose of either PCV15 or PCV20. We prefer PCV20 when available. The dose should be administered at least eight weeks after the most recent PCV dose (if applicable) [21].

The Centers for Disease Control and Prevention has developed a web-based tool (PneumoRecs VaxAdvisor) to help clinicians determine which pneumococcal vaccines children need.

Infants and children <6 years of age with certain underlying conditions who are incompletely immunized with PCV are discussed below. (See 'Age 2 through 18 years' below.)

In other countries — The WHO recommends that PCV be included in childhood immunization programs worldwide [20]. The WHO suggests that PCV be administered, beginning as early as six weeks of age, either as:

Two primary doses, separated by ≥8 weeks, and a booster at age 9 to 18 months of age (2p+1 schedule), or as

Three primary doses, separated by ≥4 weeks, without a booster (3p+0 schedule)

A 2017 systematic review of randomized and observational studies concluded that both schedules are immunogenic and highly effective in preventing IPD caused by vaccine serotypes [29]. The optimal schedule may vary geographically with the epidemiology of IPD (eg, age-specific incidence and community immunity) [30-34]. The 2p+1 schedule induces higher antibody levels in the second year of life, which may help to maintain community immunity [35].

The recommended schedules for individual countries in Europe are available through the European Centre for Disease Prevention and Control.

Efficacy and effectiveness

Invasive disease — IPD is usually defined by the isolation of pneumococcus from a normally sterile body fluid (eg blood, cerebrospinal fluid). Pneumococcal pneumonia is considered to be invasive if it is complicated by empyema or associated with bacteremia.

Routine immunization of young children with PCV is effective in preventing IPD in vaccinated children. The decline is greatest for vaccine serotypes and cross-reactive serotypes (ie, nonvaccine serotypes [eg, 6A, 9N, 18B, 23A] related to vaccine serotypes [eg, 6C, 9V, 18C, 23F]) [36,37].

In a meta-analysis of six randomized trials (including more than 113,000 children) of various valencies of PCV from several countries, PCV efficacy for preventing vaccine-type IPD in children <2 years of age was 80 percent (95% CI 58-90 percent) [36]. The efficacy for preventing IPD caused by all serotypes was 58 percent (95% CI 29-75 percent). Findings were similar in children with and without human immunodeficiency virus (HIV).

The effectiveness of PCV in preventing IPD in children <5 years of age is confirmed by surveillance demonstrating dramatic declines in the incidence of IPD after routine infant immunization was introduced [38-50]. In the United States between 1998 and 2019, the overall incidence of IPD in children <5 years of age declined from 95 to 7 cases per 100,000 children, and the incidence of IPD caused by PCV13 serotypes declined from 88 to 2 cases per 100,000 children [38].

After the switch from 7-valent PCV (PCV7) to PCV13 (in 2010), the overall incidence of IPD continued to decline [47,51-54], although the proportion of IPD cases caused by nonvaccine serotypes increased [55-59]. In multistate surveillance in the United States during 2018 to 2019, among children <5 years of age, the incidence of IPD was 7.2 per 100,000 children, PCV13 serotypes accounted for 21 percent of IPD cases, and serotypes 22F and 33F (the two additional serotypes in PCV15) accounted for 15 percent of IPD cases [8,60]. Among children age 5 to 18 years, the incidence of IPD was 1.5 per 100,000, PCV13 serotypes accounted for 34 percent of IPD cases, and serotypes 22F and 33F accounted for 23 percent of IPD cases. A study of 30 high-income countries found a similar proportion of IPD cases due to serotypes 22F and 33F; in addition, the five serotypes found only in PCV20 accounted for 27.5 percent of IPD cases [61].

The prevalence of serious IPD due to nonvaccine serotypes highlights the importance of continued vigilance and surveillance for IPD, even in immunized children. Although the incidence of IPD and pneumococcal mortality declined after the introduction of PCVs in the United States and other countries, the burden of pneumococcal disease remains substantial [62-64].

Routine immunization of infants with PCV is also effective in providing community ("herd") immunity (ie, protection for unvaccinated people, including infants and older adults) [53,65-70].

Pneumonia and empyema — PCV is modestly protective against pneumococcal pneumonia caused by vaccine serotypes as well as overall community-acquired pneumonia [36,71-78], which is often caused by pathogens other than pneumococcus, including viruses [79]. S. pneumoniae appears to contribute to the pathogenesis of CAP caused by other bacteria and viruses; therefore, vaccination against pneumococci may have the potential to reduce all-cause pneumonia burden [74,80,81].

In a meta-analysis of six randomized trials, PCV efficacy for preventing WHO radiographically defined pneumonia in children <2 years of age was 27 percent (95% CI 15-36 percent) and for preventing clinical pneumonia was 6 percent (95% CI 2-9 percent) [36]. Findings were similar in children with and without HIV.

After the switch from PCV7 to PCV13 in 2010, hospitalizations among children for culture-proven pneumococcal pneumonia (all serotypes) and complicated pneumonia declined at the eight children's hospitals in the Pediatric Multicenter Pneumococcal Surveillance Study Group [71]. Nonetheless, PCV13 serotypes 3 and 19A accounted for approximately one-half of cases between 2011 and 2014. Among 119 children hospitalized with invasive pneumococcal pneumonia at one of the eight children's hospitals between 2014 and 2017, PCV-13 serotypes were isolated from 42 percent [56].

Otitis media and conjunctivitis

Acute otitis media – Administration of PCV is associated with a modest reduction in the incidence of acute otitis media (AOM) in infants [37,82,83]. Administration of PCV changes the nasopharyngeal flora, reducing episodes of AOM caused by pneumococcal vaccine serotypes and cross-reactive serotypes, and increasing episodes of AOM caused by other serotypes.

The effectiveness of PCV in preventing recurrent episodes of AOM is discussed separately. (See "Acute otitis media in children: Prevention of recurrence", section on 'Pneumococcal conjugate vaccine'.)

Conjunctivitis – Limited evidence from population-based surveillance suggests that administration of PCV is associated with decreased rates of pneumococcal conjunctivitis, nontypeable Haemophilus influenzae conjunctivitis, and culture-positive conjunctivitis in children <2 years of age [84].

Incomplete schedules — Children may receive fewer than the recommended number of doses of PCV if immunizations are delayed or the vaccine is not available. In observational studies, the effectiveness of incomplete schedules varied with the number and timing of doses [85,86]. Nonetheless, various combinations of three or four doses before 16 months that included at least one dose at ≥12 months provided approximately 90 percent protection against IPD due to any serotype and up to 100 percent protection against IPD due to vaccine serotypes, highlighting the importance of the booster dose. (See 'In the United States' above.)

Immunogenicity — Immunogenicity is a surrogate for protection from disease. The concentrations of immunoglobulin G capsular antibodies that correlate with protection against pneumococcal disease have not been clearly defined but are proposed to be ≥0.35 mcg/mL one month after primary immunization as measured by enzyme-linked immunosorbent assay, based on a pooled meta-analysis [87]. This is the minimum protective concentration recommended by the WHO for assessing the efficacy of PCVs in infants [88].

In randomized trials, PCV13 provided comparable immunogenicity to PCV7 for the serotypes included in both vaccines; in most circumstances, the new serotypes met the WHO-proposed minimum protective concentration [89-92]. Similarly, in randomized trials in healthy children and children with sickle cell disease or HIV, PCV15 provided comparable immunity to PCV13 [9-14,93].

Serotype-specific antibody response may be decreased by elevated levels of maternal antibody and nasopharyngeal carriage of S. pneumoniae before immunization [94-97]. The booster response for individual serotypes varies with the immunization schedule; reduced dose schedules may not achieve protective antibody levels for all serotypes [98,99]. The clinical significance of these observations is uncertain [20].

IMMUNIZATION OF HIGH-RISK CHILDREN AND ADOLESCENTS

Target high-risk groups — The risk of invasive pneumococcal disease (IPD) is increased in the following groups (table 3), and these children should receive at least one dose of the 20-valent pneumococcal conjugate vaccine (PCV20) or the 23-valent pneumococcal polysaccharide vaccine (PPSV23) as reviewed by age below [21,100-106]. (See 'Aged-based immunization recommendations' below.)

Immunocompromised children and adolescents, including those with:

Functional or anatomic asplenia (eg, sickle cell disease and other hemoglobinopathies, congenital or acquired asplenia or splenic dysfunction); although celiac disease has been associated with hyposplenism and an increased risk of IPD [107], the United States Advisory Committee on Immunization Practices (ACIP) does not consider it a high-risk condition [6,100]

Congenital or acquired immunodeficiency (B or T cell deficiency, complement deficiency [particularly C1, C2, C3, and C4 deficiency], phagocyte disorders [except chronic granulomatous disease])

HIV infection [108]

Nephrotic syndrome or on maintenance dialysis

Generalized malignancy (eg, metastatic disease, disease treated with chemotherapy or radiation therapy)

Hematologic malignancy (eg, leukemia, lymphoma, Hodgkin disease, multiple myeloma)

Iatrogenic immunosuppression (eg, solid organ transplant, long-term systemic glucocorticoids, tumor necrosis factor-alpha inhibitors [eg, etanercept, infliximab], radiation therapy)

Pneumococcal immunization of patients after hematopoietic cell transplantation is discussed separately. (See "Immunizations in hematopoietic cell transplant candidates and recipients", section on 'Pneumococcus'.)

Immune-competent children and adolescents with anatomic barrier defects, including:

Cerebrospinal fluid (CSF) leak

Cochlear implant (or candidate for cochlear implant) [109]

Immune-competent children and adolescents with chronic medical condition (CMC):

Chronic heart disease, particularly cyanotic congenital heart disease, cardiac failure, and cardiomyopathy

Chronic lung disease (including moderate or severe persistent asthma) [102]

Diabetes mellitus

Chronic liver disease

Chronic kidney disease (excluding children with nephrotic syndrome and/or dialysis dependence)

Although the ACIP does not include severe IPD (eg, pneumococcal meningitis with sequelae, pneumococcal pneumonia with empyema or other complication) or recurrent acute otitis media (AOM) as high-risk conditions, some experts suggest that children with a history of severe IPD or recurrent AOM receive a dose of PCV20 or PPSV23 vaccine after completion of the standard recommended vaccine schedule, unless they have already received a dose of PCV20. (See 'Invasive pneumococcal disease' below and "Acute otitis media in children: Prevention of recurrence", section on 'Vaccines'.)

Aged-based immunization recommendations — PCV20 and PPSV23 provide protection against serotypes that are not included in the 13-valent (PCV13) or the 15-valent pneumococcal conjugate vaccine (PCV15) (table 2), and therefore high-risk children should receive one of these vaccines.

The Centers for Disease Control and Prevention has developed a tool (PneumoRecs VaxAdvisor) to provide customized recommendations for pneumococcal vaccination in children with underlying medical conditions.

Age <2 years — Administer PCV according to the schedule for healthy children. (See 'Schedule and catch-up schedule' above.)

Age 2 through 18 years — The pneumococcal vaccination schedule for children at high risk of IPD who are age 2 through 18 years is determined by the high-risk condition and history of immunization with PCV13/PCV15/PCV20 (doses of PCV7 are not counted) and PPSV23, as described below (algorithm 1 and algorithm 2) [6,100].

Catch-up for children ages 2 years to <6 years– Children <6 years of age who have not received the full recommended PCV series (with PCV13, PCV15, or PCV20) require additional pneumococcal vaccination at this age:

If the child received all three doses of the primary PCV series before age 1 year but did not receive the booster dose, then administer one additional dose of PCV15 or PCV20 at least eight weeks after the most recent PCV dose. We prefer PCV20 when available.

If the child has any other incomplete PCV vaccination status (including no prior doses or incomplete primary series), then administer two doses of PCV15 or PCV20. We prefer PCV20 when available. The first dose should be at least eight weeks after any previous PCV dose, and the second dose should be at least eight weeks after the first.

Additional doses for children who completed the recommended PCV series before age 6 years – For children who received all recommended PCV doses of PCV13/PCV15/PCV20 (according to either the routine or catch-up schedule) before age 6 years, the need for additional pneumococcal vaccination depends on the nature of the high-risk condition and whether they received at least one prior dose of PCV20:

High-risk children who are immune-competent (table 3):

-If the child received at least one prior dose of PCV20, no additional doses of any pneumococcal vaccine are indicated.

-If the child did not previously receive a dose of PCV20, administer either one dose of PCV20 or PPSV23 to complete the vaccine series.

High-risk children with immunocompromising conditions (table 3):

-If the child received at least one prior dose of PCV20, no additional doses of any pneumococcal vaccine are necessary.

-If the child did not previously receive a dose of PCV20, administer either one dose of PCV20 or a dose of PPSV23 at least eight weeks after the most recent PCV dose. If PPSV23 is given, then administer another PPSV23 dose or PCV20 at least five years after the first PPSV23 [21]. The second dose of PPSV23 is generally given five years after the first [6,100,102]; however, some experts recommend an interval of three years for children with sickle cell disease [110]. When PPSV23 is given, the ACIP recommends a total of two doses for immunocompromised children, including children with asplenia [6,100]; however, some experts suggest that children with asplenia receive PPSV23 every five years.

Ages 6 through 18 years with incomplete recommended PCV series

Administer one dose of PCV15 or PCV20 at least eight weeks after the most recent PCV. We prefer PCV20 when available.

If PCV15 vaccine is administered, administer a dose of PPSV23 at least eight weeks later.

Effectiveness

Immunogenicity – Successful vaccination is indicated by a ≥2-fold increase in antigen-specific antibody between 4 and 12 weeks after immunization. The response for individual serotypes may vary. (See "Assessing antibody function as part of an immunologic evaluation", section on 'Timing of pre- and postvaccination measurements'.)

There are few data regarding the immunogenicity of PPSVs in children belonging to high-risk groups. In observational studies, PPSVs have demonstrated immunogenicity in children with chronic renal disease, sickle cell disease, and HIV infection [111-116]. The duration of immunity following PCV is unknown [6].

Long-term follow-up data concerning antibody levels in people who received ≥2 doses of PPSV23 are not available [6]. For people who have received two doses of PPSV23 at appropriate intervals, routine revaccination generally is not recommended.

Prevention of IPD – The efficacy of PCV, PPSV, and the combination of PCV and PPSV in children at increased risk for IPD is not well studied [117]. Evidence from randomized and observational studies suggests that PCV prevents IPD in children with HIV infection and sickle cell disease [36,118-120]. In a randomized trial, the efficacy of PCV in preventing IPD in children with HIV was 65 percent (95% CI 24-86 percent) [120]. In a population-based observational study, the estimated effectiveness of ≥1 dose of PCV in preventing IPD among children ≤10 years with sickle cell disease was approximately 85 percent [119].

In an observational study, the estimated effectiveness of PPSV in preventing meningitis and bacteremia caused by vaccine serotypes in people ≥5 years of age was 57 percent (95% CI 45-66 percent) [121]. In another observational study, the estimated effectiveness of PPSV23 in preventing IPD caused by vaccine serotypes in children two to five years of age with chronic disease was 63 percent (95% CI 8-85 percent) [122]. The effectiveness against the 16 serotypes included in the PPSV23 but not in PCV7 was 94 percent.

The effectiveness of PPSV in preventing IPD in adults is discussed separately. (See "Pneumococcal vaccination in adults".)

ADMINISTRATION OF PCV13/PCV15/PCV20 AND PPSV23

Contraindications and precautions

Contraindications – The 13-valent (PCV13), the 15-valent (PCV15), and the 20-valent pneumococcal conjugate vaccines (PCV20) are contraindicated in children who had a severe allergic reaction (eg, anaphylaxis) after a previous dose of any PCV, any diphtheria toxoid-containing vaccine, or to a component of PCV13/PCV15/PCV20 or any diphtheria toxoid-containing vaccine [3,4,6,123]. (See "Allergic reactions to vaccines", section on 'Reactions to vaccine constituents'.)

The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is contraindicated in children who had a severe allergic reaction to a previous dose or to a component of PPSV23 [6,123].

Precautions – Precautions are conditions that may increase the risk for a serious reaction to immunization, cause diagnostic confusion, or compromise the ability of the vaccine to produce immunity [123].

Moderate or severe illness with or without fever is a precaution for administration of PCV13/PCV15/PCV20 and PPSV23; postponing immunization until the child has recovered will avoid diagnostic confusion between manifestations of illness and vaccine adverse effects [6,123].

Dose and route — PCV13, PCV15, and PCV20 are administered intramuscularly (IM) as a single 0.5 mL dose [6]. PPSV23 is administered IM or subcutaneously as a single 0.5 mL dose.

Timing of vaccination — If possible, pneumococcal immunization (PPSV23 and PCV13, PCV15, or PCV20) should be completed at least two weeks before splenectomy, immunocompromising therapy (including chemotherapy), or cochlear implantation [6,109,124,125]. Additional details regarding immunization of children undergoing splenectomy or cochlear implantation are provided separately. (See "Prevention of infection in patients with impaired splenic function", section on 'Vaccinations' and "Cochlear implant infections", section on 'Children'.)

Administration with other vaccines

PCV13/PCV15/PCV20

Routine childhood vaccinesPCV13, PCV15, and PCV20 may be administered concurrently with other routine childhood vaccines [8,10,12,89,92,126-130]; PCV should be injected with a separate syringe at a separate site (eg, in a different limb [preferred] or separated by at least 2.5 cm [1 inch]) [131].

To decrease immunization-related pain, we suggest administering oral rotavirus vaccine (if indicated) before injectable vaccines and administering PCV after other injectable vaccines. (See "Standard immunizations for children and adolescents: Overview", section on 'Administration of multiple vaccines at one visit'.)

In a randomized trial, the proportion of children who developed fever within two days of vaccination was similar (8 to 9 percent) whether inactivated influenza vaccine was administered on the same day as PCV and diphtheria, tetanus, and acellular pertussis vaccine or two weeks later [132].

Vaccines for high-risk childrenPCV13, PCV15, and PCV20 may be administered concurrently with most vaccines recommended for high-risk children [8,131].

PPSV23 – PPSV23 may be administered concurrently with other vaccines, but PCV13, PCV15, or PCV20 [131]. In children ≥2 years of age and adolescents, PPSV23 should be administered ≥8 weeks before or after PCV13, PCV15, or PCV20.

Adverse effects

PCV13, PCV15, PCV20 – PCVs are generally safe and well tolerated [8,20,133-135]. In a systematic review of nine randomized trials including >77,000 children, the most frequently reported adverse effects following PCV were mild local reactions, including localized pain and or tenderness (3 to 38 percent), erythema <2.5 cm (5 to 20 percent) and swelling <2.5 cm (5 to 12 percent), and fever <39°C (102.2°F) (15 to 44 percent) [135]. More severe erythema, swelling, or fever were reported in <2.5 percent of patients. Serious adverse events causally related to PCV were rare and did not differ between PCV and control groups. In randomized trials, the rate of adverse effects with PCV13 and PCV15 were similar between groups; adverse effects were typically mild and included fussiness, somnolence, injection site pain, and decreased appetite [10,12,136,137].

Surveillance for prespecified adverse events in a cohort of children (one month to two years of age) who received nearly 600,000 doses of PCV13 during the first two years after licensure (2010 to 2012) found no increased risk of febrile seizures, urticaria, angioneurotic edema, anaphylaxis, asthma, thrombocytopenia, or encephalopathy compared with PCV7 [138]. Although a potential association between PCV13 and Kawasaki disease was identified, no evidence of an association was detected when surveillance was continued through 2017 to include >2.5 million doses nor in separate surveillance of >6 million doses in the Sentinel Postlicensure Rapid Immunization Safety Monitoring (PRISM) surveillance system [139,140].

Review of reports to the passive Vaccine Adverse Event Reporting System (VAERS) in the United States for children 6 weeks through 59 months of age between 2010 and 2017 did not identify any new or unexpected patterns of adverse reactions [141]. Reported adverse events were similar to those in prelicensure trials (eg, injection site erythema, injections site swelling, fever).

PPSV23 – Approximately one-third to one-half of people who receive PPSV develop transient mild injection reactions (pain, erythema, swelling) [117,142,143]. These reactions usually persist for less than 48 hours. Moderate systemic reactions (eg, fever and myalgias) and more severe local reactions (eg, local induration) are rare. Revaccination after intervals of four years or more is not associated with an increased incidence of adverse side effects.

Health care providers in the United States should report suspected adverse events to VAERS.

SPECIAL CIRCUMSTANCES

Uncertain immunization history — Children with unknown or uncertain pneumococcal immunization status should be considered unimmunized [131]. They should be caught up according to age and risk status. (See 'Schedule and catch-up schedule' above and 'Immunization of high-risk children and adolescents' above.)

Invasive pneumococcal disease — Children who develop invasive pneumococcal disease (IPD) should still complete the full series of immunization with pneumococcal conjugate vaccine (13-valent pneumococcal conjugate vaccine [PCV13], 15-valent pneumococcal conjugate vaccine [PCV15], or 20-valent pneumococcal conjugate vaccine [PCV20]) and/or 23-valent pneumococcal polysaccharide vaccine (PPSV23) according to their age and underlying condition [20]. IPD elicits serotype-specific antibodies; it does not provide protection against the range of serotypes included in PCV13/PCV15 or PPSV23. Although the ACIP does not include severe IPD (eg, pneumococcal meningitis with sequelae, pneumococcal pneumonia with empyema or other complication) as a high-risk condition, some experts suggest that children with a history of severe IPD receive PPSV23 after completion of immunization with PCV13/PCV15. (See 'Routine immunization for children <5 years' above and 'Immunization of high-risk children and adolescents' above.)

Evaluation of immune function and HIV status may be warranted for children who develop IPD disease with a PCV13/PCV15 serotype despite having received at least two doses of PCV13/PCV15 [125]. However, in a multicenter study, immunodeficiency was detected in only 1 of 28 children who were evaluated for immunodeficiency after developing IPD with a PCV13 serotype despite having received ≥2 doses of PCV13 [56]. Additional studies are needed to clarify the need for evaluation of immune function in children who develop IPD with a PCV13/PCV15 serotype despite PCV13/PCV15 immunization.

Evaluation of immune function also may be warranted for select children who develop IPD with nonvaccine serotypes. In populations with high pneumococcal vaccine coverage, identification of primary immunodeficiency may be more likely in children with recurrent IPD and in children >2 years of age who develop IPD with a nonvaccine serotype and have no other risk factors for IPD (table 3) than in children who develop IPD despite PCV immunization [101,105,144,145]. In a systematic review of 17 predominantly retrospective studies including 6022 patients with IPD, primary immunodeficiency was identified in 11 to 67 percent of children with recurrent IPD, as many as 10.4 percent of children of all ages, and as many as 26 percent of children >2 years [105]. Primary immunodeficiencies included immunoglobulin deficiency, pneumococcal antibody deficiency, complement deficiency, asplenia/hyposplenia, and defects in toll-like receptor signalling. Additional prospective studies are needed to clarify the need for evaluation of immune function.

Vaccine mix-up

If a child <2 years of age inadvertently receives PPSV23 instead of PCV13/PCV15/PCV20, the dose of PPSV23 should not be counted [146]. The child should receive PCV13/PCV15/PCV20 as soon as possible after the mix-up is recognized.

Polysaccharide vaccines generally are not immunogenic in children <2 years of age. Although children <2 years of age may respond to some of the antigens in PPSV23, the duration of response and effect on subsequent challenge are uncertain [147-150].

If a child ≥2 years of age inadvertently receives PCV13/PCV15 instead of PPSV23 (and did not require PCV13/PCV15), PPSV23 should be administered ≥8 weeks after the inadvertent dose of PCV13/PCV15.

RESOURCES — Resources related to pneumococcal immunization in children and adolescents include:

Vaccine information statement for the pneumococcal conjugate vaccine (PCV13 or PCV15) and the 23-valent pneumococcal polysaccharide vaccine

The Centers for Disease Control and Prevention

Pneumococcal vaccine recommendations advisor tool

The Advisory Committee on Immunization Practices recommendations for pneumococcal vaccine

The American Academy of Pediatrics

Immunize.org

The World Health Organization

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Immunizations in children and adolescents" and "Society guideline links: Pneumococcal vaccination in children".)

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Beyond the Basics topics (see "Patient education: Why does my child need vaccines? (Beyond the Basics)" and "Patient education: Vaccines for infants and children age 0 to 6 years (Beyond the Basics)" and "Patient education: Vaccines for children age 7 to 18 years (Beyond the Basics)")

SUMMARY AND RECOMMENDATIONS

Types of pneumococcal vaccines – Two types of vaccines are available for the prevention of pneumococcal disease: pneumococcal polysaccharide-conjugate vaccines (usually called pneumococcal conjugate vaccines [PCV]) and pneumococcal polysaccharide vaccines (PPSV) (table 1). (See 'Pneumococcal vaccines' above.)

Routine immunization – In agreement with the World Health Organization and the United States Advisory Committee on Immunization Practices (ACIP), we recommend immunization with PCVs for all infants (Grade 1A). Children <5 years of age, particularly those <2 years of age, are at increased risk for invasive pneumococcal disease (IPD). Routine immunization with PCV is effective in preventing IPD in vaccinated children and providing community ("herd") immunity for unvaccinated people. The efficacy of PCV for preventing IPD is supported by several large randomized trials. Additional support comes from surveillance data demonstrating dramatic declines in the incidence of IPD after routine infant immunization was introduced. (See 'Routine immunization for children <5 years' above and 'Efficacy and effectiveness' above.)

Schedule in the United States – In the United States, ACIP recommends routine immunization with either the 15-valent PCV (PCV15) or the 20-valent PCV (PCV20). When available, we suggest PCV20 rather than PCV15 (Grade 2C). PCV is administered intramuscularly; the dose is 0.5 mL. The schedule for routine vaccination is as follows (see 'Schedule and catch-up schedule' above):

-Age 2 months (minimum age 6 weeks)

-Age 4 months and ≥4 weeks after the first dose

-Age 6 months and ≥4 weeks after the second dose

-Booster dose at age 12 through 15 months and ≥8 weeks after the third dose

If the infant received PCV13 for the initial doses, the series may be completed with PCV15 or PCV20. Restarting the series is not necessary.

Healthy children between 2 and <5 years of age who are incompletely immunized with PCV should receive a single dose of either PCV15 or PCV20 given at least eight weeks after the previous PCV dose (if applicable). (See 'In the United States' above.)

Schedules in other countries – The recommended schedules for European countries are available through the European Centre for Disease Prevention and Control. (See 'In other countries' above.)

Immunization for high-risk children and adolescents

Target high risk groups – The risk of IPD is increased in children ≥2 years of age who are immunocompromised or have a cerebrospinal fluid leak, cochlear implant, or certain medical conditions (table 3). The risk is particularly high in children with sickle cell disease. (See 'Target high-risk groups' above.)

Approach to immunization – For children ≥2 years with high-risk conditions (table 3) who have completed the primary vaccination series with PCV13/PCV15 and have not yet received a dose of PCV20, we suggest immunization with PCV20 or PPSV23 (Grade 2C).

PPSV23 provides protection against serotypes that are not included in PCV13, PCV15, or PCV20 (table 2), but its efficacy is limited to children older than 2 years. (See 'Aged-based immunization recommendations' above.)

The recommended schedule for PCV13/PCV15/PCV20 and PPSV23 in high-risk children varies with age and pneumococcal vaccination history:

-Age <2 years – Administer PCV according to the schedule for healthy children (see 'Schedule and catch-up schedule' above)

-Age 2 through 18 years (algorithm 1 and algorithm 2) (see 'Age 2 through 18 years' above)

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Topic 6053 Version 113.0

References

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