Pneumococcal Vaccine

[Section Outline]

Prevention of Pneumococcal Disease
Clinical Experience
Recommended Immunization for Pneumococcal Disease

Prevention of Pneumococcal Disease

Pneumococcal vaccines are used to stimulate active immunity for the prevention of diseases caused by Streptococcus pneumoniae .100,129,181,184,203,204,205,207,208 Common infections caused by S. pneumoniae include acute otitis media (AOM), sinusitis, pneumonia, bacteremia, and meningitis.105,166 S. pneumoniae is a major cause of serious or invasive illness and death worldwide.100,105,166,169,184 Adults who are immunosuppressed or have certain medical conditions including heart disease, liver disease, lung disease (including asthma), alcoholism, CSF leak, cigarette smoking, or have a cochlear implant are at increased risk for systemic disease.166 In children <5 years of age, S. pneumoniae has been a leading cause of bacterial meningitis.166 Routine infant and childhood vaccination against pneumococcal disease has reduced the incidence of invasive pneumococcal disease among unvaccinated individuals of all ages.184

Available pneumococcal vaccines in the US consist of 3 conjugate vaccines and one polysaccharide vaccine.129,181,207,208 Pneumococcal conjugate vaccines are differentiated by the number of serotypes they provide protection against and include pneumococcal 13-valent conjugate vaccine (PCV13; Prevnar 13^®),181 pneumococcal 15-valent conjugate vaccine (PCV15; Vaxneuvance^®),207 and pneumococcal 20-valent conjugate vaccine (PCV20; Prevnar 20^®).208 The only pneumococcal polysaccharide vaccine available in the US is pneumococcal vaccine polyvalent (PPSV23; Pneumovax^® 23).129

The pneumococcal vaccines have been formulated to stimulate active immunity to infection caused by Streptococcus pneumoniae serotypes contained in the specific vaccine product.129,166,181,207,208 The vaccines will not prevent pneumococcal infection caused by S. pneumoniae serotypes not represented in the vaccines.129,181,207,208

Routine use of the first FDA-approved pneumococcal conjugate vaccine in the US (pneumococcal 7-valent conjugate vaccine; no longer commercially available) resulted in a dramatic reduction in the incidence of invasive pneumococcal disease attributable to serotypes of S. pneumoniae contained in the vaccine.100 Subsequent pneumococcal conjugate vaccines have been developed to cover additional serotypes responsible for causing cases of invasive pneumococcal disease now occurring in children younger than 5 years of age.100

Although the currently available pneumococcal vaccines all contain capsular antigens extracted from S. pneumoniae , each preparation contains different amounts and forms of these antigens.129,181,207,208 PCV13 (Prevnar 13^®) contains capsular antigens from 13 different serotypes of S. pneumoniae (i.e., serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) conjugated to a T-cell dependent carrier protein (diphtheria CRM₁₉₇ protein).181 PCV15 (Vaxneuvance^®) contains capsular antigens from 15 different serotypes of S. pneumoniae (i.e., serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F) conjugated to a T-cell dependent carrier protein (diphtheria CRM₁₉₇ protein).207 PCV20 (Prevnar 20^®) contains capsular antigens from 20 different serotypes of S. pneumoniae (i.e., serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) conjugated to a T-cell dependent carrier protein (diphtheria CRM₁₉₇ protein).208 PPSV23 (Pneumovax^® 23) contains capsular antigens from 23 different serotypes of S. pneumoniae (i.e., serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F); these antigens are unconjugated.129

Choice of Pneumococcal Vaccines

Pneumococcal conjugate vaccines are labeled by FDA for different age groups depending on the specific vaccine product.181,207,208 PCV13 (Prevnar 13^®) and PCV15 (Vaxneuvance^®) are labeled by the FDA for use in adults and pediatric patients 6 weeks through 17 years of age,181,207 while PCV20 (Prevnar 20^®) is labeled by the FDA for use only in adults ≥18 years of age.208 PPSV23 (Pneumovax^® 23) is labeled by FDA for use in adults ≥50 years of age and in individuals ≥2 years of age who are at increased risk for pneumococcal disease.129

The US Public Health Service Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and other experts provide recommendations for pneumococcal vaccination and use of specific vaccine preparations based on a patient's age and whether the patient has underlying medical conditions that put them at increased risk for pneumococcal disease.199,214

Recommendations in pediatric patients:ACIP and other experts recommend that all infants 2 through 23 months of age receive routine primary vaccination with PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®).199,214 PCV13 or PCV15 is also recommended for catch-up vaccination in healthy children 2 through 4 years of age who are unvaccinated or received an incomplete pneumococcal conjugate vaccine series (with either PCV13 or PCV15).214 Additionally, PCV13 or PCV15 is recommended in children and adolescents 2-18 years of age who have certain underlying medical conditions that increase their risk for pneumococcal disease.100,199,211,214 PPSV23 is only recommended in children and adolescents 2-18 years of age with risk conditions, and should be administered after completing all recommended doses of the pneumococcal conjugate vaccine series.211,214

ACIP, AAP, and other experts state that PCV13 and PCV15 are the preferred pneumococcal vaccines for primary vaccination in infants 2-23 months of age and catch-up vaccination in healthy children 2 through 4 years of age.211,214 However, because PPSV23 (Pneumovax^® 23) contains 11 and 9 additional antigens not contained in PCV13 (Prevnar 13^®) and PCV15 (Vaxneuvance^®), respectively, use of PPSV23 in addition to either PCV13 or PCV15 provides benefits in terms of immunity against a broader range of serotypes.203,205,210,211 Therefore, sequential use of one of the recommended conjugated pneumococcal vaccines and PPSV23 in children and adolescents 2-18 years of age with certain medical conditions or risk factors is recommended.100,156,184,199,203,205,211

Recommendations in adults ≥65 years of age: ACIP and other experts recommend pneumococcal vaccination with PCV15 (Vaxneuvance^®) or PCV20 (Prevnar 20^®) in all adults 65 years of age or older who have not previously received any pneumococcal vaccine.209,212,213,214 If PCV15 (Vaxneuvance^®) is used, then a dose of PPSV23 (Pneumovax^® 23) should be given ≥1 year after the PCV15 (Vaxneuvance^®) dose is given.212,213,214 These experts also provide guidance in adults who already received a previous dose of PCV13 (Prevnar 13^®) and/or PPSV23.212,213,214 (See Recommended Immunization for Pneumococcal Disease under Uses.)

Recommendations in adults 19-64 years of age with certain risk factors or immunocompromising conditions: ACIP and other experts recommend pneumococcal vaccination with PCV15 (Vaxneuvance^®) or PCV20 (Prevnar 20^®) in adults 19-64 years of age who have certain risk factors or immunocompromising conditions.212,213,214 If PCV15 (Vaxneuvance^®) is used in these adults, then a dose of PPSV23 (Pneumovax^® 23) should be administered at least 8 weeks after the PCV15 dose is given; if PCV20 (Prevnar 20^®) is used in these adults, then a dose of PPSV23 is not indicated.209,214 These experts also provide guidance in adults who already received a previous dose of PCV13 (Prevnar 13^®) and/or PPSV23.209,214 (See Recommended Immunization for Pneumococcal Disease under Uses.)

Recommendations in adults 19-64 years of age with a cochlear implant or cerebrospinal fluid leak: ACIP and other experts recommend pneumococcal vaccination with PCV15 (Vaxneuvance^®) or PCV20 (Prevnar 20^®) in adults 19-64 years of age who have a cochlear implant or CSF leak.209,212,213,214 If PCV15 (Vaxneuvance^®) is used in these adults, then a dose of PPSV23 (Pneumovax^® 23) should be administered at least 8 weeks after the PCV15 dose is given; if PCV20 (Prevnar 20^®) is used in these adults, then a dose of PPSV23 is not indicated.209,214 These experts also provide guidance in adults who have a cochlear implant or CSF leak and who already received a previous dose of PCV13 (Prevnar 13^®) and/or PPSV23.209,214 (See Recommended Immunization for Pneumococcal Disease under Uses.)

Clinical Experience

PCV13 (Prevnar 13®)

In a US noninferiority study that evaluated the response to PCV13 (Prevnar 13^®) and PCV7 (Prevnar^®; no longer commercially available in the US) in healthy infants who received a 4-dose vaccination series (3 primary doses given at 2, 4, and 6 months of age and a fourth dose given at 12-15 months of age), responses to 10 of the 13 serotypes in PCV13 (Prevnar 13^®) measured 1 month after the third dose met the primary endpoint criterion.181,184 Approximately 87-98% of the infants had anticapsular IgG antibody concentrations of at least 0.35 mcg/mL for 12 of the 13 pneumococcal serotypes in the vaccine;181,184 only 63.5% of the infants achieved an antibody concentration of at least 0.35 mcg/mL against serotype 3.181,184 When determined 1 month after the third dose of PCV13 (Prevnar 13^®), functional antibody responses as measured by anti-pneumococcal opsonophagocytic activity (OPA) were reported for all 13 vaccine serotypes.181 These immunologic parameters generally indicated that PCV13 (Prevnar 13^®) induced antibody concentrations comparable to those induced by PCV7 (Prevnar^®) and protective against invasive pneumococcal disease.181,184 When the immune response 1 month after the fourth dose of PCV13 (Prevnar 13^®) was compared with the response 1 month after the third primary dose, geometric mean concentrations (GMCs) of anticapsular IgG antibody were higher for all 13 serotypes and geometric mean titers (GMTs) of functional antibody were greater for all 13 serotypes.181,184 After the fourth dose of vaccine, antibody responses to 12 of the 13 serotypes met the primary endpoint criterion; the response to serotype 3 did not meet this criterion.181,184

The response to a single dose of PCV13 (Prevnar 13^®) in children 5 through 17 years of age was evaluated in a US open-label study.181 In children 5 through 9 years of age who had previously received at least 1 dose of PCV7 (Prevnar^®), serotype-specific IgG concentrations measured 1 month after the PCV13 (Prevnar 13^®) dose were noninferior to the response reported in toddlers 1 month after a fourth dose of pneumococcal vaccine (after the fourth dose of PCV7 (Prevnar^®) for the 7 common serotypes and after the fourth dose of PCV13 (Prevnar 13^®) for the 6 additional serotypes).181 In children 10 through 17 years of age who had not previously received any pneumococcal vaccine, OPA GMTs 1 month after the PCV13 (Prevnar 13^®) dose were noninferior to functional OPA antibody responses reported in children 5 through 9 years of age for 12 of 13 serotypes, but not for serotype 3.181

Immunogenicity of PCV13 (Prevnar 13^®) in adults has been evaluated in various studies that included healthy adults and immunocompetent adults with stable underlying medical conditions or behaviors known to increase the risk of serious pneumococcal pneumonia and invasive pneumococcal disease (e.g., chronic cardiovascular disease, chronic pulmonary disease, renal disorders, diabetes mellitus, chronic liver disease, alcoholism, smoking).181 In 2 noninferiority trials, the immune response to a single dose of PCV13 (Prevnar 13^®) was compared with the immune response to PPSV23 (Pneumovax^® 23) in previously unvaccinated adults 50 through 64 years of age or in adults 70 years of age or older who had received at least 1 dose of PPSV23 (Pneumovax^® 23) at least 5 years previously. 181 PCV13 (Prevnar 13^®) elicited functional OPA antibody responses in adults 60 through 64 years of age that were noninferior to those induced by PPSV23 (Pneumovax^® 23) for the 12 serotypes in common to both vaccines; PCV13 also elicited functional OPA antibody GMTs in adults 50 through 59 years of age that were noninferior to the corresponding functional OPA antibody GMTs elicited by PCV13 (Prevnar 13^®) in adults 60 through 64 years of age.181 In adults 70 years of age who had received PPSV23 (Pneumovax^® 23) at least 5 years previously, vaccination with PCV13 (Prevnar 13^®) elicited immune responses that were noninferior to those elicited by revaccination with PPSV23 (Pneumovax^® 23).181

PCV15 (Vaxneuvance®)

Efficacy of PCV15 (Vaxneuvance^®) was evaluated in phase 2/3 randomized controlled trials comparing the immunogenicity of PCV15 with PCV13 in healthy infants and children, individuals 5-17 years of age with sickle cell disease, and individuals 6-17 years of age with HIV infection.211 The outcomes compared 30 days after one or more doses of PCV were serotype-specific immunoglobulin G (IgG) geometric mean concentration (GMC), proportion of participants meeting the serotype-specific IgG value of ≥0.35 µg/mL (response rate), and OPA GMTs in a subset of the study population.211 PCV15 met criteria for noninferiority to PCV13 for the 13 shared serotypes, except for serotype 6A GMC ratio after the third dose.211 PCV15 elicited statistically significantly higher immune response for serotype 3 than for PCV13, and PCV15 also met the noninferiority criteria compared with PCV13 for the two unique serotypes 22F and 33F.211 Safety of PCV15 was assessed in seven randomized controlled trials that included 4,778 individuals 6 weeks-17 years of age who received at least one dose of PCV15; four of 4,540 children who received PCV15 developed serious adverse events that were considered to be vaccine-related.211

Immunogenicity and safety of PCV15 (Vaxneuvance^®) were evaluated in phase 2/3 randomized controlled trials in healthy adults ≥50 years of age, adults 18-49 years of age who are Native American (a population with higher rates of invasive pneumococcal disease than the general US population) or have ≥1 risk condition for pneumococcal disease, and adults ≥18 years of age with HIV infection.209 Serotype-specific functional antibody responses were measured 1 month after vaccination using an OPA assay.209 In one phase 3 study among adults ≥50 years of age, PCV15 met the noninferiority criteria compared with PCV13 for the 13 shared serotypes and had statistically significantly greater response for shared serotype 3 and PCV15-unique serotypes 22F and 33F.209 Safety of PCV15 was assessed in seven randomized controlled trials that included 5,630 participants ≥18 years of age who received 1 dose of PCV15.209 The rates of serious adverse events within 6 months of vaccination were 2.5% among PCV15 recipients; however, no serious adverse events or deaths were considered to be related to the study vaccines.209

PCV20 (Prevnar 20®)

Immunogenicity and safety of PCV20 compared with PCV13 and with PPSV23 for the seven additional serotypes included in PCV20 were evaluated in a phase 2 study in adults 60-64 years of age and in two phase 3 randomized controlled studies in adults ≥18 years of age.209 The PCV20 recipients elicited responses that met noninferiority criteria for all 13 serotypes in a phase 3 trial in adults ≥60 years of age compared to PCV13 recipients; however, PCV20 recipients appeared to have lower GMTs and included a lower percentage of seroresponders to 12-13 of the 13 PCV13-shared serotypes.209 Compared with PPSV23 recipients, PCV20 recipients had numerically higher GMTs and a higher percentage of seroresponders to 6 of 7 (excluding serotype 8) shared non-PCV13 serotypes and noninferiority criteria were met for those 6 serotypes.209 Safety of PCV20 was assessed in 6 clinical studies that included a total of 4,552 participants in immunocompetent adults ≥18 years of age.209 Participants included those who were naive to pneumococcal vaccination and those who had previously received pneumococcal vaccination, and no serious adverse effects or deaths were found to be related to study vaccines.209

PPSV23 (Pneumovax® 23)

A retrospective cohort analysis study based on the CDC pneumococcal surveillance system evaluated protective effectiveness against invasive infections caused by serotypes included in PPSV23.129 The analysis showed 57% effectiveness in individuals ≥6 years of age, 65 to 84% effectiveness among specific patient groups (e.g., persons with diabetes mellitus, coronary vascular disease, congestive heart failure, chronic pulmonary disease, and anatomic asplenia) and 75% effectiveness in immunocompetent individuals ≥65 years of age.129

Recommended Immunization for Pneumococcal Disease

Infants 2 through 23 Months of Age

Infants 2 through 23 months of age are at increased risk for invasive pneumococcal disease.184,199 Therefore, ACIP, AAP, and other experts recommend that all infants 2 through 23 months of age (minimum age 6 weeks) receive routine primary immunization against pneumococcal disease using PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®).100,199,211 For routine childhood immunization initiated in early infancy, ACIP, AAP, and other experts recommend a 4-dose regimen of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) with doses given at 2, 4, 6, and 12 through 15 months of age.100,199,211

All infants 2 through 23 months of age who are unvaccinated or incompletely vaccinated against pneumococcal disease should receive catch-up vaccination using the age-appropriate number of doses of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®).100,199,211 ACIP recommends that if pneumococcal conjugate vaccine is initiated at 7-11 months of age, 3 doses of either PCV13 or PCV15 are recommended; the first 2 doses should be given with an interval of ≥4 weeks between the doses and the third dose should be administered at 12-15 months of age with an interval of ≥8 weeks after the second dose.211 ACIP also recommends that if pneumococcal conjugate vaccine is initiated at 12-23 months of age, 2 doses (either PCV13 or PCV15) are recommended with an interval of ≥8 weeks between doses.211

Healthy Children 2 through 5 Years of Age Catch-up Vaccination

ACIP and AAP recommend a single dose of pneumococcal conjugate vaccine (either PCV13 or PCV15) in unvaccinated healthy children 24-59 months of age.199,211 No further doses are needed for healthy children if the first vaccine dose was administered at 24 months of age or older.199,211 Routine use of PCV13 or PCV15 is not recommended in healthy children ≥5 years of age who have not previously received a dose of pneumococcal conjugate vaccine.211

For healthy children 24-59 months of age with an incomplete pneumococcal vaccination schedule (either PCV13 or PCV15) at 24 months of age, then one additional dose of either PCV13 or PCV15 is recommended.199,211,214

Children 2 through 5 Years of Age at Increased Risk for Pneumococcal Disease

ACIP, AAP, and other experts recommend 2 doses of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) given ≥8 weeks apart in all previously unvaccinated children 2 through 5 years of age who are at increased risk for pneumococcal disease because of certain medical conditions or risk factors such as functional or anatomic asplenia (including sickle cell disease or other hemoglobinopathies, congenital or acquired asplenia), immunocompromising medical conditions (congenital or acquired immunodeficiency, HIV infection, chronic renal failure, nephrotic syndrome, malignant neoplasms, leukemia, lymphoma, Hodgkin's disease, solid organ transplantation), or certain other medical conditions (chronic heart disease [especially cyanotic congenital heart disease and cardiac failure], diseases and conditions treated with immunosuppressive drugs or radiation therapy, chronic lung disease [including asthma if treated with high-dose oral corticosteroid therapy], diabetes mellitus, CSF leaks, or cochlear implants).199,211,214

For children 2 through 5 years of age who have an incomplete series of pneumococcal vaccination, ACIP recommends 2 additional doses of a pneumococcal conjugate vaccine (either PCV13 or PCV15) in children 24-71 months of age with any risk conditions who have received any incomplete schedule of <3 pneumococcal conjugate vaccine doses before 24 months of age.199,211,214 Additionally, a single additional dose of pneumococcal conjugate vaccine, either PCV13 or PCV15, is recommended in children 24-71 months of age with any risk conditions who have received 3 doses of pneumococcal conjugate vaccine before 12 months of age, but did not receive a fourth booster dose.211,214 The minimum interval between pneumococcal conjugate vaccine doses is 8 weeks.211

ACIP, AAP, and other experts also recommend PPSV23 (Pneumovax^® 23) in children ≥2 years of age who have risk factors for pneumococcal disease.100,199,211 Children ≥2 years of age with any risk conditions should receive a single dose of PPSV23 after completing all recommended pneumococcal conjugate vaccine doses (either PCV13 or PCV15).199,211 Pneumococcal conjugate vaccines and PPSV23 should not be administered during the same visit; the PPSV23 dose should be administered ≥8 weeks after the most recent pneumococcal conjugate vaccine dose.211 Children who have received PPSV23 but have not yet completed their recommended pneumococcal conjugate vaccine doses should receive the pneumococcal conjugate vaccine ≥8 weeks after the PPSV23 dose.211 ACIP also recommends that children ≥2 years of age who have an immunocompromising condition should also receive a second dose of PPSV23 ≥5 years after the first PPSV23 dose.211

Children and Adolescents 6 through 18 Years of Age at Increased Risk for Pneumococcal Disease

ACIP, AAP, and other experts recommend PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) in children and adolescents 6 through 18 years who are at increased risk for pneumococcal disease because of certain medical conditions or risk factors such as functional or anatomic asplenia (including sickle cell disease or other hemoglobinopathies, congenital or acquired asplenia), chronic heart disease (especially cyanotic congenital heart disease and cardiac failure), chronic lung disease (including asthma if treated with prolonged high-dose oral corticosteroids), or diabetes mellitus, diseases and conditions treated with immunosuppressive drugs or radiation therapy, immunocompromising medical conditions (congenital or acquired immunodeficiency, HIV infection, chronic renal failure, nephrotic syndrome, malignant neoplasms, leukemia, lymphoma, Hodgkin's disease, generalized malignancy, solid organ transplantation, multiple myeloma), or certain other medical conditions (CSF leaks, cochlear implants).199,211

Children and adolescents 6 through 18 years of age with these medical conditions who have not previously received PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) should receive a single dose of the vaccine.199,211 The dose of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) is indicated in these children and adolescents even if they were vaccinated with the previously available 7-valent vaccine (PCV7; Prevnar^®).211

ACIP, AAP, and other experts also recommend PPSV23 (Pneumovax^® 23) in children and adolescents 2 through 18 years of age who have risk factors for pneumococcal disease.199 Children and adolescents 2 through 18 years of age with these medical conditions who have not previously received PPSV23 (Pneumovax^® 23) should receive a single dose of the vaccine.199 In addition, ACIP and other experts recommend that those children 2 through 18 years of age with immunocompromising conditions receive revaccination with a second dose of PPSV23 ≥5 years after the first dose.199,211

Adults 19 Years of Age or Older at Increased Risk for Pneumococcal Disease Because of Certain Medical Conditions or other Risk Factors

ACIP and other experts recommend PCV15 (Vaxneuvance^®) or PCV20 (Prevnar 20^®) in adults 19 years of age or older with certain underlying medical conditions or other risk factors such as alcoholism, functional or anatomic asplenia (including sickle cell disease or other hemoglobinopathies, congenital or acquired asplenia, splenic dysfunction, splenectomy), immunocompromising medical conditions (congenital or acquired immunodeficiency, HIV infection, chronic renal failure, nephrotic syndrome, leukemia, lymphoma, Hodgkin's disease, generalized malignancy, solid organ transplantation, multiple myeloma), iatrogenic immunosuppression (including long-term systemic corticosteroid therapy or radiation therapy), chronic heart disease, chronic liver disease, chronic lung disease, cigarette smoking, diabetes mellitus, or other medical conditions (CSF leaks, cochlear implants).206,209,212,213,214 Adults with these medical conditions who have not previously received a pneumococcal vaccine or have unknown vaccination status should be vaccinated according to the current recommendations.209,212,213,214

If PCV15 (Vaxneuvance^®) is given in adults 19 years of age or older who are at increased risk for pneumococcal disease because of certain medical conditions or other risk factors, then a dose of PPSV23 (Pneumovax^® 23) should be administered at least 8 weeks later.212,213 To minimize the risk of invasive pneumococcal disease caused by serotypes unique to PPSV23 in vulnerable groups such as those with immunocompromising conditions, cochlear implant, or CSF leak, the minimum of 8 weeks can be considered as the recommended interval between administration of PCV15 and PPSV23 in such patients.209,212,213,214 If PCV20 (Prevnar 20^®) is used, then no additional pneumococcal vaccination is necessary.209,212,214 If PPSV23 (Pneumovax^® 23) is given first or if PPSV23 is given, but not any pneumococcal conjugate vaccine, then either PCV15 (Vaxneuvance^®) or PCV20 (Prevnar 20^®) should be administered at least a year later.209,212,213,214

Adults with increased risk for pneumococcal disease who previously only received PCV13 (Prevnar 13^®) should receive either one dose of PCV20 (Prevnar 20^®) at least a year later or alternatively, a dose of PPSV23 (Pneumovax^® 23) at least 8 weeks after the dose of PCV13.212,213,214 Adults with immunocompromising conditions receiving PPSV23 should then receive 2 additional doses of PPSV23 (Pneumovax^® 23) - one at ≥5 years after the first dose of PPSV23 and another at ≥65 years of age.212,214 Patients with other risk factors (alcoholism, chronic heart disease including congestive heart failure and cardiomyopathies, chronic liver disease, chronic lung disease including chronic obstructive pulmonary disease, emphysema, asthma, cigarette smoking, diabetes mellitus) will require only a second dose of PPSV23 (Pneumovax^® 23) at ≥65 years of age at least 5 years after the first PPSV23 dose.212,214

Adults with an immunocompromising condition who received a previous dose of PCV13 (Prevnar 13^®) and a previous dose of PPSV23 (Pneumovax^® 23) may receive a dose of PCV20 (Prevnar 20^®) or PPSV23 (Pneumovax^® 23) at least 5 years later; vaccine recommendations for patients in this population should be reviewed again when the patient turns 65 years of age.212,213,214 Adults with a cochlear implant or CSF leak who received a previous dose of PCV13 (Prevnar 13^®) and a previous dose of PPSV23 (Pneumovax^® 23) may receive a dose of PCV20 (Prevnar 20^®) at least 5 years after the last PPSV23 dose or at least 1 year after the last PCV13 dose; vaccine recommendations for patients in this population should be reviewed again when the patient turns 65 years of age.212,213,214 Adults with immunocompromising conditions who previously received PCV13 (Prevnar 13^®) and 2 doses of PPSV23 (Pneumovax^® 23) before 65 years of age can also receive a dose of PCV20 (Prevnar 20^®) at least 5 years after their last pneumococcal vaccine dose.212 Pneumococcal vaccine recommendations for patients in this population should be reviewed when the patient turns 65 years of age.212,213

Healthy Adults 19 through 64 Years of Age

Although PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), and PCV20 (Prevnar 20^®) are labeled by FDA for prevention of pneumonia and invasive pneumococcal disease in adults as young as 18 years of age,181,207,208 and PPSV23 (Pneumovax^® 23) is labeled by FDA for prevention of pneumococcal disease in adults as young as 50 years of age,129 ACIP and other experts do not recommend routine vaccination in healthy adults 19 through 64 years of age who do not have medical conditions that increase the risk for pneumococcal disease.209,210,212,213

Adults 65 Years of Age or Older

ACIP and other experts recommend routine vaccination with a single dose of PCV15 (Vaxneuvance^®) or PCV20 (Prevnar 20^®) in all adults ≥65 years of age who have never received a pneumococcal vaccine or have unknown vaccination status.212 If PCV15 (Vaxneuvance^®) is given, then PPSV23 should be administered at least a year later to complete the series.209,212,213 If PCV20 (Prevnar 20^®) is used, then no additional pneumococcal vaccination is necessary.209,212

In patients who previously received PPSV23 (Pneumovax^® 23), either PCV15 (Vaxneuvance^®) or PCV20 (Prevnar 20^®) should be given at least a year later.209,212,213

Adults ≥65 years of age who previously received only PCV13 (Prevnar 13^®) can receive PSV20 (Prevnar 20^®) or PPSV23 (Pneumovax^® 23) vaccination at least a year later to complete the series.212 Adults who received a previous dose of PCV13 (Prevnar 13^®) and PPSV23 (Pneumovax^® 23) before 65 years of age should receive a dose of PCV20 (Prevnar 20^®) or another dose of PPSV23 at least 5 years later.212,213 Adults who received a previous dose of PCV13 (Prevnar 13^®) at any age and PPSV23 (Pneumovax^® 23) at 65 years of age or older may be given a dose of PCV20 (Prevnar 20^®) at least 5 years after the PPSV23 dose is given based on individual patient assessment.213

HIV-infected Individuals

Because HIV-infected individuals are at high risk for invasive or recurrent pneumococcal infection compared with those who are not infected with HIV, the ACIP, AAP, US Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), HIV Medicine Association of the Infectious Diseases Society of America (IDSA), Pediatric Infectious Diseases Society, and others recommend that all HIV-infected infants and children 2 months of age or older, adolescents, and adults receive vaccination against pneumococcal disease.100,155,156,199,203,205,211,212,213

HIV-infected infants and children 2 months through 23 months of age should receive PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) according to the usual primary and catch-up immunization schedules recommended for infants and children in this age group.100,156,199,211

HIV-infected children 24-71 months of age should receive two doses of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) given ≥8 weeks apart.199,211

HIV-infected children and adolescents 6 through 18 years of age who have not previously received PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) should receive a single dose of the vaccine.156,199,203,211 The dose of PCV vaccines are indicated in these children and adolescents even if they were vaccinated with the previously available 7-valent vaccine (PCV7; Prevnar^®).156,203

HIV-infected adults 19 years of age or older who have not previously received PCV13 (Prevnar 13^®) or have an unknown vaccination status should receive a single dose of PCV15 (Vaxneuvance^®) or PCV20 (Prevnar 20^®).155,209

Additionally, HIV-infected children 2 years of age and older, adolescents, and adults who have not previously received PPSV23 (Pneumovax^® 23) or have an unknown vaccination status should receive the vaccine.155,156,184,199,203,205,211 Adults who received a dose of PCV20 (Prevnar 20^®) do not require vaccination with PPSV23.209

ACIP and other experts state that HIV-infected individuals should be revaccinated with a second dose of PPSV23 (Pneumovax^® 23) at least 5 years after the first dose.155,156 Some experts recommend a third dose of PPSV23 (Pneumovax^® 23) in HIV-infected individuals at 65 years of age or later if they were younger than 65 years of age at the time of the second dose, as long as 5 years have elapsed since the previous dose.155 No more than 3 lifetime doses of PPSV23 (Pneumovax^® 23) are recommended.155

Cochlear Implant Recipients

Because cochlear implant recipients are at substantially increased risk for pneumococcal meningitis, AAP, ACIP, CDC, and other experts recommend that all individuals with cochlear implants receive age-appropriate vaccination against pneumococcal disease.100,184,189,199,203,205,217

Depending on the patient's vaccination history, doses of PCV15 (Vaxneuvance^®), or PCV20 (Prevnar 20^®) and PPSV23 (Pneumovax^® 23) may be indicated.100,184,189,217 When cochlear implant placement is being planned for an individual who is unvaccinated or incompletely vaccinated against pneumococcal disease, ACIP, CDC, and AAP recommend that age-appropriate vaccination be completed at least 2 weeks prior to surgery.184,189,211,217

Internationally Adopted Infants and Children

Children adopted from other countries whose immune status is uncertain should be vaccinated according to the US recommended Childhood and Adolescent Immunization Schedules.215 Consider that immunization schedules of other countries may differ from US schedules (e.g., different recommended vaccines, recommended ages of administration, and/or number and timing of vaccine doses).215

When the immune status of an internationally adopted child is uncertain, ACIP recommends that health-care providers either repeat vaccination and/or use selective serologic testing to determine the need for immunizations (helps avoid unnecessary injections).215 Although pneumococcal vaccine is recommended in many countries, the fact that the vaccine may not be routinely administered should be considered.215 ACIP recommends that PCV13 (Prevnar 13^®) or PVC15 (Vaxneuvance^®) and PPSV23 (Pneumovax^® 23) be administered to internationally adopted children as age-appropriate and indicated by the presence of underlying medical conditions that put them at risk for pneumococcal disease.215

Dosage and Administration ⬆ ⬇

[Section Outline]

General
Administration
Dosage
Special Populations

General

Patient Monitoring

Monitor all individuals who receive a pneumococcal vaccine for immediate adverse reactions according to CDC (ACIP) guidelines.215

Dispensing and Administration Precautions

Appropriate medications and supplies for managing immediate allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of pneumococcal vaccines.181,207,208,215
Syncope may occur following administration of parenteral vaccines, especially in adolescents.215 Patients should be seated or lying down during vaccination.215 Observe vaccine recipients (especially adolescents) for 15 minutes after vaccination.215 If syncope develops, observe patients until symptoms resolve.215

Administration

Pneumococcal 13-valent conjugate vaccine (PCV13; Prevnar 13^®), pneumococcal 15-valent conjugate vaccine (PCV15; Vaxneuvance^®),207 and pneumococcal 20-valent conjugate vaccine (PCV20; Prevnar 20^®)208 are administered only by IM injection.181

Pneumococcal vaccine, polyvalent (pneumococcal 23-valent vaccine; PPSV23; Pneumovax^® 23) is administered only by IM or subcutaneous injection.129

PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), PCV20 (Prevnar 20^®), and PPSV23 (Pneumovax^® 23) should not be diluted or mixed with any other vaccine or solution.129,181,208,215

PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) should not be administered concomitantly with PPSV23 (Pneumovax^® 23).100,184,199,213 When these vaccines are indicated, PPSV23 (Pneumovax^® 23) should be administered sequentially after the recommended age-appropriate regimen of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®), if possible.100,184,199,203,204,205,206 However, PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), PCV20 (Prevnar 20^®), or PPSV23 (Pneumovax^® 23) may be given simultaneously with other age-appropriate vaccines during the same health-care visit.105,184,207,208 When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given with a different syringe and at different injection sites, and injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.105,215

PCV13 (Prevnar 13^®) should be stored at 2-8°C;181 after shipping, the vaccine may arrive at temperatures ranging from 2-25°C.181 PCV13 (Prevnar 13^®) should not be frozen.215,181 Since the vaccine contains an aluminum adjuvant,215,181 exposure to freezing temperatures causes irreversible loss of vaccine potency.215

PCV15 (Vaxneuvance^®) should be stored at 2-8°C and should not be frozen.207

PCV20 (Prevnar 20^®) should be stored at 2-8°C;208 after shipping, the vaccine may arrive at temperatures ranging from 2-25°C.208 PCV20 (Prevnar 20^®) should not be frozen.208 Store syringes horizontally in the refrigerator to minimize the resuspension time.208

PPSV23 (Pneumovax^® 23) should be stored at 2-8°C.129

IM Administration

Depending on patient age, IM injections should be made into the anterolateral muscles of the thigh or deltoid muscle of the arm.215 In infants and children 6 weeks to 2 years of age, IM injections should preferably be made into the anterolateral thigh;215 alternatively, the deltoid muscle can be used in those 1 through 2 years of age if muscle mass is adequate.215 In adults, adolescents, and children 3 years of age or older, IM injections should preferably be made into the deltoid muscle.215

To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual's age and body mass, thickness of adipose tissue and muscle at the injection site, and injection technique.215

IM injections should not be made into the gluteal area or any area where there may be a major nerve trunk.181,215 If the gluteal muscle is chosen for infants younger than 12 months of age because of special circumstances (e.g., physical obstruction of other sites), it is essential that the clinician identify anatomic landmarks prior to injection.215

Because apnea has been reported following IM vaccination in some infants born prematurely, decisions regarding use of IM vaccines in such infants should be based on consideration of the individual infant's medical status and potential benefits and possible risks of vaccination.181,207

Subcutaneous Administration

Subcutaneous injections should be made at a 45° angle using a 5/8 inch, 23- to 25-gauge needle.215

Subcutaneous injections should be made into the upper-outer triceps area or anterolateral thigh for infants <12 months of age.215 In adults, adolescents, and children ≥12 months of age, subcutaneous injections should be made into the upper-outer triceps area.215

Specific Vaccine Formulations

Pneumococcal 13-valent Conjugate Vaccine (PCV13; Prevnar 13®)

PCV13 (Prevnar 13^®) is administered only by IM injection.181 The vaccine should not be administered subcutaneously or intradermally.215

PCV13 (Prevnar 13^®) is commercially available in single-dose prefilled syringes.181 After attaching a sterile needle, the entire contents of the prefilled syringe should be administered IM.181

PCV13 (Prevnar 13^®) must be shaken vigorously immediately prior to administration to obtain a uniform, white suspension.181 The vaccine should be discarded if it cannot be resuspended or if particulate matter or discoloration are present.181

Pneumococcal 15-valent Conjugate Vaccine (PCV15; Vaxneuvance®)

PCV15 (Vaxneuvance^®) is administered only by IM injection.207 The vaccine should not be administered subcutaneously or intradermally.215

PCV15 (Vaxneuvance^®) is commercially available in single-dose prefilled syringes.207 After attaching a sterile needle, the entire contents of the prefilled syringe should be administered IM.207

PCV15 (Vaxneuvance^®) must be shaken vigorously immediately prior to administration to obtain a uniform, opalescent suspension.207 The vaccine should be discarded if it cannot be resuspended or if particulate matter or discoloration is present.207

Pneumococcal 20-valent Conjugate Vaccine (PCV20; Prevnar 20®)

PCV20 (Prevnar 20^®) is administered only by IM injection.208 The vaccine should not be administered subcutaneously or intradermally.215

PCV20 (Prevnar 20^®) is commercially available in single-dose prefilled syringes.208 After attaching a sterile needle, the entire contents of the prefilled syringe should be administered IM.208

PCV20 (Prevnar 20^®) must be shaken vigorously immediately prior to administration to obtain a uniform, white suspension.208 The vaccine should be discarded if it cannot be resuspended or if particulate matter or discoloration is present.208

Pneumococcal 23-valent Vaccine (PPSV23; Pneumovax® 23)

PPSV23 (Pneumovax^® 23) is administered by IM or, alternatively, by subcutaneous injection.129 The vaccine should not be administered IV or intradermally.129

PPSV23 (Pneumovax^® 23) is commercially available in single-dose prefilled syringes and single-dose vials.129 If a single-dose prefilled syringe is used, a sterile needle should be attached to the syringe according to the manufacturer's instructions and the entire contents of the prefilled syringe administered IM.129 If a vial is used, withdraw 0.5 mL of the vaccine from the vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.129

PPSV23 (Pneumovax^® 23) should be inspected visually for particulate matter and discoloration prior to administration.129 The vaccine should be a clear colorless solution and should not be administered if it contains particulates or appears discolored.129

Dosage

The dosage schedule (i.e., number of doses) and specific pneumococcal vaccine administered vary depending on age, immunization status, and presence of medical conditions that increase the risk of pneumococcal disease.100,105,129,181,184 The age-appropriate recommendations for the specific preparation used should be followed. 129,181,207,208

Medically stable preterm infants (i.e., gestational age less than 37 weeks), regardless of birthweight, should be vaccinated at the usual chronologic age using the usual dosage and dosage schedules.215

Interruptions resulting in an interval between doses longer than recommended should not interfere with the final immunity achieved; there is no need to administer additional doses or start the vaccination series over.215

Each IM dose of PCV13 (Prevnar 13^®) in infants and children 6 weeks of age or older, adolescents, and adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe.181

Each IM dose of PCV15 (Vaxneuvance^®) in infants and children 6 weeks of age or older, adolescents, and adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe.207

Each IM dose of PCV20 (Prevnar 20^®) in adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe.208

Each IM or subcutaneous dose of PPSV23 (Pneumovax^® 23) in children 2 years of age or older, adolescents, and adults consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe or 0.5 mL from a single-dose vial.129

Infants 2-23 Months of Age

PCV13 (Prevnar 13®) or PCV15 (Vaxneuvance®)

For routine primary immunization initiated in early infancy, PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) is given in a series of 4 doses.100,181,184,199,207,211 The US Public Health Service Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and other experts recommend that PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) be given at 2, 4, 6, and 12 through 15 months of age.100,181,184,199,207,211 Although the first dose of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) usually is given at 2 months of age, the first dose can be given as early as 6 weeks of age.100,181,184,199,207,211 The first 3 doses of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) should be given at approximately 4- to 8-week intervals and the fourth dose should be given at least 8 weeks (2 months) after the third dose.100,181,184,199,207,211

For catch-up vaccination in infants 7 through 23 months of age who did not receive PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) at the usually recommended time in early infancy, the recommended number of doses of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) varies depending on the age of the child when the first dose was given.100,181,184,199,207,211 Infants who are 7 through 11 months of age when they receive the first dose of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) should receive 2 doses given at least 4 weeks apart and a third dose given after 12 months of age and at least 8 weeks (2 months) after the second dose;181,199,207,211 a fourth dose is not necessary in healthy infants unless all previous doses were given before 12 months of age.199 Infants who are 12 through 23 months of age when they receive the first dose of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) should receive 2 doses given at least 8 weeks (2 months) apart;181,199,207,211 a third dose is not necessary if the second dose was given at 24 months of age or older.199,211

Healthy Children 2-5 Years of Age

PCV13 (Prevnar 13®) or PCV15 (Vaxneuvance®)

For catch-up vaccination in otherwise healthy children 2 through 5 years of age who are unvaccinated and have not received any doses of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®), ACIP, AAP, and other experts recommend a single dose of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®).100,181,184,199,207,211 Additional doses are not necessary in healthy children if the PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) dose is given at 2 years of age or older.199,207,211

For catch-up vaccination in otherwise healthy children 2 through 5 years of age who are incompletely vaccinated for their age and have not received the total recommended age-appropriate number of doses of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®), ACIP, AAP, and other experts recommend a single dose of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) given at least 8 weeks after the most recent dose of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®).181,184,199,207,211

Children 2-5 Years of Age at Increased Risk for Pneumococcal Disease

PCV13 (Prevnar 13®) or PCV15 (Vaxneuvance®)

Children 2 through 5 years of age with certain medical conditions that put them at increased risk for pneumococcal disease who previously received fewer than 3 doses of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) should receive 2 doses of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) given at least 8 weeks apart.100,184,199,211 Children 2 through 5 years of age with these medical conditions who previously received a total of 3 doses of PCV given as PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) should receive a single dose of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®).100,184,199,211

PPSV23 (Pneumovax® 23)

Children 2 through 5 years of age with certain medical conditions that put them at increased risk for pneumococcal disease who have not previously received PPSV23 (Pneumovax^® 23) should receive a single dose of the vaccine.100,184,199,211

Sequential Administration

When both PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) and PPSV23 (Pneumovax^® 23) are indicated in a child 2 through 5 years of age at increased risk for pneumococcal disease, PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) should be given first and PPSV23 (Pneumovax^® 23) should be given at least 8 weeks after the most recent dose of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®).199,211

Recipients of hematopoietic stem cell transplants are recommended to receive 3 sequential PCV doses (PCV13 or PCV15) followed by a dose of PPSV23 beginning 3-6 months after the transplant, but for children with graft-versus-host disease, PPSV23 can be replaced with a fourth dose of PCV13 or PCV15.211

Two doses of PPSV23 (Pneumovax^® 23) are indicated in children 2 through 5 years of age with chronic renal failure or nephrotic syndrome, congenital immunodeficiency, asplenia or splenic dysfunction, immunosuppression from diseases, immunosuppressive drugs or radiation therapy, HIV infection, or sickle cell disease and other hemoglobinopathies; the first dose should be given at least 8 weeks after PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) and the second dose given at least 5 years after the previous PPSV23 (Pneumovax^® 23) dose.199,203,205,211

In those who have not previously received PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) but have previously received PPSV23 (Pneumovax^® 23), PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) should be given at least 8 weeks after the most recent dose of PPSV23 (Pneumovax^® 23).199,211

PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) and PPSV23 (Pneumovax^® 23) should not be given concurrently.100,184,199,203,205,211

Children and Adolescents 6-18 Years of Age at Increased Risk for Pneumococcal Disease

PCV13 (Prevnar 13®) or PCV15 (Vaxneuvance®)

Children and adolescents 6 through 18 years of age with certain medical conditions that put them at increased risk for pneumococcal disease who have not previously received PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) should receive a single dose of the vaccine.184,199,203,205,211

PPSV23 (Pneumovax® 23)

Children and adolescents 6 through 18 years of age with certain medical conditions that put them at increased risk for pneumococcal disease who have not previously received PPSV23 (Pneumovax^® 23) should receive a single dose of the vaccine.184,199,203,205,211 In addition, those with functional or anatomic asplenia or immunocompromising conditions should be revaccinated with a second dose of PPSV23 (Pneumovax^® 23) ≥5 years after the first dose.199,203,205,211

Sequential Administration

When both PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) and PPSV23 (Pneumovax^® 23) are indicated in a child or adolescent 6 through 18 years of age at increased risk for pneumococcal disease, PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) should be given first and PPSV23 (Pneumovax^® 23) should be given at least 8 weeks after the most recent dose of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®).199,203,205,211

Recipients of hematopoietic stem cell transplants are recommended to receive 3 sequential pneumococcal conjugate vaccine doses (PCV13 or PCV15) followed by a dose of PPSV23 beginning 3-6 months after the transplant, but for children with graft-versus-host disease, PPSV23 can be replaced with a fourth dose of PCV13 or PCV15.211

Two doses of PPSV23 (Pneumovax^® 23) are indicated in a child or adolescent 6 through 18 years of age with chronic renal failure or nephrotic syndrome, congenital immunodeficiency, asplenia or splenic dysfunction, immunosuppression from diseases, immunosuppressive drugs or radiation therapy, HIV infection, or sickle cell disease and other hemoglobinopathies; the first dose should be given at least 8 weeks after PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) and the second dose given at least 5 years after the previous PPSV23 (Pneumovax^® 23) dose.199,203,205,211

If a child or adolescent 6 through 18 years of age at increased risk for pneumococcal disease has not previously received PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) but has previously received PPSV23 (Pneumovax^® 23), PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) should be given at least 8 weeks after the most recent dose of PPSV23 (Pneumovax^® 23).199,203,205,211

When a second dose of PPSV23 (Pneumovax^® 23) is indicated, it should be given at least 8 weeks after PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) and at least 5 years after the previous PPSV23 (Pneumovax^® 23) dose.199,203,205,211

PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) and PPSV23 (Pneumovax^® 23) should not be given concurrently.100,184,199,203,205,211

Adults 19-64 Years of Age at Increased Risk for Pneumococcal Disease

PCV15 (Vaxneuvance®) or PCV20 (Prevnar 20®

Adults 19-64 years of age with certain medical conditions that put them at increased risk for pneumococcal disease who have not previously received a pneumococcal conjugate vaccine, should receive a single dose of PCV15 (Vaxneuvance^®) or PCV20 (Prevnar 20^®).207,208,212

PPSV23 (Pneumovax® 23)

Adults 19-64 years of age with certain medical conditions that put them at increased risk for pneumococcal disease who have received a dose of PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®), but have not previously received PPSV23 (Pneumovax^® 23) should receive a dose of the PPSV23 vaccine at least 8 weeks later.169,212,214 Additionally, for those adults with immunocompromising conditions or other risk factors that previously received a dose of PCV13 (Prevnar 13^®) and a dose of PPSV23 (Pneumovax^® 23), they should also receive another dose of PPSV23 or PCV20 (Prevnar 20^®) ≥5 years later.169,212,214 Adults 19-64 years of age with certain medical conditions that put them at increased risk for pneumococcal disease who received a dose of PCV20 (Prevnar 20^®) do not need to receive a dose of PPSV23 (Pneumovax^® 23).212

Sequential Administration

When both PCV15 (Vaxneuvance^®) and PPSV23 (Pneumovax^® 23) are indicated in an adult 19-64 years of age at increased risk for pneumococcal disease, PCV15 (Vaxneuvance^®) should be given first and PPSV23 (Pneumovax^® 23) should be given at least 8 weeks later.212,213

If an adult 19-64 years of age at increased risk has previously received only PPSV23 (Pneumovax^® 23), then PCV15 (Vaxneuvance^®) or PCV20 (Prevnar 20^®) should be given at least 1 year after the most recent dose of PPSV23 (Pneumovax^® 23).206,212,213,214

If an adult 19-64 years of age at increased risk due to a CSF leak or cochlear implant has previously received PCV13 (Prevnar 13^®) but has not previously received PPSV23 (Pneumovax^® 23), then PCV20 (Prevnar 20^®) should be given ≥1 year or PPSV23 (Pneumovax^® 23) should be given at least 8 weeks after PCV13 (Prevnar 13^®).206,212,213 If PPSV23 (Pneumovax^® 23) is used, then vaccine recommendations should be reviewed again when the patient turns 65 years of age.212,214

If an adult 19-64 years of age at increased risk due to an immunocompromising condition has previously received PCV13 (Prevnar 13^®) but has not previously received PPSV23 (Pneumovax^® 23), PCV20 (Prevnar 20^®) may be given ≥1 year later or PPSV23 (Pneumovax^® 23) should be given at least 8 weeks after PCV13 (Prevnar 13^®).212,213,214 A second dose of PPSV23 should then be given at least 5 years later.212,213,214 Vaccine recommendations should be reviewed again when the patient turns 65 years of age. 212,213

Adults with immunocompromising conditions who previously received PCV13 (Prevnar 13^®) and 2 doses of PPSV23 (Pneumovax^® 23) can also receive a dose of PCV20 (Prevnar 20^®) ≥5 years after their last pneumococcal vaccine dose.212 Pneumococcal vaccine recommendations for patients in this population should be revisited when the patient turns 65 years of age.212

PCV13 (Prevnar 13^®) and PPSV23 (Pneumovax^® 23) should not be given concurrently.206,212,213

Healthy Adults 19-64 Years of Age

PCV13 (Prevnar 13®)

Although a single 0.5-mL dose of PCV13 (Prevnar 13^®) is labeled by FDA for prevention of pneumonia and invasive pneumococcal disease in adults as young as 18 years of age,181 ACIP and other experts do not recommend routine vaccination in healthy adults 19 through 64 years of age who do not have medical conditions that increase the risk for pneumococcal disease.209,210,212

PCV15 (Vaxneuvance®)

Although a single 0.5-mL dose of PCV15 (Vaxneuvance^®) is labeled by FDA for prevention of pneumonia and invasive pneumococcal disease in adults as young as 18 years of age,207 ACIP and other experts do not recommend routine vaccination in healthy adults 19 through 64 years of age who do not have medical conditions that increase the risk for pneumococcal disease.209,210,212

PCV20 (Prevnar 20®)

Although a single 0.5-mL dose of PCV20 (Prevnar 20^®) is labeled by FDA for prevention of pneumonia and invasive pneumococcal disease in adults as young as 18 years of age,208 ACIP and other experts do not recommend routine vaccination in healthy adults 19 through 64 years of age who do not have medical conditions that increase the risk for pneumococcal disease.209,210,212

PPSV23 (Pneumovax® 23)

Although a single dose of PPSV23 (Pneumovax^® 23) is labeled by FDA for prevention of pneumococcal disease in adults as young as 50 years of age,129 ACIP and other experts do not recommend routine vaccination in healthy adults 19 through 64 years of age who do not have medical conditions that increase the risk for pneumococcal disease.209,210,212

Adults 65 Years of Age or Older

PCV15 (Vaxneuvance®) and PCV20 (Prevnar 20®)

Adults 65 years of age or older who are unvaccinated or have unknown vaccination status should receive a single dose of PCV15 (Vaxneuvance^®) or PCV20 (Prevnar 20^®).207,208,209,212,213

PPSV23 (Pneumovax® 23)

Adults 65 years of age or older who received a dose of PCV15 (Vaxneuvance^®) should also receive a dose of PPSV23 (Pneumovax^® 23).209,212,213 Adults 65 years of age or older who received a dose of PCV20 (Prevnar 20^®) do not need to receive a dose of PPSV23 (Pneumovax^® 23); their pneumococcal vaccination is complete.209,212

Sequential Administration

If PCV15 (Vaxneuvance^®) and PPSV23 (Pneumovax^® 23) are indicated in an adult 65 years of age or older who is unvaccinated or has unknown vaccination status, PCV15 (Vaxneuvance^®) should be given first212 and PPSV23 (Pneumovax^® 23) should be given at least 1 year after the PCV15 (Vaxneuvance^®) dose.209,212

If an adult has not previously received PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) but previously received PPSV23 (Pneumovax^® 23) at less than 65 years of age, a dose of PCV15 (Vaxneuvance^®) or PCV20 (Prevnar 20^®) may be given at least 1 year after the most recent PPSV23 (Pneumovax^® 23) dose.212

If an adult 65 years of age or older previously received PCV13 (Prevnar 13^®) at any age, they should receive a PPSV23 (Pneumovax^® 23) or PCV20 (Prevnar 20^®) dose at least 1 year after the PCV13 (Prevnar 13^®) dose.212,213,214

If an adult 65 years of age or older previously received PCV13 (Prevnar 13^®) at any age and PPSV23 (Pneumovax^® 23) at <65 years of age, they should receive a dose of PPSV23 (Pneumovax^® 23) at least 1 year since the last PCV13 dose and at least 5 years since the last PPSV23 dose or a dose of PCV20 (Prevnar 20^®) at least 5 years later.212,214

PCV15 (Vaxneuvance^®) and PPSV23 (Pneumovax^® 23) should not be given concurrently.209,212

Special Populations

Hepatic Impairment

No specific dosage recommendations.129,181,207,208

Renal Impairment

No specific dosage recommendations.129,181,207,208

Geriatric Patients

No specific dosage recommendations.129,181,207,208

Cautions ⬆ ⬇

[Section Outline]

Contraindications
Warnings/Precautions
Common Adverse Effects

Contraindications

PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), and PCV20 (Prevnar 20^®) are contraindicated in individuals who have had a severe allergic reaction (e.g., anaphylaxis) to any ingredient in the formulation or to any vaccine containing diphtheria toxoid.181,207,208
PPSV23 (Pneumovax^® 23) is contraindicated in individuals with a history of anaphylactic/anaphylactoid reactions or severe allergic reaction to any ingredient in the formulation.129

Warnings/Precautions

Sensitivity Reactions

Allergic reactions

Prior to administration of PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), PCV20 (Prevnar 20^®), or PPSV23 (Pneumovax^® 23), all known precautions should be taken to prevent adverse reactions, including a review of the patient's history with respect to health status, possible sensitivity to the vaccine, and similar vaccines.184

Allergic reactions, including anaphylactic/anaphylactoid reactions,129,181,207,208 rash,129,181,207 urticaria,129,181,207,208 bronchospasm,181,208 erythema multiforme,129,181 and angioedema,129,181 have been reported with pneumococcal vaccines. Epinephrine and other appropriate agents and equipment should be available for immediate treatment if an anaphylactic or other serious allergic reaction occurs following vaccination.181,207,208

The patient and/or the patient's parent or guardian should be informed of the benefits and risks of immunization with PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), PCV20 (Prevnar 20^®), or PPSV23 (Pneumovax^® 23).129,167,168,181,207 Patients and/or the patient's parent or guardian also should be instructed to report any severe or unusual adverse reactions to their health-care provider.129,181,207,208 Clinicians or individuals can report any adverse reactions that occur following vaccination to VAERS at 800-822-7967 or [Web].129,181,207,208

Other Warnings and Precautions

Individuals with Altered Immunocompetence

Like other inactivated vaccines, PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), PCV20 (Prevnar 20^®), and PPSV23 (Pneumovax^® 23) may be administered to individuals immunosuppressed as a result of disease or immunosuppressive therapy; however, immune responses to the vaccines may be diminished or suboptimal in these individuals.129,181,207,208

If possible, pneumococcal vaccines should be administered at least 2 weeks prior to initiation of immunosuppressive therapy or deferred until at least 3 months after immunosuppressive therapy is discontinued or at least 6 months following therapy with anti-B cell agents (e.g., rituximab).215

Since antibody response may be impaired after splenectomy, the US Public Health Service Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) recommend that vaccination with pneumococcal vaccines be completed at least 2 weeks prior to elective splenectomy, if possible.105,184,215

Apnea in Premature Infants

Apnea has been observed following intramuscular vaccination with PCV13 (Prevnar 13^®) and PCV15 (Vaxneuvance^®) in some infants that were born prematurely.181,207 Consider the individual infant's medical status and the potential benefits and possible risks of vaccination when deciding when to administer an intramuscular vaccine.181,207

Concomitant Illnesses

The decision to administer or delay vaccination in an individual with a current or recent acute illness depends on the severity of symptoms and etiology of the illness.129,215

ACIP, AAP, and other experts state that minor acute illness, such as mild diarrhea or mild upper respiratory infection (with or without fever), usually does not preclude vaccination.105,215 However, vaccination of individuals with moderate or severe acute illness (with or without fever) generally should be deferred until they have recovered from the acute phase of the illness.105,215 This precaution avoids superimposing adverse effects of the vaccine on the underlying illness or mistakenly concluding that a manifestation of the underlying illness resulted from vaccination.215

The manufacturer of PPSV23 (Pneumovax^® 23) states that vaccination should be deferred in individuals with moderate or severe acute illness.129

The manufacturer of PPSV23 (Pneumovax^® 23) states that the vaccine should be administered with caution in individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction could pose a substantial risk.129

Limitations of Vaccine Effectiveness

PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), PCV20 (Prevnar 20^®), and PPSV23 (Pneumovax^® 23) may not protect all vaccine recipients against pneumococcal disease.129,181,207,208

Pneumococcal vaccines will not prevent pneumococcal infection caused by Streptococcus pneumoniae serotypes not represented in the vaccines.129,181,207,208

Primary immunization with the usually recommended age-appropriate vaccination regimen before an expected exposure to pneumococcal infection ensures the highest level of protection.100,105,184

The manufacturers of PCV13 (Prevnar 13^®) and PCV15 (Vaxneuvance^®) state that effectiveness of the vaccines have not been established in premature infants,181,207 children with sickle cell disease,181,207 or in individuals with hematopoietic stem cell transplant,181 or HIV infection.181,207

Although ACIP and AAP recommend use of PPSV23 (Pneumovax^® 23) in individuals with CSF leaks,203 the manufacturer of PPSV23 (Pneumovax^® 23) states that the vaccine may not be effective in preventing pneumococcal meningitis in patients who have chronic CSF leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.129

Antigens in PCV13 (Prevnar 13^®) and PCV15 (Vaxneuvance^®) are conjugated to a carrier protein181,207 and conjugated antigens are more immunogenic in infants and young children than the unconjugated antigens in PPSV23 (Pneumovax^® 23).100,184

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees.215 Consult the CDC recommendations and best practices for storage and handling of vaccines.215

All vaccines should be inspected upon delivery and monitored during storage to ensure that the appropriate temperature is maintained.215 Vaccine that has been mishandled or has not been stored at the recommended temperature should not be administered.215

Specific Populations

Pregnancy

Data are insufficient to date regarding use of pneumococcal vaccines in pregnant women to inform vaccine-associated risks during pregnancy.129,181,207,208

ACIP states that the safety of pneumococcal polysaccharide vaccine and PCV13 during the first trimester of pregnancy has not been evaluated, although no adverse consequences have been reported among newborns whose mothers were inadvertently vaccinated during pregnancy.216

Animal developmental and reproduction studies in female rabbits using PCV13 (Prevnar 13^®) at doses 20 times the human dose based on body weight did not reveal evidence of fetal harm or impaired female fertility.181 There are no adequate and well-controlled studies using PCV13 (Prevnar 13^®) in pregnant women, and the vaccine should be used during pregnancy only when clearly needed.181

Animal reproduction studies have not been conducted with PPSV23 (Pneumovax^® 23).129 It is not known whether PPSV23 (Pneumovax^® 23) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.129 PPSV23 (Pneumovax^® 23) should be administered during pregnancy only when clearly needed.129

ACIP, AAP, and other experts state that PPSV23 (Pneumovax^® 23) may be used when indicated in pregnant women at increased risk for pneumococcal disease.105 ACIP has not addressed pregnancy recommendations for PCV15 or PCV20 at this time.216

AAP states that pneumococcal vaccination generally should be deferred during pregnancy, but the risk of severe pneumococcal disease in a pregnant woman who has not received PPSV23 (Pneumovax^® 23) within the previous 5 years and has an underlying medical condition that increases the risk of invasive pneumococcal disease should prompt immunization with PPSV23 (Pneumovax^® 23).105

Lactation

It is not known if antigens contained in PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), PCV20 (Prevnar 20^®), or PPSV23 (Pneumovax^® 23) are distributed into milk.129,181,207,208 The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vaccination and any potential adverse effects on the breastfed child from the vaccine or from the underlying maternal condition (the susceptibility to disease prevented by the vaccine). 129,181,207,208

ACIP states that, because inactivated vaccines do not multiply within the body, they should not pose any unusual problems for lactating women or their infants.215

Pediatric Use

Safety and efficacy of PCV13 (Prevnar 13^®) have not been established in infants younger than 6 weeks of age.181

The manufacturer of PCV13 (Prevnar 13^®) states that the immune response to the vaccine in preterm infants has not been adequately studied to date.181 Although the vaccination schedule differed from the US recommended schedule, there is some evidence from a study in preterm infants (gestational age less than 37 weeks) that immunoglobulin G (IgG) antibody responses to some of the pneumococcal vaccine serotypes were lower after the third and fourth vaccine dose compared with responses in term infants (gestational age 37 weeks or greater).181

The manufacturer of PCV15 (Vaxneuvance^®) states that the immune responses and safety profile in preterm infants receiving a 4-dose series were similar to those observed in term infants in clinical studies.207 However, the effectiveness of PCV15 (Vaxneuvance^®) in premature infants has not been established.207

Safety and efficacy of PCV20 (Prevnar 20^®) have not been established in individuals younger than 18 years of age.208

Safety and efficacy of PPSV23 (Pneumovax^® 23) have not been established in children younger than 2 years of age.129 Such children may not have a satisfactory antibody response to PPSV23 (Pneumovax^® 23).129

Geriatric Use

Antibody responses to PCV13 (Prevnar 13^®) in adults 65 years of age or older are lower compared with antibody responses in adults 50 through 59 years of age.181 There are no overall differences in safety outcomes in adults 65 years of age or older compared with adults 50 through 59 years of age.181

Several clinical studies evaluating PPSV23 (Pneumovax^® 23) included individuals 65 years of age or older.129 In one study, the rate of vaccine-related systemic adverse effects was similar following primary vaccination and revaccination in adults 50-64 years of age, but was higher following revaccination than primary vaccination in those 65 years of age or older.129 The possibility that some older adults may exhibit a higher frequency and/or greater severity of adverse reactions to the vaccine cannot be ruled out.129

Clinical studies of PCV15 (Vaxneuvance^®) included individuals who were 65 years and older, and individuals who were 75 years and older.207 No clinically meaningful differences in the safety profile or immune responses were observed in the groups of older individuals (65-74 years and ≥75 years of age) when compared to younger individuals.207

In safety studies of PCV20 (Prevnar 20^®) in adults, 26.7% were 65 years of age and older and 1.7% were 80 years of age and older.208 Prevnar 20^® recipients 70-79 years of age and ≥80 years of age had lower antibody responses for all pneumococcal serotypes compared to Prevnar 20^® recipients 18-49, 50-59, and 60-64 years of age.208

Common Adverse Effects

Local Effects with Pneumococcal 13-valent Conjugate Vaccine (PCV13; Prevnar 13^®): The most common adverse effects reported with PCV13 (Prevnar 13^®) are local reactions at the injection site, including pain/tenderness, redness, and swelling.181 In infants who received a 4-dose immunization series of PCV13 (Prevnar 13^®) at 2, 4, 6, and 12-15 months of age in 3 US safety studies, tenderness at the injection site was reported in 59-65% of infants after each of the first 3 vaccine doses and in 58% after the fourth dose; tenderness interfered with limb movement in 8-10% and 7% of these infants, respectively.181 Redness was reported in 24-37% of infants after the first 3 vaccine doses and in 42% after the fourth dose.181 Swelling at the injection site was reported in 20-27% of infants after the first 3 vaccine doses and in 32% after the fourth dose.181 When a dose of PCV13 (Prevnar 13^®) was administered to adults 50-64 years of age who were previously unvaccinated (had not received PPSV23 [Pneumovax^® 23]), local reactions at the injection site, including pain (69-89%), redness (12-20%), and swelling (10-22%), were commonly reported and limitation of arm movement was reported in 24-41%.181 When a dose of PCV13 (Prevnar 13^®) was administered to previously vaccinated adults 68 years of age or older (had received PPSV23 [Pneumovax^® 23] at least 3-5 years prior to study enrollment), pain, redness, swelling, and limitation of arm movement were reported in 51-52%, 11-14%, 10-13%, and 11-16%, respectively.181 Dermatitis, urticaria, and pruritus at the injection site were reported during postmarketing experience with PCV13 (Prevnar 13^®).181

Systemic Effects with Pneumococcal 13-valent Conjugate Vaccine (PCV13; Prevnar 13^®): In infants who received a 4-dose immunization series of PCV13 (Prevnar 13^®) at 2, 4, 6, and 12-15 months of age in 3 US safety studies, fever (38°C or greater) occurred in 24-37% of infants after each of the first 3 doses; fever was reported in 32% after the fourth dose.181 Irritability was reported in 80-86%, increased sleep in 58-72%, and decreased sleep in 43-47% of infants after each of the first 3 doses; after the fourth dose, these effects were reported in 80, 49, and 45%, respectively.181 Decreased appetite was reported in 48% of infants after each of the first 3 doses of PCV13 (Prevnar 13^®) and in 51% after the fourth dose.181 Diarrhea, vomiting, and rash have been reported in greater than 1% of infants and children receiving PCV13 (Prevnar 13^®) in clinical studies.181 Adverse reactions occurring in less than 1% of infants and children receiving the vaccine included crying, hypersensitivity reaction (e.g., facial edema, dyspnea, bronchospasm), seizures (e.g., febrile seizures), and urticaria or urticaria-like rash.181 When a dose of PCV13 (Prevnar 13^®) was administered to adults 50-64 years of age who were previously unvaccinated (had not received PPSV23 [Pneumovax^® 23]), fatigue occurred in 51-63%, headache in 50-66%, chills in 20-24%, muscle pain in 22-62%, joint pain in 14-32%, rash in 9-17%, decreased appetite in 15-25%, vomiting in 3-7%, and fever in 2-4%.181 When a dose of PCV13 (Prevnar 13^®) was administered to previously vaccinated adults 68 years of age and older (had received PPSV23 [Pneumovax^® 23] at least 3-5 years prior to study enrollment), fatigue occurred in 34%, headache in 24-26%, chills in 8%, muscle pain in 12-37%, joint pain in 10-13%, rash in 7-8%, decreased appetite in 10-11%, vomiting in 1-2%, and fever in 1%.181 Lymphadenopathy in the region of the injection site, cyanosis, pallor, hypotonia, anaphylactic/anaphylactoid reactions (including shock), angioedema, erythema multiforme, and apnea were reported during postmarketing experience with PCV13 (Prevnar 13^®).181

Local Effects with PCV15 (Vaxneuvance^®: The most commonly reported local adverse reactions reported in infants receiving a 4-dose series at 2, 4, 6, and 12 through 15 months of age were injection-site pain (25.9-40.3%), injection-site induration (13.2-15.4%), injection-site erythema (13.7-21.4%), and injection-site swelling (11.3-13.4%).207 Reported local adverse reactions in children and adolescents 2 through 17 years of age vaccinated with a single dose were injection-site pain (54.8%), injection-site swelling (20.9%), injection-site erythema (19.2%), and injection-site induration (6.8%).207 The most commonly reported adverse reactions in adults 18-49 years of age were injection-site pain (75.8%), injection-site swelling (21.7%), and injection-site erythema (15.1%).207 The most commonly reported adverse reactions in adults ≥50 years of age were injection-site pain (66.8%), injection-site swelling (15.4%), and injection-site erythema (10.9%).207

Systemic Effects with PCV15 (Vaxneuvance^®: The most commonly reported systemic adverse reactions reported in infants receiving a 4-dose series at 2, 4, 6, and 12 through 15 months of age were irritability (57.3-63.4%), somnolence (24.2-47.5%), fever ≥38.0°C (13.3-20.4%), and decreased appetite (14.1-19.0%).207 Reported systemic reactions in children and adolescents 2 through 17 years of age vaccinated with a single dose were myalgia (23.7%), fatigue (15.8%), and headache (11.9%).207 The most commonly reported systemic reactions in adults 18-49 years of age were fatigue (34.3%), myalgia (28.8%), headache (26.5%), and arthralgia (12.7%).207 The most commonly reported systemic reactions in adults ≥50 years of age were myalgia (26.9%), fatigue (21.5%), headache (18.9%), and arthralgia (7.7%).207

Local Effects with PCV20 (Prevnar 20^®): In adults 18-59 years of age, the most commonly reported local adverse reactions (>10%) were pain at the injection site and injection site swelling.208 In adults ≥60 years of age, the most commonly reported local adverse reaction (>10%) was pain at the injection site.208

Systemic Effects with PCV20 (Prevnar 20^®): In adults 18-59 years of age, the most commonly reported systemic reactions (>10%) were muscle pain, fatigue, headache, and arthralgia.208 In adults ≥60 years of age, the most commonly reported systemic reactions (>10%) were muscle pain and fatigue, headache, and arthralgia.208

Local Effects with Pneumococcal 23-valent Vaccine (PPSV23; Pneumovax^® 23): The most common adverse effects reported after initial vaccination with PPSV23 (Pneumovax^® 23) are local reactions at the injection site, including pain/soreness/tenderness (60%),129 swelling/induration (20%), and erythema (16%).129 Following revaccination with PPSV23 (Pneumovax^® 23) approximately 3-5 years after the initial vaccine dose, the most common local adverse effects were pain/soreness/tenderness (77%), swelling (40%), and erythema (35%).129 Injection site reactions generally resolved within 5 days after vaccination.129 Data from one study in adults indicate that the incidence of adverse effects at the injection site in those 50-64 years of age is similar following initial vaccination (73%) and revaccination (80%).129 However, the incidence of injection site reactions is higher following revaccination than following initial vaccination in those ≥65 years of age.129 There have been postmarketing reports of cellulitis or cellulitis-like reactions, warmth at the injection site, decreased limb mobility, and peripheral edema in the injected extremity following administration of PPSV23 (Pneumovax^® 23).129

Systemic Effects with Pneumococcal 23-valent Vaccine (PPSV23; Pneumovax^® 23): The most common systemic adverse effects reported after initial vaccination with PPSV23 (Pneumovax^® 23) are headache (18%), asthenia/fatigue (13%), and myalgia (12%).129 Following revaccination with PPSV23 (Pneumovax^® 23) approximately 3-5 years after the initial vaccine dose, the most common systemic adverse effects were headache (18%), asthenia/fatigue (18%), and myalgia (17%).129 Rash,129 urticaria,129 and erythema multiforme129 have been reported following vaccination with PPSV23 (Pneumovax^® 23).129 Anaphylactoid reactions,129 serum sickness,129 and angioedema129 also have been reported.129 Other systemic reactions reported following vaccination with PPSV23 (Pneumovax^® 23) during clinical studies or postmarketing experience include fever,129 chills,129 arthralgia,129 arthritis,129 malaise,129 diarrhea,129 dyspepsia,129 nausea,129 and vomiting.129 In addition, there have been postmarketing reports of lymphadenitis,129 lymphadenopathy,129 thrombocytopenia (in patients with stabilized idiopathic thrombocytopenic purpura),129 hemolytic anemia (in patients who have had other hematologic disorders),129 and leukocytosis.129 There also have been postmarketing reports of adverse nervous system effects, including paresthesia,129 radiculoneuropathy,129 Guillain-Barré syndrome,129 and febrile seizures.129 Data from one study in adults indicate that the incidence of systemic adverse effects in those 50-64 years of age is similar following initial vaccination (36%) and revaccination (38%).129 However, the incidence of systemic reactions is higher following revaccination than following initial vaccination in those ≥65 years of age.129

Drug Interactions ⬆ ⬇

[Section Outline]

Acetaminophen
Immune Globulins
Immunosuppressive Agents
Vaccines

Acetaminophen

In infants receiving vaccination with pneumococcal 13-valent conjugate vaccine (PCV13; Prevnar 13^®), acetaminophen for prophylaxis (first dose given at the time of each vaccine dose and additional doses given every 6-8 hours) reduced the antibody response to some pneumococcal vaccine serotypes following the third dose of PCV13 (Prevnar 13^®) compared with antibody responses in infants who received antipyretics only as needed for treatment.181 Reduced antibody responses were not observed after the fourth dose of PCV13 (Prevnar 13^®) in those receiving acetaminophen prophylactically.181

ACIP states that evidence does not support the use of antipyretics before or at the time of vaccination; however, antipyretics can be used for treatment of fever and local discomfort that might occur following vaccination.215

Immune Globulins

There is no evidence that immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV]) or specific hyperimmune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG]) interferes with the immune response to inactivated vaccines.215 The US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that inactivated vaccines such as pneumococcal vaccines may be given simultaneously with (using different syringes and different injection sites) or at any interval before or after immune globulin or specific hyperimmune globulin preparations.215

Immunosuppressive Agents

Individuals receiving immunosuppressive therapy (e.g., alkylating agents, antimetabolites, corticosteroids, radiation) may have diminished or suboptimal antibody responses to pneumococcal vaccines.215 Pneumococcal vaccination should be administered before initiation of chemotherapy, or before treatment with other immunosuppressive drugs; administration during chemotherapy or radiation therapy should be avoided.215 If possible, pneumococcal vaccines should be administered at least 2 weeks prior to initiation of immunosuppressive therapy.215 Individuals receiving chemotherapy with anti-B cell antibodies (e.g., rituximab) should wait at least 6 months after this therapy before being vaccinated with non-live vaccines; some experts recommend waiting longer than 6 months for some anti-B cell antibodies.215 However, if patients require therapy for chronic inflammatory conditions, this therapy should not be delayed because of past administration of pneumococcal vaccines.215 If pneumococcal vaccines are administered during chemotherapy, the patient should be revaccinated after immune competence is regained; however, revaccination after chemotherapy or radiation therapy is considered unnecessary if the previous vaccination occurred before therapy.215

Vaccines

Although specific studies may not be available regarding concurrent administration with each antigen, simultaneous administration of PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), PCV20 (Prevnar 20^®), or PPSV23 (Pneumovax^® 23) with many other age-appropriate vaccines during the same health-care visit in most cases is not expected to affect immunologic responses or adverse reactions to any of the preparations.105,215 However, each parenteral vaccine should be administered using a different syringe and different injection site.105,215

Diphtheria and Tetanus Toxoids and Pertussis Vaccines

PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), or PPSV23 (Pneumovax^® 23) may be administered concurrently with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP) using different syringes and different injection sites.105,181,207

In clinical studies evaluating PCV13 (Prevnar 13^®) in infants, the pneumococcal vaccine was administered concurrently with the first 3 doses of a fixed-combination vaccine containing DTaP (DTaP-HepB-IPV; Pediarix^®) at 2, 4, and 6 months of age.181

Haemophilus b Vaccines

PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), or PPSV23 (Pneumovax^® 23) may be administered concurrently with haemophilus b (Hib) conjugate vaccine at a different site using a separate syringe.105,181,207

In clinical studies evaluating PCV13 (Prevnar 13^®) and PCV15 (Vaxneuvance^®) in infants, the pneumococcal vaccine was administered concurrently with the first 3 doses of Hib at 2, 4, and 6 months of age.181,207

ACIP states that the fixed-combination vaccine containing Hib conjugate vaccine and meningococcal polysaccharide groups C and Y vaccine (Hib-MenCY; MenHibrix^®) may be administered concurrently with PCV13 (Prevnar 13^®) in infants 2 through 18 months of age at a different site using a different syringe.177

Hepatitis A Vaccine

PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), or PPSV23 (Pneumovax^® 23) may be administered concomitantly with hepatitis A virus vaccine inactivated using different syringes and different injection sites.105,181,207,215

In clinical studies, hepatitis A virus vaccine inactivated was administered concurrently with the fourth dose of PCV13 (Prevnar 13^®) in infants 12-15 months of age.181 In a study evaluating concomitant administration of hepatitis A vaccine (Havrix^®) and the previously available 7-valent vaccine (PCV7; Prevnar^®) in infants 15 months of age, there was no evidence of decreased immune response to any of the serotypes contained in PCV7 (Prevnar^®).172

Hepatitis B Vaccine

PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), or PPSV23 (Pneumovax^® 23) may be administered concurrently with hepatitis B virus vaccine inactivated using different syringes and different injection sites.105,181,207,215

In clinical studies evaluating PCV13 (Prevnar 13^®) in infants, the pneumococcal vaccine was administered concurrently with the first 3 doses of a fixed-combination vaccine containing hepatitis B virus vaccine (DTaP-HepB-IPV; Pediarix^®) at 2, 4, and 6 months of age.181

Influenza Virus Vaccine

Influenza Virus Vaccine Inactivated

PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), PCV20 (Prevnar 20^®), or PPSV23 (Pneumovax^® 23) may be administered concurrently with parenteral influenza virus vaccine inactivated using different syringes and different injection sites.105,207,215

Concomitant administration of PCV13 (Prevnar 13^®) and parenteral influenza virus vaccine inactivated (using different syringes and different injection sites) in adults 50 years of age or older resulted in similar frequencies of local reactions at the injection site compared with administration of PCV13 (Prevnar 13^®) alone.181 However, there was an increase in some solicited systemic reactions when PCV13 (Prevnar 13^®) and parenteral influenza virus vaccine inactivated were administered concomitantly compared with administration of the influenza vaccine alone (headache, chills, rash, decreased appetite, muscle and joint pain) or the pneumococcal vaccine alone (fatigue, headache, chills, decreased appetite, joint pain).215

There have been some reports of an increased incidence of adverse local and systemic effects when PPSV23 (Pneumovax^® 23) was administered concomitantly with influenza virus vaccine inactivated (at a different injection site) compared with administration of influenza virus vaccine inactivated alone, but these reactions generally were mild and well tolerated and do not preclude simultaneous administration of the vaccines at different sites.145,146 ACIP states that concomitant administration of PPSV23 (Pneumovax^® 23) and parenteral influenza virus vaccine inactivated results in satisfactory antibody responses without increasing the incidence or severity of adverse reactions.215

Influenza Vaccine Live Intranasal

Concomitant administration of pneumococcal vaccines and influenza vaccine live intranasal has not been specifically studied.179 ACIP states that, in the absence of specific data indicating interference, inactivated vaccines can be administered simultaneously with or at any interval before or after influenza vaccine live intranasal.178,215

Measles, Mumps, Rubella, and Varicella Vaccines

In clinical studies evaluating PCV13 (Prevnar 13^®) in infants, MMR and varicella virus vaccine live or, alternatively, the fixed-combination vaccine containing MMR and varicella virus vaccine live (MMRV; ProQuad^®) was administered concurrently with the fourth dose of PCV13.181 In clinical studies evaluating PCV15 (Vaxneuvance^®) in infants, MMR and varicella virus vaccine live were administered concurrently with PCV15 at 12-15 months of age.207

Meningococcal Vaccines

The manufacturer of PCV13 (Prevnar 13^®) states that data are insufficient to assess concomitant administration with meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV4-D, MenACWY-D; Menactra^®) in children and adolescents.181

ACIP and AAP state that MCV4-D (Menactra^®) should not be administered concurrently with or within 4 weeks after PCV13 (Prevnar 13^®).105,177,215 To avoid possible interference with the immune response to PCV13 in infants and children with anatomic or functional asplenia, the PCV13 immunization series should be completed first and MCV4-D (Menactra^®) administered at least 4 weeks later.177,215

PPSV23 (Pneumovax^® 23) can be administered concurrently with MCV4 (Menactra^®, Menveo^®) or MPSV4 (Menomune^®) at a different site using a different syringe.105

ACIP states that the fixed-combination vaccine containing meningococcal polysaccharide groups C and Y vaccine and Hib conjugate vaccine (Hib-MenCY; MenHibrix^®) may be administered concurrently with PCV13 (Prevnar 13^®) in infants 2 through 18 months of age at a different site using a different syringe.177

Poliovirus Vaccine Inactivated

PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), or PPSV23 (Pneumovax^® 23) may be given concurrently with poliovirus vaccine inactivated (IPV) using different syringes and different injection sites.105,207,215

In clinical studies evaluating PCV13 (Prevnar 13^®) in infants, the pneumococcal vaccine was administered concurrently with the first 3 doses of a fixed-combination vaccine containing IPV (DTaP-HepB-IPV; Pediarix^®) at 2, 4, and 6 months of age.181

Rotavirus Vaccines

PCV13 (Prevnar 13^®) or PCV15 (Vaxneuvance^®) may be given concurrently with rotavirus vaccine live oral (Rotarix^®, RotaTeq^®).105,207,215

Zoster Vaccine

The manufacturer of zoster vaccine live and PPSV23 (Pneumovax^® 23) states that consideration should be given to administering these 2 vaccines at least 4 weeks apart.129,186

Data from a randomized, double-blind, controlled study in adults 60 years of age or older indicate that concurrent administration of zoster vaccine live and PPSV23 (Pneumovax^® 23) resulted in reduced antibody response to zoster vaccine live compared with that reported when the vaccines were administered 4 weeks apart.129,180,186 When assessed using representative pneumococcal serotypes (3, 14, 19A, 22F), the antibody response to PPSV23 (Pneumovax^® 23) following concomitant administration was similar to that reported when the vaccines were administered 4 weeks apart.180,186 Concurrent administration of zoster vaccine live and PPSV23 (Pneumovax^® 23) did not result in a clinically important increase in adverse effects compared with administration during separate visits (4 weeks apart).180,186

Other Information ⬆ ⬇

Description

Pneumococcal 13-valent conjugate vaccine (PCV13; Prevnar 13^®), pneumococcal 15-valent conjugate vaccine (PCV15; Vaxneuvance^®),207 pneumococcal 20-valent conjugate vaccine (PCV20; Prevnar 20^®),208 and pneumococcal vaccine, polyvalent (pneumococcal 23-valent vaccine; PPSV23; Pneumovax^® 23) are used to stimulate active immunity to infection caused by the serotypes of Streptococcus pneumoniae contained in the vaccines.100,129,181,184,207,208

The capsular saccharides present in PCV13 (Prevnar 13^®), PCV15 (Vaxneuvance^®), and PCV20 (Prevnar 20^®) promote production of antibody specific for each pneumococcal capsular type in the vaccine.181,207,208 PCV13 (Prevnar 13^®) elicits a T-cell dependent immune response.181 Protein carrier-specific T-cells provide the signals needed for maturation of the B-cell response.181 Antibodies produced in response to pneumococcal conjugate vaccines enhance opsonization, phagocytosis, and killing of S. pneumoniae by leukocytes and other phagocytic cells.181,207,208

Nonclinical and clinical data support opsonophagocytic activity, as measured by opsonophagocytic activity (OPA) antibody assay, as a contributor to protection against pneumococcal disease.181,207,208 The OPA antibody assay provides an in vitro measurement of the ability of serum antibodies to eliminate pneumococci by promoting complement-mediated phagocytosis and is believed to reflect relevant in vivo mechanisms of protection against pneumococcal disease.181,207,208 In infants who receive PCV13 (Prevnar 13^®), OPA correlates well with serotype specific anticapsular polysaccharide immunoglobulin G (IgG) levels as measured by enzyme-linked immunosorbent assay (ELISA).181 A serum anticapsular polysaccharide antibody concentration of at least 0.35 mcg/mL as measured by ELISA 1 month after the third dose of a single antibody reference concentration has been used to estimate the effectiveness of PCV13 (Prevnar 13^®) against invasive pneumococcal disease in infants and children.181 An antipolysaccharide binding antibody IgG level to predict protection against invasive pneumococcal disease or nonbacteremic pneumonia has not been defined in adults.181,207

The extent and duration of immunologic response may vary depending on age and immunocompetence of the vaccinee.100 Antigens in PCV13 (Prevnar 13^®) and PCV15 (Vaxneuvance^®) are conjugated to a carrier protein and are more immunogenic in infants and young children than the unconjugated antigens in PPSV23 (Pneumovax^® 23).100,184,207,211

The capsular polysaccharides present in PPSV23 (Pneumovax^® 23) promote production of antibody specific for each pneumococcal capsular type in the vaccine.129,184 These antibodies enhance opsonization, phagocytosis, and killing of S. pneumoniae by leukocytes and other phagocytic cells.129 Although the immune response to PPSV23 (Pneumovax^® 23) generally has been evaluated using quantitative measurements of antibodies, antibody levels that correlate with protections against pneumococcal disease have not been clearly defined.129,184

Following administration of a single dose of PPSV23 (Pneumovax^® 23) in healthy adults, more than 80% develop antibodies specific for the pneumococcal capsular types present in the vaccine, usually within 2-3 weeks.166 The antibody response to the pneumococcal capsular polysaccharides contained in PPSV23 (Pneumovax^® 23) generally is poor or inconsistent in infants younger than 2 years of age.129,166

A retrospective cohort analysis study based on US Centers for Disease Control and Prevention (CDC) pneumococcal surveillance data indicated that the overall protective effectiveness of PPSV23 (Pneumovax^® 23) against invasive pneumococcal infection caused by serotypes included in the vaccine was 57% in individuals 6 years of age or older, 65-84% among specific patient groups (e.g., those with diabetes mellitus, coronary vascular disease, congestive heart failure, chronic pulmonary disease, and anatomic asplenia), and 75% in immunocompetent adults 65 years of age or older.129

Individuals with immunodeficiency diseases (e.g., hypogammaglobulinemia, leukemia, lymphoma, multiple myeloma), individuals receiving immunosuppressive therapy, and individuals with Hodgkin's disease who have received extensive chemotherapy, radiation therapy, and splenectomy may have diminished or suboptimal antibody responses to PPSV23 (Pneumovax^® 23).129,166

Following administration of PPSV23 (Pneumovax^® 23) in healthy adults, antibodies formed in response to the vaccine remain elevated for at least 5 years,126,166 but antibody levels decline after 5-10 years.166 Antibody levels decline more rapidly in individuals with certain underlying illnesses,166 including those who have undergone splenectomy following trauma and those with sickle cell disease or nephrotic syndrome.124,125

Antigens contained in PPSV23 (Pneumovax^® 23) cannot induce long-lasting immunity, since they do not induce T-cell-dependent responses associated with immunologic memory.166

Pneumococcal vaccine is commercially available in the US as 2 different vaccine types: pneumococcal conjugate vaccines: pneumococcal conjugate vaccine (pneumococcal 13-valent conjugate vaccine,181 pneumococcal 15-valent conjugate vaccine,207 and pneumococcal 20-valent conjugate vaccine)208 and pneumococcal vaccine polyvalent (pneumococcal 23-valent vaccine; PPSV23; Pneumovax^® 23).129,181 Although both vaccine types contain capsular antigens extracted from Streptococcus pneumoniae , the vaccines contain different numbers and forms of these antigens.129,181,207,208

PCV13 (Prevnar 13^®) is a sterile suspension containing purified capsular saccharide antigens extracted from 13 serotypes of S. pneumoniae and individually conjugated to diphtheria CRM₁₉₇.181,184 PCV13 (Prevnar 13^®) contains the following 13 capsular saccharide serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.181,184 Each serotype of S. pneumoniae is cultured in soy peptone broth and the individual polysaccharides are purified using centrifugation, precipitation, ultrafiltration, and column chromatography.181 The polysaccharides are chemically inactivated to make saccharides and these are directly conjugated by reductive amination to the protein carrier (diphtheria CRM₁₉₇) to form the glycoconjugate.181 Potency of the vaccine is determined by quantification of each of the saccharide antigens and by the saccharide to protein ratios in the individual glycoconjugates.181 After shaking, PCV13 (Prevnar 13^®) occurs as a homogeneous white suspension.181

PCV15 (Vaxneuvance^®) is a sterile suspension of purified capsular polysaccharides extracted from 15 serotypes of S. pneumoniae and individually conjugated to diphtheria CRM₁₉₇.207 PCV15 (Vaxneuvance^®) contains the following 15 capsular saccharide serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F.207 Each S. pneumoniae serotype is grown in media containing yeast extract, dextrose, salts and soy peptone and purified by a series of chemical and physical methods.207 Then each polysaccharide is chemically activated and conjugated to the carrier protein CRM₁₉₇ to form each glycoconjugate.207 The final vaccine is prepared by blending the fifteen glycoconjugates with aluminum phosphate adjuvant in a final buffer containing histidine, polysorbate 20, and sodium chloride.207 After shaking, PCV15 (Vaxneuvance^®) occurs as an opalescent suspension.207

PCV20 (Prevnar 20^®) is a sterile suspension of purified capsular polysaccharides extracted from 20 serotypes of S. pneumoniae and individually conjugated to diphtheria CRM₁₉₇.208 PCV20 (Prevnar 20^®) contains the following 20 capsular saccharide serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.208 Each serotype of S. pneumoniae is grown in soy peptone broth and the individual polysaccharides are purified by a series of chemical and physical methods.208 The polysaccharides are chemically activated and then directly conjugated to the carrier protein CRM₁₉₇, to form the glycoconjugate.208 Potency of the formulated vaccine is determined by quantification of each of the saccharide antigens and by the saccharide to protein ratios in the individual glycoconjugates.208 After shaking, PCV20 (Prevnar 20^®) occurs as a homogeneous white suspension.208 Each 0.5 mL dose of the vaccine is formulated to contain approximately 2.2 µg of each of S. pneumoniae serotypes.208

PPSV23 (Pneumovax^® 23) is a sterile solution containing purified capsular polysaccharide antigens extracted from 23 different serotypes of S. pneumoniae .129 PPSV23 (Pneumovax^® 23) contains the following 23 capsular polysaccharide 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.129 PPSV23 (Pneumovax^® 23) occurs as a clear, colorless solution.129

Each 0.5-mL dose of PPSV23 (Pneumovax^® 23) contains 25 mcg of each type of capsular polysaccharide antigen129 in 0.9% sodium chloride injection.129 The vaccine does not contain thimerosal, but does contain phenol as a preservative.105,129

Advice to Patients

Advise patient and/or patient's parent or guardian of the risks and benefits of vaccination with pneumococcal vaccine.129,181
Advise patient and/or patient's parent or guardian of the importance of receiving pneumococcal vaccination if they are at increased risk of pneumococcal disease and inform them that specific vaccine products are given based on the patient's age.100,167,181,184,199,203,204,205,207,208,213
Advise patient and/or patient's parent or guardian that pneumococcal vaccines may not provide protection in all vaccinees.129,181,207,208
Importance of informing clinicians of any history of allergic reactions to pneumococcal vaccines (i.e., PCV13, PCV15, PCV20) or any vaccine containing diphtheria toxoid.129,181
Importance of informing clinicians if any severe or unusual adverse reactions (including allergic reactions) occur with pneumococcal vaccine.129,167 Clinicians or individuals can report any adverse reactions that occur following vaccination to the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or [Web].129,181
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.129,181
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.129,181
Importance of informing patients of other important precautionary information.129,181 (See Cautions.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations ⬆ ⬇

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (PCV13)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injectable suspension, for IM use		Prevnar 13^® (available as single-dose prefilled syringes)	Wyeth

Pneumococcal 15-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (PCV15)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injectable suspension, for IM use		Vaxneuvance^® (available as single-dose prefilled syringes)	Merck

Pneumococcal 20-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (PCV20)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injectable suspension, for IM use		Prevnar 20^® (available as single-dose prefilled syringes)	Wyeth

Pneumococcal Vaccine, Polyvalent (PPSV23)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection	Consists of a mixture of purified capsular polysaccharides from Streptococcus pneumoniae types (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F); each 0.5-mL dose contains 25 mcg of each polysaccharide type	Pneumovax^® 23 (available as single-dose vials and single-dose prefilled syringes)	Merck

References ⬆

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105. American Academy of Pediatrics. 2021 Red Book: Report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2021.

108. Sanofi Pasteur. Menactra^® (meningococcal [groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine) information. Swiftwater, PA; 2014 Aug.

109. Huang KL, Ruben FL, Rinaldo CR et al. Antibody responses after influenza and pneumococcal immunization in HIV-infected homosexual men. JAMA . 1987; 257:2047-50. [PubMed 3560380]

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129. Merck & Co. Pneumovax^® 23 (pneumococcal vaccine polyvalent) prescribing information. Whitehouse Station, NJ; 2021 Apr.

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140. Swiatlo E, Benton K, Brilles DE. Pneumococcal vaccine response inhuman immunodeficiency virus-infected patients. J Infect Dis . 1996; 173:177.

143. Gebo KA, Moore RD, Keruly JC et al. Risk factors for pneumococcal disease in human immunodeficiency virus-infected patients. J Infect Dis . 1996; 173:8557-62.

145. Reviewers' comments (personal observations) on influenza vaccine 80:12.

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148. Wyeth. Prevnar^® (pneumococcal 7-valent conjugate vaccine [diphtheria CRM₁₉₇ protein]) prescribing information. Philadelphia, PA; 2009 Jul.

151. Eskola J, Kilpi T, Palmu A et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med . 2001; 344:403-9. [PubMed 11172176]

152. Fireman B, Black SB, Shinefield HR et al. Impact of the pneumococcal conjugate vaccine on otitis media. Pediatr Infect Dis . 2003; 22:10-16.

153. Veenhoven R, Bogaert D, Ulterwaal C et al. Effect of conjugate pneumococcal vaccine followed by polysaccharide pneumococcal vaccine on recurrent acute otitis media: a randomized study. Lancet . 2003; 361:2189-95. [PubMed 12842372]

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156. Panel on Opportunistic Infections in HIV-exposed and HIV-infected children, US Department of Health and Human Services (HHS). Guidelines for the prevention and treatment of opportunistic infections in HIV-exposed and HIV-infected children: recommendations from the National Institutes of Health, Centers for Disease Control and Prevention, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics (Sept 2, 2022). Updates may be available at HHS AIDS Information (AIDSinfo) website. [Web]

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170. GlaxoSmithKline Biologicals. Rotarix^® (Rotavirus Vaccine, Live, Oral) prescribing information. Research Triangle Park, NC; 2014 Sep.

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172. GlaxoSmithKline. Havrix^® (hepatitis A vaccine) suspension for intramuscular injection prescribing information. Research Triangle Park, NC; 2014 Jul.

173. Centers for Disease Control and Prevention. Prevention of herpes zoster. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep . 2008; 57 (RR-5):1-30. [Fulltext MMWR]

174. Dennehy PH, Bertrand HR, Silas PE et al. Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. Pediatrics . 2008; 122:e1062-6. [PubMed 18977955]

175. Merck & Co. RotaTeq^® (Rotavirus Vaccine, Live, Oral, Pentavalent) prescribing information. Whitehouse Station, NJ; 2013 Jun.

176. Novartis Vaccines and Diagnostics, Inc. Menveo^® (meningococcal [Groups A, C, Y and W-135] oligosaccharide diphtheria CRM₁₉₇ conjugate vaccine) prescribing information. Cambridge, MA; 2013 Aug.

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179. MedImmune LLC. FluMist^® Quadrivalent (influenza vaccine live, intranasal 2014-2015 formula) intranasal spray prescribing information. Gaithersburg, MD; 2014 Jul.

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207. Merck & Co. Vaxneuvance^® (pneumococcal 15-valent conjugate vaccine) prescribing information. Whitehouse Station, NJ; 2022 Jul.

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209. Centers for Disease Control and Prevention (CDC). Use of 15-valent pneumococcal conjugate vaccine and 20-valent pneumococcal conjugate vaccine among U.S. adults: Recomendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep . 2022; 71:109-17. [PubMed 35085226]

210. Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults ≥65 years: Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep . 2019; 68:1069-75. [PubMed 31751323]

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section name header

Introduction ⬇

AHFS Class:

Generic Name(s):

Uses ⬆ ⬇

Dosage and Administration ⬆ ⬇

Cautions ⬆ ⬇

Drug Interactions ⬆ ⬇

Other Information ⬆ ⬇

Preparations ⬆ ⬇

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (PCV13)

Pneumococcal 15-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (PCV15)

Pneumococcal 20-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (PCV20)

Pneumococcal Vaccine, Polyvalent (PPSV23)

Copyright ⬆ ⬇

References ⬆