Pneumococcal Vaccine

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

Introduction

Inactivated (polysaccharide) vaccine.105 129 134 181 Pneumococcal vaccine is commercially available in the 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.100 105 115 129 181 184 Various other pneumococcal vaccines are being investigated or may be available in other countries.188

Uses for Pneumococcal Vaccine

Prevention of Invasive Pneumococcal Infection

Prevention of serious or invasive infection (e.g., pneumonia, meningitis, bacteremia) caused by Streptococcus pneumoniae serotypes represented in the vaccine.100 115 129 176 181 184 199

Will not prevent pneumococcal infection caused by S. pneumoniae serotypes not represented in the vaccine and will not prevent infections caused by other pathogens.129 181

Not indicated for treatment of pneumococcal infection.181 Previously unvaccinated or incompletely vaccinated children who recover from invasive pneumococcal disease should be vaccinated using a usually recommended age-appropriate regimen.105

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

USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and American Academy of Family Physicians (AAFP) recommend that all infants be vaccinated against pneumococcal infection in early infancy beginning at 2 months of age (minimum age 6 weeks) using a regimen of PCV13 (Prevnar 13).100 105 184 199 In addition, routine and catch-up vaccination using an age-appropriate regimen of PCV13 (Prevnar 13) is recommended in all previously unvaccinated or incompletely vaccinated infants and children 2 through 59 months of age.100 105 184 199

ACIP, AAP, and AAFP also recommend vaccination with an age-appropriate regimen of PCV13 (Prevnar 13) in all previously unvaccinated or incompletely vaccinated children 60 through 71 months of age with underlying medical conditions that put them at increased risk for pneumococcal disease or its complications.100 105 184 199 (See Preexposure Vaccination Against Pneumococcal Infection in Groups At Risk under Uses.)

Although not labeled by FDA for use in children ≥6 years of age, ACIP and AAP state that a single dose of PCV13 (Prevnar 13) can be considered in certain children and adolescents 6 through 18 years of age at increased risk for pneumococcal disease.100 184

ACIP, AAFP, ACOG, and American College of Physicians (ACP) recommend routine vaccination with a single dose of PPSV23 (Pneumovax 23) in all unvaccinated adults 19 through 64 years of age who are at increased risk for pneumococcal disease or its complications, including residents of nursing homes or other long-term care facilities and individuals who smoke cigarettes, are immunocompromised, or have certain chronic medical conditions such as asthma.115 169 200 (See Preexposure Vaccination Against Pneumococcal Infection in Groups At Risk under Uses.)

ACIP, AAFP, ACOG, and ACP recommend routine vaccination with PPSV23 (Pneumovax 23) in all adults ≥65 years of age who are unvaccinated or have unknown vaccination status and routine revaccination with PPSV23 (Pneumovax 23) in all adults ≥65 years of age who received the vaccine ≥5 years earlier and were <65 years of age at the time of vaccination.115 130 169 200

Choice of Pneumococcal Vaccines

Two different types of pneumococcal vaccine are commercially available in the US for active immunization against pneumococcal disease: PCV13 (Prevnar 13)181 and PPSV23 (Pneumovax 23).129 Both vaccines contain capsular antigens extracted from S. pneumoniae, but contain different numbers and forms of these antigens.129 181

PCV13 (Prevnar 13) contains conjugated saccharide antigens representing 13 S. pneumoniae serotypes (i.e., 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F).181 PCV13 (Prevnar 13) is labeled by FDA for use in infants and children 6 weeks through 5 years of age (prior to the sixth birthday)181 and is recommended for routine primary and catch-up vaccination in all infants and children 2 through 59 months of age.100 184 199 Also recommended in previously unvaccinated children 60 through 71 months of age with underlying medical conditions that put them at increased risk for pneumococcal disease and can be considered in certain children and adolescents 6 through 18 years of age at increased risk for pneumococcal disease.100 184

PPSV23 (Pneumovax 23) contains unconjugated polysaccharide antigens representing 23 serotypes (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 PPSV23 (Pneumovax 23) is labeled by FDA for use in adults, adolescents, and children ≥2 years of age129 and is recommended for routine vaccination in children 2 through 18 years of age with underlying medical conditions that put them at increased risk for pneumococcal disease, certain adolescents and adults 19 through 64 years of age at increased risk for pneumococcal disease, and all unvaccinated adults ≥65 years of age.100 115 169 184 199 200

Pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein) (PCV7; Prevnar; no longer commercially available in the US)148 185 contained conjugated saccharide antigens representing 7 serotypes (i.e., 4, 6B, 9V, 14, 18C, 19F, 23F) and was available in the US from February 2000 until September 2010.185 PCV13 (Prevnar 13 ), approved by FDA in February 2010,176 184 has replaced PCV7 (Prevnar) for primary and catch-up vaccination in infants and children.100 176 184 185 PCV13 (Prevnar 13) contains all 7 conjugated antigens that were in the 7-valent vaccine and also contains 6 additional conjugated antigens representing 6 more S. pneumoniae serotypes associated with invasive pneumococcal disease.100 184

If pneumococcal vaccination in infants and children 6 weeks through 71 months of age was initiated using PCV7 (Prevnar), use PCV13 (Prevnar 13 ) to complete age-appropriate vaccination.100 184 Since PCV13 (Prevnar 13) contains additional antigens not contained in PCV7 (Prevnar) and may provide additional protection, a single supplemental dose of PCV13 (Prevnar 13) is recommended in some individuals who previously completed age-appropriate vaccination with the 7-valent vaccine, including otherwise healthy children 14 through 59 months of age and children 14 through 71 months of age with medical conditions that put them at increased risk for pneumococcal disease.100 176 184

Because conjugated antigens in PCV13 (Prevnar 13) are more immunogenic in infants and young children than unconjugated antigens in PPSV23 (Pneumovax 23), PCV13 (Prevnar 13) is the preferred pneumococcal vaccine for routine vaccination in infants and children 2 through 59 months of age and in children 60 through 71 months of age with underlying medical conditions that put them at increased risk of pneumococcal disease or its complications.100 105 184

Since PPSV23 (Pneumovax 23) can provide immunogenicity against a broader range of pneumococcal serotypes, sequential use of PCV13 (Prevnar 13) followed by PPSV23 (Pneumovax 23) is recommended for children ≥2 years of age with medical conditions that put them at increased risk for pneumococcal disease.100 105 184

Do not administer PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) simultaneously since safety and efficacy of concurrent administration not studied.184 (See Administration under Dosage and Administration.)

PCV13 (Prevnar 13) used for prevention of AOM caused by certain serotypes of S. pneumoniae181 (see Prevention of Pneumococcal Acute Otitis Media [AOM] under Uses); PPSV23 (Pneumovax 23) not recommended for prevention of AOM.105

Preexposure Vaccination Against Pneumococcal Infection in Groups at Risk

Preexposure vaccination in previously unvaccinated infants, children, adolescents, and adults who are 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

Infants 2 through 23 months of age are at increased risk for invasive pneumococcal disease.100 105 184 ACIP, AAP, and AAFP recommend routine primary vaccination and catch-up vaccination against pneumococcal infection in all infants in this age group (minimum age 6 weeks) using an age-appropriate regimen of PCV13 (Prevnar 13).100 105 184 199 This includes otherwise healthy infants and infants with underlying medical conditions that put them at increased risk for pneumococcal infection.100 105 184 (See Routine Primary Vaccination in Infants 2 through 23 Months of Age [PCV13; Prevnar 13] under Dosage and Administration.)

If primary immunization was initiated (but not completed) in infancy using the previously available 7-valent vaccine (PCV7; Prevnar), use the age-appropriate number of doses of PCV13 (Prevnar 13 ) to complete the vaccination series.100 181 184 Since it may provide additional protection, a single supplemental dose of PCV13 (Prevnar 13) is recommended in infants 14 through 23 months of age who previously completed the age-appropriate vaccination series using the recommended number of doses of PCV7 (Prevnar).100 184 (See Routine Primary Vaccination in Infants 2 through 23 Months of Age [PCV13; Prevnar 13] under Dosage and Administration.)

Healthy children 24 through 59 months of age who have not been vaccinated against pneumococcal disease should receive catch-up vaccination with a single dose of PCV13 (Prevnar 13).100 105 184 Healthy children in this age group who previously completed the age-appropriate vaccination series using the recommended number of doses of PCV7 (Prevnar) should receive a single supplemental dose of PCV13 (Prevnar 13) since it may provide additional protection.100 184 (See Routine Primary Vaccination in Healthy Children 24 through 59 Months of Age [PCV13; Prevnar 13] under Dosage and Administration.)

Children 24 through 71 months of age at increased risk for pneumococcal disease because of underlying medical conditions should be vaccinated. This includes those with anatomic or functional asplenia(including sickle cell disease [SCD] or other hemoglobinopathies), HIV infection, cochlear implants, congenital immunodeficiencies, phagocytic disorders, chronic cardiac disease, chronic pulmonary disease, chronic renal insufficiency, diabetes mellitus, CSF leaks, diseases requiring immunosuppressive drugs or radiation therapy, or solid organ transplants.100 105 166 184 Such children may benefit from sequential vaccination with PCV13 (Prevnar 13) followed by PPSV23 (Pneumovax 23).100 105 166 184 (See Children 24 through 71 Months of Age at Increased Risk [PCV13; Prevnar 13 and PPSV23; Pneumovax 23] under Dosage and Administration.)

ACIP and AAP recommend that all unvaccinated or incompletely vaccinated children 24 through 71 months of age at increased risk for pneumococcal disease receive catch-up vaccination with 2 doses of PCV13 (Prevnar 13) administered at least 8 weeks apart.100 105 176 184

PPSV23 (Pneumovax 23) also is recommended in children ≥24 months of age at increased risk for pneumococcal disease.100 105 184 Children in this age group who previously received PPSV23 (Pneumovax 23) may benefit from PCV13 (Prevnar 13).105 106 184 Conversely, those who already received age-appropriate vaccination with PCV13 (Prevnar 13) may benefit from PPSV23 (Pneumovax 23).105 184

Children 24 through 71 months of age at increased risk for pneumococcal disease who previously completed the age-appropriate vaccination series using the recommended number of doses of 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 This supplemental dose of PCV13 (Prevnar 13) is recommended regardless of previous vaccination with PPSV23 (Pneumovax 23).100 184

Children and adolescents 6 through 18 years of age at increased risk for pneumococcal disease may receive PCV13 (Prevnar 13).100 184 Although PCV13 (Prevnar 13) not labeled by FDA for use in children ≥6 years of age,181 ACIP and AAP state that a single dose of PCV13 (Prevnar 13) may be used in children and adolescents 6 through 18 years of age who have not previously received the vaccine and are at increased risk for invasive pneumococcal disease.100 184 This single dose of PCV13 (Prevnar 13) may be given to such individuals regardless of previous vaccination with PCV7 (Prevnar) or PPSV23 (Pneumovax 23).100 184 Routine use of PCV13 (Prevnar 13) not recommended in otherwise healthy children and adolescents ≥6 years of age.100 184

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

Individuals with anatomic or functional asplenia, including those with SCD or other hemoglobinopathies, are at increased risk for invasive pneumococcal disease.100 105 166 169 184 Complete pneumococcal vaccination at least 2 weeks before elective splenectomy.105 115 200

Children with SCD who are receiving penicillin prophylaxis for prevention of pneumococcal disease should continue such prophylaxis if indicated, regardless of vaccination status.103 105 Pneumococcal vaccines do not protect against all possible serotypes of S. pneumoniae, and penicillin prophylaxis substantially reduces the risk for invasive pneumococcal infection in these individuals.105

HIV-infected infants, children, adolescents, and adults are at increased risk for pneumococcal disease.100 155 156 166 169 184

ACIP, AAP, CDC, National Institutes of Health (NIH), IDSA, Pediatric Infectious Diseases Society, and others recommend that all HIV-infected infants and children 2 through 71 months of age receive primary immunization with PCV13 (Prevnar 13).100 156 184 PPSV23 (Pneumovax 23) also recommended for all HIV-infected children ≥2 years of age at least 8 weeks after last dose of either PCV13 (Prevnar 13) or the previously available 7-valent vaccine (PCV7; Prevnar).156 184 (See HIV-infected Infants and Children 2 through 71 Months of Age [PCV13; Prevnar 13 and PPSV23; Pneumovax 23] under Dosage and Administration.)

CDC, NIH, IDSA, and other experts recommend that all HIV-infected adolescents and adults with CD4+ T-cell counts ≥200 cells/mm3 receive PPSV23 (Pneumovax 23), unless they received the vaccine within the previous 5 years.155 These experts recommend that PPSV23 (Pneumovax 23) be offered to HIV-infected adults and adolescents with CD4+ T-cell counts <200 cells/mm3; however, since efficacy not clearly established in such patients, revaccination may be considered when CD4+T-cell count increases to >200 cells/mm3 in response to antiretroviral therapy.155 (See HIV-infected Adults [PPSV23; Pneumovax 23] under Dosage and Administration.)

Revaccination with PPSV23 (Pneumovax 23) 5 years after the initial dose is recommended in HIV-infected adults, adolescents, and children;100 105 155 156 169 184 some experts state that revaccination every 5 years can be considered in HIV-infected adults and adolescents.155 Consider that pneumococcal vaccines may be less immunogenic in immunocompromised individuals.105 109 112 113 129 134 181 (See Individuals with Altered Immunocompetence under Cautions.)

Although PCV13 (Prevnar 13) not labeled by FDA for use in children ≥6 years of age,181 ACIP, AAP, and CDC state that a single dose of the vaccine may be used in HIV-infected children and adolescents 6 through 18 years of age who have not previously received PCV13 (Prevnar 13), regardless of previous vaccination with PCV7 (Prevnar) or PPSV23 (Pneumovax 23).100 184

Cochlear implant recipients are at substantially increased risk for pneumococcal meningitis.100 110 184 189 Incidence of bacterial meningitis, particularly pneumococcal meningitis, is higher among children with cochlear implants than children in the general population.154 161 189 AAP, ACIP, and CDC recommend that all individuals who have or are scheduled to receive a cochlear implant receive age-appropriate vaccination against pneumococcal disease.100 110 184 189 Depending on the vaccination history, doses of PCV13 (Prevnar 13) and/or PPSV23 (Pneumovax23) may be indicated.100 184 189 Complete vaccination at least 2 weeks prior to placement of cochlear implant.110 184 189

Alaskan Natives and American Indians are at increased risk for invasive pneumococcal disease and should receive the usually recommended age-appropriate regimens for primary and catch-up vaccination against pneumococcal disease.184 PPSV23 (Pneumovax 23) not routinely recommended for Alaskan Native or American Indian children ≥24 months of age, but public health authorities may recommend a dose of PPSV23 after PCV13 (Prevnar 13) or the previously available 7-valent vaccine (PCV7; Prevnar) in those who live in areas where the risk of invasive pneumococcal disease is increased.184 Although routine use of PPSV23 not recommended for Alaskan Native or American Indian adults <65 years of age unless they have underlying medical conditions that put them at increased risk, public health authorities may recommend use of the vaccine in those 50 through 64 years of age who live in areas with an increased risk of invasive pneumococcal disease.169 200

Cigarette smokers are at substantially increased risk for invasive pneumococcal disease and should be vaccinated.169 Unvaccinated adults 19 through 64 years of age who smoke cigarettes should receive a dose of PPSV23 (Pneumovax 23) and smoking cessation counseling.169

Adults ≥65 years of age, including immunocompetent adults, are at increased risk for pneumococcal infection.169 Adults in this age group with underlying medical conditions (e.g., chronic cardiovascular disease, chronic pulmonary disease, chronic liver disease, chronic alcoholism, diabetes mellitus, anatomic or functional asplenia [including SCD], cochlear implants, CSF leaks) have an even higher risk for severe pneumococcal disease and its complications.169 Therefore, ACIP, AAFP, ACOG, and ACP recommend routine vaccination with PPSV23 (Pneumovax 23) in all adults ≥65 years of age who are unvaccinated or have unknown vaccination status and routine revaccination with PPSV23 (Pneumovax 23) in those who received the vaccine ≥5 years earlier at <65 years of age.115 130 169 200

Travelers at high risk for pneumococcal disease include young children, the elderly, individuals of any age with chronic medical conditions (e.g., cardiovascular disease, pulmonary disease, diabetes mellitus, asplenia, immunosuppressive disease such as HIV infection), and cigarette smokers.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) used for prevention of AOM caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in infants and young children.181 Current indication for prevention of AOM caused by these S. pneumoniae serotypes is based on efficacy studies that evaluated use of the previously available 7-valent vaccine (PCV7; Prevnar);181 efficacy data not available to date 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

Following vaccination, protection against AOM caused by S. pneumoniae is expected to be substantially lower than protection against invasive disease.181 Because AOM is caused by many organisms other than S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F, protection against all causes of AOM is expected to be lower than that for pneumococcal AOM caused by these vaccine serotypes.181

Will not prevent AOM caused by S. pneumoniae serotypes not represented in the vaccine and will not prevent AOM caused by other pathogens.181

PPSV23 (Pneumovax 23) not recommended for prevention of AOM.105

Pneumococcal Vaccine Dosage and Administration

Administration

PCV13 (Prevnar 13) is administered by IM injection.181

PPSV23 (Pneumovax 23) is administered by IM or sub-Q injection.129

Do notdilute.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 PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) are indicated (e.g., children 24 through 71 months of age at increased risk for pneumococcal disease), administer PPSV23 (Pneumovax 23) sequentially after the recommended age-appropriate regimen of PCV13 (Prevnar 13), provided at least 8 weeks have elapsed since last dose of PCV13 (Prevnar 13).100 184 Safety and immunogenicity data not available regarding sequential administration of PCV13 (Prevnar 13) followed by PPSV23 (Pneumovax 23),184 but studies evaluating sequential use of the previously available 7-valent vaccine (PCV7; Prevnar) followed by PPSV23 (Pneumovax 23) demonstrated that PPSV23 elicited a strong booster response to the 7 S. pneumoniae serotypes the vaccines had in common.184

Safety and immunogenicity data not available regarding sequential administration of PCV13 (Prevnar 13) after PPSV23 (Pneumovax 23).184 However, if indicated, administer recommended doses of PCV13 (Prevnar 13) to children who previously received PPSV23 (Pneumovax 23).100 184

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23) may be given simultaneously with other age-appropriate vaccines during the same health-care visit (using different syringes and different injection sites).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) may occur following vaccination; 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

Administer PCV13 (Prevnar 13) by IM injection.181 Do not administer IV, sub-Q, or intradermally.181

Shake PCV13 (Prevnar 13) 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

Administer PPSV23 (Pneumovax 23) 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 intradermal administration may result in severe local reactions.129

Depending on patient age, administer IM into the deltoid muscle or anterolateral thigh.129 134 181 In infants and children 6 weeks to 2 years of age, anterolateral thigh is preferred; alternatively, deltoid muscle can be used in those 1–2 years of age if muscle mass is adequate.134 In adults, adolescents, and children ≥3 years of age, deltoid muscle is preferred.134 181

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

Do not make IM injections into gluteal area or any area where there may be a major nerve trunk.134 181 If 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 the clinician identify anatomic landmarks prior to injection.134

Avoid injection of vaccines into or near blood vessels.134 ACIP and AAP state that the aspiration procedure (i.e., pulling back on the syringe plunger after needle insertion and before injection) used by some clinicians to ensure that a blood vessel has not been entered is not required because large blood vessels are not present at recommended IM injection sites.134

Sub-Q Administration

Administer PPSV23 (Pneumovax 23) by sub-Q injection; alternatively, administer by IM injection.129 (See IM Administration under Dosage and Administration.) Do not administer IV or intradermally;129 intradermal administration may result in severe local reactions.129

Administer sub-Q into the upper-outer triceps area or anterolateral thigh.129 134 In adults, adolescents, and children ≥24 months of age, the upper-outer triceps area is 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

Dosage

Dosage schedule (i.e., number of doses) varies according to the individual’s age and immunization status and specific vaccine administered (PCV13 [Prevnar 13] or PPSV23 [Pneumovax 23]).100 105 129 181 184 Follow dosage recommendations for the specific preparation used.

Vaccinate medically stable preterm (i.e., <37 weeks’ gestation) and low birthweight (≤1.5 kg) infants at the usual chronologic age using usual dosage.134 184

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.134

PCV13 (Prevnar 13): Used in infants and children 6 weeks through 5 years of age.181 Although not labeled by FDA for use in children ≥6 years of age,181 ACIP and AAP state that PCV13 (Prevnar 13) may be used in certain children and adolescents 6 through 18 years of age at increased risk for pneumococcal disease.100 184

PPSV23 (Pneumovax 23): Used in adults, adolescents, and children ≥2 years of age.129

Pediatric Patients

Prevention of Pneumococcal Infection
Routine Primary Vaccination in Infants 2 through 23 Months of Age (PCV13; Prevnar 13)
IM

Each dose consists of entire contents (0.5 mL) of commercially available single-dose prefilled syringe.181

Routine immunization in early infancy (i.e., initiated before 6 months of age): Primary immunization consists of a series of 3 primary doses and 1 additional (booster) dose.100 105 181 184 ACIP, AAP, AAFP, and the manufacturer 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; minimum interval between third and fourth dose is 8 weeks.100 181 184

Previously unvaccinated infants 7 through 11 months of age: Primary immunization consists of 2 primary doses and 1 additional (booster) dose.100 105 181 184 199 Give second dose at least 4 weeks after first dose and give third dose at 12 through 15 months of age (provided at least 8 weeks have elapsed since second dose).100 181 184 199

Previously unvaccinated infants 12 through 23 months of age: Primary immunization consists of 2 doses.100 181 184 Give second dose at least 8 weeks after first dose.100 181 184 199

Incompletely vaccinated infants 12 through 23 months of age: Complete the vaccination series using the age-appropriate number of doses of PCV13 (Prevnar 13).100 181 184 Those who received 3 doses of the previously available 7-valent vaccine (PCV7; Prevnar) at <12 months of age should receive a single dose of PCV13 (Prevnar 13)100 176 184 at least 8 weeks after most recent PCV7 (Prevnar) dose.100 181 184 Those who received 2 or 3 doses of PCV7 (Prevnar) at <12 months of age and at least 1 dose of PCV13 (Prevnar 13) at ≥12 months of age do not need to receive any additional doses of PCV13 (Prevnar 13).100 184

Infants 14 through 23 months of age who previously completed a 4-dose age-appropriate vaccination series of PCV7 (Prevnar) but have not received any doses of PCV13 (Prevnar 13 ): ACIP and AAP recommend a single dose of PCV13 (Prevnar 13) given at least 8 weeks after most recent PCV7 (Prevnar) dose.100 184

Duration of immunity following the recommended age-appropriate regimens of PCV13 (Prevnar 13) not fully determined.181 (See Duration of Immunity under Cautions.)

Routine Primary Vaccination in Healthy Children 24 through 59 Months of Age (PCV13; Prevnar 13)
IM

Each dose consists of entire contents (0.5 mL) of commercially available single-dose prefilled syringe.181

Catch-up vaccination in otherwise healthy children 24 through 59 months of age who are unvaccinated and have not received any doses of PCV13 (Prevnar 13) or the previously available 7-valent vaccine PCV7 (Prevnar): ACIP, AAP, AAFP, and the manufacturer recommend a single dose of PCV13 (Prevnar 13).100 181 184 199

Catch-up vaccination in otherwise healthy children 24 through 59 months of age who are incompletely vaccinated for their age and have not received the total age-appropriate number of doses of PCV13 (Prevnar 13 ) or PCV7 (Prevnar): ACIP, AAP, and AAFP recommend a single dose of PCV13 (Prevnar 13) given at least 8 weeks after most recent dose of PCV13 (Prevnar 13) or PCV7 (Prevnar).181 184 199

Catch-up vaccination in otherwise healthy children 24 through 59 months of age who previously received a complete 4-dose vaccination series of PCV7 (Prevnar) or age-appropriate series of PCV7 (Prevnar) but have not received any doses of PCV13 (Prevnar 13 ): ACIP and AAP recommend a single dose of PCV13 (Prevnar 13 ) given at least 8 weeks after most recent dose of PCV7 (Prevnar).100 184

Duration of immunity following the recommended age-appropriate regimens of PCV13 (Prevnar 13) not fully determined.181 (See Duration of Immunity under Cautions.)

Children 24 through 71 Months of Age at Increased Risk (PCV13; Prevnar 13 and PPSV23; Pneumovax 23)
IM or Sub-Q

Each IM dose of PCV13 (Prevnar 13) consists of entire contents (0.5 mL) of commercially available single-dose prefilled syringe.181

Each IM or sub-Q dose of PPSV23 (Pneumovax 23) consists of entire contents (0.5 mL) of commercially available single-dose vial or 0.5 mL from multiple-dose vial.129

Children 24 through 71 months of age at increased risk for pneumococcal disease (see Preexposure Vaccination Against Pneumococcal Infection in Groups at Risk under Uses): ACIP, AAP, and AAFP recommend catch-up vaccination with an age-appropriate regimen of PCV13 (Prevnar 13) followed by a single dose of PPSV23 (Pneumovax 23) given at least 8 weeks after last dose of PCV13 (Prevnar 13).100 105 129 184

Catch-up vaccination in previously unvaccinated children 24 through 71 months of age at increased risk who have not received any doses of PCV13 (Prevnar 13) or the previously available 7-valent vaccine (PCV7; Prevnar): ACIP and AAP recommend 2 doses of PCV13 (Prevnar 13) given at least 8 weeks apart.100 184

Catch-up vaccination in children 24 through 71 months of age at increased risk who are incompletely vaccinated and have received <3 doses of PCV13 (Prevnar 13) or PCV7 (Prevnar): ACIP, AAP, and AAFP recommend 2 doses of PCV13 (Prevnar 13).100 184 Give doses at least 8 weeks apart with first dose given at least 8 weeks after most recent dose of PCV13 (Prevnar 13) or PCV7 (Prevnar).100 184

Children 24 through 71 months of age at increased risk who previously received a complete 4-dose vaccination series of PCV7 (Prevnar) or age-appropriate series of PCV7 (Prevnar) but have not received any doses of PCV13 (Prevnar 13 ): ACIP and AAP recommend a single dose of PCV13 (Prevnar 13 ) given at least 8 weeks after most recent dose of PCV7 (Prevnar) or PPSV23 (Pneumovax 23).100 184

Children 24 through 71 months of age at increased risk: Give a single dose of PPSV23 (Pneumovax 23) at least 8 weeks after last dose of PCV13 (Prevnar 13) or PCV7 (Prevnar).100 184

Duration of immunity and need for additional (booster) doses or revaccination following the recommended age-appropriate regimens of PCV13 (Prevnar 13) not fully determined.181 (See Duration of Immunity under Cautions.)

Duration of immunity and need for additional (booster) doses or revaccination with PPSV23 (Pneumovax 23) not fully determined.115 169 (See Duration of Immunity under Cautions.) Routine revaccination with PPSV23 (Pneumovax 23) not recommended in immunocompetent children.105 115 129 169 184 Revaccination with PPSV23 (Pneumovax 23) 5 years after initial dose is recommended in those at highest risk for serious pneumococcal infection (e.g., those with functional or anatomic asplenia, HIV infection, altered immunocompetence).100 105 156 184

HIV-infected Infants and Children 2 through 71 Months of Age (PCV13; Prevnar 13 and PPSV23; Pneumovax 23)
IM or Sub-Q

Each IM dose of PCV13 (Prevnar 13) consists of entire contents (0.5 mL) of commercially available single-dose prefilled syringe.181

Each IM or sub-Q dose of PPSV23 (Pneumovax 23) consists of entire contents (0.5 mL) of commercially available single-dose vial or 0.5 mL from multiple-dose vial.129

Previously unvaccinated HIV-infected infants 2 through 23 months of age: Primary immunization consists of 4 doses of PCV13 (Prevnar 13) given at 2, 4, 6, and 12 through 15 months of age.100 184

HIV-infected children 24 through 71 months of age who are incompletely vaccinated and received <3 doses of PCV13 (Prevnar 13) or the previously available 7-valent vaccine (PCV7; Prevnar) at <24 months of age: Give 2 doses of PCV13 (Prevnar 13) at least 8 weeks apart.100 184 In those who previously received 3 doses, give a single dose of PCV13 (Prevnar 13).100 184

HIV-infected children ≥2 years of age: Give a single dose of PPSV23 (Pneumovax 23) at least 8 weeks after last dose of PCV13 (Prevnar 13) or PCV7 (Prevnar).100 184

HIV-infected Adolescents (PPSV23; Pneumovax 23)
IM or Sub-Q

Single 0.5-mL dose.129 155

HIV-infected adolescents with CD4+ T-cell counts >200 cells/mm3 who have not previously received PPSV23 (Pneumovax 23) or have not received a dose in the last 5 years: Single dose of PPSV23 (Pneumovax 23).155

HIV-infected adolescents with CD4+ T-cell counts <200 cells/mm3 who have not previously received PPSV23 (Pneumovax 23) or have not received a dose in the last 5 years: Offer single dose of PPSV23 (Pneumovax 23).155 If given when CD4+ T-cell count is <200 cells/mm3, consider revaccination when CD4+ T-cell count increases to >200 cells/mm3 in response to antiretroviral therapy.155

Duration of immunity and need for additional (booster) doses or revaccination not fully determined.155 (See Duration of Immunity under Cautions.) Revaccination with PPSV23 (Pneumovax 23) 5 years after initial dose is recommended in HIV-infected individuals;155 169 184 some experts state that revaccination every 5 years may be considered in HIV-infected adolescents.155

Children and Adolescents 6 through 18 Years of Age at Increased Risk (PCV13; Prevnar 13and PPSV23; Pneumovax23)
IM

Each IM dose of PCV13 (Prevnar 13) consists of entire contents (0.5 mL) of commercially available single-dose prefilled syringe.181

Each IM or sub-Q dose of PPSV23 (Pneumovax 23) consists of entire contents (0.5 mL) of commercially available single-dose vial or 0.5 mL from multiple-dose vial.129

Children and adolescents 6 through 18 years of age at increased risk for pneumococcal disease who have not previously received PCV13 (Prevnar 13): ACIP and AAP state that a single dose of PCV13 (Prevnar 13) may be given regardless of previous vaccination with PCV7 (Prevnar) or PPSV23 (Pneumovax 23).100 184

If both PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) are recommended (e.g., in those at increased risk of pneumococcal disease), give PCV13 (Prevnar 13) dose first followed by a single dose of PPSV23 (Pneumovax 23) at least 8 weeks later.100 184 199

Duration of immunity and need for additional (booster) doses or revaccination following the recommended age-appropriate regimens of PCV13 (Prevnar 13) not fully determined.181 (See Duration of Immunity under Cautions.)

Duration of immunity and need for additional (booster) doses or revaccination with PPSV23 (Pneumovax 23) not fully determined.115 169 (See Duration of Immunity under Cautions.) Routine revaccination with PPSV23 (Pneumovax 23) in immunocompetent children and adolescents not recommended.115 129 184 Revaccination with PPSV23 (Pneumovax 23) 5 years after initial dose is recommended in those at highest risk for serious pneumococcal infection (e.g., those with functional or anatomic asplenia, HIV infection, altered immunocompetence).100 105 156 184

Adults

Prevention of Pneumococcal Infection
Adults 19 through 64 Years of Age at Increased Risk (PPSV23; Pneumovax 23)
IM or Sub-Q

Single 0.5-mL dose.115 129

ACIP, AAFP, ACOG, and ACP recommend that adults 19 through 64 years of age who are cigarette smokers, residents of nursing homes or other long-term care facilities, immunocompromised, or have certain underlying medical conditions that put them at increased risk for pneumococcal disease receive a single dose of PPSV23 (Pneumovax 23).169 200 (See Preexposure Vaccination Against Pneumococcal Infection in Groups at Risk under Uses.)

Duration of immunity and need for additional (booster) doses or revaccination with PPSV23 (Pneumovax 23) not fully determined.115 169 (See Duration of Immunity under Cautions.) Routine revaccination not recommended in immunocompetent adults.115 129 169 Revaccination with PPSV23 (Pneumovax 23) 5 years after initial dose is recommended in those at highest risk for serious pneumococcal infection (e.g., those with functional or anatomic asplenia, HIV infection, altered immunocompetence).155 169 184 200

HIV-infected Adults (PPSV23; Pneumovax 23)
IM or Sub-Q

Single 0.5-mL dose.129 155

HIV-infected adults with CD4+ T-cell counts >200 cells/mm3 who have not previously received PPSV23 (Pneumovax 23) or have not received a dose in the last 5 years: Single dose of PPSV23 (Pneumovax 23).155

HIV-infected adults with CD4+ T-cell counts <200 cells/mm3 who have not previously received PPSV23 (Pneumovax 23) or have not received a dose in the last 5 years: Offer single dose of PPSV23 (Pneumovax 23).155 If given when CD4+T-cell count is <200 cells/mm3, consider revaccination when CD4+ T-cell count increases to >200 cells/mm3 in response to antiretroviral therapy.155

Duration of immunity and need for additional (booster) doses or revaccination not fully determined.155 (See Duration of Immunity under Cautions.) Revaccination with PPSV23 (Pneumovax 23) 5 years after initial dose is recommended in HIV-infected individuals;155 169 some experts state that revaccination every 5 years may be considered in HIV-infected adults.155

Adults ≥65 Years of Age (PPSV23; Pneumovax 23)
IM or Sub-Q

Single 0.5-mL dose.115 129

ACIP and AAFP recommend a routine dose in all adults ≥65 years of age who are unvaccinated or have unknown vaccination status.115 130 169 200

Duration of immunity and need for additional (booster) doses or revaccination not fully determined.115 169 (See Duration of Immunity under Cautions.) Routine revaccination with PPSV23 (Pneumovax 23) in immunocompetent individuals not recommended.115 129 184 However, those who received PPSV23 (Pneumovax 23) when they were <65 years of age should receive routine revaccination with a single dose of the vaccine at ≥65 years of age if at least 5 years have elapsed since the first dose.130 169 200 Data are insufficient to date to make recommendations concerning revaccination of healthy adults who received the vaccine at ≥65 years of age.130 169

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): Hypersensitivity to any ingredient in the formulation.129

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Allergic reactions (e.g., anaphylaxis, anaphylactoid reactions, urticaria, bronchospasm, serum sickness, facial edema, angioedema) have been reported with pneumococcal vaccines.129 181

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.129 181 184

Epinephrine and other appropriate agents should be readily available in case anaphylaxis or other serious allergic reaction occurs.129 181

General Precautions

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.105 129 134 Consider possibility that the immune response to the vaccine and efficacy may be suboptimal in these individuals.105 129 134 181 Avoid pneumococcal vaccination during chemotherapy or radiation therapy.129 If possible, administer the vaccine at least 2 weeks prior to initiation of immunosuppressive therapy or defer until at least 3 months after immunosuppressive therapy is discontinued.129 134 (See Specific Drugs under Interactions.)

Although data are limited regarding efficacy of pneumococcal vaccines in HIV-infected individuals (especially those with CD4+ T-cell counts <200 cells/mm3),128 139 140 143 155 most HIV experts believe that potential benefits of vaccination against pneumococcal disease in HIV-infected individuals outweigh risks.115 128 131 141 143 155 Since HIV-infected individuals may have a reduced response to vaccination and are at continued risk, revaccination with PPSV23 (Pneumovax 23) usually is recommended.155 156 (See Duration of Immunity under Cautions.)

Individuals with Hodgkin’s disease are at increased risk of invasive pneumococcal infection,105 and those who have received extensive chemotherapy and/or radiation therapy may have an impaired antibody response to pneumococcal vaccine.105 129 (See Specific Drugs under Interactions.) When planning for cancer chemotherapy or other immunosuppressive therapy in patients with Hodgkin’s disease or those undergoing organ or bone marrow transplantation, PPSV23 (Pneumovax 23) should be administered at least 10–14 days before the start of immunosuppressive therapy.105 129 Manufacturer states that immunization against pneumococcal infection should be avoided during chemotherapy or radiation therapy.129 AAP states that individuals with Hodgkin’s disease who receive the vaccine during chemotherapy or radiation therapy should be revaccinated 3 months after therapy is discontinued.105

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

Manufacturer of PPSV23 (Pneumovax 23) states the vaccine may be delayed in individuals with febrile respiratory illness or other acute infection, unless withholding the vaccine poses greater risk to the patient.129

ACIP, AAP, and AAFP state that minor acute illness, such as mild upper respiratory infection (with or without fever) or mild diarrhea, usually does not preclude vaccination.134 184 However, vaccination of individuals with moderate or severe acute illness generally should be deferred until they have recovered from the acute phase of the illness.134 184

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

Individuals with Bleeding Disorders

ACIP states that IM vaccines can be used in individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient’s bleeding risk determines that the injection can be administered with reasonable safety.134 In these cases, use a fine needle (23 gauge) to administer the vaccine and apply firm pressure to the injection site (without rubbing) for ≥2 minutes.134 If patient is receiving antihemophilia therapy, administer the IM vaccine shortly after a scheduled dose of such therapy.134

Limitations of Vaccine Effectiveness

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

Pneumococcal vaccines provide protection only against those serotypes from which the vaccines are prepared.129 181 Will not prevent pneumococcal infection caused by S. pneumoniae serotypes not represented in the vaccines and will not prevent infections caused by other pathogens.129 181

May not prevent infection in individuals who do not achieve protective antibody titers; the minimum titer of serum anticapsular antibody needed to confer immunity against S. pneumoniae serotypes not established.103 115 129 181

Primary immunization with the usually recommended age-appropriate vaccination regimen before an expected exposure to pneumococcal infection ensures the highest level of protection.100 103 105 (See Dosage under Dosage and Administration.)

Extent and duration of immunologic response may vary depending on age and immunocompetence of the vaccinee.106 115 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).100 103 106 184 (See Actions.)

Duration of Immunity

Duration of protection and need for subsequent doses after initial age-appropriate vaccination with PCV13 (Prevnar 13) not fully determined.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 and a strong anamnestic response and substantial booster response could occur after re-exposure to the antigens.106 134 However, additional doses or revaccination with PCV13 (Prevnar 13) after the usually recommended age-appropriate vaccination regimens of PCV13 (Prevnar 13) not recommended.184

Duration of protection and need for subsequent doses after initial dose of PPSV23 (Pneumovax 23) not fully determined.115 Because PPSV23 (Pneumovax 23) is an unconjugated vaccine, the vaccine antigens do not induce long-lasting immunity or an anamnestic response after subsequent exposure to the same antigen.115 134 Bactericidal antibodies formed in response to PPSV23 (Pneumovax 23) remain elevated for at least 5 years, and decline after 5–10 years.115 126 129 Antibody levels decline within 3–5 years in certain children (e.g., those with functional or anatomic asplenia, SCD, nephrotic syndrome).115 124 125 129 Limited data also suggest antibody levels may decline in adults >60 years of age.129

Routine revaccination not recommended in immunocompetent children who received a dose of PPSV23 (Pneumovax 23).105 115 129 169 However, children ≥2 years of age who remain at increased risk for infection and are likely to have a rapid decline in pneumococcal antibody levels (e.g., those with functional or anatomic asplenia, SCD, nephrotic syndrome) should receive revaccination with a second dose of PPSV23 (Pneumovax 23), provided at least 5 years have elapsed since the initial dose.100 115 129 169 184

Routine revaccination not recommended in immunocompetent adolescents and adults <65 years of age who received a dose of PPSV23 (Pneumovax 23).115 129 169 However, revaccination with PPSV23 (Pneumovax 23) 5 years after initial dose is recommended for those with immunodeficiency, chronic renal failure, nephrotic syndrome, or functional or anatomic asplenia (e.g., SCD or splenectomy).169 200 For HIV-infected adults and adolescents, some experts state that revaccination every 5 years can be considered.155

Routine revaccination with a single dose of PPSV23 (Pneumovax 23) is recommended in adults ≥65 years of age if first dose was given at <65 years of age and at least 5 years have elapsed since first dose.130 169 200 Revaccination following a second dose of PPSV23 (Pneumovax 23) not recommended in these individuals because safety and clinical benefit data are insufficient when the vaccine is administered ≥3 times.115 129 169 184

Improper Storage and Handling

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

Do not administer pneumococcal vaccine that has been mishandled or has not been stored at the recommended temperature.134 (See Storage under Stability.)

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.134 If there are concerns about mishandling, contact the manufacturer or state or local health departments for guidance on whether the vaccine is usable.134 164

Specific Populations

Pregnancy

PCV13 (Prevnar 13) and PSV23 (Pneumovax 23): Category C.129 181

PPSV23 (Pneumovax 23): ACIP, AAFP, ACOG, and ACP state the vaccine may be used when indicated in pregnant women in high-risk groups, including women with asplenia; altered immunocompetence; metabolic, renal, cardiac, and/or pulmonary diseases; and those who smoke cigarettes.170 200 CDC, NIH, HIV Medicine Association of IDSA, and other experts state PPSV23 (Pneumovax 23) may be used in HIV-infected pregnant women.155

AAP states that pneumococcal vaccines generally should be deferred during pregnancy and the risk of severe pneumococcal disease in a pregnant woman, including the risk associated with underlying medical conditions, should be considered when making decisions regarding the need for pneumococcal immunization.105

Because pneumococcal vaccine is an inactivated vaccine, the theoretical risk to the fetus is expected to be low.105

Lactation

Not known whether antigens contained in pneumococcal vaccine are distributed into milk.129

PCV13 (Prevnar 13): Data not available regarding use in nursing women.187

PPSV23 (Pneumovax 23): Use with caution in nursing women.129

Because inactivated vaccines do not multiply within the body, 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 Generally shown to be immunogenic in infants, but immune response not adequately studied to date in infants born prematurely.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.181 184

Although PCV13 (Prevnar 13) not labeled by FDA for use in children ≥6 years of age,181 ACIP and AAP state that the vaccine may be used in certain children and adolescents 6 through 18 years of age at increased risk for pneumococcal disease.100 184 (See Preexposure Vaccination Against Pneumococcal Infection in Groups at Risk under Uses.)

PPSV23 (Pneumovax 23): Safety and efficacy not established in children <2 years of age.129

Geriatric Use

PCV13 (Prevnar 13): Do not use as a substitute for PPSV23 (Pneumovax 23) in geriatric adults.181

PPSV23 (Pneumovax 23): No overall differences in safety between adults ≥65 years of age and younger adults; however, consider possibility that some older adults may exhibit increased sensitivity to the vaccine.129

Common Adverse Effects

PCV13 (Prevnar 13): Local reactions at injection site (e.g., redness, swelling, tenderness), fever, decreased appetite, irritability, increased sleep, decreased sleep.181

PPSV23 (Pneumovax 23): Local reactions at injection site (e.g., erythema, soreness, warmth, swelling, induration), fever, myalgia, headache, asthenia/fatigue.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.105 134 181 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.100 105 134 173 181 184 However, each parenteral vaccine should be administered using a different syringe and different injection site.100 105 134 181 184

Specific Drugs

Drug

Interaction

Comments

Diphtheria and tetanus toxoids and pertussis vaccine adsorbed (DTaP)

PCV13 (Prevnar 13): Concurrent administration with DTaP given as a fixed-combination vaccine (DTaP-HepB-IPV; Pediarix) in infants did not reduce antibody responses to any of the antigens or increase adverse effects181 184

PPSV23 (Pneumovax 23): Concurrent administration with DTaP did not reduce antibody responses or increase severity of adverse reactions105

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with DTaP (using different syringes and different injection sites)105 134 184

Haemophilus b (Hib) vaccine

PCV13 (Prevnar 13): Concurrent administration with Hib vaccine in infants did not reduce antibody responses or increase adverse effects181 184

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with Hib vaccine (using different syringes and different injection sites)105 184

Hepatitis A (HepA) vaccine

PCV13 (Prevnar 13): Concurrent administration with HepA vaccine resulted in comparable safety;181 immune response not evaluated187

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 either vaccine172

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with HepA vaccine (using different syringes and different injection sites)181 184

Hepatitis B (HepB) vaccine

PCV13 (Prevnar 13): Concurrent administration with HepB given as a fixed-combination vaccine (DTaP-HepB-IPV; Pediarix) in infants did not reduce antibody responses to any of the antigens or increase adverse effects181 184

PPSV23 (Pneumovax 23): Concurrent administration with HepB vaccine is unlikely to result in reduced antibody responses or increased adverse effects105 134

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with HepB vaccine (using different syringes and different injection sites)105 115 184

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 115 129 134 181

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

If pneumococcal vaccine is administered to a patient with Hodgkin’s disease during immunosuppressive therapy (chemotherapy, radiation), AAP recommends that the patient be revaccinated 3 months after immunosuppressive therapy is discontinued105

Influenza vaccine

Parenteral inactivated influenza vaccine: Concomitant administration with PPSV23 (Pneumovax 23) did not reduce antibody response or increase adverse effects105 107 115 129 134

Intranasal live influenza vaccine: Concomitant administration with pneumococcal vaccines not studied178

Parenteral inactivated influenza vaccine may be administered simultaneously (using different syringes and different injection sites) or at any time before or after PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23)105 107 115 129 134 178

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

Measles, mumps, and rubella vaccine (MMR)

PCV13 (Prevnar 13): Concurrent administration with MMR in infants did not reduce antibody responses or increase adverse effects181 184

PPSV23 (Pneumovax 23): Concurrent administration with MMR is unlikely to result in reduced antibody responses to MMR105 134

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with MMR (using different syringes and different injection sites)100 184

Meningococcal vaccine

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with meningococcal polysaccharide diphtheria toxoid conjugate vaccine (MCV4; Menactra) or meningococcal polysaccharide vaccine (MPSV4; Menomune) using different syringes and different injection sites105

Poliovirus vaccine inactivated (IPV)

PCV13 (Prevnar 13): Concurrent administration with IPV given as a fixed-combination vaccine (DTaP-HepB-IPV; Pediarix) in infants did not reduce antibody responses to any of the antigens or increase adverse effects181 184

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with IPV (using different syringes and different injection sites)105 115 184

Rotavirus vaccine

PCV13 (Prevnar 13): Concurrent administration with rotavirus vaccine did not reduce antibody responses or increase adverse effects184

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 vaccine174 175

PCV13 (Prevnar 13): May be administered concurrently with rotavirus vaccine184

Varicella vaccine

PCV13 (Prevnar 13): Concurrent administration with varicella vaccine in infants did not reduce antibody responsess or increase adverse effects181

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23): May be administered concurrently with varicella vaccine (using different syringes and different injection sites)105 134 184

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 apart180 186

Manufacturer of zoster vaccine states consider giving PPSV23 (Pneumovax 23) and zoster vaccine at least 4 weeks apart186

Stability

Storage

Parenteral

Injection, for IM Use (PCV13; Prevnar 13)

2–8°C.134 181 Do not freeze or expose to freezing temperatures.134 181

Contains an aluminum adjuvant181 that may precipitate if the vaccine is exposed to freezing temperatures (≤0° C).183

Does not contain thimerosal or any other preservatives.100 176 184

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

2–8°C.129 Do not freeze or expose to freezing temperatures.164

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

Actions

  • PCV13 (Prevnar 13) is a 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.176 181 184 Surveillance data from 2008 indicated that these 13 serotypes account for approximately 61% of US cases of invasive pneumococcal disease occurring in children <5 years of age; serotype 19A accounts for 43% of cases.184

  • PPSV23 (Pneumovax 23) is a 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 Surveillance data from 2008 indicated that these 23 antigens account for 78, 76, and 66% of US cases of invasive pneumococcal disease occurring in individuals 18–49, 50–64, and ≥65 years of age, respectively.169

  • 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

  • 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 These antibodies enhance opsonization, phagocytosis, and killing of S. pneumoniae by leukocytes and other phagocytic cells.103 115 Minimum titer of anticapsular antibodies conferring protection against S. pneumoniae serotypes contained in the vaccines not established.115 103 129 148 181

  • Conjugated antigens like those contained in PCV13 (Prevnar 13) are more immunogenic in infants and young children than the unconjugated antigens in PPSV23 (Pneumovax 23).100 103 106 184 Conjugated antigens may result in improved antibody responses following primary vaccination and a strong anamnestic response and substantial booster response could occur after re-exposure to the antigens;106 134 unconjugated antigens contained in PPSV23 (Pneumovax 23) do not induce long-lasting immunity or an anamnestic response after subsequent exposure to the same antigens.115 134

  • Extent and duration of the immunologic response to pneumococcal vaccines may vary depending on the age of the recipient.115 PPSV23 (Pneumovax 23) is less immunogenic in children <2 years of age than in older children and adults.115 Age-specific immune responses may vary by serotype; response to some common pediatric pneumococcal serotypes (e.g., 6A, 14) is decreased in children 2–5 years of age.115

  • A reduced immune response to pneumococcal vaccines and lower antibody titers may occur in immunocompromised individuals (e.g., HIV-infected individuals, those with leukemia, lymphoma, or generalized malignancy, those receiving immunosuppressive therapy).134

  • Following administration of 3-dose primary vaccination series of PCV13 (Prevnar 13) in healthy infants, responses to 10 of the 13 serotypes contained in the vaccine met the primary end point criterion of serum anticapsular IgG antibody concentrations of 0.35 mcg/mL.181 184 There is evidence that 4 doses of PCV13 (Prevnar 13) result in an antibody response to 12 of the 13 vaccine serotypes in 87–98% of infants.181 184

  • Following administration of PPSV23 (Pneumovax 23), protective anticapsular antibodies generally appear in serum within 2–3 weeks.115 129 After a single dose of PPSV23 (Pneumovax 23), 80% of healthy adults demonstrate at least a twofold increase in anticapsular antibodies specific for each antigen contained in the vaccine.115

Advice to Patients

  • Prior to administration of the 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 that routine vaccination with PCV13 (Prevnar 13) is recommended in the US for all infants 2 through 23 months of age.100 181 184 199 Importance of completing an initial 3-dose vaccination series followed by an additional (booster) dose by the time the child is 12–15 months of age with catch-up vaccination for infants ≤23 months of age previously unvaccinated or incompletely vaccinated against pneumococcal infection.100 167 181 184 199

  • Advise patient and/or patient’s parent or guardian that catch-up vaccination with PCV13 (Prevnar 13) is recommended for allhealthy children 24 through 59 months of age previously unvaccinated or incompletely vaccinated against pneumococcal infection.100 181 184 199

  • Advise patient and/or patient’s parent or guardian that PCV13 (Prevnar 13) is recommended for children 24 through 71 months of age with underlying medical conditions that put them at increased risk for pneumococcal infection (e.g., HIV infection, functional or anatomical asplenia [including SCD], immunosuppressive conditions).100 184 199

  • Advise patient and/or guardian that routine vaccination with PPSV23 (Pneumovax 23) is recommended for adults ≥65 years of age who lack evidence of prior immunization or who received the vaccine >5 years earlier.115 130 168 169 200 PPSV23 (Pneumovax 23) also is recommended for younger adults who are at increased risk for pneumococcal disease or its complications (e.g., those who smoke cigarettes, are immunocompromised, or have certain medical conditions).115 168 169 200

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

  • Importance of informing clinicians of any history of allergic reactions to pneumococcal vaccine (i.e., PCV7, PCV13, PPSV23) or any vaccine containing diphtheria toxoid.129 167 168 181

  • Importance of informing clinicians if any severe or unusual adverse reactions (including allergic reactions) occur with pneumococcal vaccine.167 168 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 .129 167 168 181

  • 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.

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, 2004-2014, Selected Revisions February 1, 2012. 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

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