Pneumococcal Vaccine

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

Introduction

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

Uses for Pneumococcal Vaccine

Prevention of Pneumococcal Disease

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

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

S. pneumoniae is a major cause of serious or invasive illness and death worldwide. 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. Case fatality rates are higher in the elderly (60–80% for pneumococcal bacteremia or meningitis in this age group). In children <5 years of age, S. pneumoniae has been a leading cause of bacterial meningitis.

Epidemiology of pneumococcal disease in the US changed substantially after routine infant and childhood vaccination against the disease was initiated in 2000. 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. Routine infant and childhood vaccination against pneumococcal disease also reduced incidence of invasive pneumococcal disease among unvaccinated individuals of all ages. 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.

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

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

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

Pneumococcal 7-valent conjugate vaccine (PCV7; Prevnar) was available in the US from 2000 until 2010 when it was replaced by PCV13 (Prevnar 13). Since PCV13 (Prevnar 13) contains 6 additional antigens not contained in PCV7 (Prevnar), individuals who previously received age-appropriate vaccination or incomplete vaccination with PCV7 (Prevnar) should receive PCV13 (Prevnar 13).

Vaccination Against Pneumococcal Disease in Groups at Risk

Vaccination against pneumococcal disease is recommended in infants, children, adolescents, and adults at risk of exposure to S. pneumoniae or at risk of developing invasive pneumococcal disease if they become infected with S. pneumoniae.

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

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

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

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

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

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

Children 2 through 5 years of age with functional or anatomic asplenia (including sickle cell disease or other hemoglobinopathies, congenital or acquired asplenia), immunocompromising medical conditions (congenital or acquired immunodeficiency, HIV infection, chronic renal failure, nephrotic syndrome, malignant neoplasms, leukemia, lymphoma, Hodgkin's disease, solid organ transplantation), or certain other medical conditions (chronic heart disease [especially cyanotic congenital heart disease and cardiac failure], chronic lung disease [including asthma if treated with high-dose oral corticosteroid therapy], diabetes mellitus, CSF leaks, cochlear implants) are considered at increased risk for pneumococcal disease.

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

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

ACIP, AAP, and others recommend sequential vaccination with both PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) in children and adolescents 6 through 18 years of age with functional or anatomic asplenia (including sickle cell disease or other hemoglobinopathies, congenital or acquired asplenia), immunocompromising medical conditions (congenital or acquired immunodeficiency, HIV infection, chronic renal failure, nephrotic syndrome, malignant neoplasms, leukemia, lymphoma, Hodgkin's disease, generalized malignancy, solid organ transplantation, multiple myeloma), or certain other medical conditions (CSF leaks, cochlear implants).

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

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

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

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

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

ACIP and others recommend sequential vaccination with both PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) in adults ≥19 years of age with functional or anatomic asplenia (including sickle cell disease or other hemoglobinopathies, congenital or acquired asplenia, splenic dysfunction, splenectomy), immunocompromising medical conditions (congenital or acquired immunodeficiency, HIV infection, chronic renal failure, nephrotic syndrome, leukemia, lymphoma, Hodgkin's disease, generalized malignancy, solid organ transplantation, multiple myeloma), iatrogenic immunosuppression (including long-term systemic corticosteroid therapy or radiation therapy), or certain other medical conditions (CSF leaks, cochlear implants).

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

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

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

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

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

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

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

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

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

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

HIV-infected individuals are at increased risk for pneumococcal disease and should be vaccinated against the disease.

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

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

Revaccination with PPSV23 (Pneumovax 23) at least 5 years after the initial dose is recommended in HIV-infected individuals. Some experts recommend a third dose of PPSV23 (Pneumovax 23) in HIV-infected individuals at ≥65 years of age, as long as 5 years have elapsed since the previous dose. No more than 3 lifetime doses of PPSV23 (Pneumovax 23) are recommended.

Cochlear implant recipients are at substantially increased risk for pneumococcal meningitis and should be vaccinated against the disease. Incidence of bacterial meningitis, particularly pneumococcal meningitis, is higher among children with cochlear implants than children in the general population, and S. pneumoniae is the most common pathogen causing bacterial meningitis in cochlear implant recipients of all ages with meningitis of known etiology.

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

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

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. 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. Although pneumococcal vaccine is recommended in many countries, consider that the vaccine may not be routinely administered.

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

Prevention of Pneumococcal Acute Otitis Media (AOM)

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

Pneumococcal Vaccine Dosage and Administration

Administration

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

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

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

Do not administer PCV13 (Prevnar 13) concomitantly with PPSV23 (Pneumovax 23). When both vaccines indicated, administer PPSV23 (Pneumovax 23) sequentially after the recommended age-appropriate regimen of PCV13 (Prevnar 13), if possible.

PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23) may be given simultaneously with other age-appropriate vaccines during the same health-care visit . (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; separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.

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

IM Administration

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

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.

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

PCV13 (Prevnar 13)

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

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

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

PPSV23 (Pneumovax 23)

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

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

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

Sub-Q Administration

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

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

PPSV23 (Pneumovax 23)

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

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

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

Dosage

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

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

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

Pediatric Patients

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

PCV13 (Prevnar 13)

IM

Each dose is 0.5 mL.

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

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

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

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

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

PCV13 (Prevnar 13)

IM

Single 0.5-mL dose.

Catch-up vaccination in otherwise healthy children 2 through 5 years of age who are unvaccinated and have not received any doses of PCV13 (Prevnar 13): Give a single dose of PCV13 (Prevnar 13). Additional doses unnecessary in healthy children if PCV13 (Prevnar 13) dose given at ≥2 years of age.

Catch-up vaccination in otherwise healthy children 2 through 5 years of age who are incompletely vaccinated for their age and have not received the total age-appropriate number of doses of PCV13 (Prevnar 13 ) and/or PCV7 (Prevnar): Give a single dose of PCV13 (Prevnar 13) at least 8 weeks after most recent dose of PCV13 (Prevnar 13) or PCV7 (Prevnar).

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

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

PCV13 (Prevnar 13)

IM

Each dose is 0.5 mL.

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

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

PPSV23 (Pneumovax 23)

IM or Sub-Q

Single 0.5-mL dose.

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

Sequential Administration

IM or Sub-Q

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

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

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

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

PCV13 (Prevnar 13)

IM

Single 0.5-mL dose.

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

PPSV23 (Pneumovax 23)

IM or Sub-Q

Each dose is 0.5 mL.

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

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

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

Sequential Administration

IM or Sub-Q

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

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

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

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

Adults

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

PCV13 (Prevnar 13)

IM

Single 0.5-mL dose.

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

PPSV23 (Pneumovax 23)

IM or Sub-Q

Each dose is 0.5 mL.

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

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

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

Sequential Administration

IM or Sub-Q

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

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

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

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

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

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

PCV13 (Prevnar 13)

IM

Single 0.5-mL dose.

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

PPSV23 (Pneumovax 23)

IM or Sub-Q

Single 0.5-mL dose.

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

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

PCV13 (Prevnar 13)

IM

Single 0.5-mL dose.

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

PPSV23 (Pneumovax 23)

IM or Sub-Q

Each dose is 0.5 mL.

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

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

Sequential Administration

IM or Sub-Q

Has not previously received PCV13 (Prevnar 13) or PPSV23 (Pneumovax 23) or has unknown vaccination status: Give PCV13 (Prevnar 13) first and give PPSV23 (Pneumovax 23) at least 1 year after PCV13 (Prevnar 13) dose.

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

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

Previously received PCV13 (Prevnar 13) at <65 years of age but has not previously received PPSV23 (Pneumovax 23): Give PPSV23 (Pneumovax 23) dose at least 1 year after PCV13 (Prevnar 13) dose.

Previously received PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) at <65 years of age: Give another dose of PPSV23 (Pneumovax 23) at least 1 year after PCV13 (Prevnar 13) dose and at least 5 years after most recent PPSV23 (Pneumovax 23) dose.

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

To facilitate completion of pneumococcal vaccination in immunocompetent adults ≥65 years of age, ACIP recommends an interval of at least 1 year between PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23), regardless of which order the vaccines are given. If PPSV23 (Pneumovax 23) dose inadvertently given earlier than 1 year after PCV13 (Prevnar 13), the dose does not need to repeated. The minimum interval between PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) is 8 weeks.

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.

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

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

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

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

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

General Precautions

Individuals with Altered Immunocompetence

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

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

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

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.

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

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

Manufacturer of PPSV23 (Pneumovax 23) states administer with caution in individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction could pose a substantial risk.

Limitations of Vaccine Effectiveness

May not protect all vaccine recipients against pneumococcal disease.

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

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

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

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

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

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

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

Duration of Immunity

Duration of protection after age-appropriate vaccination with PCV13 (Prevnar 13) not known. 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. Revaccination with PCV13 (Prevnar 13) after age-appropriate vaccination not currently recommended.

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

Improper Storage and Handling

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

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

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

Specific Populations

Pregnancy

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

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

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

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

Lactation

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

Use with caution in nursing women.

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

Pediatric Use

PCV13 (Prevnar 13): Safety and efficacy not established in infants <6 weeks of age. Manufacturer states immune response to the vaccine in preterm infants not adequately studied to date. 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.

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

Geriatric Use

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

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

Common Adverse Effects

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

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

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. 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. However, each parenteral vaccine should be administered using a different syringe and different injection site.

Specific Drugs

Stability

Storage

Parenteral

Injection, for IM Use (PCV13; Prevnar 13)

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

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

Does not contain thimerosal or any other preservatives.

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

2–8°C.

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

Actions

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

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

• 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. S. pneumoniae is a common cause of AOM, sinusitis, and pneumonia and can cause invasive disease, including bacteremia and meningitis. Infection with S. pneumoniae has been a leading cause of bacterial meningitis in the US among children <5 years of age.

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

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

• Conjugated antigens contained in PCV13 (Prevnar 13) are more immunogenic in infants and young children than the unconjugated antigens contained in PPSV23 (Pneumovax 23). Conjugated antigens elicit a T-cell dependent immune response; antibodies produced in response to pneumococcal conjugate vaccines enhance opsonization, phagocytosis, and killing of S. pneumoniae by leukocytes and other phagocytic cells. Unconjugated antigens contained in PPSV23 (Pneumovax 23) do not induce long-lasting immunity or an anamnestic response after subsequent exposure to the same antigens.

• Following primary vaccination with PCV13 (Prevnar 13) in healthy infants (doses given at 2, 4, 6, and 12–15 months of age), 87–98% had anticapsular IgG antibody concentrations ≥0.35 mcg/mL against 12 of the 13 pneumococcal serotypes in the vaccine 1 month after the third dose; 64% achieved an antibody concentration ≥0.35 mcg/mL against serotype 3. Antibody concentrations 1 month after the fourth dose were higher for all 13 serotypes compared with concentrations 1 month after the third dose.

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

Advice to Patients

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

• Advise patient and/or patient’s parent or guardian of the risks and benefits of vaccination with pneumococcal vaccine.

• Advise patient and/or patient’s parent or guardian of the importance of completing the primary immunization series or catch-up vaccination with the age-appropriate number of doses of PCV13 (Prevnar 13) in infants 2 through 23 months of age and healthy children 2 through 5 years of age.

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

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

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

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

• Importance of informing clinicians if any severe or unusual adverse reactions (including allergic reactions) occur with pneumococcal vaccine. Clinicians or individuals can report any adverse reactions that occur following vaccination to the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or [Web].

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

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

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

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