Sunday, June 3, 2012

Pneumococcal Vaccine


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

Introduction

Inactivated (polysaccharide) vaccine.102 129 148 Pneumococcal vaccine is commercially available in the US as pneumococcal 7-valent conjugate vaccine (diphtheria cross-reactive material [CRM]197 protein) (PCV7; Prevnar)102 148 and pneumococcal vaccine, polyvalent (pneumococcal 23-valent vaccine; PPSV23; Pneumovax 23).102 129 Both vaccines contain capsular antigens extracted from Streptococcus pneumoniae and are used to stimulate active immunity to pneumococcal infection.100 102 103 106 115 129 148 Various other pneumococcal vaccines are being investigated or may be available in other countries.103


Uses for Pneumococcal Vaccine


Prevention of Invasive Pneumococcal Infection


Prevention of serious or invasive pneumococcal infection (e.g., pneumonia, meningitis, bacteremia) caused by vaccine serotypes of Streptococcus pneumoniae in adults, adolescents, and infants and children ≥2 months of age.100 103 129 137 148 160


Invasive pneumococcal infection is caused by S. pneumoniae and is transmitted person-to-person by the respiratory route.102 166 Annual overall US incidence is estimated to be approximately 24 cases/100,000 population.166 Pneumococcal pneumonia results in an estimated 175,000 hospitalizations each year with a case fatality rate of 5–7%.166 Estimates indicate that pneumococcal disease is responsible for >50,000 cases of bacteremia annually with a case fatality rate of about 20%.166 There also are 3000–6000 cases of pneumococcal meningitis each year with a case fatality rate of about 30%.166 Case fatality rates are higher in the elderly.166 Invasive pneumococcal infection accounts for more deaths than any other vaccine-preventable bacterial disease.115


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 PCV7 (Prevnar), unless contraindicated.100 102 103 137 (See Contraindications under Cautions.) In addition, catch-up vaccination using an age-appropriate regimen of PCV7 (Prevnar) is recommended for all infants ≤23 months of age who are unvaccinated or incompletely vaccinated.100 102 103 137


ACIP, AAP, and AAFP also recommend vaccination of selected children 24 through 59 months at high risk or presumed high risk for pneumococcal disease using an age-appropriate regimen of PCV7 (Prevnar) followed by PPSV23 (Pneumovax 23).100 102 103 137 165 Pneumococcal vaccination using a regimen of PCV7 (Prevnar) or PPSV23 (Pneumovax 23) also may be considered for other previously unvaccinated children 24 through 59 months of age, especially those at moderate risk for pneumococcal disease.102 103 Data are limited regarding efficacy of pneumococcal vaccines in children 5–9 years of age; however, use of the vaccines is not contraindicated in these children.102 103


ACIP, AAFP, American College of Obstetricians and Gynecologists (ACOG), and American College of Physicians (ACP) recommend vaccination against pneumococcal infection using PPSV23 (Pneumovax 23) in all unvaccinated adults 19 through 64 years of age who are at increased risk for pneumococcal disease or its complications because they smoke cigarettes, are residents of nursing homes or other long-term care facilities, or have certain medical conditions.115 160 176 (See Uses: Preexposure Vaccination Against Pneumococcal Infection in Groups At Risk.)


ACIP, AAFP, ACOG, and ACP recommend routine vaccination against pneumococcal infection using PPSV23 (Pneumovax 23) in all adults ≥65 years of age who are unvaccinated or have unknown vaccination status and routine revaccination in all adults ≥65 years of age who were immunized ≥5 years earlier and were <65 years of age at the time of vaccination, unless contraindicated.115 130 160


PCV7 (Prevnar) contains conjugated antigens representing 7 different serotypes of S. pneumoniae and is labeled for use in infants and children 6 weeks of age up to 10 years of age.100 102 103 148 PPSV23 (Pneumovax 23) contains unconjugated antigens representing 23 different serotypes of S. pneumoniae and is labeled for use in adults, adolescents, and children ≥2 years of age.100 102 103 129 Although PPSV23 (Pneumovax 23) potentially provides coverage against a broader range of pneumococcal infections, it is less immunogenic than PCV7 (Prevnar) in infants and young children since it is an unconjugated vaccine.100 102 103 (See Actions.) Therefore, PCV7 (Prevnar) is the preferred vaccine for routine vaccination in infants 2 through 23 months of age100 102 103 148 and also is the preferred vaccine for children 24 through 59 months of age with medical conditions that put them at high-risk of invasive pneumococcal infection.100 102 103 129 148 However, because PPSV23 (Pneumovax 23) can provide additional benefits in terms of immunity against a broader range of pneumococcal serotypes, sequential use of both vaccines is recommended for these high-risk children.100 102 103 (See Dosage under Dosage and Administration.)


Pneumococcal vaccines will not prevent pneumococcal infection caused by S. pneumoniae serogroups not represented in the vaccines and will not prevent infections caused by other pathogens.129 148


Pneumococcal vaccines are not indicated for treatment of acute pneumococcal infections.148 Previously unvaccinated or incompletely vaccinated children who recover from invasive pneumococcal disease should be vaccinated using the usually recommended age-appropriate regimens.102


Although the antigens in PCV7 (Prevnar) are conjugated to diphtheria toxoid protein, this vaccine is not indicated for immunization against diphtheria.103 148


Prevention of Pneumococcal Acute Otitis Media (AOM)


Prevention of severe or recurrent AOM caused by vaccine serotypes of S. pneumoniae in infants and young children.100 102 148


PCV7 (Prevnar) provides a modest decrease in AOM and recurrent AOM in infants <2 years of age.102 Protection against AOM caused by vaccine serotypes is expected to be substantially lower than protection against invasive disease caused by these serotypes.148


PPSV23 (Pneumovax 23) has not been shown to decrease the incidence of AOM in children of any age and is not recommended for prevention of AOM.100 102


Pneumococcal vaccine will not prevent AOM caused by S. pneumoniae serotypes not represented in the vaccine and will not prevent AOM caused by other pathogens.148


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.100 102 103


Infants 2 through 23 months of age are at increased risk of pneumococcal disease.100 102 103 Therefore, ACIP, AAP, and AAFP recommend routine primary vaccination and catch-up vaccination against pneumococcal infection in this age group using PCV7 (Prevnar).100 102 103


Children 24 through 59 months of age at high risk of pneumococcal disease (e.g., those with anatomic or functional asplenia [including sickle cell disease], HIV infection, cochlear implants) or at presumed high risk (e.g., those with congenital immunodeficiencies, phagocytic disorders, chronic cardiac disease, chronic pulmonary disease, chronic renal insufficiency, diabetes mellitus, CSF leaks, diseases associated with immunosuppressive or radiation therapy, solid organ transplantation) should be vaccinated against pneumococcal infection and may benefit from sequential vaccination with PCV7 (Prevnar) followed by PPSV23 (Pneumovax 23).100 102 103


Children 24 through 59 months of age at moderate or low risk of pneumococcal disease (e.g., those ≤35 months of age; those 36 through 59 months of age who attend group child-care centers or who are black or Native American, including Alaskan Native and American Indian) may receive immunization with PCV7 (Prevnar).100 102 103 148 Although routine primary immunization against pneumococcal disease is not recommended for this age group, ACIP and AAP state that use of PCV7 (Prevnar) can be considered for otherwise healthy children with priority given to those who are at moderate risk of pneumococcal disease.100 102 103 PPSV23 (Pneumovax 23) is an acceptable alternative in these children if there are economic or other barriers to use of PCV7 (Prevnar).100


Children 5 through 9 years of age generally are at lower risk of pneumococcal disease than younger children, unless they have medical conditions that put them at high risk.102 103 Although data are limited regarding use of the vaccine in this age group, those at high risk who are unvaccinated may receive PCV7 (Prevnar).102 103 Alternatively, PPSV23 (Pneumovax 23) may be used.102 137


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.128 (See Dosage and Administration.) 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.128 Consider that pneumococcal vaccine is not administered in the majority of countries.128


Individuals with anatomic or functional asplenia, including those with sickle cell disease (SCD), are at increased risk for invasive pneumococcal disease.103 High risk for pneumococcal infection in individuals with SCD may be caused by a combination of low levels of circulating antibodies, splenic dysfunction, and complement deficiency resulting in decreased clearance of encapsulated bacteria from the bloodstream.103 Pneumococcal vaccination should be completed at least 2 weeks before elective splenectomy.100 102 Children with SCD who are receiving penicillin prophylaxis for prevention of pneumococcal disease should continue such prophylaxis if indicated, regardless of vaccination status.100 102 103 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.103


HIV-infected infants, children, adolescents, and adults have a markedly increased risk for pneumococcal disease.103 161 162 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 59 months of age receive primary immunization with PCV7 (Prevnar)162 and that all HIV-infected children ≥2 years of age receive PPSV23 (Pneumovax 23).162 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.161 These experts recommend that PPSV23 (Pneumovax 23) be offered to HIV-infected adults and adolescents with CD4+ T-cell counts <200 cells/mm3, but revaccination should be considered when CD4+ T-cell count increases to >200 cells/mm3 in response to antiretroviral therapy.161 Revaccination with PPSV23 (Pneumovax 23) also is recommended in HIV-infected individuals after 3–5 years (children ≤10 years of age) or after 5 years (adults, adolescents, children >10 years of age).161 162 (See Dosage and Administration: Dosage.) Consider that pneumococcal vaccines may be less immunogenic in immunocompromised individuals.100 102 103 115 128 129 148 (See Individuals with Altered Immunocompetence under Cautions.)


Cochlear transplant recipients have a higher incidence of bacterial meningitis, particularly pneumococcal meningitis, than children in the general population.154 155 ACIP and CDC recommend that all individuals who have or are scheduled to receive a cochlear implant receive age-appropriate vaccination against pneumococcal disease.110 Vaccination against pneumococcal infection should be completed at least 2 weeks prior to placement of a cochlear implant, if possible.110


Infants and children attending group child-care centers have an increased risk for invasive pneumococcal disease and AOM.103 Preexposure age-appropriate vaccination with PCV7 (Prevnar) should be considered if these children are unvaccinated.100 102 103


Individuals from certain racial and ethnic populations, including blacks, Alaskan Natives, and American Indians, have higher rates of invasive pneumococcal disease compared with whites.103 Preexposure vaccination against pneumococcal infection using the usually recommended age-appropriate regimens should be considered if these individuals are unvaccinated.100 102 103 Although PPSV23 is not routinely recommended for Alaskan Native or American Indian children 24 through 59 months of age, public health authorities may recommend use of PPSV23 after PCV7 in such children who live in areas where the risk of invasive pneumococcal disease is increased.176 In addition, although routine use of PPSV23 is 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 for those 50 through 64 years of age who live in areas with an increased risk of invasive pneumococcal disease.160 176


Adults who smoke cigarettes, are residents of nursing homes or other long-term care facilities, or have certain underlying medical conditions (e.g., chronic cardiovascular disease, diabetes mellitus, chronic pulmonary disease [including asthma], chronic liver disease, cirrhosis, chronic alcoholism, chronic renal failure, nephrotic syndrome) are at increased risk for pneumococcal disease and should be vaccinated with PPSV23 (Pneumovax 23).160 176


Adults ≥65 years of age, including immunocompetent adults, are at increased risk for pneumococcal infection.115 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.115 Therefore, ACIP, AAFP, ACOG, and ACP recommend routine vaccination with PPSV23 (Pneumovax 23) for all adults ≥65 years of age who are unvaccinated or have an uncertain history of vaccination and routine revaccination for those who received the vaccine >5 years earlier at <65 years of age.115 130 160 Both ACIP and ACP recommend that all adults be evaluated at 50 years of age to determine their vaccination status and need for PPSV23 (Pneumovax 23).115 130


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


Pneumococcal Vaccine Dosage and Administration


Administration


PCV7 (Prevnar) is administered by IM injection.100 102 103 148


PPSV23 (Pneumovax 23) is administered by IM or sub-Q injection.102 115 129


Do not dilute.129 148 Do not mix with any other vaccine or solution.129 148


Do not administer PCV7 (Prevnar) concomitantly with PPSV23 (Pneumovax 23).100 102 103 When both vaccines are indicated (e.g., children 24 through 59 months of age at high risk for pneumococcal disease), PPSV23 (Pneumovax 23) may be administered sequentially after a regimen of PCV7 (Prevnar), provided ≥2 months have elapsed since the last dose of PCV7 (Prevnar).102 103 Only very limited data available regarding administration of PCV7 (Prevnar) sequentially after PPSV23 (Pneumovax 23).103 If PCV7 (Prevnar) is considered necessary in those who already received PPSV23 (Pneumovax 23), it should be given ≥2 months after PPSV23 (Pneumovax 23).103


PCV7 (Prevnar) 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).100 102 103 128 (See Interactions.)


When multiple vaccines are administered during a single healthcare visit, each vaccine should be given with a different syringe and at different injection sites.128 Separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.128


IM Administration


Administer PCV7 (Prevnar) by IM injection.100 102 103 128 148 Do not administer IV.148 Safety and efficacy not evaluated following administration by other routes (e.g., sub-Q).148


Shake PCV7 (Prevnar) well immediately prior to administration to provide a uniform, white suspension.148 164 Discard vaccine if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation.148 164


As with other aluminum-containing vaccines, a nodule may occasionally be palpable at the injection site for several weeks following administration of PCV7 (Prevnar).148


Administer PPSV23 (Pneumovax 23) by IM injection;102 115 129 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.128 129 148 To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual's age and body mass, the thickness of adipose tissue and muscle at the injection site, and the injection technique.128


For infants up to 12 months of age, IM injections should be made into the anterolateral thigh.128 For infants and children 1–2 years of age, IM injections should preferably be administered into the anterolateral thigh; deltoid muscle is an alternative if muscle mass is adequate.128 For children and adolescents 3–18 years of age and for adults, deltoid muscle is preferred, although anterolateral thigh is an alternative.128


Generally, do not administer vaccine into buttock muscle in children because of potential for injection-associated injury to the sciatic nerve.128 148


Avoid injection of vaccines into or near blood vessels.128 148 Although the manufacturer of PCV7 (Prevnar) and some experts recommend that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) be performed to ensure that a blood vessel has not been entered,148 ACIP and AAP state that this procedure is not required because large blood vessels are not present at recommended IM injection sites.128


Sub-Q Administration


Administer PPSV23 (Pneumovax 23) by sub-Q injection; alternatively, administer by IM injection.102 115 129 (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.128 For adults, adolescents, and children ≥24 months of age, the upper-outer triceps area is preferred.128


To ensure appropriate delivery, sub-Q injections should be made at a 45° angle using a 5/8 inch, 23- to 25-gauge needle.128


Dosage


Dosing schedule varies according to the individual's age and immunization status and specific vaccine administered (Pneumovax 23, Prevnar).100 102 103 129 148 Follow dosage recommendations for the specific preparation used.


Medically stable preterm and low birthweight infants should be vaccinated at the usual chronologic age using usual dosage.102 103


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.103


PCV7 (Prevnar): Used in infants and children ≥6 weeks of age up to 10 years of age.148


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


Pediatric Patients


Prevention of Pneumococcal Infection

Routine Primary Vaccination in Infants >6 Weeks through 23 Months of Age (PCV7; Prevnar)

IM

Each dose consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe.102 148


Routine primary immunization in early infancy consists of a series of 3 doses and an additional (booster) dose.100 102 103 148 ACIP, AAP, and AAFP recommend that doses be given at 2, 4, 6, and 12 through 15 months of age.100 102 103 137 148 Initial dose may be given as early as 6 weeks of age.100 102 103 148 Minimum interval between first 3 doses is 4 weeks; minimum interval between third and fourth dose is 8 weeks.137 148


Catch-up vaccination using the age-appropriate number of doses indicated below is recommended in all infants ≤23 months of age who are unvaccinated or incompletely vaccinated.102 137


Previously unvaccinated infants 7 through 11 months of age: Primary immunization consists of 2 primary doses and an additional (booster) dose.100 102 103 148 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).100 102 103 137 148


Previously unvaccinated infants 12 through 23 months of age: Primary immunization consists of 2 doses.100 102 103 148 Give second dose at least 8 weeks after first dose.100 102 103 137 148


Duration of immunity following the recommended age-appropriate regimens of PCV7 (Prevnar) not fully determined.103 (See Duration of Immunity under Cautions.)


Preexposure Vaccination Against Pneumococcal Infection in Groups at Risk

Children 24 through 59 Months of Age at High Risk (PCV7; Prevnar and PPSV23; Pneumovax 23)

IM or Sub-Q

Each IM dose of PCV7 (Prevnar) consists of the entire contents (0.5 mL) of the commercially available single-dose prefilled syringe.148


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


ACIP, AAP, and AAFP recommend that children 24 through 59 months of age who are immunocompromised or have certain underlying medical conditions that put them at high risk for pneumococcal disease (see Preexposure Vaccination Against Pneumococcal Infection in Groups at Risk under Uses) receive a vaccination regimen of PCV7 (Prevnar) followed by a single dose of PPSV23 (Pneumovax 23) given 8 weeks later.100 102 103 137 165 (See Table 1.)


Adapted from American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006:525-37.






























Table 1. Recommended Vaccination Schedules for Children 24 through 59 Months of Age at High Risk for Pneumococcal Infection102165

Previous Doses of Any Pneumococcal Vaccine



Dosage Recommendations



Minimum Dosing Interval



No previous dose of PCV7 or PPSV23



2 doses of PCV7



8 weeks between doses



 



1 dose of PPSV23



8 weeks after last dose of PCV7



1 dose of PPSV23



2 doses of PCV7



8 weeks between doses beginning 6–8 weeks after last dose of PPSV23



<3 doses of PCV7



2 additional doses of PCV7



8 weeks between doses beginning 8 weeks after most recent dose of PCV7



 



1 dose of PPSV23



8 weeks after last dose of PCV7



3 doses of PCV7



1 additional dose of PCV7



8 weeks after third dose of PCV7



 



1 dose of PPSV23



8 weeks after last dose of PCV7



4 doses of PCV7



1 dose of PPSV23 at 24 months of age



8 weeks after last dose of PCV7


Duration of immunity and need for additional (booster) doses not fully determined.100 102 103 148 ACIP, AAFP, and AAP recommend revaccination with a single 0.5-mL dose of PPSV23 (Pneumovax 23) for children ≥2 years of age who are at highest risk for serious pneumococcal infection (e.g., those with functional or anatomic asplenia, altered immunocompetence).102 103 115 176 For such children ≤10 years of age, ACIP and AAP recommend revaccination with a single 0.5-mL dose of PPSV23 (Pneumovax 23) 3–5 years after the initial dose.102 103 129 176 For those >10 years of age, ACIP and AAP recommend revaccination with a single 0.5-mL dose of PPSV23 (Pneumovax 23) ≥5 years after the initial dose.102 103 (See Duration of Immunity under Cautions.)


Previously Unvaccinated HIV-infected Infants and Children 2 through 59 Months of Age (PCV7; Prevnar and PPSV23; Pneumovax 23)

IM or Sub-Q

Each IM dose of PCV7 (Prevnar) consists of the entire contents (0.5 mL) of the commercially available single-dose or prefilled syringe.148


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


HIV-infected infants 2 through 23 months of age: 4 doses of PCV7 (Prevnar) given at 2, 4, 6, and 12 through 15 months of age.162


HIV-infected children 24 through 59 months of age who are incompletely vaccinated: 2 doses of PCV7 (Prevnar) given at least 8 weeks apart.162 Give a single dose of PCV7 (Prevnar) to those who previously received 3 doses.162


HIV-infected adolescents and children ≥2 years of age: A single dose of PPSV23 (Pneumovax 23) and revaccination with a dose of PPSV23 (Pneumovax 23) 3–5 years after the initial dose (those ≤10 years of age) or 5 years after the initial dose (those >10 years of age).103 161 162


HIV-infected Adolescents (PPSV23; Pneumovax 23)

IM or Sub-Q

Single 0.5-mL dose.129 161


HIV-infected adolescents with CD4+ T-cell counts >200 cells/mm3: Single dose of PPSV23 (Pneumovax 23) if it has been >5 years since the last dose.161


HIV-infected adolescents with CD4+ T-cell counts <200 cells/mm3: Offer single dose of PPSV23 (Pneumovax 23).161 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.161


Duration of immunity and need for additional (booster) doses not fully determined.161 (See Duration of Immunity under Cautions.) CDC, NIH, IDSA, and others state revaccination every 5 years may be considered in HIV-infected adults.161


Previously Unvaccinated Children 24 through 59 Months of Age at Moderate or Low Risk (PCV7; Prevnar)

IM

Single 0.5-mL dose.100 102 103 148


Duration of immunity and need for additional (booster) doses not fully determined.103 (See Duration of Immunity under Cautions.)


Previously Unvaccinated Children ≥24 Months of Age at Moderate or Low Risk (PPSV23; Pneumovax 23)

IM or Sub-Q

Single 0.5-mL dose.100 102 129


Duration of immunity and need for additional (booster) doses not fully determined.103 Routine revaccination with PPSV23 (Pneumovax 23) in immunocompetent children currently not recommended.102 115 129 (See Duration of Immunity under Cautions.)


Previously Unvaccinated Children 5 through 9 Years of Age (PCV7; Prevnar and PPSV23; Pneumovax 23)

IM

PCV7 (Prevnar): Single 0.5-mL dose.100 102 148


PPSV23 (Pneumovax 23): Single 0.5-mL dose.100 102 129


If both pneumococcal vaccines are indicated (e.g., in those at high risk of pneumococcal disease), give PCV7 (Prevnar) first.100 102 103 Give PPSV23 (Pneumovax 23) ≥8 weeks later.100 102


Duration of immunity and need for additional (booster) doses not fully determined.103 Routine revaccination with PPSV23 (Pneumovax 23) in immunocompetent children currently not recommended.102 115 129 However, ACIP, AAFP, and AAP recommend revaccination with a single dose of PPSV23 (Pneumovax 23) for children ≥2 years of age who are at highest risk for serious pneumococcal infection (e.g., those with functional or anatomic asplenia, HIV infection, altered immunocompetence).102 103 115 176 For such children ≤10 years of age, ACIP and AAP recommend revaccination with a single 0.5-mL dose of PPSV23 (Pneumovax 23) 3–5 years after the initial dose.102 103 129 176 For those >10 years of age, ACIP and AAP recommend revaccination with a single 0.5-mL dose of PPSV23 (Pneumovax 23) ≥5 years after the initial dose.102 103 (See Duration of Immunity under Cautions.)


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 PPSV23 (Pneumovax 23).115 160 176 (See Uses: Preexposure Vaccination Against Pneumococcal Infection in Groups At Risk.)


Duration of immunity and need for additional (booster) doses not fully determined.103 (See Duration of Immunity under Cautions.) One-time revaccination with a single 0.5-mL dose of PPSV23 (Pneumovax 23) 5 years after the initial dose is recommended for those with immunodeficiency, chronic renal failure, nephrotic syndrome, or functional or anatomic asplenia (e.g., SCD or splenectomy).160


HIV-infected Adults (PPSV23; Pneumovax 23)

IM or Sub-Q

Single 0.5-mL dose.129 161


HIV-infected adults with CD4+ T-cell count is >200 cells/mm3: Single dose of PPSV23 (Pneumovax 23) if it has been >5 years since the last dose.161


HIV-infected adults with CD4+ T-cell count is <200 cells/mm3: Offer single dose of PPSV23 (Pneumovax 23).161 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.161


Duration of immunity and need for additional (booster) doses not fully determined.161 (See Duration of Immunity under Cautions.) CDC, NIH, IDSA, and others state revaccination every 5 years may be considered in HIV-infected adults.161


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.115 160 Manufacturer recommends routine dose for adults ≥50 years of age.129


Duration of immunity and need for additional (booster) doses not fully determined.103 (See Duration of Immunity under Cautions.) ACIP, AAFP, ACOG, and ACP recommend that individuals who received PPSV23 (Pneumovax 23) when they were <65 years of age should receive routine revaccination with a single 0.5-mL dose of the vaccine at ≥65 years of age, provided at least 5 years have elapsed since the first dose.130 160 Data are insufficient to date to make recommendations concerning revaccination of healthy adults who received the vaccine at ≥65 years of age.130 (See Duration of Immunity under Cautions.)


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



  • PCV7 (Prevnar): Hypersensitivity to any ingredient in the formulation, including diphtheria toxoid.103 148




  • PPSV23 (Pneumovax 23): Hypersensitivity to any ingredient in the formulation.103 129



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.129 148


Take all known precautions to prevent adverse reactions, including a review of the patient's history with respect to possible hypersensitivity to the vaccine or similar vaccines.129 148


Epinephrine and other appropriate agents should be readily available in case anaphylaxis or other serious allergic reaction occurs.129 148


General Precautions


Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.102 128 129 148 Consider possibility that the immune response to the vaccine and efficacy may be reduced in these individuals.100 102 103 115 128

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