Pneumococcal Vaccine (Monograph)

Brand names: Pneumovax 23, Prevnar 13, Prevnar 20, Vaxneuvance
Drug class: Vaccines
ATC class: J07A1
VA class: IM100

Introduction

Inactivated (polysaccharide) vaccine. Commercially available in US as 2 different vaccine types: pneumococcal conjugate vaccine and pneumococcal polysaccharide vaccine. All of the vaccines contain capsular antigens extracted from Streptococcus pneumoniae and are used to stimulate active immunity to pneumococcal infection.

Uses for Pneumococcal Vaccine

Prevention of Pneumococcal Disease

Pneumococcal vaccines are used to stimulate active immunity for the prevention of diseases caused by Streptococcus pneumoniae. Common infections caused by S. pneumoniae include acute otitis media (AOM), sinusitis, pneumonia, bacteremia, and meningitis.

Adults who are immunosuppressed or have certain medical conditions are at increased risk for systemic disease. In children <5 years of age, S. pneumoniae has been a leading cause of bacterial meningitis.

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

PCV13 (Prevnar 13) is indicated for prevention of invasive disease (e.g., pneumonia, meningitis, bacteremia) caused by S. pneumoniae in infants 6 weeks through 23 months of age, healthy children 2–5 years of age, children and adolescents 6–18 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).

PCV15 (Vaxneuvance) is indicated for prevention of invasive disease (e.g., pneumonia, meningitis, bacteremia) caused by S. pneumoniae in infants and children 6 weeks through 17 years of age and in adults ≥18 years of age. Provides protection only against the 15 S. pneumoniae serotypes represented in the vaccine: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F.

PCV20 (Prevnar 20) is indicated for use in adults ≥18 years of age. Provides protection only against the 20 S. pneumoniae serotypes represented in the vaccine: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.

PPSV23 (Pneumovax 23) is indicated for prevention of invasive disease (e.g., pneumonia, meningitis, bacteremia) caused by S. pneumoniae in adults ≥50 years of age and individuals ≥2 years of age who are at increased risk for pneumococcal disease. 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).

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

Underlying conditions that may increase the risk of pneumococcal disease include functional or anatomic asplenia (including sickle cell disease or other hemoglobinopathies, congenital or acquired asplenia), chronic heart disease (especially cyanotic congenital heart disease and cardiac failure), chronic lung disease (including asthma if treated with prolonged high-dose oral corticosteroids), diabetes mellitus, diseases and conditions treated with immunosuppressive drugs or radiation therapy, immunocompromising medical conditions (congenital or acquired immunodeficiency, HIV infection, chronic renal failure, nephrotic syndrome, malignant neoplasms, leukemia, lymphoma, Hodgkin's disease, generalized malignancy, solid organ transplantation, multiple myeloma), CSF leaks, or cochlear implants.

Infants 2–23 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) or PCV15 (Vaxneuvance). ACIP and other experts recommend that all infants 2–23 months of age receive routine primary vaccination with PCV13 or PCV15. PPSV23 (Pneumovax 23) is not recommended in these infants.

Healthy children 2–5 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) or PCV15 (Vaxneuvance). PPSV23 (Pneumovax 23) is not recommended in these children.

Children and adolescents 2–18 years of age with certain underlying medical conditions should be vaccinated with PCV13 or PCV15. ACIP and other experts state that these individuals should receive a sequential regimen of PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) followed by PPSV23 (Pneumovax 23) at least 8 weeks after the most recent PCV dose. The addition of PPSV23 to a primary series with PCV13 or PCV15 provides immunity against a broader range of serotypes.

Healthy adults 19–64 years of age do not require routine pneumococcal vaccination. Although PCV13 (Prevnar 13), PCV15 (Vaxneuvance), and PCV20 (Prevnar 20) are labeled by FDA for prevention of pneumonia and invasive pneumococcal disease in adults, and PPSV23 (Pneumovax 23) is labeled for adults as young as 50 years of age, ACIP and others do not recommend routine pneumococcal vaccination in healthy adults 19–64 years of age who do not have medical conditions that increase the risk for pneumococcal disease.

Adults 19–64 years of age with certain risk factors or immunocompromising conditions should be vaccinated against the disease. ACIP and others recommend PCV15 or PCV20 in these individuals. If PCV15 is used, then a dose of PPSV23 should be administered at least 1 year after the PCV15 dose is given; if PCV20 is used, then a dose of PPSV23 is not indicated. A minimum interval of 8 weeks can be considered between administration of PCV15 and PPSV23 for adults with an immunocompromising condition.

Adults 19–64 years of age with a cochlear implant or cerebrospinal fluid leak should be vaccinated with PCV15 or PCV20. If PCV15 is used, then a dose of PPSV23 (Pneumovax 23) should be administered at least 8 weeks after the PCV15 dose; if PCV20 (Prevnar 20) is used, a dose of PPSV23 is not indicated.

Adults ≥65 years of age, including immunocompetent adults, are at increased risk for pneumococcal infection and should be routinely vaccinated against the disease with a single dose of PCV20 (Prevnar 20) or a sequential regimen of PCV15 (Vaxneuvance) followed by PPSV23 (Pneumovax 23) at least 1 year later.

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

Cochlear implant recipients are also at substantially increased risk for pneumococcal meningitis and should be vaccinated against the disease according to recommendations.

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.

Pneumococcal Vaccine Dosage and Administration

General

Patient Monitoring

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

Dispensing and Administration Precautions

• Appropriate medications and supplies for managing immediate allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of pneumococcal vaccines.

• Syncope may occur following administration of parenteral vaccines, especially in adolescents. Patients should be seated or lying down during vaccination. Observe vaccine recipients (especially adolescents) for 15 minutes after vaccination. If syncope develops, observe patients until symptoms resolve.

Administration

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

PCV15 (Vaxneuvance): Administer only by IM injection.

PCV20 (Prevnar 20): Administer only by IM injection.

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

Do not dilute PCV13 (Prevnar 13), PCV15 (Vaxneuvance), PCV20 (Prevnar 20), and PPSV23 (Pneumovax 23); do not mix with any other vaccine or solution.

Do not administer PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) concomitantly with PPSV23 (Pneumovax 23). When these vaccines are indicated, administer PPSV23 (Pneumovax 23) sequentially after the recommended age-appropriate regimen of PCV13 (Prevnar 13) or PCV15 (Vaxneuvance), if possible.

PCV13 (Prevnar 13), PCV15 (Vaxneuvance), PCV20 (Prevnar 20), or PPSV23 (Pneumovax 23) may be given simultaneously with other age-appropriate vaccines during the same health-care visit. 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.

IM Administration

Depending on patient age, administer IM injections 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 1–2 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. 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.

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

Sub-Q Administration

Make sub-Q injections into upper-outer triceps area or anterolateral thigh for infants <12 months of age. In adults, adolescents, and children ≥12 months 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.

Specific Vaccine Formulations

PCV13 (Prevnar 13)

Administer only by IM injection. 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.

PCV15 (Vaxneuvance)

Administer only by IM injection. Do not administer sub-Q or intradermally.

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

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

PCV20 (Prevnar 20)

PCV20 (Prevnar 20) is administered only by IM injection. The vaccine should not be administered sub-Q or intradermally.

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

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

PPSV23 (Pneumovax 23)

Administer by IM injection or alternatively, by sub-Q injection. Do not administer IV or intradermally.

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

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 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 2–23 Months of Age

PCV13 (Prevnar 13) or PCV15 (Vaxneuvance)

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) or PCV15 (Vaxneuvance). 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 7–11 months of age: Give 2 doses of PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) 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 12–23 months of age: Give 2 doses of PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) at least 8 weeks (2 months) apart. A third dose is unnecessary if second dose was given at ≥24 months of age.

Healthy Children 2–5 Years of Age

PCV13 (Prevnar 13) or PCV15 (Vaxneuvance)

IM

Single 0.5-mL dose.

Catch-up vaccination in otherwise healthy children 2–5 years of age who are unvaccinated and have not received any doses of PCV13 (Prevnar 13) or PCV15 (Vaxneuvance): Give a single dose of PCV13 (Prevnar 13) or PCV15 (Vaxneuvance). Additional doses unnecessary in healthy children if PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) dose given at ≥2 years of age.

Catch-up vaccination in otherwise healthy children 2–5 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 ) or PCV15 (Vaxneuvance): Give a single dose of PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) at least 8 weeks after most recent dose of PCV13 (Prevnar 13) or PCV15 (Vaxneuvance).

Children 2–5 Years of Age at Increased Risk

PCV13 (Prevnar 13) or PCV15 (Vaxneuvance)

IM

Each dose is 0.5 mL.

Children who previously received <3 doses of PCV13 (Prevnar 13) or PCV15 (Vaxneuvance): Give 2 doses of PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) at least 8 weeks apart.

Children who previously received a total of 3 doses of PCV given as PCV13 (Prevnar 13) or PCV15 (Vaxneuvance): Give a single dose of PCV13 (Prevnar 13) or PCV15 (Vaxneuvance).

PPSV23 (Pneumovax 23)

IM or Sub-Q

Single 0.5-mL dose.

Children who have not previously received PPSV23 (Pneumovax 23): Give a single dose of PPSV23 (Pneumovax 23).

Sequential Administration

IM or Sub-Q

Children who have not previously received PCV13 (Prevnar 13), PCV15 (Vaxneuvance), or PPSV23 (Pneumovax 23): Give PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) first and give PPSV23 (Pneumovax 23) at least 8 weeks after most recent PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) dose.

Children with immunocompromising conditions: Give 2 doses of PPSV23 (Pneumovax 23); the first dose should be given at least 8 weeks after PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) and the second dose given at least 5 years after the previous PPSV23 (Pneumovax 23) dose.

Hematopoietic stem cell transplant recipient: Give 3 sequential PCV doses (PCV13 or PCV15) followed by a dose of PPSV23 beginning 3–6 months after the transplant. In children with graft-versus-host disease, PPSV23 can be replaced with a fourth dose of PCV13 or PCV15.

Children who have not previously received PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) but previously received PPSV23 (Pneumovax 23): Give PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) at least 8 weeks after most recent PPSV23 (Pneumovax 23) dose.

Do not give PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) and PPSV23 (Pneumovax 23) concurrently.

Children and Adolescents 6–18 Years of Age at Increased Risk

PCV13 (Prevnar 13) or PCV15 (Vaxneuvance)

IM

Single 0.5-mL dose.

Children and adolescents who have not previously received PCV13 (Prevnar 13) or PCV15 (Vaxneuvance): Give a single dose of PCV13 (Prevnar 13) or PCV15 (Vaxneuvance).

PPSV23 (Pneumovax 23)

IM or Sub-Q

Each dose is 0.5 mL.

Children and adolescents who have not previously received PPSV23 (Pneumovax 23): Give a single dose of PPSV23 (Pneumovax 23).

Children and adolescents with 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) or PCV15 (Vaxneuvance) dose.

Sequential Administration

IM or Sub-Q

Children and adolescents who have not previously received PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) or PPSV23 (Pneumovax 23): Give PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) first and give PPSV23 (Pneumovax 23) at least 8 weeks after most recent PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) dose.

Children and adolescents with immunocompromising conditions: Give 2 doses of PPSV23 (Pneumovax 23); the first dose should be given at least 8 weeks after PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) and the second dose given ≥5 years after the previous PPSV23 (Pneumovax 23) dose.

Hematopoietic stem cell transplant recipient: Give 3 sequential PCV doses (PCV13 or PCV15) followed by a dose of PPSV23 beginning 3–6 months after the transplant. In children with graft-versus-host disease, PPSV23 can be replaced with a fourth dose of PCV13 or PCV15.

Children and adolescents who have not previously received PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) but previously received PPSV23 (Pneumovax 23): Give PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) 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) or PCV15 (Vaxneuvance) and at least 5 years after previous PPSV23 (Pneumovax 23) dose.

Do not give PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) and PPSV23 (Pneumovax 23) concurrently.

Adults

Adults 19–64 Years of Age at Increased Risk Due to Immunocompromising Conditions

PCV15 (Vaxneuvance) or PCV20 (Prevnar 20)

IM

Single 0.5-mL dose.

Adults who have not previously received PCV13 (Prevnar 13), PCV15 (Vaxneuvance), or PCV20 (Prevnar 20): Give a single dose of PCV15 (Vaxneuvance) or PCV20 (Prevnar 20).

PPSV23 (Pneumovax 23)

IM or Sub-Q

Each dose is 0.5 mL.

Adults who have not previously received PPSV23 (Pneumovax 23): Give a single dose of PPSV23 (Pneumovax 23) ≥8 weeks after the most recent dose of PCV15 (Vaxneuvance). Individuals who received a dose of PCV20 (Prevnar 20) do not need to receive a dose of PPSV23 (Pneumovax 23); their pneumococcal vaccination is complete.

Sequential Administration

IM or Sub-Q

Adults who have not previously received PCV15 (Vaxneuvance) or PPSV23 (Pneumovax 23): Give PCV15 (Vaxneuvance) first and give PPSV23 (Pneumovax 23) at least 8 weeks later.

Adults who have not previously received PCV15 (Vaxneuvance) or PCV20 (Prevnar 20) but previously received PPSV23 (Pneumovax 23) at any age: Give PCV15 (Vaxneuvance) or PCV20 (Prevnar 20) at least 1 year after most recent PPSV23 (Pneumovax 23) dose.

Adults who have previously received only PCV13 (Prevnar 13): Give PCV20 (Prevnar 20) ≥1 year or PPSV23 (Pneumovax 23) at least 8 weeks after PCV13 (Prevnar 13). Review pneumococcal vaccine recommendations again when patient turns 65 years of age.

Adults who have previously received PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23): Give PCV20 (Prevnar 20) or PPSV23 (Pneumovax 23) ≥5 years after the PPSV23 (Pneumovax 23) dose. Review pneumococcal vaccine recommendations again when patient turns 65 years of age.

Adults who have previously received PCV13 (Prevnar 13) and received 2 doses of PPSV23 (Pneumovax 23): Give PCV20 (Prevnar 20) ≥5 years after the last PPSV23 (Pneumovax 23) dose. Review pneumococcal vaccine recommendations again when patient turns 65 years of age.

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

Adults 19–64 Years of Age With a Cochlear Implant or Cerebrospinal Fluid Leak

PCV15 (Vaxneuvance) or PCV20 (Prevnar 20)

IM

Single 0.5-mL dose.

Adults who have not previously received PCV13 (Prevnar 13), PCV15 (Vaxneuvance), or PCV20 (Prevnar 20): Give a single dose of PCV15 (Vaxneuvance) or PCV20 (Prevnar 20).

PPSV23 (Pneumovax 23)

IM or Sub-Q

Each dose is 0.5 mL.

Adults who have not previously received PPSV23 (Pneumovax 23): Give a single dose of PPSV23 (Pneumovax 23) ≥8 weeks after the most recent dose of PCV15 (Vaxneuvance). Individuals who received a dose of PCV20 (Prevnar 20) do not need to receive a dose of PPSV23 (Pneumovax 23); their pneumococcal vaccination is complete.

Sequential Administration

IM or Sub-Q

Adults who have not previously received PCV15 (Vaxneuvance) or PPSV23 (Pneumovax 23): Give PCV15 (Vaxneuvance) first and give PPSV23 (Pneumovax 23) at least 8 weeks later.

Adults who have not previously received PCV15 (Vaxneuvance) or PCV20 (Prevnar 20) but previously received PPSV23 (Pneumovax 23) at any age: Give PCV15 (Vaxneuvance) or PCV20 (Prevnar 20) at least 1 year after most recent PPSV23 (Pneumovax 23) dose.

Adults who have previously received PCV13 (Prevnar 13): Give PCV20 (Prevnar 20) ≥1 year or PPSV23 (Pneumovax 23) at least 8 weeks after PCV13 (Prevnar 13). Review pneumococcal vaccine recommendations again when patient turns 65 years of age.

Adults who have previously received PCV13 (Prevnar 13) at any age and received one dose of PPSV23 (Pneumovax 23): Give PCV20 (Prevnar 20) ≥5 years after the PPSV23 (Pneumovax 23) dose. Review pneumococcal vaccine recommendations again when patient turns 65 years of age.

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

Healthy Adults 19–64 Years of Age

PCV13 (Prevnar 13)

IM

Although a single 0.5-mL dose is labeled by FDA in adults as young as 18 years of age, ACIP and other experts do not recommend routine vaccination in healthy adults 19–64 years of age who do not have medical conditions that increase the risk for pneumococcal disease.

PCV15 (Vaxneuvance)

IM

Although a single 0.5-mL dose is labeled by FDA in adults as young as 18 years of age, ACIP and other experts do not recommend routine vaccination in healthy adults 19–64 years of age who do not have medical conditions that increase the risk for pneumococcal disease.

PCV20 (Prevnar 20)

IM

Although a single 0.5-mL dose is labeled by FDA in adults as young as 18 years of age, ACIP and other experts do not recommend routine vaccination in healthy adults 19–64 years of age who do not have medical conditions that increase the risk for pneumococcal disease.

PPSV23 (Pneumovax 23)

IM or Sub-Q

Although a single 0.5-mL dose is labeled by FDA in adults as young as 50 years of age, ACIP and other experts do not recommend routine vaccination in healthy adults 19–64 years of age who do not have medical conditions that increase the risk for pneumococcal disease.

Adults ≥65 Years of Age

PCV15 (Vaxneuvance) or PCV20 (Prevnar 20)

IM

Single 0.5-mL dose.

Adults who have or unknown vaccination status: Give a single dose of PCV15 (Vaxneuvance) or PCV20 (Prevnar 20).

PPSV23 (Pneumovax 23)

IM or Sub-Q

Each dose is 0.5 mL.

Adults who have received PCV15 (Vaxneuvance): Give a single dose of PPSV23 (Pneumovax 23) at least a year later.

Sequential Administration

IM or Sub-Q

Adults who have not previously received PCV13 (Prevnar 13), PCV15 (Vaxneuvance), PCV20 (Prevnar 20), or PPSV23 (Pneumovax 23) or have unknown vaccination status: Give PCV15 (Vaxneuvance) or PCV20 (Prevnar 20) first and if PCV15 (Vaxneuvance) is used, give PPSV23 (Pneumovax 23) at least 1 year after PCV15 (Vaxneuvance) dose. Individuals who received a dose of PCV20 (Prevnar 20) do not need to receive a dose of PPSV23 (Pneumovax 23); their pneumococcal vaccination is complete.

Adults who have not previously received PCV13 (Prevnar 13), PCV15 (Vaxneuvance), or PCV20 (Prevnar 20), but previously received PPSV23 (Pneumovax 23) at any age: Give PCV15 (Vaxneuvance) or PCV20 (Prevnar 20) dose at least 1 year after most recent PPSV23 (Pneumovax 23) dose.

Adults who have previously received only PCV13 (Prevnar 13) at any age: Give PCV20 (Prevnar 20) or PPSV23 (Pneumovax 23) dose at least 1 year after PCV13 (Prevnar 13) dose.

Adults who have previously received PCV13 (Prevnar 13) at any age and received one dose of PPSV23 (Pneumovax 23) at <65 years of age: Give PCV20 (Prevnar 20) or PPSV23 (Pneumovax 23) ≥5 years after the last PPSV23 (Pneumovax 23) dose.

Adults who have previously received PCV13 (Prevnar 13) at any age and received one dose of PPSV23 (Pneumovax 23) at ≥65 years of age: Give PCV20 (Prevnar 20) ≥5 years after the last PPSV23 (Pneumovax 23) dose based on individual patient assessment.

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

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), PCV15 (Vaxneuvance), or PCV20 (Prevnar 20): 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, 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 or at least 6 months following therapy with anti-B cell agents.

Since antibody response may be impaired after splenectomy, ACIP and AAP recommend that vaccination with pneumococcal vaccines be completed at least 2 weeks prior to elective splenectomy, if possible.

Apnea in Premature Infants

Apnea observed in some premature infants following IM vaccination with PCV13 (Prevnar 13) and PCV15 (Vaxneuvance). Consider individual infant’s medical status and the potential benefits and possible risks of vaccination when deciding when to administer an IM vaccine.

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 to defer vaccination in individuals with moderate or severe illness.

Manufacturer of PPSV23 (Pneumovax 23) states to 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.

The manufacturer of PCV13 (Prevnar 13) states that effectiveness of the vaccine has not been established in premature infants, children with sickle cell disease, individuals with hematopoietic stem cell transplant, or in adults with HIV infection. The manufacturer of PCV15 (Vaxneuvance) states that effectiveness of the vaccine has not been established in premature infants, children with sickle cell disease, and children and adults with HIV infection.

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.

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.

Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.

Specific Populations

Pregnancy

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

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

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

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), PCV15 (Vaxneuvance), PCV20 (Prevnar 20), or PPSV23 (Pneumovax 23) are distributed into milk.

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for vaccination and any potential adverse effects on the breastfed child from the vaccine or underlying maternal condition (susceptibility to disease prevented by the vaccine).

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) and PCV15 (Vaxneuvance): Safety and efficacy not established in infants <6 weeks of age. Manufacturer of PCV13 (Prevnar 13) states immune response to the vaccine in preterm infants not adequately studied to date. Manufacturer of PCV15 (Vaxneuvance) states the immune responses and safety profile in preterm infants receiving a 4-dose series were similar to those observed in term infants in clinical studies.

Safety and efficacy of PCV20 (Prevnar 20) not been established in individuals <18 years of age.

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 50–59 years of age; no overall differences in safety between adults ≥65 years of age compared to adults 50–59 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.

PCV15 (Vaxneuvance): No clinically meaningful differences in the safety profile or immune responses observed in older individuals (65–74 years and ≥75 years of age) when compared to younger individuals.

PCV20 (Prevnar 20): Prevnar 20 recipients 70–79 years of age and ≥80 years of age had lower antibody responses for all pneumococcal serotypes compared to Prevnar 20 recipients 18–49, 50–59, and 60–64 years of age.

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.

PCV 15 (Vaxneuvance): Local reactions at injection site (induration, erythema, pain, and swelling), myalgia, arthralgia, fatigue, headache, irritability, somnolence, fever, decreased appetite.

PCV20 (Prevnar 20): Local reactions at injection site (pain at the injection site and injection site swelling), muscle pain, fatigue, headache, and arthralgia.

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

Simultaneous administration with other age-appropriate vaccines during the same health-care visit in most cases not expected to affect immunologic responses or adverse reactions. 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 IM Use (PCV15; Vaxneuvance)

2–8°C; do not freeze. Protect from light.

Injection, for IM Use (PCV20; Prevnar 20)

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

Do not freeze. Store syringes horizontally in the refrigerator to minimize the resuspension time.

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.

• PCV15 (Vaxneuvance): Sterile suspension of purified capsular polysaccharides extracted from 15 serotypes of S. pneumoniae (i.e., 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) and individually conjugated to diphtheria CRM₁₉₇.

• PCV20 (Prevnar 20): Sterile suspension of purified capsular polysaccharides extracted from 20 serotypes of S. pneumoniae (i.e., 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) and individually conjugated to diphtheria CRM₁₉₇.

• 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).

• 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) and PCV15 (Vaxneuvance) 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.

Advice to Patients

• 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 receiving pneumococcal vaccination if they are at increased risk of pneumococcal disease and inform them that specific vaccine products are given based on the patient's age.

• 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., PCV13, PCV15, PCV20) 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.)

Additional Information

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

Preparations

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

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

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