Skip to Content

Pneumococcal Vaccine

Class: Vaccines
ATC Class: J07A1
VA Class: IM100
Brands: Pneumovax 23, Prevnar 13

Introduction

Inactivated (polysaccharide) vaccine.105 129 134 181 Commercially available in US as pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PCV13; Prevnar 13)181 and pneumococcal vaccine, polyvalent (pneumococcal 23-valent vaccine; PPSV23; Pneumovax 23).129 Both vaccines contain capsular antigens extracted from Streptococcus pneumoniae and are used to stimulate active immunity to pneumococcal infection.105 129 134 181 Various other pneumococcal vaccines are being investigated or may be available in other countries.188

Uses for Pneumococcal Vaccine

Prevention of Pneumococcal Disease

PCV13 (Prevnar 13): Prevention of invasive disease (e.g., pneumonia, meningitis, bacteremia) caused by Streptococcus pneumoniae in infants 6 weeks through 23 months of age, healthy children 2 through 5 years of age, children and adolescents 6 through 18 years of age at increased risk for pneumococcal disease, adults 19 through 64 years of age at increased risk for pneumococcal disease, and adults ≥65 years of age.100 181 184 199 200 202 203 204 205 Provides protection only against the 13 S. pneumoniae serotypes represented in the vaccine (i.e., 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F).181

PPSV23 (Pneumovax 23): Prevention of invasive disease (e.g., pneumonia, meningitis, bacteremia) caused by S. pneumoniae in children 2 through 18 years of age at increased risk for pneumococcal disease, adults 19 through 64 years of age at increased risk for pneumococcal disease, and adults ≥65 years of age.100 129 169 184 202 203 204 205 Provides protection only against the 23 S. pneumoniae serotypes represented in the vaccine (i.e., 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F).129

S. pneumoniae is a major cause of serious or invasive illness and death worldwide.100 105 166 169 184 In the US, pneumococcal pneumonia results in an estimated 175,000 hospitalizations each year (case fatality rate 5–7%); there are >50,000 cases of pneumococcal bacteremia (case fatality rate about 20%) and 3000–6000 cases of pneumococcal meningitis (case fatality rate about 30%) reported annually.166 Case fatality rates are higher in the elderly (60–80% for pneumococcal bacteremia or meningitis in this age group).166 In children <5 years of age, S. pneumoniae has been a leading cause of bacterial meningitis.166

Epidemiology of pneumococcal disease in the US changed substantially after routine infant and childhood vaccination against the disease was initiated in 2000.100 184 Overall incidence of invasive pneumococcal disease in children <5 years of age decreased from approximately 99 cases/100,000 population in 1998–1999 to 21 cases/100,000 population in 2008.184 Routine infant and childhood vaccination against pneumococcal disease also reduced incidence of invasive pneumococcal disease among unvaccinated individuals of all ages.184 Data from 1998–1999 and 2008 indicate that overall rates of invasive pneumococcal disease in individuals 18–49, 50–64, and ≥65 years of age decreased 34, 14, and 37%, respectively.184

PCV13 (Prevnar 13) is the pneumococcal vaccine recommended by the USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and others for routine primary and catch-up vaccination in all infants 2 through 23 months of age and healthy children 2 through 5 years of age.100 184 199 Vaccine antigens in PCV13 (Prevnar 13) are conjugated to a T-cell dependent carrier protein (diphtheria CRM197 protein) and are more immunogenic in infants and young children than the unconjugated antigens contained in PPSV23 (Pneumovax 23).100 184

PPSV23 (Pneumovax 23) contains 11 additional antigens not contained in PCV13 (Prevnar 13) and PCV13 contains one antigen not found in PPSV23; use of both vaccines provides benefits in terms of immunity against a broader range of serotypes.202 203 205 Therefore, ACIP, AAP, and others recommend vaccination with PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) in children ≥2 years of age, adolescents, and adults 19 through 64 years of age with certain medical conditions that put them at increased risk for pneumococcal disease.100 155 156 184 199 200 202 203 205 Vaccination with PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) also is recommended in all adults ≥65 years of age or older.200 204 (See Vaccination Against Pneumococcal Disease in Groups At Risk under Uses.)

When both PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) are indicated, give the vaccines sequentially; do not give concurrently.100 184 199 200 202 203 204 205 If possible, give all required doses of PCV13 (Prevnar 13) before PPSV23 (Pneumovax 23).100 184 199 200 202 203 204 205 (See Dosage and Administration.)

Pneumococcal 7-valent conjugate vaccine (PCV7; Prevnar) was available in the US from 2000 until 2010148 184 185 when it was replaced by PCV13 (Prevnar 13).100 184 185 Since PCV13 (Prevnar 13) contains 6 additional antigens not contained in PCV7 (Prevnar), individuals who previously received age-appropriate vaccination or incomplete vaccination with PCV7 (Prevnar) should receive PCV13 (Prevnar 13).100 184 199 203 205

Vaccination Against Pneumococcal Disease in Groups at Risk

Vaccination against pneumococcal disease is recommended in infants, children, adolescents, and adults at risk of exposure to S. pneumoniae or at risk of developing invasive pneumococcal disease if they become infected with S. pneumoniae.100 105 169 184 199 200 202 203 204 205

Infants 2 through 23 months of age are at increased risk for invasive pneumococcal disease and should be vaccinated against the disease with the appropriate number of doses of PCV13 (Prevnar 13).100 105 184 PPSV23 (Pneumovax 23) is not recommended in these infants.129

ACIP, AAP, and others recommend routine primary and catch-up vaccination against pneumococcal infection in all previously unvaccinated or incompletely vaccinated infants 2 through 23 months of age using the age-appropriate number of doses of PCV13 (Prevnar 13).100 184 199

Infants 14 through 23 months of age who received age-appropriate vaccination with the previously available 7-valent vaccine (PCV7; Prevnar) should receive a single supplemental dose of PCV13 (Prevnar 13) since this may provide additional protection.100 184 199

Healthy children 2 through 5 years of age who have not been vaccinated or are incompletely vaccinated against pneumococcal disease should receive catch-up vaccination with a single dose of PCV13 (Prevnar 13).100 184 199 PPSV23 (Pneumovax 23) is not recommended in healthy children 2 through 5 years of age who do not have medical conditions that put them at increased risk for pneumococcal disease.100 184 199

Children 2 through 5 years of age who received age-appropriate vaccination with the previously available 7-valent vaccine (PCV7; Prevnar) should receive a single supplemental dose of PCV13 (Prevnar 13) since this may provide additional protection.100 184 199

Children 2 through 5 years of age at increased risk for pneumococcal disease because of certain medical conditions should be vaccinated against the disease with a sequential regimen of both PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23).100 184 199

Children 2 through 5 years of age with 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], chronic lung disease [including asthma if treated with high-dose oral corticosteroid therapy], diabetes mellitus, CSF leaks, cochlear implants) are considered at increased risk for pneumococcal disease.100 184 199

ACIP, AAP, and others recommend that unvaccinated or incompletely vaccinated children 2 through 5 years of age with these medical conditions should receive catch-up vaccination using an age-appropriate regimen of PCV13 (Prevnar 13) followed by a dose of PPSV23 (Pneumovax 23).100 184 199

Children and adolescents 6 through 18 years of age at increased risk for pneumococcal disease because of certain medical conditions should be vaccinated against the disease.100 184 199 203 205

ACIP, AAP, and others recommend sequential vaccination with both PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) in children and adolescents 6 through 18 years of age with 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, generalized malignancy, solid organ transplantation, multiple myeloma), or certain other medical conditions (CSF leaks, cochlear implants).184 199 203 205

These experts usually recommend vaccination with PPSV23 (Pneumovax 23) alone in children and adolescents 6 through 18 years of age with chronic heart disease (especially cyanotic congenital heart disease and cardiac failure), chronic lung disease (including asthma if treated with prolonged high-dose oral corticosteroids), diabetes mellitus, alcoholism, or chronic liver disease and in those who smoke cigarettes.184 199 203 However, AAP states that sequential vaccination with both PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) can be considered in those with chronic heart disease (especially cyanotic congenital heart disease and cardiac failure), chronic lung disease (including asthma if treated with prolonged high-dose oral corticosteroids), and diabetes mellitus.205

ACIP, AAP, and other experts do not recommend routine use of PCV13 (Prevnar 13) and/or PPSV23 (Pneumovax 23) in healthy children and adolescents 6 through 18 years of age who do not have medical conditions that put them at increased risk for pneumococcal disease.100 184 199

Children and adolescents 6 through 18 years of age at increased risk for pneumococcal disease because of medical conditions who received age-appropriate vaccination with the previously available 7-valent vaccine (PCV7; Prevnar) should receive a single supplemental dose of PCV13 (Prevnar 13) since this may provide additional protection.203

When PPSV23 (Pneumovax 23) is indicated in children and adolescents 6 through 18 years of age at increased risk for pneumococcal disease because of medical conditions, a dose of the vaccine should be given to those who have not previously received a dose.184 199 203 205 In addition, ACIP, AAP, and others recommend that children and adolescents with functional or anatomic asplenia and those with immunocompromising conditions receive revaccination with a second dose of PPSV23 (Pneumovax 23) 5 years after the first dose.199 203 205 A second dose of PPSV23 (Pneumovax 23) is not considered necessary in immunocompetent individuals who have chronic heart disease, chronic lung disease, diabetes mellitus, CSF leaks, cochlear implants, alcoholism, or chronic liver disease or smoke cigarettes.199 203 205

Adults 19 through 64 years of age at increased risk for pneumococcal disease because of certain medical conditions should be vaccinated against the disease.200 202

ACIP and others recommend sequential vaccination with both PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) in adults 19 through 64 years of age with 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), or certain other medical conditions (CSF leaks, cochlear implants).200 202

These experts usually recommend vaccination with PPSV23 (Pneumovax 23) alone in adults 19 through 64 years of age with chronic heart disease (including congestive heart failure and cardiomyopathies [excluding hypertension]), chronic lung disease (COPD, emphysema, asthma), diabetes mellitus, alcoholism, chronic liver disease, or cirrhosis and in those who smoke cigarettes.169 200 202

When PCV13 (Prevnar 13) is indicated in adults 19 through 64 years of age at increased risk for pneumococcal disease because of medical conditions, a single dose of the vaccine should be given.203

When PPSV23 (Pneumovax 23) is indicated in adults 19 through 64 years of age at increased risk for pneumococcal disease because of medical conditions, a dose of the vaccine should be given to those who have not previously received a dose.169 200 202 In addition, ACIP and others recommend that those with functional or anatomic asplenia and those with immunocompromising conditions receive revaccination with a second dose of PPSV23 (Pneumovax 23) 5 years after the first dose.169 200 202 A second dose of PPSV23 (Pneumovax 23) is not considered necessary in immunocompetent individuals who have chronic heart disease, chronic lung disease, diabetes mellitus, CSF leaks, cochlear implants, alcoholism, or chronic liver disease or smoke cigarettes.169 200 202

Healthy adults 50 through 64 years of age. Although PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) are labeled by FDA for prevention of pneumonia and invasive pneumococcal disease in adults as young as 50 years of age,181 ACIP and others do not recommend routine pneumococcal vaccination in healthy adults 50 through 64 years of age who do not have medical conditions that increase the risk for pneumococcal disease.200 201 204

Adults ≥65 years of age, including immunocompetent adults, are at increased risk for pneumococcal infection and should be vaccinated against the disease with a sequential regimen of PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23).200 204

ACIP and other experts recommend that all adults ≥65 years of age who are unvaccinated or have unknown vaccination status should receive a dose of PCV13 (Prevnar 13) followed by a dose of PPSV23 (Pneumovax 23) 6–12 months later.200 204

Adults ≥65 years of age who have not received PCV13 (Prevnar 13) but previously received PPSV23 (Pneumovax 23) at <65 years of age should receive a dose of PCV13 (Prevnar 13) at least 1 year after the most recent dose of PPSV23 (Pneumovax 23).200 204 These individuals should then be revaccinated with a dose of PPSV23 (Pneumovax 23) 6–12 months after the PCV13 (Prevnar 13) dose and at least 5 years after the previous PPSV23 (Pneumovax 23) dose.200 204

Adults ≥65 years of age who have not received PCV13 (Prevnar 13) but previously received PPSV23 (Pneumovax 23) at ≥65 years of age should receive a dose of PCV13 (Prevnar 13) at least 1 year after the most recent PPSV23 (Pneumovax 23) dose.200 204 No additional doses of PPSV23 (Pneumovax 23) recommended.200 204

Adults ≥65 years of age who previously received PCV13 (Prevnar 13) at <65 years of age but have not received PPSV23 (Pneumovax 23) should receive a dose of PPSV23 (Pneumovax 23) 6–12 months after the PCV13 (Prevnar 13) dose.200

Adults ≥65 years of age who previously received PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) at <65 years of age should be revaccinated with a dose of PPSV23 (Pneumovax 23) 6–12 months after the PCV13 (Prevnar 13) dose and at least 5 years after the previous PPSV23 (Pneumovax 23) dose.200

HIV-infected individuals are at increased risk for pneumococcal disease and should be vaccinated against the disease.100 155 156 166 169 184 199 200 202 203 205

ACIP, AAP, CDC, National Institutes of Health (NIH), IDSA, Pediatric Infectious Diseases Society, and others recommend vaccination using an age-appropriate regimen of PCV13 (Prevnar 13) in all HIV-infected infants 2 through 23 months of age and an age-appropriate sequential regimen of PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) in all HIV-infected adults, adolescents, and children ≥2 years of age as soon as possible after diagnosis.100 155 156 184 199 200 203 205

PCV13 (Prevnar 13) can be used in HIV-infected adults and adolescents regardless of CD4+ T-cell count.155 200 202 Although ACIP and other experts state that PPSV23 (Pneumovax 23) also can be used in HIV-infected adults regardless of CD4+ T-cell count,200 some experts state that it may be preferable to defer administration of PPSV23 (Pneumovax 23) in HIV-infected adults and adolescents until CD4+ T-cell counts increase to >200 cells/mm3 in response to antiretroviral therapy.155

Revaccination with PPSV23 (Pneumovax 23) at least 5 years after the initial dose is recommended in HIV-infected individuals.105 155 156 169 184 202 203 205 Some experts recommend a third dose of PPSV23 (Pneumovax 23) in HIV-infected individuals at ≥65 years of age, 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 are at substantially increased risk for pneumococcal meningitis and should be vaccinated against the disease.100 184 199 200 202 203 205 Incidence of bacterial meningitis, particularly pneumococcal meningitis, is higher among children with cochlear implants than children in the general population,154 161 189 and S. pneumoniae is the most common pathogen causing bacterial meningitis in cochlear implant recipients of all ages with meningitis of known etiology.189

AAP, ACIP, CDC, and others recommend vaccination with an age-appropriate sequential regimen of PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) in all individuals ≥2 years of age who have or are scheduled to receive a cochlear implant.100 110 184 189 Vaccination should be completed at least 2 weeks prior to placement of cochlear implant.184 189

Cigarette smokers are at substantially increased risk for invasive pneumococcal disease.169 ACIP and others recommend that unvaccinated individuals who smoke cigarettes should receive a dose of PPSV23 (Pneumovax 23) and smoking cessation counseling.169 200 202 203

Internationally adopted infants and children whose immune status is uncertain should be vaccinated against pneumococcal disease according to the US recommended childhood and adolescent immunization schedules.134 These children should receive pneumococcal vaccine as age-appropriate and as indicated by the presence of underlying medical conditions that increase the risk for pneumococcal disease.134 Although pneumococcal vaccine is recommended in many countries, consider that the vaccine may not be routinely administered.134

Travelers at highest risk for pneumococcal disease include young children, the elderly, and individuals of any age with chronic medical conditions or immunosuppression.171 Although pneumococcal disease occurs worldwide, CDC makes no specific recommendations regarding pneumococcal vaccination in travelers.171

Prevention of Pneumococcal Acute Otitis Media (AOM)

PCV13 (Prevnar 13) is labeled by FDA for prevention of AOM caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in infants and children 6 weeks through 5 years of age.181 This indication is based on efficacy studies that evaluated use of the previously available 7-valent vaccine (PCV7; Prevnar);181 efficacy data not available regarding use of PCV13 (Prevnar 13) for prevention of AOM caused by the other S. pneumoniae serotypes represented in the vaccine (i.e., 1, 3, 5, 6A, 7F, 19A).181

Pneumococcal Vaccine Dosage and Administration

Administration

PCV13 (Prevnar 13): Administer only by IM injection.181

PPSV23 (Pneumovax 23): Administer only by IM or sub-Q injection.129

Do not dilute;129 181 do not mix with any other vaccine or solution.129 181

Do not administer PCV13 (Prevnar 13) concomitantly with PPSV23 (Pneumovax 23).100 184 When both vaccines indicated, administer PPSV23 (Pneumovax 23) sequentially after the recommended age-appropriate regimen of PCV13 (Prevnar 13), if possible.100 184 199 200 202 203 204 205

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23) may be given simultaneously with other age-appropriate vaccines during the same health-care visit .105 134 184 (See Interactions.) When multiple parenteral vaccines are administered during a single health-care visit, each vaccine should be given with a different syringe and at different injection sites;105 134 separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.134

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination;134 such reactions occur most frequently in adolescents and young adults.134 Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination.134 If syncope occurs, observe patient until symptoms resolve.134

IM Administration

Depending on patient age, administer IM into deltoid muscle or anterolateral thigh.134 In infants and children 6 weeks to 2 years of age, anterolateral thigh is preferred; 134 alternatively, deltoid muscle can be used in those 1 through 2 years of age if muscle mass is adequate.134 In adults, adolescents, and children ≥3 years of age, deltoid muscle is preferred.134

To ensure delivery into muscle, make IM injections at a 90° angle to the skin using a needle length appropriate for individual’s age and body mass, thickness of adipose tissue and muscle at injection site, and injection technique.134

Avoid injection into gluteal area or into or near blood vessels or nerves.134 Generally do not administer vaccines into gluteal area or any area where there may be a major nerve trunk.134 If the gluteal muscle is chosen for infants <12 months of age because of special circumstances (e.g., physical obstruction of other sites), it is essential that clinician identify anatomic landmarks prior to injection.134

PCV13 (Prevnar 13)

Administer only by IM injection.181 Contains an aluminum adjuvant;134 181 do not administer sub-Q or intradermally.134

Available in single-dose prefilled syringes.181 After attaching sterile needle to prefilled syringe, administer entire contents IM.181

Shake vigorously immediately prior to administration to provide a uniform, white suspension.181 Discard vaccine if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation. 181

PPSV23 (Pneumovax 23)

Administer by IM injection; alternatively, administer by sub-Q injection.129 (See Sub-Q Administration under Dosage and Administration.) Do not administer IV or intradermally.129

Available in single-dose prefilled syringes and in single- or multiple-dose vials.129 If single-dose prefilled syringe used, attach sterile needle according to manufacturer's instructions and administer entire contents IM.129 If single- or multiple-dose vial used, withdraw 0.5 mL of vaccine from vial using sterile needle and syringe free of preservatives, antiseptics, and detergents and administer IM.129

Should be a clear colorless solution;129 discard vaccine if it contains particulates or appears discolored.129

Sub-Q Administration

Make sub-Q injections into upper-outer triceps area or anterolateral thigh.129 134 In adults, adolescents, and children ≥2 years of age, upper-outer triceps area preferred.134

To ensure appropriate delivery, administer sub-Q injections at a 45° angle using a 5/8 inch, 23- to 25-gauge needle.134

PPSV23 (Pneumovax 23)

Administer by sub-Q injection; alternatively, administer by IM injection.129 (See IM Administration under Dosage and Administration.) Do not administer IV or intradermally.129

Available in single-dose prefilled syringes and in single- or multiple-dose vials.129 If single-dose prefilled syringe used, attach sterile needle according to manufacturer's instructions and administer entire contents sub-Q.129 If single- or multiple-dose vial used, withdraw 0.5 mL of vaccine from vial using sterile needle and syringe free of preservatives, antiseptics, and detergents and administer sub-Q.129

Should be a clear colorless solution;129 discard vaccine if it contains particulates or appears discolored.129

Dosage

Dosage schedule (i.e., number of doses) and specific pneumococcal vaccine administered (PCV13 [Prevnar 13] and/or PPSV23 [Pneumovax 23]) depend on individual’s age, immunization status, and risk factors for pneumococcal disease.100 105 129 181 184 Follow age-appropriate recommendations for the specific preparation used.129 181

Medically stable preterm infants (i.e., gestational age <37 weeks), regardless of birthweight, should be vaccinated at usual chronologic age using usual dosage and dosage schedules.134

Interruptions resulting in an interval between doses longer than recommended should not interfere with final immunity achieved; there is no need to administer additional doses or start the vaccination series over.134

Pediatric Patients

Infants 2 through 23 Months of Age (PCV13 [Prevnar 13])
PCV13 (Prevnar 13)
IM

Each dose is 0.5 mL.181

Routine immunization in early infancy (i.e., initiated before 6 months of age): Give series of 4 doses of PCV13 (Prevnar 13).100 181 184 199 ACIP, AAP, and others recommend that doses be given at 2, 4, 6, and 12 through 15 months of age.100 181 184 199 Initial dose may be given as early as 6 weeks of age.100 181 184 199 Minimum interval between first 3 doses is 4 weeks;100 181 184 199 minimum interval between third and fourth dose is 8 weeks.100 181 184 199

Catch-up vaccination in previously unvaccinated infants 7 through 11 months of age: Give 2 doses of PCV13 (Prevnar 13) at least 4 weeks apart followed by a third dose after 12 months of age and at least 8 weeks (2 months) after second dose.181 199 A fourth dose is unnecessary in healthy infants unless all previous doses were given at <12 months of age.199

Catch-up vaccination in previously unvaccinated infants 12 through 23 months of age: Give 2 doses of PCV13 (Prevnar 13) at least 8 weeks (2 months) apart.181 199 A third dose is unnecessary if second dose was given at ≥24 months of age.199

Infants 14 through 23 months of age who previously received age-appropriate vaccination with the previously available 7-valent vaccine (PCV7; Prevnar) but have not received any PCV13 (Prevnar 13) dose: Give a single supplemental dose of PCV13 (Prevnar 13).199

Healthy Children 2 through 5 Years of Age (PCV13; Prevnar 13)
PCV13 (Prevnar 13)
IM

Single 0.5-mL dose.181

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): Give a single dose of PCV13 (Prevnar 13).100 181 184 199 Additional doses unnecessary in healthy children if PCV13 (Prevnar 13) dose given at ≥2 years of age.199

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 age-appropriate number of doses of PCV13 (Prevnar 13 ) and/or PCV7 (Prevnar): Give a single dose of PCV13 (Prevnar 13) at least 8 weeks after most recent dose of PCV13 (Prevnar 13) or PCV7 (Prevnar).181 184 199

Children 2 through 5 years of age who received age-appropriate vaccination with the previously available 7-valent vaccine (PCV7; Prevnar) but have not received any doses of PCV13 (Prevnar 13 ): Give a single supplemental dose of PCV13 (Prevnar 13).199

Children 2 through 5 Years of Age at Increased Risk (PCV13; Prevnar 13 and PPSV23; Pneumovax 23)
PCV13 (Prevnar 13)
IM

Each dose is 0.5 mL.181

Previously received <3 doses of PCV13 (Prevnar 13) or <3 doses of previously available 7-valent vaccine (PCV7; Prevnar): Give 2 doses of PCV13 (Prevnar 13) at least 8 weeks apart.100 129 184 199

Previously received a total of 3 doses of PCV given as PCV13 (Prevnar 13) and/or PCV7 (Prevnar) or received 4 doses or other age-appropriate vaccination series of PCV7 (Prevnar): Give a single dose of PCV13 (Prevnar 13).100 184 199

PPSV23 (Pneumovax 23)
IM or Sub-Q

Single 0.5-mL dose.129

Has not previously received PPSV23 (Pneumovax 23): Give a single dose of PPSV23 (Pneumovax 23).100 129 184 199

Sequential Administration
IM or Sub-Q

Has not previously received PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): Give PCV13 (Prevnar 13) first and give PPSV23 (Pneumovax 23) at least 8 weeks after most recent PCV13 (Prevnar 13) dose.199

Has not previously received PCV13 (Prevnar 13) but previously received PPSV23 (Pneumovax 23): Give PCV13 (Prevnar 13) at least 8 weeks after most recent PPSV23 (Pneumovax 23) dose.199

Do not give PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) concurrently.199

Children and Adolescents 6 through 18 Years of Age at Increased Risk (PCV13; Prevnar 13 and PPSV23; Pneumovax 23)
PCV13 (Prevnar 13)
IM

Single 0.5-mL dose.181

Has not previously received PCV13 (Prevnar 13): Give a single dose of PCV13 (Prevnar 13).199 203 205

PPSV23 (Pneumovax 23)
IM or Sub-Q

Each dose is 0.5 mL.129

Has not previously received PPSV23 (Pneumovax 23): Give a single dose of PPSV23 (Pneumovax 23).199 203 205

Functional or anatomic asplenia or immunocompromising conditions: Revaccinate with a second dose of PPSV23 (Pneumovax 23) 5 years after first PPSV23 (Pneumovax 23) dose and at least 8 weeks after most recent PCV13 (Prevnar 13) dose.199 203 205

HIV-infected: Revaccinate with a second dose of PPSV23 (Pneumovax 23) 5 years after first PPSV23 (Pneumovax 23) dose and at least 8 weeks after PCV13 (Prevnar 13).156 199

Sequential Administration
IM or Sub-Q

Has not previously received PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): Give PCV13 (Prevnar 13) first and give PPSV23 (Pneumovax 23) at least 8 weeks after most recent PCV13 (Prevnar 13) dose.199 203 205

Has not previously received PCV13 (Prevnar 13) but previously received PPSV23 (Pneumovax 23): Give PCV13 (Prevnar 13) at least 8 weeks after most recent PPSV23 (Pneumovax 23) dose.199 203 205

If second dose of PPSV23 (Pneumovax 23) indicated, give at least 8 weeks after PCV13 (Prevnar 13) and at least 5 years after previous PPSV23 (Pneumovax 23) dose.156 199 203 205

Do not give PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) concurrently.199

Adults

Adults 19 through 64 Years of Age at Increased Risk (PCV13; Prevnar 13 and PPSV23; Pneumovax 23)
PCV13 (Prevnar 13)
IM

Single 0.5-mL dose.181

Has not previously received PCV13 (Prevnar 13): Give a single dose of PCV13 (Prevnar 13).200 202

PPSV23 (Pneumovax 23)
IM or Sub-Q

Each dose is 0.5 mL.129

Has not previously received PPSV23 (Pneumovax 23): Give a single dose of PPSV23 (Pneumovax 23).200 202

Functional or anatomic asplenia or immunocompromising conditions: Revaccinate with a second dose of PPSV23 (Pneumovax 23) 5 years after first PPSV23 (Pneumovax 23) dose and at least 8 weeks after PCV13 (Prevnar 13).200 202

HIV-infected adults: Revaccinate with a second dose of PPSV23 (Pneumovax 23) 5 years after first PPSV23 (Pneumovax 23) dose and at least 8 weeks after PCV13 (Prevnar 13).155 200 202 Some experts recommend a third dose of PPSV 23 (Pneumovax 23) at ≥65 years of age, provided it has been at least 5 years since previous PPSV23 (Pneumovax 23) dose.155 No more than 3 lifetime doses of PPSV23 (Pneumovax 23) recommended.155

Sequential Administration
IM or Sub-Q

Has not previously received PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): Give PCV13 (Prevnar 13) first and give PPSV23 (Pneumovax 23) at least 8 weeks after most recent PCV13 (Prevnar 13) dose.200 202

Has not previously received PCV13 (Prevnar 13) but previously received PPSV23 (Pneumovax 23): Give PCV13 (Prevnar 13) at least 1 year after most recent PPSV23 (Pneumovax 23) dose.200 202

Has previously received PCV13 (Prevnar 13) but has not previously received PPSV23 (Pneumovax 23): Give PPSV23 (Pneumovax 23) at least 8 weeks after PCV13 (Prevnar 13).200 202

If additional dose of PPSV23 (Pneumovax 23) indicated, give at least 8 weeks after PCV13 (Prevnar 13) and at least 5 years after previous PPSV23 (Pneumovax 23) dose.155 200 202

Do not give PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) concurrently.200 202

Healthy Adults 50 through 64 Years of Age (PCV13; Prevnar 13 and PPSV23; Pneumovax 23)
PCV13 (Prevnar 13)
IM

Single 0.5-mL dose.181

ACIP and other experts do not recommend routine pneumococcal vaccination in healthy adults 50 through 64 years of age who do not have medical conditions that increase risk for pneumococcal disease.200 201 204

PPSV23 (Pneumovax 23)
IM or Sub-Q

Single 0.5-mL dose.129

ACIP and other experts do not recommend routine pneumococcal vaccination in healthy adults 50 through 64 years of age who do not have medical conditions that increase risk for pneumococcal disease.200 201 204

Adults ≥65 Years of Age (PCV13; Prevnar 13 and PPSV23; Pneumovax 23)
PCV13 (Prevnar 13)
IM

Single 0.5-mL dose.181

Unvaccinated or unknown vaccination status: Give a single dose of PCV13 (Prevnar 13).200 204

PPSV23 (Pneumovax 23)
IM or Sub-Q

Each dose is 0.5 mL.129

Unvaccinated or unknown vaccination status: Give a single dose of PPSV23 (Pneumovax 23).169 200 204

Received a dose of PPSV23 (Pneumovax 23) at <65 years of age for any indication: Revaccinate with another dose of PPSV23 (Pneumovax 23) at 65 years of age, provided it has been at least 5 years since previous dose.169 200 204

Sequential Administration
IM or Sub-Q

Has not previously received PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23) or has unknown vaccination status: Give PCV13 (Prevnar 13) first and give PPSV23 (Pneumovax 23) 6–12 months after PCV13 (Prevnar 13) dose.200 204 If PPSV23 (Pneumovax 23) cannot be given 6–12 months after PCV13 (Prevnar 13) dose, give as soon as possible after that time;200 204 minimum interval between PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) is 8 weeks.200 204

Has not previously received PCV13 (Prevnar 13) but previously received PPSV23 (Pneumovax 23) at <65 years of age: Give PCV13 (Prevnar 13) dose at least 1 year after most recent PPSV23 (Pneumovax 23) dose.200 204 Then, revaccinate with another dose of PPSV23 (Pneumovax 23) 6–12 months after PCV13 (Prevnar 13) dose and at least 5 years after most recent PPSV23 (Pneumovax 23) dose.200 204

Has not previously received PCV13 (Prevnar 13) but previously received PPSV23 (Pneumovax 23) at ≥65 years of age: Give PCV13 (Prevnar 13) dose at least 1 year after most recent PPSV23 (Pneumovax 23) dose.200 204

Previously received PCV13 (Prevnar 13) at <65 years of age but has not previously received PPSV23 (Pneumovax 23): Give PPSV23 (Pneumovax 23) dose 6–12 months after PCV13 (Prevnar 13) dose.200

Previously received PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) at <65 years of age: Give another dose of PPSV23 (Pneumovax 23) 6–12 months after PCV13 (Prevnar 13) dose and at least 5 years after most recent PPSV23 (Pneumovax 23) dose.200

Do not give PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) concurrently.200 204

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations.

Cautions for Pneumococcal Vaccine

Contraindications

  • PCV13 (Prevnar 13): Severe allergic reaction (e.g., anaphylaxis) to any ingredient in the formulation or any vaccine containing diphtheria toxoid.181

  • PPSV23 (Pneumovax 23): Anaphylactic/anaphylactoid or severe allergic reaction to any ingredient in the formulation.129

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Allergic reactions, including anaphylactic/anaphylactoid reactions,129 181 rash,129 181 urticaria,129 181 bronchospasm,181 serum sickness,129 facial edema,181 erythema multiforme,129 181 and angioedema,129 181 reported with pneumococcal vaccines.

Take all known precautions to prevent adverse reactions, including review of the patient’s history with respect to health status and possible sensitivity to the vaccine or similar vaccines.184

Epinephrine and other appropriate agents should be readily available in case anaphylaxis or other serious allergic reaction occurs.181

General Precautions

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.129 134 181 Consider possibility that immune response to vaccines may be diminished or suboptimal in these individuals.129 134 181

If possible, administer pneumococcal vaccine at least 2 weeks prior to initiation of immunosuppressive therapy or defer until at least 3 months after immunosuppressive therapy is discontinued.134 (See Specific Drugs under Interactions.)

Since antibody response may be impaired after splenectomy, ACIP and AAP recommend that vaccination with PCV13 (Prevnar 13) and/or PPSV23 (Pneumovax 23) be completed at least 2 weeks prior to elective splenectomy, if possible.105 134 184

Concomitant Illness

A decision to administer or delay administration of vaccination in an individual with a current or recent acute illness depends on the severity of symptoms and etiology of the illness.129 134

ACIP, AAP, and others state that minor acute illness, such as mild diarrhea or mild upper respiratory infection (with or without fever), usually does not preclude vaccination.105 134 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.105 134

Manufacturer of PPSV23 (Pneumovax 23) states defer vaccination in individuals with moderate or severe illness.129

Manufacturer of PPSV23 (Pneumovax 23) states administer 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

May not protect all vaccine recipients against pneumococcal disease.129 181

Will not prevent pneumococcal infection caused by S. pneumoniae serotypes not represented in the vaccines.129 181

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

May not prevent infection in individuals who do not achieve protective antibody titers;129 181 minimum titer of serum anticapsular antibody needed to confer immunity against S. pneumoniae serotypes not established.129 181

Manufacturer of PCV13 (Prevnar 13) states effectiveness of the vaccine administered <5 years after PPSV23 (Pneumovax 23) not known.181

Vaccination with PCV13 (Prevnar 13) and/or PPSV23 (Pneumovax 23) does not replace prophylaxis with penicillin (or other appropriate anti-infectives) for prevention of pneumococcal disease in patients with functional or anatomic asplenia (e.g., sickle cell disease).105 129 If such prophylaxis indicated, continue regardless of vaccination status.105 129

Although ACIP and AAP recommend use of PPSV23 (Pneumovax 23) in individuals with CSF leaks,202 203 the manufacturer states the vaccine may not be effective in preventing pneumococcal meningitis in patients with chronic CSF leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.129

Antigens in PCV13 (Prevnar 13) are conjugated to a carrier protein;181 conjugated antigens are more immunogenic in infants and young children than the unconjugated antigens in PPSV23 (Pneumovax 23).100 134 184 (See Actions.)

Duration of Immunity

Duration of protection after age-appropriate vaccination with PCV13 (Prevnar 13) not known.181 Because the capsular antigens contained in PCV13 (Prevnar 13) are conjugated to a T-cell dependent carrier protein (diphtheria CRM197 protein), this may result in improved primary response to the antigens.134 166 Revaccination with PCV13 (Prevnar 13) after age-appropriate vaccination not currently recommended.166 199 200

Duration of protection after administration of PPSV23 (Pneumovax 23) not fully determined.155 169 Because capsular antigens in PPSV23 (Pneumovax 23) are unconjugated, the vaccine antigens do not induce long-lasting immunity or an anamnestic response after subsequent exposure to the same antigens.134 166 Although routine revaccination of immunocompetent individuals who previously received a dose of PPSV23 (Pneumovax 23) not recommended,129 166 169 revaccination indicated in individuals with certain medical conditions that put them at increased risk for pneumococcal disease, provided at least 5 years have elapsed since the last dose.100 129 155 156 166 169 184 199 200 202 203 205 Revaccination with PPSV23 (Pneumovax 23) also recommended in adults ≥65 years of age who received a dose of the vaccine at a younger age, provided at least 5 years have elapsed since the previous dose.169 200 204 (See Dosage under Dosage and Administration.)

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees.134

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.134 (See Storage under Stability.)

Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.134 If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable.134

Specific Populations

Pregnancy

PCV13 (Prevnar 13): Category B.181 No evidence of fetal harm or impaired fertility in animal studies using the vaccine at doses 20 times the human dose;181 no adequate and well-controlled studies in pregnant women.181 Use during pregnancy only when clearly needed.181

PPSV23 (Pneumovax 23): Category C.129 No animal reproduction studies; not known whether the vaccine can cause fetal harm or affect reproductive capacity.129 Use during pregnancy only when clearly needed.129

ACIP, AAP, and others state PPSV23 (Pneumovax 23) may be used when indicated in pregnant women at increased risk for pneumococcal disease.105 200

AAP states that pneumococcal vaccination generally should be deferred during pregnancy, but risk of severe pneumococcal disease in a pregnant woman who has not received PPSV23 (Pneumovax 23) within the previous 5 years and has underlying medical conditions that increase risk of invasive pneumococcal disease should prompt immunization with PPSV23 (Pneumovax) 23.105

Lactation

Not known whether antigens contained in PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23) are distributed into milk.129 181

Use with caution in nursing women.129 181

Because inactivated vaccines do not multiply within the body, ACIP states they should not pose any unusual problems for lactating women or their infants.134

Pediatric Use

PCV13 (Prevnar 13): Safety and efficacy not established in infants <6 weeks of age.181 Manufacturer states immune response to the vaccine in preterm infants not adequately studied to date.181 Because apnea reported following IM vaccination in some infants born prematurely, base decisions regarding use of IM vaccines in such infants on consideration of the individual infant’s medical status and potential benefits and possible risks of vaccination.181

PPSV23 (Pneumovax 23): Safety and efficacy not established in children <2 years of age.129 Children <2 years of age may not have a satisfactory antibody response to PPSV23 (Pneumovax 23).129

Geriatric Use

PCV13 (Prevnar 13): Antibody responses in adults ≥65 years of age are lower compared with those in adults 50 through 59 years of age;181 no overall differences in safety between adults ≥65 years of age compared to adults 50 through 59 years of age.181

PPSV23 (Pneumovax 23): Rate of vaccine-related systemic adverse effects was higher following revaccination than primary vaccination in those ≥65 years of age.129 Possibility that some older adults may exhibit increased frequency and/or greater severity of adverse reactions cannot be ruled out.129

Common Adverse Effects

PCV13 (Prevnar 13): Local reactions at injection site (e.g., pain/tenderness, swelling, erythema, limitation of arm movement), fever, headache, fatigue, muscle or joint pain, chills, rash, decreased appetite, irritability, increased sleep, decreased sleep.181

PPSV23 (Pneumovax 23): Local reactions at injection site (e.g., pain/soreness/tenderness, swelling/induration, erythema), headache, asthenia/fatigue, myalgia.129

Interactions for Pneumococcal Vaccine

Other Vaccines

Although specific studies may not be available evaluating concurrent administration with each antigen, simultaneous administration with other age-appropriate vaccines, including live virus vaccines, toxoids, or inactivated or recombinant vaccines, during the same health-care visit generally is not expected to affect immunologic responses or adverse reactions to any of the preparations.105 134 Immunization with pneumococcal vaccines can be integrated with immunization against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib), hepatitis A, hepatitis B, human papillomavirus (HPV), influenza, measles, mumps, rubella, meningococcal disease, poliomyelitis, rotavirus, and varicella.105 134 However, each parenteral vaccine should be administered using a different syringe and different injection site.105 134

Specific Drugs

Drug

Interaction

Comments

Acetaminophen

Infants receiving PCV13 (Prevnar 13): Prophylactic acetaminophen (first dose given at time of each vaccine dose and additional doses given at 6- to 8-hour intervals) reduced antibody response to some pneumococcal vaccine serotypes after third vaccine dose compared with antibody responses among infants who received antipyretics only as needed for treatment;181 reduced antibody responses not observed after fourth dose of PCV13 in those receiving prophylactic acetaminophen181

ACIP states evidence does not support use of antipyretics before or at time of vaccination, but antipyretics can be used for treatment of fever and local discomfort occurring following vaccination134

Diphtheria and tetanus toxoids and pertussis vaccine adsorbed (DTaP)

PCV13 (Prevnar 13): Has been administered concurrently with fixed-combination vaccine containing DTaP (DTaP-HepB-IPV; Pediarix) in infants at 2, 4, and 6 months of age181

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with DTaP (using different syringes and different injection sites)105 134

Haemophilus b (Hib) vaccine

PCV13 (Prevnar 13): Has been administered concurrently with Hib vaccine in infants at 2, 4, and 6 months of age181

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with Hib vaccine (using different syringes and different injection sites)105 134

Fixed-combination vaccine containing Hib 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 (using different syringes and different injection sites)177

Hepatitis A (HepA) vaccine

PCV13 (Prevnar 13): Has been administered concurrently with HepA vaccine in infants 12–15 months of age181

Concomitant administration of previously available 7-valent vaccine (PCV7; Prevnar) and HepA vaccine (Havrix) in infants 15 months of age did not result in decreased immune response to any pneumococcal serotypes contained in PCV7172

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with HepA vaccine (using different syringes and different injection sites)105 134

Hepatitis B (HepB) vaccine

PCV13 (Prevnar 13): Has been administered concurrently with fixed-combination vaccine containing HepB (DTaP-HepB-IPV; Pediarix) in infants at 2, 4, and 6 months of age181

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with HepB vaccine (using different syringes and different injection sites)105 134

Immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV]) or specific immune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG])

No evidence that immune globulin preparations interfere with immune response to pneumococcal vaccine134

Pneumococcal vaccine may be administered simultaneously with or at any interval before or after immune globulin or specific hyperimmune globulin134

Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)

Potential for suboptimal antibody response to vaccines105 129 134 181

Pneumococcal vaccine may be administered at least 2 weeks before initiation of immunosuppressive therapy or deferred until ≥3 months after therapy discontinued129 134

If administered during chemotherapy, revaccinate after immune competence is regained134

Influenza vaccine

Parenteral inactivated influenza vaccine: Concomitant administration with PCV13 (Prevnar 13) in adults ≥50 years of age did not increase frequency of local adverse effects, but increases in some solicited systemic reactions were reported compared with administration of either vaccine alone;181 concomitant administration with PPSV23 (Pneumovax 23) has resulted in increased incidence of adverse local and systemic effects compared with administration of influenza vaccine alone;145 146 ACIP states concomitant administration of these vaccines results in satisfactory antibody responses without increasing incidence or severity of adverse reactions134

Intranasal live influenza vaccine: Concomitant administration with pneumococcal vaccines not studied179

Parenteral inactivated influenza vaccine: May be administered concomitantly (using different syringes and different injection sites) with PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23)105 134

Intranasal live influenza vaccine: May be administered simultaneously with or at any time before or after PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23) 134 178

Measles, mumps, and rubella vaccine (MMR)

PCV13 (Prevnar 13): Has been administered concurrently with MMR or fixed-combination vaccine containing MMR and varicella vaccine (MMRV; ProQuad) in infants 12–15 months of age181

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with MMR or MMRV (using different syringes and different injection sites)105 134

Meningococcal vaccine

PCV13 (Prevnar 13): Manufacturer states data insufficient to assess concurrent administration with meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV4-D, MenACWY-D; Menactra) or meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine (MCV4-CRM, MenACWY-CRM; Menveo) in children and adolescents181

MCV4-D (Menactra): Concurrent administration with PCV7 (Prevnar) in infants 12 months of age resulted in decreased immune response to some of the pneumococcal vaccine serotypes compared with administration of PCV7 without MCV4-D108 177

MCV4-CRM (Menveo): Concurrent administration with PCV7 (Prevnar) in infants at 2, 4, 6, and 12 months of age resulted in possible interference with antibody response to 2 of the pneumococcal vaccine serotypes at 1 month after third dose, but no evidence of immune interference to any pneumococcal vaccine serotypes after fourth dose176

PCV13 (Prevnar 13): Do not administer MCV4-D (Menactra) concurrently or within 4 weeks after PCV13;105 177 to avoid possible interference with immune response in infants and children with anatomic or functional asplenia, complete PCV13 (Prevnar 13) vaccination series first and then administer MCV4-D (Menactra) at least 4 weeks later177

PPSV23 (Pneumovax 23): May be administered concurrently with MCV4-D (Menactra) or meningococcal polysaccharide vaccine (MPSV4; Menomune) using different syringes and different injection sites105

Fixed-combination vaccine containing Hib 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 (using different syringes and different injection sites)177

Poliovirus vaccine inactivated (IPV)

PCV13 (Prevnar 13): Has been administered concurrently with fixed-combination vaccine containing IPV (DTaP-HepB-IPV; Pediarix) in infants at 2, 4, and 6 months of age181

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with IPV (using different syringes and different injection sites)105 134

Rotavirus vaccine

Concomitant administration of rotavirus vaccine live (Rotarix, RotaTeq) with previously available 7-valent vaccine (PCV7; Prevnar) did not result in reduced immune responses to either vaccine170 174 175

PCV13 (Prevnar 13): May be administered concurrently with rotavirus vaccine105 134

Varicella vaccine

PCV13 (Prevnar 13): Has been administered concurrently with varicella vaccine (Varivax) or fixed-combination vaccine containing MMR and varicella vaccine (MMRV; ProQuad) in infants 12–15 months of age181

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with varicella vaccine or MMRV (using different syringes and different injection sites)105 134

Zoster vaccine

PPSV23 (Pneumovax 23): Concurrent administration with zoster vaccine in adults ≥60 years of age resulted in substantially reduced antibody responses to zoster vaccine compared with that reported when the vaccines were administered 4 weeks apart129 180 186

Manufacturer of zoster vaccine and PPSV23 (Pneumovax 23) states consider giving the 2 vaccines at least 4 weeks apart129 186

Stability

Storage

Parenteral

Injection, for IM Use (PCV13; Prevnar 13)

2–8°C;181 after shipping, may arrive at temperatures ranging from 2–25°C.181

Do not freeze.134 181 Since it contains an aluminum adjuvant,134 181 exposure to freezing temperatures causes irreversible loss of vaccine potency.134

Does not contain thimerosal or any other preservatives.100 184

Injection, for Sub-Q or IM Use (PPSV23; Pneumovax 23)

2–8°C.129

Does not contain thimerosal, but does contain phenol 0.25% as a preservative.105 129

Actions

  • PCV13 (Prevnar 13): Sterile suspension containing purified capsular polysaccharide antigens extracted from 13 serotypes of S. pneumoniae (i.e., 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and individually conjugated to diphtheria CRM197 protein.181 184

  • PPSV23 (Pneumovax 23): Sterile solution containing purified capsular polysaccharide antigens extracted from 23 serotypes of S. pneumoniae (i.e., 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F).129

  • Principal mode of transmission of pneumococcal infection is the respiratory route, most commonly through close personal contact with an individual with invasive pneumococcal disease or direct exposure to nasopharyngeal secretions from an infected individual or by autoinoculation in persons carrying the bacteria in their upper respiratory tract.105 166 S. pneumoniae is a common cause of AOM, sinusitis, and pneumonia and can cause invasive disease, including bacteremia and meningitis.105 Infection with S. pneumoniae has been a leading cause of bacterial meningitis in the US among children <5 years of age.166

  • Surveillance data from 2008 indicated that the 13 serotypes contained in PCV13 (Prevnar 13) accounted for approximately 61% of US cases of invasive pneumococcal disease occurring in children <5 years of age; serotype 19A accounted for 43% of cases.184 Surveillance data from 2007–2009 indicated that 49% of cases of invasive pneumococcal disease in immunocompromised children and adolescents 6 through 18 years of age were caused by serotypes contained in PCV13 (Prevnar 13); an additional 23% of cases were caused by serotypes contained in PPSV23 (Pneumovax 23).203 For adults, surveillance data from 2008 indicated that the 13 serotypes contained in PCV13 (Prevnar 13) accounted for 44–53% of invasive pneumococcal disease and the 23 serotypes contained in PPSV23 (Pneumovax 23) accounted for 66–78% of cases.169 Data from 2010 indicated that 50% of cases of invasive pneumococcal disease in immunocompromised adults were caused by serotypes contained in PCV13 (Prevnar 13); an additional 21% of cases were caused by serotypes contained in PPSV23 (Pneumovax 23).202

  • Pneumococcal vaccines stimulate active immunity to pneumococcal infection by inducing production of antibodies specific for each pneumococcal capsular type represented in the vaccines.129 181 Minimum titers of anticapsular antibodies needed to confer protection against S. pneumoniae serotypes contained in the vaccines not established.129 181

  • Conjugated antigens contained in PCV13 (Prevnar 13) are more immunogenic in infants and young children than the unconjugated antigens contained in PPSV23 (Pneumovax 23).100 184 Conjugated antigens elicit a T-cell dependent immune 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 Unconjugated antigens contained in PPSV23 (Pneumovax 23) do not induce long-lasting immunity or an anamnestic response after subsequent exposure to the same antigens.134 166

  • Following primary vaccination with PCV13 (Prevnar 13) in healthy infants (doses given at 2, 4, 6, and 12–15 months of age), 87–98% had anticapsular IgG antibody concentrations ≥0.35 mcg/mL against 12 of the 13 pneumococcal serotypes in the vaccine 1 month after the third dose;181 184 64% achieved an antibody concentration ≥0.35 mcg/mL against serotype 3.181 184 Antibody concentrations 1 month after the fourth dose were higher for all 13 serotypes compared with concentrations 1 month after the third dose.181 184

  • Following a single dose of PPSV23 (Pneumovax 23) in healthy adults, >80% develop antibodies specific for the pneumococcal capsular types in the vaccine, usually within 2–3 weeks.166 There is some evidence that the overall protective effectiveness of PPSV23 (Pneumovax 23) against invasive pneumococcal infection caused by serotypes included in the vaccine is 57% in individuals ≥6 years of age, 65–84% among specific patient groups (e.g., those with diabetes mellitus, coronary vascular disease, congestive heart failure, COPD, anatomic asplenia), and 75% in immunocompetent adults ≥65 years of age.129 Antibody response to the unconjugated antigens in PPSV23 (Pneumovax 23) generally is poor or inconsistent in infants <2 years of age.129 166

Advice to Patients

  • Prior to administration of each vaccine dose, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient’s legal representative (VISs are available at ).129 167 168 181

  • 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 completing the primary immunization series or catch-up vaccination with the age-appropriate number of doses of PCV13 (Prevnar 13) in infants 2 through 23 months of age and healthy children 2 through 5 years of age.100 167 181 184 199

  • Advise patient and/or patient's parent or guardian of the importance of completing age-appropriate vaccination with PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) in children ≥2 years of age, adolescents, and adults 19 through 64 years of age who are at increased risk for pneumococcal disease because of certain medical conditions.100 181 184 199 200 202 203 205

  • Advise patient and/or patient's guardian of the importance of routine vaccination with PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) in adults ≥65 years of age.169 200 204

  • Advise patient and/or patient’s parent or guardian that pneumococcal vaccines may not provide protection in all vaccinees.129 181

  • Importance of informing clinicians of any history of allergic reactions to pneumococcal vaccines (i.e., PCV7, PCV13, PPSV23) 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 .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.)

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

Injection

Prevnar 13

Wyeth

Pneumococcal Vaccine, Polyvalent (PPSV23)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection

Pneumovax 23

Merck

AHFS DI Essentials. © Copyright, 2004-2015, Selected Revisions June 2, 2015. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

100. American Academy of Pediatrics Committee on Infectious Diseases. Policy statement recommendations for the prevention of Streptococcus pneumoniae infections in infants and children: use of 13-valent pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPSV23). Pediatrics. 2010; 126:186-90. [PubMed 20498180]

105. American Academy of Pediatrics. 2012 Red Book: Report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012.

108. Sanofi Pasteur. Menactra (meningococcal [groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine) prescribing 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. [IDIS 227924] [PubMed 3560380]

110. Centers for Disease Control and Prevention. Pneumococcal vaccination for cochlear implant candidates and recipients: Updated recommendations of the Advisory Committee on Immunization Practice. MMWR Morb Mortal Wkly Rep. 2003; 52:739-40. [PubMed 12908457]

111. Food and Drug Administration. Public health web notification: cochlear implant recipients may be at greater risk for meningitis. Updated October 17, 2002.

114. Witt DJ, Craven DE, McCabe WR. Bacterial infections in adult patients with the acquired immune deficiency syndrome (AIDS) and AIDS-related complex. Am J Med. 1987; 82:900-6. [PubMed 3578359]

124. Giebink GS, Le CT, Schiffman G et al. Decline of serum antibody in splenectomized children after vaccination with pneumococcal capsular polysaccharides. J Pediatr. 1984; 105:576-82. [IDIS 190929] [PubMed 6481533]

125. Weintrub PS, Schiffman G, Addiego JE Jr et al. Long-term follow-up and booster immunization with polyvalent pneumococcal polysaccharide in patients with sickle cell anemia. J Pediatr. 1984; 105:261-3. [IDIS 188413] [PubMed 6747758]

126. Mufson MA, Krause HE, Schiffman G. Long-term persistence of antibody following immunization with pneumococcal polysaccharide vaccine (41643). Proc Soc Exp Biol Med. 1983; 173:270-5. [IDIS 171144] [PubMed 6867005]

129. Merck. Pneumovax 23 (pneumococcal vaccine polyvalent) prescribing information. Whitehouse Station, NJ; 2014 May.

134. National Center for Immunization and Respiratory Diseases. General Recommendations on Immunization --- Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Surveill Summ. 2011; 60:1-64. [PubMed 21293327]

139. Keller DW, Breiman RF. Preventing bacterial respiratory tract infections among persons infected with human immunodeficiency virus. Clin Infect Dis. 1995; 21(Suppl 1):S77-83. [IDIS 352667] [PubMed 8547517]

140. Swiatlo E, Benton K, Brilles DE. Pneumococcal vaccine response in human 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.

146. Honkanen PO, Keistinen T, Kivelä SL. Reactions following administration of influenza vaccine alone or with pneumococcal vaccine to the elderly. Arch Intern Med. 1996;156:205-8. [IDIS 361434] [PubMed 8546555]

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

150. Hausdorff WP, Yothers G, Dagan R et al. Multinational study of pneumococcal serotypes causing acute otitis media in children. Pediatr Infect Dis J. 2002; 21:1008-16. [PubMed 12442021]

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. [IDIS 459241] [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. [IDIS 501102] [PubMed 12842372]

154. Reefhuis J, Honein MA, Whitney CG et al. Risk of bacterial meningitis in children with cochlear implants. N Engl J Med. 2003; 349:435-45. [PubMed 12890842]

155. Panel on Opportunistic Infections in HIV-infected Adults and Adolescents. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America (May 7, 2013). Updates may be available at HHS AIDS Information (AIDSinfo) website.

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 (Nov 6, 2013). Updates may be available at HHS AIDS Information (AIDSinfo) website.

161. Food and Drug Administration. Public health web notification: risk of bacterial meningitis in children with cochlear implants. Updated July 31, 2003. From FDA website.

166. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. 12th ed. Washington DC: Public Health Foundation; 2012:233-48. Available at CDC website.

167. Centers for Disease Control and Prevention. Pneumococcal conjugate vaccine information statement (interim). 2013 Feb 27. From CDC website.

168. Centers for Disease Control and Prevention. Pneumococcal polysaccharide vaccine information statement. 2009 Oct 6. From CDC website.

169. Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices. Updated recommendations for prevention of invasive pneumococcal disease among adults using the 23-valent pneumococcal polysaccharide vaccine (PPSV23). MMWR Morb Mortal Wkly Rep. 2010; 59:1102-6. [PubMed 20814406]

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

171. Centers for Disease Control and Prevention. CDC health information for international travel, 2014. Atlanta, GA: US Department of Health and Human Services. Updates available from CDC website.

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.

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.

177. Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, CDC. Prevention and control of meningococcal disease. MMWR Recomm Rep. 2013; 62(RR-2):1-22. [PubMed 23515099]

178. Influenza Division, National Center for Immunization and Respiratory Diseases, CDC. Prevention and control of seasonal influenza with vaccines. MMWR Recomm Rep. 2013; 62(RR-07):1-43.

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

180. Macintyre CR, Egerton T, McCaughey M et al. Concomitant administration of zoster and pneumococcal vaccines in adults ≥60 years old. Hum Vaccin. 2010; 6:894-902. [PubMed 20980796]

181. Wyeth Pharmaceuticals. Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) prescribing information. Philadelphia, PA; 2015 Jan.

184. Nuorti JP, Whitney CG, Centers for Disease Control and Prevention (CDC). Prevention of pneumococcal disease among infants and children - use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine - recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2010; 59(RR-11):1-18. [PubMed 21150868]

185. Alexa PL. Dear health care professional letter regarding important update on the transition to Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]). New York, NY: Pfizer Inc; 2010 Jul.

186. Merck & Co. Zostavax (zoster vaccine live suspension for subcutaneous injection) prescribing information. Whitehouse Station, NJ; 2014 Feb.

187. Pfizer, New York, NY: Personal communication.

188. Dinleyici EC. Current status of pneumococcal vaccines: lessons to be learned and new insights. Expert Rev Vaccines. 2010; 9:1017-22. [PubMed 20822344]

189. Rubin LG, Papsin B, Committee on Infectious Diseases and Section on Otolaryngology-Head and Neck Surgery. Cochlear implants in children: surgical site infections and prevention and treatment of acute otitis media and meningitis. Pediatrics. 2010; 126:381-91. [PubMed 20660544]

190. Food and Drug Administration. Public health notification: continued risk of bacterial meningitis in children with cochlear implants with a positioner beyond twenty-four months post-implantation. February 6, 2006. From FDA website.

199. Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) recommended immunization schedules for persons aged 0 through 18 years–United States, 2015. Updates may be available at CDC website.

200. Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) recommended adult immunization schedule–United States, 2015. Updates may be available at CDC website.

201. Centers for Disease Control and Prevention (CDC). Licensure of 13-valent pneumococcal conjugate vaccine for adults aged 50 years and older. MMWR Morb Mortal Wkly Rep. 2012; 61:394-5. [PubMed 22647745]

202. Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2012; 61:816-9. [PubMed 23051612]

203. Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among children aged 6-18 years with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2013; 62:521-4. [PubMed 23803961]

204. Tomczyk S, Bennett NM, Stoecker C et al. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2014; 63:822-5. [PubMed 25233284]

205. Committee On Infectious Diseases. Immunization for Streptococcus pneumoniae infections in high-risk children. Pediatrics. 2014; 134:1230-3. [PubMed 25422018]

(web3)