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.^{105 129 134 181} Commercially available in US as 2 different vaccine types: pneumococcal conjugate vaccine and pneumococcal polysaccharide vaccine.^{129 166 181 207} All of the vaccines contain capsular antigens extracted from Streptococcus pneumoniae and are used to stimulate active immunity to pneumococcal infection.^{105 129 181 207 208}

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.^{100 129 181 184 203 204 205 207 208} Common infections caused by S. pneumoniae include acute otitis media (AOM), sinusitis, pneumonia, bacteremia, and meningitis.^{105 166}

Adults who are immunosuppressed or have certain medical conditions are at increased risk for systemic disease.¹⁶⁶ In children <5 years of age, S. pneumoniae has been a leading cause of bacterial meningitis.¹⁶⁶

Available pneumococcal vaccines in the US consist of 3 conjugate vaccines and one polysaccharide vaccine.^{129 181 207 208} The conjugate vaccines are differentiated by the number of serotypes they provide protection against and include pneumococcal 13-valent conjugate vaccine (PCV13; Prevnar 13),¹⁸¹ pneumococcal 15-valent conjugate vaccine (PCV15; Vaxneuvance),²⁰⁷ and pneumococcal 20-valent conjugate vaccine (PCV20; Prevnar 20).²⁰⁸ The only pneumococcal polysaccharide vaccine available in the US is pneumococcal vaccine polyvalent (PPSV23; Pneumovax 23).¹²⁹

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.^{100 181 184 199 203 204 205 206 213} Provides protection only against the 13 S. pneumoniae serotypes represented in the vaccine (i.e., 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F).¹⁸¹

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.²⁰⁷ 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.²⁰⁷

PCV20 (Prevnar 20) is indicated for use in adults ≥18 years of age.²⁰⁸ 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.²⁰⁸

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.¹²⁹ Provides protection only against the 23 S. pneumoniae serotypes represented in the vaccine (i.e., 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F).¹²⁹

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.^{199 214}

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.^{184 199 203 205 211}

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).^{100 181 199 207 211} ACIP and other experts recommend that all infants 2–23 months of age receive routine primary vaccination with PCV13 or PCV15.^{199 214} PPSV23 (Pneumovax 23) is not recommended in these infants.^{129 211}

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).^{100 184 199 207 211} PPSV23 (Pneumovax 23) is not recommended in these children.^{100 184 199 211}

Children and adolescents 2–18 years of age with certain underlying medical conditions should be vaccinated with PCV13 or PCV15.^{100 199 211 214} 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.^{100 184 199 211} The addition of PPSV23 to a primary series with PCV13 or PCV15 provides immunity against a broader range of serotypes.^{100 184}

Healthy adults 19–64 years of age do not require routine pneumococcal vaccination.²¹³ Although PCV13 (Prevnar 13), PCV15 (Vaxneuvance), and PCV20 (Prevnar 20) are labeled by FDA for prevention of pneumonia and invasive pneumococcal disease in adults,^{129 181 207 208} 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.^{201 204 209 210 212 213}

Adults 19–64 years of age with certain risk factors or immunocompromising conditionsshould be vaccinated against the disease.²¹³ ACIP and others recommend PCV15 or PCV20 in these individuals.^{209 212 214} 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.^{209 214} A minimum interval of 8 weeks can be considered between administration of PCV15 and PPSV23 for adults with an immunocompromising condition.^{209 212 213 214}

Adults 19–64 years of age with a cochlear implant or cerebrospinal fluid leak should be vaccinated with PCV15 or PCV20.^{212 213 214} 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.^{213 214}

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.^{209 213}

HIV-infected individuals are at increased risk for pneumococcal disease and should be vaccinated against the disease according to recommendations.^{100 155 156 166 169 184 199 205 212 213}

Cochlear implant recipients are also at substantially increased risk for pneumococcal meningitis and should be vaccinated against the disease according to recommendations.^{100 184 189 199 203 205 217}

Internationally adopted infants and children whose immune status is uncertain should be vaccinated against pneumococcal disease according to the US recommended childhood and adolescent immunization schedules.^{134 215}

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.²¹⁵

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.^{181 207 208 215}

• Syncope may occur following administration of parenteral vaccines, especially in adolescents.²¹⁵ Patients should be seated or lying down during vaccination.²¹⁵ Observe vaccine recipients (especially adolescents) for 15 minutes after vaccination.²¹⁵ If syncope develops, observe patients until symptoms resolve.²¹⁵

Administration

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

PCV15 (Vaxneuvance): Administer only by IM injection.²⁰⁷

PCV20 (Prevnar 20): Administer only by IM injection.²⁰⁸

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

Do not dilute PCV13 (Prevnar 13), PCV15 (Vaxneuvance), PCV20 (Prevnar 20), and PPSV23 (Pneumovax 23);^{129 181 207 208 215} do not mix with any other vaccine or solution.^{129 181 181 208 215}

Do not administer PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) concomitantly with PPSV23 (Pneumovax 23).^{100 184 215} 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.^{100 184 199 203 204 205 213 215}

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.^{105 184 215} When multiple parenteral vaccines are administered during a single health-care visit, each vaccine should be given with a different syringe and at different injection sites;^{105 215} separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.²¹⁵

IM Administration

Depending on patient age, administer IM injections into deltoid muscle or anterolateral thigh.²¹⁵ In infants and children 6 weeks to 2 years of age, anterolateral thigh is preferred; ²¹⁵ alternatively, deltoid muscle can be used in those 1–2 years of age if muscle mass is adequate.²¹⁵ In adults, adolescents, and children ≥3 years of age, deltoid muscle is preferred.²¹⁵

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.²¹⁵

Avoid injection into gluteal area or into or near blood vessels or nerves.²¹⁵ 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.²¹⁵

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.^{181 207}

Sub-Q Administration

Make sub-Q injections into upper-outer triceps area or anterolateral thigh for infants <12 months of age.²¹⁵ In adults, adolescents, and children ≥12 months of age, upper-outer triceps area preferred.²¹⁵

To ensure appropriate delivery, administer sub-Q injections at a 45° angle using a 5/8 inch, 23- to 25-gauge needle.²¹⁵

Specific Vaccine Formulations

PCV13 (Prevnar 13)

Administer only by IM injection.¹⁸¹ Do not administer sub-Q or intradermally.²¹⁵

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

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

PCV15 (Vaxneuvance)

Administer only by IM injection.²⁰⁷ Do not administer sub-Q or intradermally.^{207 215}

PCV15 (Vaxneuvance) is commercially available in single-dose prefilled syringes.²⁰⁷ After attaching a sterile needle, the entire contents of the prefilled syringe should be administered IM.²⁰⁷

PCV15 (Vaxneuvance) must be shaken vigorously immediately prior to administration to obtain a uniform, opalescent suspension.²⁰⁷ The vaccine should be discarded if it cannot be resuspended or if particulate matter or discoloration is present.²⁰⁷

PCV20 (Prevnar 20)

PCV20 (Prevnar 20) is administered only by IM injection.²⁰⁸ The vaccine should not be administered sub-Q or intradermally.²¹⁵

PCV20 (Prevnar 20) is commercially available in single-dose prefilled syringes.²⁰⁸ After attaching a sterile needle, the entire contents of the prefilled syringe should be administered IM.²⁰⁸

PCV20 (Prevnar 20) must be shaken vigorously immediately prior to administration to obtain a uniform, white suspension.²⁰⁸ The vaccine should be discarded if it cannot be resuspended or if particulate matter or discoloration is present.²⁰⁸

PPSV23 (Pneumovax 23)

Administer by IM injection or alternatively, by sub-Q injection.¹²⁹ Do not administer IV or intradermally.¹²⁹

Available in single-dose prefilled syringes and single-dose vials.¹²⁹ If single-dose prefilled syringe is used, attach sterile needle according to manufacturer's instructions and administer entire contents IM.¹²⁹ 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.¹²⁹

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

Dosage

Dosage schedule (i.e., number of doses) and specific pneumococcal vaccine administered depend on individual’s age, immunization status, and risk factors for pneumococcal disease.^{100 105 129 181 184 207 208} Follow age-appropriate recommendations for the specific preparation used.^{129 181}

Medically stable preterm infants (i.e., gestational age <37 weeks), regardless of birthweight, should be vaccinated at usual chronologic age using usual dosage and dosage schedules.²¹⁵

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.²¹⁵

Pediatric Patients

Infants 2–23 Months of Age

PCV13 (Prevnar 13) or PCV15 (Vaxneuvance)

IM

Each dose is 0.5 mL.^{181 207}

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).^{100 181 184 199 207 211} ACIP, AAP, and others recommend that doses be given at 2, 4, 6, and 12 through 15 months of age.^{100 181 184 199 207 211} Initial dose may be given as early as 6 weeks of age.^{100 181 184 199 207 211} Minimum interval between first 3 doses is 4 weeks;^{100 181 184 199 207 211} minimum interval between third and fourth dose is 8 weeks.^{100 181 184 199 207 211}

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.^{181 199 207 211} A fourth dose is unnecessary in healthy infants unless all previous doses were given at <12 months of age.^{199 211}

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.^{181 199 207 211} A third dose is unnecessary if second dose was given at ≥24 months of age.^{199 207 211}

Healthy Children 2–5 Years of Age

PCV13 (Prevnar 13) or PCV15 (Vaxneuvance)

IM

Single 0.5-mL dose.^{181 207}

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).^{100 181 184 199 207 211} Additional doses unnecessary in healthy children if PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) dose given at ≥2 years of age.^{199 207 211}

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).^{181 184 199 207 211}

Children 2–5 Years of Age at Increased Risk

PCV13 (Prevnar 13) or PCV15 (Vaxneuvance)

IM

Each dose is 0.5 mL.^{181 207}

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.^{100 129 184 199 207 211}

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).^{100 184 199 207 211}

PPSV23 (Pneumovax 23)

IM or Sub-Q

Single 0.5-mL dose.¹²⁹

Children who have not previously received PPSV23 (Pneumovax 23): Give a single dose of PPSV23 (Pneumovax 23).^{100 129 184 199 211}

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.^{199 211}

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.^{199 203 205 211}

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.²¹¹ In children with graft-versus-host disease, PPSV23 can be replaced with a fourth dose of PCV13 or PCV15.²¹¹

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.^{199 211}

Do not give PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) and PPSV23 (Pneumovax 23) concurrently.^{199 211}

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

PCV13 (Prevnar 13) or PCV15 (Vaxneuvance)

IM

Single 0.5-mL dose.¹⁸¹

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).^{199 203 205 211}

PPSV23 (Pneumovax 23)

IM or Sub-Q

Each dose is 0.5 mL.¹²⁹

Children and adolescents who have not previously received PPSV23 (Pneumovax 23): Give a single dose of PPSV23 (Pneumovax 23).^{199 203 205 211}

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.^{199 203 205 211}

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.^{199 203 205 211}

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.^{199 203 205 211}

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.²¹¹ In children with graft-versus-host disease, PPSV23 can be replaced with a fourth dose of PCV13 or PCV15.²¹¹

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.^{199 203 205 211}

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.^{156 199 203 205 211}

Do not give PCV13 (Prevnar 13) or PCV15 (Vaxneuvance) and PPSV23 (Pneumovax 23) concurrently.^{199 211}

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.^{181 207 208}

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).^{212 213}

PPSV23 (Pneumovax 23)

IM or Sub-Q

Each dose is 0.5 mL.¹²⁹

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).^{212 213} 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.²¹²

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.^{206 212 213}

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.^{206 212 213}

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).^{206 212} Review pneumococcal vaccine recommendations again when patient turns 65 years of age.²¹²

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.^{212 213 214} Review pneumococcal vaccine recommendations again when patient turns 65 years of age.²¹²

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.²¹² Review pneumococcal vaccine recommendations again when patient turns 65 years of age.²¹²

Do not give PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) concurrently.²⁰⁶

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.^{181 207 208}

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).^{212 213}

PPSV23 (Pneumovax 23)

IM or Sub-Q

Each dose is 0.5 mL.¹²⁹

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).^{212 213} 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.^{212 214}

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.^{206 212 213}

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.^{206 212 213}

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).^{206 212} Review pneumococcal vaccine recommendations again when patient turns 65 years of age.²¹²

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.^{212 213 214} Review pneumococcal vaccine recommendations again when patient turns 65 years of age.²¹²

Do not give PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) concurrently.²⁰⁶

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,¹⁸¹ 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.^{209 210 212}

PCV15 (Vaxneuvance)

IM

Although a single 0.5-mL dose is labeled by FDA in adults as young as 18 years of age,²⁰⁷ 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.^{209 210 212}

PCV20 (Prevnar 20)

IM

Although a single 0.5-mL dose is labeled by FDA in adults as young as 18 years of age,²⁰⁸ 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.^{209 210 212}

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,¹²⁹ 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.^{209 210 212}

Adults ≥65 Years of Age

PCV15 (Vaxneuvance) or PCV20 (Prevnar 20)

IM

Single 0.5-mL dose.^{181 207 208}

Adults who have or unknown vaccination status: Give a single dose of PCV15 (Vaxneuvance) or PCV20 (Prevnar 20).^{204 207 208 212 213}

PPSV23 (Pneumovax 23)

IM or Sub-Q

Each dose is 0.5 mL.¹²⁹

Adults who have received PCV15 (Vaxneuvance): Give a single dose of PPSV23 (Pneumovax 23) at least a year later.^{169 204 212 213}

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.²¹² 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.^{209 212}

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.^{204 206 212}

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.^{206 212}

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.^{212 213 214}

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.^{212 213 214}

Do not give PCV13 (Prevnar 13) and PPSV23 (Pneumovax 23) concurrently.^{204 206 213}

Special Populations

Hepatic Impairment

No specific dosage recommendations.^{129 181 207 208}

Renal Impairment

No specific dosage recommendations.^{129 181 207 208}

Geriatric Patients

No specific dosage recommendations.^{129 181 207 208}

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.^{181 207 208}

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

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Allergic reactions, including anaphylactic/anaphylactoid reactions,^{129 181 207 208} rash,^{129 181 207} urticaria,^{129 181 207 208} bronchospasm,¹⁸¹ facial edema,¹⁸¹ erythema multiforme,^{129 181} and angioedema,^{129 181} reported with pneumococcal vaccines.

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

Epinephrine and other appropriate agents should be readily available in case anaphylaxis or other serious allergic reaction occurs.^{181 207 208}

General Precautions

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.^{129 181 207 208} Consider possibility that immune response to vaccines may be diminished or suboptimal in these individuals.^{129 181 207 208}

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.²¹⁵

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.^{105 184 215}

Apnea in Premature Infants

Apnea observed in some premature infants following IM vaccination with PCV13 (Prevnar 13) and PCV15 (Vaxneuvance).^{181 207} Consider individual infant’s medical status and the potential benefits and possible risks of vaccination when deciding when to administer an IM vaccine.^{181 207}

Concomitant Illness

A decision to administer or delay administration of vaccination in an individual with a current or recent acute illness depends on the severity of symptoms and etiology of the illness.^{129 215}

ACIP, AAP, and others state that minor acute illness, such as mild diarrhea or mild upper respiratory infection (with or without fever), usually does not preclude vaccination.^{105 215} However, vaccination of individuals with moderate or severe acute illness (with or without fever) generally should be deferred until they have recovered from the acute phase of the illness.^{105 215}

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

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.¹²⁹

Limitations of Vaccine Effectiveness

May not protect all vaccine recipients against pneumococcal disease.^{129 181 207 208}

Will not prevent pneumococcal infection caused by S. pneumoniae serotypes not represented in the vaccines.^{129 181 207 208}

Primary immunization with the usually recommended age-appropriate vaccination regimen before an expected exposure to pneumococcal infection ensures the highest level of protection.^{100 105 184}

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.¹⁸¹ 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.²⁰⁷

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

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees.²¹⁵

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.²¹⁵

Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.²¹⁵

Specific Populations

Pregnancy

Data are insufficient to date regarding use of pneumococcal vaccines in pregnant women to inform vaccine-associated risks during pregnancy.^{129 181 207 208}

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.²¹⁶

ACIP, AAP, and others state PPSV23 (Pneumovax 23) may be used when indicated in pregnant women at increased risk for pneumococcal disease.¹⁰⁵ ACIP has not addressed pregnancy recommendations for PCV15 or PCV20 at this time.²¹⁶

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

Lactation

Not known whether antigens contained in PCV13 (Prevnar 13), PCV15 (Vaxneuvance), PCV20 (Prevnar 20), or PPSV23 (Pneumovax 23) are distributed into milk.^{129 181 207 208}

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).^{129 181 207 208}

Because inactivated vaccines do not multiply within the body, ACIP states they should not pose any unusual problems for lactating women or their infants.²¹⁵

Pediatric Use

PCV13 (Prevnar 13) and PCV15 (Vaxneuvance): Safety and efficacy not established in infants <6 weeks of age.^{181 207} Manufacturer of PCV13 (Prevnar 13) states immune response to the vaccine in preterm infants not adequately studied to date.¹⁸¹ 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.²⁰⁷

Safety and efficacy of PCV20 (Prevnar 20) not been established in individuals <18 years of age.²⁰⁸

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

Geriatric Use

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

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

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.²⁰⁷

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.²⁰⁸

Common Adverse Effects

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

PCV 15 (Vaxneuvance): Local reactions at injection site (induration, erythema, pain, and swelling), myalgia, arthralgia, fatigue, headache, irritability, somnolence, fever, decreased appetite.²⁰⁷

PCV20 (Prevnar 20): Local reactions at injection site (pain at the injection site and injection site swelling), muscle pain, fatigue, headache, and arthralgia.²⁰⁸

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

Drug Interactions

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.^{105 215} However, each parenteral vaccine should be administered using a different syringe and different injection site.^{105 215}

Specific Drugs

Stability

Storage

Parenteral

Injection, for IM Use (PCV13; Prevnar 13)

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

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

Does not contain thimerosal or any other preservatives.^{100 184}

Injection, for IM Use (PCV15; Vaxneuvance)

2–8°C; do not freeze.²⁰⁷ Protect from light.²⁰⁷

Injection, for IM Use (PCV20; Prevnar 20)

2–8°C;²⁰⁸ after shipping, the vaccine may arrive at temperatures ranging from 2–25°C.²⁰⁸

Do not freeze.²⁰⁸ Store syringes horizontally in the refrigerator to minimize the resuspension time.²⁰⁸

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

2–8°C.¹²⁹

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

Actions

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

• 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 CRM₁₉₇.²⁰⁷

• 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 CRM₁₉₇.²⁰⁸

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

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

• Conjugated antigens contained in PCV13 (Prevnar 13) and PCV15 (Vaxneuvance) are more immunogenic in infants and young children than the unconjugated antigens contained in PPSV23 (Pneumovax 23).^{100 184} Conjugated antigens elicit a T-cell dependent immune response;¹⁸¹ antibodies produced in response to pneumococcal conjugate vaccines enhance opsonization, phagocytosis, and killing of S. pneumoniae by leukocytes and other phagocytic cells.¹⁸¹ Unconjugated antigens contained in PPSV23 (Pneumovax 23) do not induce long-lasting immunity or an anamnestic response after subsequent exposure to the same antigens.^{166 215}

Advice to Patients

• Advise patient and/or patient’s parent or guardian of the risks and benefits of vaccination with pneumococcal vaccine.^{129 181}

• Advise patient and/or patient’s parent or guardian of the importance of 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.^{100 167 181 184 199 203 204 205 207 208 213}

• Advise patient and/or patient’s parent or guardian that pneumococcal vaccines may not provide protection in all vaccinees.^{129 181 207 208}

• Importance of informing clinicians of any history of allergic reactions to pneumococcal vaccines (i.e., PCV13, PCV15, PCV20) or any vaccine containing diphtheria toxoid.^{129 181}

• Importance of informing clinicians if any severe or unusual adverse reactions (including allergic reactions) occur with pneumococcal vaccine.^{129 167} Clinicians or individuals can report any adverse reactions that occur following vaccination to the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or [Web].^{129 181}

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.^{129 181}

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{129 181}

• Importance of informing patients of other important precautionary information.^{129 181} (See Cautions.)

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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