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Canadian Immunization Guide

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Part 4
Active Vaccines

Pneumococcal Vaccine

Key Information (Refer to text for details)

What

  • Streptococcus pneumoniae infections are a major cause of illness and death worldwide.
  • Invasive pneumococcal disease (IPD) is most common in the very young, the elderly and persons at high risk, such as those with functional or anatomic asplenia, or congenital or acquired immunodeficiency.
  • In children, efficacy of pneumococcal conjugate 7-valent (Pneu-C-7) vaccine against IPD due to serotypes contained in the vaccine is estimated to range from 89% to 97%. There are no efficacy data available for other pneumococcal conjugate vaccines.
  • Pneu-P-23 vaccine efficacy against IPD is estimated to be 50% to 80% among the elderly and in high risk groups.
  • There may be redness, swelling and soreness at the injection site following pneumococcal immunization.

Who

  • Routine pneumococcal immunization is recommended for all children.
  • Adults and children considered to be at increased risk from IPD should be vaccinated using the pneumococcal vaccine according to the schedule recommended for their age group and specific risk condition.

How

Pneu-C-13 vaccine

  • Routine infant immunization: administer three doses of Pneu-C-13 vaccine at minimum 8-week intervals beginning at 2 months of age, followed by a fourth dose at 12 to 15 months of age. For healthy infants, a three-dose schedule may be used, with doses at 2 months, 4 months, and 12 months of age.
  • 12 to 23 months of age: administer two doses of Pneu-C-13 vaccine at least 8 weeks apart to children not previously vaccinated with a conjugate pneumococcal vaccine or who received only 1 dose before 12 months of age.
  • 24 to 35 months of age: administer one dose of Pneu-C-13 vaccine to children with no or incomplete vaccination schedules with any conjugated pneumococcal vaccine.
  • 36 to 59 months of age - administer one dose of Pneu-C-13 vaccine to:
    • Healthy children who are of aboriginal origin or who attend group child care who have received age-appropriate pneumococcal conjugate vaccination but have not received Pneu-C-13 vaccine. Consider one dose of Pneu-C-13 vaccine for other healthy children.
    • Children at high risk of IPD who have received age-appropriate pneumococcal conjugate vaccination but have not received Pneu-C-13 vaccine.
    • Children with no or incomplete vaccination schedules with any conjugate pneumococcal vaccine.
  • 60 months to 17 years of age: administer one dose of Pneu-C-13 vaccine to children and adolescents at high risk of IPD who have not previously received Pneu-C-13 vaccine.
  • Adults with immunocompromising conditions (except hematopoietic stem cell transplant [HSCT]): administer one dose of Pneu-C-13 followed 8 weeks later by one dose of Pneu-P-23 (if not previously immunized with Pneu-P-23). The Pneu-C-13 dose should be administered at least one year after any previous dose of Pneu-P-23. A single re-immunization with Pneu-P-23 is recommended.
  • Adults with HSCT: administer three doses of Pneu-C-13 starting 3-9 months after transplant. These doses should be administered at least 4 weeks apart, followed by a dose of Pneu-P-23 12 to 18 months post transplant (i.e. 6 to 12 months after the last dose of Pneu-C-13). A single re-immunization with Pneu-P-23 is recommended.

Pneu-P-23 vaccine

  • Administer one dose of Pneu-P-23 vaccine after pneumococcal conjugate vaccine to children 24 months of age and older, adolescents and adults who are at high risk of IPD (refer to Table 1).
  • Administer one dose of Pneu-P-23 vaccine to all adults 65 years of age and older and to immunocompetent adults less than 65 years of age in long-term care facilities. Immunocompromised adults should be immunized with Pneu-C-13 and Pneu-P-23 as indicated in the preceding bullet.
  • One lifetime re-immunization with Pneu-P-23 vaccine is recommended for those at highest risk of IPD.

Why

  • S. pneumoniae is a common cause of invasive disease, such as pneumonia, bacteremia, and meningitis.
  • The case fatality rate of bacteremic pneumococcal pneumonia is 5% to 7% and is higher among elderly persons.

Significant revisions since the last chapter update are highlighted in the CIG Table of Updates, which is available on the Public Health Agency of Canada (PHAC) website.

For additional information, refer to previously published National Advisory Committee on Immunization (NACI) Statements and Statement Updates.

Epidemiology

Disease description

Infectious agent
Pneumococcal disease is caused by a bacterium, Streptococcus pneumoniae (S. pneumoniae or pneumococcus), of which 15 serotypes cause the majority of disease.

Reservoir
Humans carry S.pneumoniae in their nasopharynx.

Transmission
S. pneumoniae is transmitted by direct oral contact, respiratory droplets, or indirect contact with respiratory secretions of infected or colonized persons. A person can transmit the infection as long as nasal and throat secretions contain pneumococci in large numbers, usually until 24 hours following appropriate antibiotic treatment. The incubation period has not been clearly defined and may be as short as 1 to 3 days.

Risk factors
IPD is most common in the very young, the elderly and groups at high risk (refer to Table 1). Persons with a cochlear implant appear to be at increased risk of pneumococcal meningitis. Attendance at a child care center has been shown to increase the risk of IPD and acute otitis media (AOM) 2-fold to 3-fold among children under 5 years of age. Homeless populations have high rates of respiratory infections, including those caused by S. pneumoniae.

Table 1: Conditions resulting in high risk of IPD
Conditions without immunocompromise
Table 1 - Footnote *
Generally asplenia (functional or anatomic), sickle cell disease and other hemoglobinopathies are not considered immunocompromising conditions, but for the purposes of pneumococcal vaccine recommendations they are included in this category.
Chronic cerebral spinal fluid (CSF) leak
Chronic neurologic condition that may impair clearance of oral secretions
Cochlear implants (including those children who are to receive implants)
Chronic cardiac or pulmonary disease
Diabetes mellitus
Chronic kidney disease
Chronic liver disease (including hepatic cirrhosis due to any cause)
Asthma that required medical care in the preceding 12 months
Conditions with immunocompromise
Sickle cell disease or other hemoglobinopathiesTable 1 - Footnote *
Congenital immunodeficiencies involving any part of the immune system, including B-lymphocyte (humoral) immunity, T-lymphocyte (cell) mediated immunity, complement system (properdin, or factor D deficiencies), or phagocytic functions
Asplenia (functional or anatomic)Table 1 - Footnote *
Immunocompromising therapy including use of long-term corticosteroids, chemotherapy, radiation therapy, post-organ transplant therapy, and certain anti-rheumatic drugs
HIV infection
Hematopoietic stem cell transplant (recipient)
Malignant neoplasms including leukemia and lymphoma
Nephrotic syndrome
Solid organ or islet transplant (candidate or recipient)

Seasonal/temporal pattern
IPD is more common in the winter and spring in temperate climates.

Spectrum of clinical illness
Pneumonia with secondary bacteremia, bacteremia, and meningitis are the most common IPDs. Bacteremia is the most common manifestation of IPD among children 2 years of age and younger. Bacteremic pneumococcal pneumonia is the most common presentation among adults and is a common complication following influenza. The case fatality rate of bacteremic pneumococcal pneumonia is 5% to 7% and is higher among elderly persons. Bacterial spread within the respiratory tract may result in AOM, sinusitis or recurrent bronchitis.

Disease distribution

Worldwide, pneumococcal disease is a major cause of morbidity and mortality. The World Health Organization (WHO) estimates that almost 500,000 deaths among children aged less than 5 years are attributable to pneumococcal disease each year. IPD occurs when the bacteria enter a normally sterile site, such as the bloodstream or brain. Pneumococcus is also among the top two causes of bacterial meningitis in infants and young children.

In Canada, IPD is most common among the very young, and the elderly. The epidemiology of IPD changed significantly, with markedly reduced incidence with the use of effective conjugate vaccines. For more information about IPD distribution in Canada, refer to the PHAC IPD web page. Comprehensive updates on the epidemiology of IPD in Canada are published periodically in the Canadian Communicable Disease Report (CCDR).

Preparations Authorized for Use in Canada

Pneumococcal vaccines

Conjugate pneumococcal vaccines

  • Prevnar®13 (pneumococcal 13-valent conjugate vaccine, CRM197 protein), Pfizer Canada Inc. (licensee) (Pneu-C-13)
  • SYNFLORIX® (pneumococcal 10-valent conjugate vaccine, non-typeable Haemophilus influenzae protein D, diphtheria or tetanus toxoid conjugates adsorbed), GlaxoSmithKline Inc. (Pneu-C-10).

The tetanus, diphtheria and non-typeable Haemophilus influenzae carrier proteins used in conjugate pneumococcal vaccines do not confer protection against diphtheria, tetanus or Haemophilus influenzae type b disease.

Pneumococcal 23-valent polysaccharide vaccines

  • PNEUMOVAX® 23 (pneumococcal 23-valent polysaccharide vaccine), Merck Canada Inc. (Pneu-P-23)
Table 2: S. pneumoniae serotypes included in pneumococcal vaccines
Vaccine Serotypes in Pneumococcal Vaccines
4 9V 6B 14 18C 19F 23F 1 5 7F 3 6A 19A 2 8 9N 10A 11A 12F 15B 17F 20 22F 33F
Table 2 - Footnote *
Pneu-C-7 vaccine is no longer available.
Pneu-C-7Table 2 - Footnote *                                  
Pneu-C-10                            
Pneu-C-13                      
Pneu-P-23  

Text Equivalent - Table 2

For complete prescribing information, consult the product leaflet or information contained within Health Canada’s authorized product monograph available through the Drug Product DatabaseExternal site. Refer to Contents of Immunizing Agents Available for Use in Canada in Part 1 for a list of all vaccines available for use in Canada and their contents.

Efficacy, Effectiveness and Immunogenicity

Efficacy and effectiveness

Conjugate pneumococcal vaccines

In children, the efficacy of Pneu-C-7 vaccine is 89% to 97% against IPD serotypes whose antigens are contained in the vaccine. Pneu-C-7 vaccine provides a 54% reduction in AOM and a 20% reduction in tympanostomy tube placement due to vaccine serotypes. There are no efficacy data available for Pneu-C-13 vaccine for any indication and no efficacy data available for Pneu-C-10 vaccine for its primary indication against IPD. However, preliminary estimates from an unpublished case control study that was conducted in the US suggest 79% to 95% vaccine effectiveness among 2-59 month old children against Pneu-C-13 serotype IPD.

Pneumococcal polysaccharide vaccines

Pneu-P-23 vaccine efficacy is more than 80% against IPD among healthy young adults and ranges from 50% to 80% among the elderly and in high-risk groups. Effectiveness in preventing community-acquired pneumonia in the elderly remains a challenge. Immunogenicity and efficacy are decreased in certain groups at particularly high risk of pneumococcal infection, such as persons with renal failure, sickle cell anemia, or impaired immune responsiveness, including HIV infection. Following immunization with Pneu-P-23 vaccine, antibody levels decline after 5 to 10 years and decrease more rapidly in some groups than others. The duration of immunity is not known.

Immunogenicity

Conjugate pneumococcal vaccines

Infants immunized with Pneu-C-7 vaccine develop a 3.4-fold to 20-fold increase in serum antibodies against vaccine serotypes. Anamnestic responses are induced upon boosting with either conjugate pneumococcal or Pneu-P-23 vaccines. The immunogenicity of Pneu-C-7 vaccine has been demonstrated in children with immunodeficiency.

New conjugate pneumococcal vaccines Pneu-C-10 and Pneu-C-13 were authorized based on identifying an immune response to all serotypes in the vaccine and demonstrating non-inferiority to each of the 7 serotypes common to the new vaccine and Pneu-C-7 vaccine. Studies on Pneu-C-10 vaccine demonstrated an antibody response to all 10 serotypes. Studies on Pneu-C-13 vaccine demonstrated an antibody response to all 13 serotypes. There are no studies comparing the immunogenicity of Pneu-C-10 and Pneu-C-13 vaccines.

Pneumococcal polysaccharide vaccines

In healthy young adults, a single dose of pneumococcal polysaccharide vaccine stimulates an antibody response to each of the serotypes in the vaccine. Polysaccharide vaccine is less immunogenic in children than the conjugate pneumococcal vaccine.

Recommendations for Use

Infants and children (2 months to 17 years of age)

Routine infant immunization (2 to 11 months of age)
Conjugate pneumococcal vaccine is recommended for routine infant immunization. Pneu-C-13 vaccine is recommended as the product of choice.

Children (12 to 23 months of age)
Children with no pneumococcal vaccinations or interrupted or incomplete vaccination schedules should be assessed to determine the number of doses required to complete the series; children who have received complete, age-appropriate pneumococcal vaccination but have not received Pneu-C-13 vaccine should receive one dose of Pneu-C-13 vaccine (refer to Table 3). Children at high risk of IPD (refer to Table 1) should also receive one dose of Pneu-P-23 vaccine when they reach 24 months of age.

Children (24 to 35 months of age)
One dose of Pneu-C-13 vaccine is recommended for:

  • Children with no pneumococcal vaccinations or incomplete vaccination schedules with any conjugate pneumococcal vaccine product.
  • Children who have received complete, age-appropriate pneumococcal vaccination but have not received Pneu-C-13 vaccine.

Children at high risk of IPD (refer to Table 1) should also receive one dose of Pneu-P-23 vaccine, at least 8 weeks after Pneu-C-13 vaccine.

Children (36 to 59 months of age)
One dose of Pneu-C-13 vaccine is recommended for:

  • Healthy children who have received age-appropriate pneumococcal vaccination but have not received Pneu-C-13 vaccine and who are of aboriginal origin or who attend group child care.
  • Children at high risk of IPD (refer to Table 1) who have received age-appropriate pneumococcal vaccination but have not received Pneu-C-13 vaccine.
  • Children with no or incomplete vaccination schedules with any conjugate pneumococcal vaccine product (refer to Table 3).
  • Other healthy children who have received age-appropriate pneumococcal vaccination but have not received Pneu-C-13 vaccine, one dose of Pneu-C-13 vaccine may be considered. The age of the child (incidence of IPD declines from 24 to 59 months of age), the degree of exposure to other young children, and the local epidemiology of IPD need to be considered.

If a child at high risk of IPD has not previously received Pneu-P-23 vaccine, one dose of Pneu-P-23 vaccine should also be administered 8 weeks after Pneu-C-13 vaccine. Refer to Booster doses and re-immunization for re-immunization recommendations.

Children (60 months to 17 years of age)
Children and adolescents at high risk of IPD (refer to Table 1) who have not previously received Pneu-C-13 vaccine should receive one dose of Pneu-C-13 vaccine. If a child or adolescent at high risk of IPD has not previously received Pneu-P-23 vaccine, one dose of Pneu-P-23 vaccine should also be administered, at least 8 weeks after the Pneu-C-13 vaccine. Refer to Schedule and Booster doses and re-immunization.

Healthy children and adolescents in this age group do not need pneumococcal vaccine.

Adults (18 years of age and older)

One dose of Pneu-P-23 vaccine is recommended for all adults 65 years of age and older, and for immunocompetent adults less than 65 years of age in long-term care facilities or who have conditions putting them at increased risk of pneumococcal disease (refer to Table 1). In addition, the following adults who are immunocompetent are recommended for vaccination with Pneu-P-23 vaccine:

  • Persons with alcoholism,
  • Smokers,
  • Persons who are homeless, and
  • Individuals who use illicit drugs should also be considered for vaccination

Immunization with Pneu-C-13 vaccine is recommended for adults with immunocompromising conditions (refer to Table 1). Adults with immunocompromising conditions (except HSCT) should receive one dose of Pneu-C-13 followed 8 weeks later by one dose of Pneu-P-23, if they have not been previously immunized with Pneu-P-23. The Pneu-C-13 dose should be administered at least one year after any previous dose of Pneu-P-23. Adults with HSCT should receive three doses of Pneu-C-13, starting 3-9 months after transplant. These doses should be administered at least 4 weeks apart, followed by a booster dose of Pneu-P-23, 12 to 18 months post transplant (6 to 12 months after the last dose of Pneu-C-13).

There is currently no evidence that a Pneu-C-13 booster dose adds any benefit. Refer to Booster doses and re-immunization for re-immunization recommendations for Pneu-P-23. Individuals who have previously received Pneu-P-23 vaccine and who require re-immunization following immunization with Pneu-C-13 vaccine, should receive Pneu-P-23 no sooner than 8 weeks after Pneu-C-13 vaccine and no sooner than 5 years after the initial dose of Pneu-P-23.

Some experts suggest that a conjugated pneumococcal vaccine may be given as the initial dose, followed by the Pneu-P-23 vaccine for immunocompetent adults at increased risk of IPD, as this may theoretically improve antibody response and immunologic memory. If this strategy is chosen, Pneu-C-13 vaccine should be administered first, followed at least 8 weeks later by Pneu-P-23 vaccine. However, Pneu-P-23 vaccine is the vaccine of choice for these individuals, and if only one vaccine can be provided, it should be Pneu-P-23 vaccine, because of the greater number of serotypes prevented by the vaccine. Refer to Booster doses and re-immunization.

Persons with inadequate immunization records

Children and adults lacking adequate documentation of immunization should be considered unimmunized and should be started on an immunization schedule appropriate for their age and risk factors. Conjugated and polysaccharide pneumococcal vaccine, as appropriate for age and risk condition, may be given, regardless of possible previous receipt of the vaccine, as adverse events associated with repeated immunization have not been demonstrated. Refer to Immunization of Persons with Inadequate Immunization Records in Part 3 for additional general information.

Pregnancy and breastfeeding

Pneu-P-23 , Pneu-C-13 or both vaccines are recommended for pregnant women who are at high risk of IPD (refer to Recommendations for Use - Adults). There is no evidence to suggest a risk to the fetus or to the pregnancy from maternal immunization with inactivated vaccines. Women who are breastfeeding can be vaccinated with Pneu-P-23 or Pneu-C-13 vaccine. Refer to Immunization in Pregnancy and Breastfeeding in Part 3 for additional general information.

Infants born prematurely

Premature infants in stable clinical condition should be immunized with conjugate pneumococcal vaccine at the same chronological age and according to the same schedule as full-term infants. Infants born prematurely, especially those weighing less than 1,500 grams at birth, are at higher risk of apnea and bradycardia following vaccination. Hospitalized premature infants should have continuous cardiac and respiratory monitoring for 48 hours after their first immunization. Refer to Immunization of Infants Born Prematurely in Part 3 for additional general information.

Persons and residents in health care institutions

Residents of long-term care facilities should receive Pneu-P-23 vaccine. For adults with immunocompromising conditions, Pneu-C-13 is also recommended with the Pneu-C-13 administered first, if possible. A single re-immunization of Pneu-P-23 is recommended for some conditions. Refer to Booster doses and re-immunization.

Refer to Immunization of Patients in Health Care Institutions in Part 3 for additional general information.

Immunocompromised persons

Conjugate pneumococcal vaccine (Pneu-C-13) followed by polysaccharide pneumococcal vaccine (Pneu-P-23) is recommended for individuals aged 2 years and over with immunocompromising conditions due to underlying disease or therapy (refer to Table 1). Immunologic abnormalities may decrease the protection provided by either type of pneumococcal vaccine and those at highest risk should be counselled regarding the risk of fulminant pneumococcal sepsis, which may occur despite immunization. When considering immunization of an immunocompromised person, consultation with the individual’s attending physicians may be of assistance, in addition to the guidance provided below. For complex cases, referral to a physician with expertise in immunization or immunodeficiency is advised.

Congenital (primary) immunodeficiency
Individuals with congenital immunodeficiencies involving any part of the immune system should be immunized against pneumococcal disease. Both Pneu-C-13 and Pneu-P-23 vaccines are recommended along with a single re-immunization with Pneu-P-23 (refer to Table 3 and Table 4).

Acquired (secondary) immunodeficiency
Hematopoietic stem cell transplantation (HSCT-autologous or allogeneic)
HSCT are at increased risk of pneumococcal diseases and pneumococcal vaccine is recommended for all persons. Regardless of age, pneumococcal vaccination should be started at 3 to 9 months after HSCT with three doses of Pneu-C-13 vaccine provided at least 4 weeks apart, followed by a dose of Pneu-P-23 vaccine 6 to 12 months later or when recipient reaches age 2 years. Because antibody response to pneumococcal vaccination is known to be poor in these persons, some experts recommend that all transplant recipients over 2 years of age receive a booster dose of Pneu-P-23 vaccine 1 year after their initial Pneu-P-23 immunization.

Solid organ transplantation
If possible, individuals being considered for solid organ transplantation should receive age-appropriate pneumococcal vaccines at least 2 weeks before transplantation. If the vaccination was not completed prior to transplant, in general, it should not be re-initiated until at least 3 to 6 months after transplantation. Both Pneu-C-13 and Pneu-P-23 vaccines are recommended along with a single re-immunization with Pneu-P-23 (refer to Table 3 and Table 4).

Immunocompromising therapy
Vaccination status for pneumococcal disease should be reviewed for immunocompetent persons who might be anticipating initiation of immunocompromising treatments or who have diseases that might lead to immunodeficiency. Although pneumococcal vaccine can be safely administered at any time before, during or after immunosuppression, all attempts should be made to time vaccination so that optimal immunogenicity is achieved.

If indicated, pneumococcal vaccine should be administered at least 14 days before the initiation of immunocompromising therapy, including use of long-term corticosteroids (e.g., high-dose systemic corticosteroids [≥2 mg/kg per day for a child or ≥20 mg/day for an adult of prednisone or its equivalent] for 14 days or more), chemotherapy, radiation therapy, post-organ-transplant therapy, biologic and non-biologic immunocompromising therapies for rheumatologic and other inflammatory diseases. If this process cannot be completed, a period of 3 months should elapse after immunocompromising drugs (except high-dose systemic corticosteroids) have been stopped before administration of pneumococcal vaccine, to ensure immunogenicity. A period of at least 4 weeks should elapse between discontinuation of high-dose systemic steroids and administration of pneumococcal vaccines. The interval between discontinuation of immunocompromising drugs and pneumococcal vaccine may vary with the intensity of the immunocompromising therapy, underlying disease and other factors.

If immunocompromising therapy cannot be stopped, pneumococcal vaccine should be given when the person is least immunosuppressed. Both Pneu-C-13 and Pneu-P-23 vaccines are recommended along with a single re-immunization with Pneu-P-23 (refer to Table 3 and Table 4).

HIV-infected
When possible, pneumococcal vaccine should be given early in the course of HIV infection; however, there is no contraindication to the use of pneumococcal vaccines at any time. Both Pneu-C-13 and Pneu-P-23 vaccines are recommended along with a single re-immunization with Pneu-P-23 (refer to Table 3 and Table 4).

Refer to Booster doses and re-immunization for reason and schedule for re-vaccination. Refer to Immunization of Immunocompromised Persons in Part 3 for additional general information.

Persons with chronic diseases

Hyposplenism or asplenia
Hyposplenic or asplenic individuals should receive pneumococcal vaccine, as they are at risk of serious pneumococcal infections. When elective splenectomy is planned, all recommended vaccines should ideally be administered at least 2 weeks before surgery. In the case of an emergency splenectomy, vaccines should be given 2 weeks after surgery or before discharge, particularly if it is suspected that the person might not return for vaccination after discharge. Both Pneu-C-13 and Pneu-P-23 vaccines are recommended, along with a single re-immunization with Pneu-P-23 (refer to Table 3 and Table 4).

Chronic renal disease/dialysis
Individuals with chronic renal disease or on dialysis should be vaccinated using the pneumococcal vaccine (conjugated vs. polysaccharide) and according to the schedule recommended for their age. Children and adolescents less than 18 years of age should receive both Pneu-C-13 and Pneu-P-23. For adults, only Pneu-P-23 is generally recommended. Due to the decreased immunogenicity and efficacy of polysaccharide vaccine in people with chronic renal failure, a single re-immunization is recommended. Refer to Booster doses and re-immunization for schedule for re-vaccination.

Asthma
Individuals who required medical attention for asthma in the past 12 months should be vaccinated using the pneumococcal vaccine (conjugated vs. polysaccharide) and according to the schedule recommended for their age group. Children and adolescents less than 18 years of age should receive both Pneu-C-13 and Pneu-P-23. For adults, only Pneu-P-23 is generally recommended. No re-immunization is recommended.

Neurologic disorders
Persons with chronic CSF leak or chronic neurologic conditions that may impair clearance of oral secretions should be vaccinated using the pneumococcal vaccine (conjugated vs. polysaccharide) and according to the schedule recommended for their age group. Children and adolescents less than 18 years of age should receive both Pneu-C-13 and Pneu-P-23. For adults, only Pneu-P-23 is generally recommended. No re-immunization is recommended.

Refer to Immunization of Persons with Chronic Diseases in Part 3 for additional general information.

Travellers

The primary series of conjugate pneumococcal vaccine may be started at 6 weeks of age for infants who will be travelling. Refer to Immunization of Travellers in Part 3 for additional general information.

Persons new to Canada

Health care providers who see persons newly arrived in Canada should review the immunization status and update immunization for these individuals. Review of pneumococcal vaccination status is particularly important for persons from areas of the world where sickle cell disease is present, as persons with sickle cell disease are at risk of serious pneumococcal infections. Information on vaccination schedules in other countries is available at the World Health Organization (WHO) websiteExternal Link.

Refer to Immunization of Persons New to Canada in Part 3 for additional general information.

Outbreak control

During outbreaks of pneumococcal infection due to Pneu-C-13 vaccine serotypes, immunization with Pneu-C-13 vaccine is recommended for children who have not previously received adequate vaccination with Pneu-C-13. Pneu-P-23 vaccine has also been used to control outbreaks of pneumococcal infection due to Pneu-P-23 vaccine serotypes in adults. Pneu-C-10 or Pneu-13 vaccine can be used in adults if the serotype of the outbreak is prevented by the vaccine.

Vaccine Administration

Dose, route of administration, and schedule

Dose
Each dose of pneumococcal vaccine is 0.5 mL.

Route of administration
Conjugated pneumococcal vaccine should be administered intramuscularly (IM). Pneu-P-23 vaccine may be given either IM or subcutaneously (SC). Refer to Vaccine Administration Practices in Part 1 for additional information.

Schedule

Infants and children: For routine infant immunization, three doses of conjugate pneumococcal vaccine with a minimum of 8 weeks intervals beginning at 2 months of age, followed by a fourth dose (booster) at 12 to 15 months of age should be administered. Pneu-C-13 vaccine is recommended as the product of choice. For healthy infants, a 3-dose schedule may be used, with doses given at 2, 4, and 12 months of age. A 4-dose schedule is recommended for immunization of infants at high risk of IPD.

Infants 7 to 11 months of age who have not been previously immunized against IPD should receive two doses of conjugate pneumococcal vaccine at least 8 weeks apart followed by a third dose after 12 months of age, at least 8 weeks after the second dose.

Children between 12 and 23 months require two doses of Pneu-C-13 at least 8 weeks apart. Older children who are recommended to receive pneumococcal vaccine (see Recommendations for Use) require only one dose Pneu-C-13.

The number of doses required to complete a vaccination series for children with interrupted or incomplete schedules varies with the age of the child. Infants who are less than 12 months of age when they re-present should complete their immunization schedule as if no interruption had occurred. Older children with interrupted or incomplete vaccination schedules should be assessed to determine the number of doses required to complete the series (refer to Table 3).

Children who are at high risk of IPD should also receive one dose of Pneu-P-23 vaccine at 24 months of age with possible re-immunization depending on the condition (refer to Booster doses and re-immunization). Refer to Table 3 and Recommendations for Use.

Table 3: Recommended schedules for conjugate pneumococcal vaccine for children 2 months up to and including 17 years of age, by conjugate pneumococcal vaccination history
Age at presentation for immunization Number of doses of Pneu-C-7, Pneu-C-10 or Pneu-C-13 previously received Recommended schedule for  Pneu-C-13Table 3 - Footnote *
Table 3 - Footnote *
The minimum interval between doses of conjugate pneumococcal vaccine is 8 weeks.
Table 3 - Footnote **
Children at high risk of IPD should follow the 4-dose schedule and also receive one dose of Pneu-P-23 at 24 months of age. A single re-immunization with Pneu-P-23 is recommended for some conditions (refer Booster doses and re-immunization).
Table 3 - Footnote
Follow relevant provincial/territorial schedule.
Table 3 - Footnote Ʊ
Programs using a 3-dose schedule should offer the third dose early in the second year of life (at 12 months of age) to allow for early complete protection.
Table 3 - Footnote ¥
Children at high risk of IPD should also receive one dose of Pneu-P-23 at 24 months of age. When both Pneu-C-13 and Pneu-P-23 need to be given, the conjugate vaccine should be given first. A single re-immunization with Pneu-P-23 is recommended for some conditions (refer to Booster doses and re-immunization).
2-6 months†, Table 3 - Footnote ** 0 dose 2 or 3 dosesTable 3 - Footnote + booster at 12Table 3 - Footnote Ʊ-15 months of age
1 dose 1 or 2 dosesTable 3 - Footnote + booster at 12Table 3 - Footnote Ʊ-15 months of age
2 doses 0 or 1 doseTable 3 - Footnote + booster at 12Table 3 - Footnote Ʊ-15 months of age
7-11 monthsTable 3 - Footnote ¥ 0 doses 2 doses + booster at 12-15 months of age
1 dose 1 dose at 7-11 months + booster at 12-15 months of age
2 doses  booster at 12-15 months of age
12-23 months, healthy or high risk of IPDTable 3 - Footnote ¥ 0 dose 2 doses
1 dose at less than 12 months of age
2 or more doses at less than 12 months of age 1 dose
1 dose at 12 months of age or older
Complete, age-appropriate vaccination with Pneu-C-7 or Pneu-C-10 (0 doses Pneu-C-13)
24-35 months,
healthy or high risk of IPDTable 3 - Footnote ¥
0 dose or incomplete vaccination schedule with any product 1 dose
Complete, age-appropriate vaccination with Pneu-C-7 or Pneu-C-10 (0 doses Pneu-C-13)
36-59 months,
healthy
0 dose or incomplete vaccination schedule with any product 1 dose
Complete, age-appropriate vaccination with Pneu-C-7 or Pneu-C-10 (0 doses Pneu-C-13)
  • If of aboriginal origin or attending group child  care, 1 dose
  • All other children, consider 1 dose
36-59 months,
high risk of IPDTable 3 - Footnote ¥
0 dose or incomplete vaccination schedule with any product 1 dose
Complete, age-appropriate vaccination with Pneu-C-7 or Pneu-C-10 (0 doses Pneu-C-13)
60 months – 17 years, high risk of IPDTable 3 - Footnote ¥ 0 dose Pneu-C-13 1 dose

Adults: Immunocompetent adults who are at high risk of IPD (refer to Table 1), immunocompetent residents of long-term care facilities and all adults 65 years of age and older without contraindications should receive one dose of Pneu-P-23 vaccine. Adults with immunocompromising conditions require Pneu-C-13 and Pneu-P-23 with the Pneu-C-13 given first (refer to Table 4). A single re-immunization with Pneu-P-23 is recommended for some conditions (refer to Booster doses and re-immunization).

Table 4: Recommended schedules for adult (18 years of age and over) immunization with pneumococcal vaccine
Age, underlying condition Type of vaccine Number of doses and recommended schedule
Table 4 - Footnote *
Some experts suggest that a conjugate pneumococcal vaccine may be given as the initial dose followed by the Pneu-P-23 vaccine for immunocompetent adults at increased risk of IPD, as this may theoretically improve antibody response and immunologic memory. If this strategy is chosen, Pneu-C-13 vaccine should be administered first, followed at least 8 weeks later by Pneu-P-23 vaccine. However, Pneu-P-23 vaccine is the vaccine of choice for these individuals, and if only one vaccine can be provided, it should be Pneu-P-23 vaccine
Table 4 - Footnote **
The Pneu-C-13 dose should be administered at least one year after any previous dose of Pneu-P-23.
Immunocompetent adults 18-64 years of age at high risk of IPD (refer to Table 1) Pneu-P-23Table 1 - Footnote * 1 dose, followed by a single re-immunization with Pneu-P-23 recommended 5 years later for some conditions
Immunocompetent residents of long-term care facilities 18-64 years of age Pneu-P-23 1 dose
Adults 65 years or greater, regardless of risk factors Pneu-P-23 1 dose of Pneu-P-23 at least 8 weeks after Pneu-C-13 and no sooner than 5 years after a previous dose of Pneu-P-23
Immunocompromising condition (other than hematopoietic stem cell transplant [HSCT]) Pneu-C-13;
Pneu-P-23
- 1 dose of Pneu-C-13Table 4 - Footnote **
- 1 dose of Pneu-P-23 at least 8 weeks after Pneu-C-13
- a single re-immunization with Pneu-P-23 recommended 5 years later
HSCT Pneu-C-13;
Pneu-P-23
- 3 doses of Pneu-C-13 starting 3-9 months after transplant, administered at least 4 weeks apart
- 1 dose of Pneu-P-23 12 to 18 months post transplant (6 to 12 months after the last dose of Pneu-C-13)
- a single re-immunization with Pneu-P-23 recommended as early as 1 year later by some experts
Booster doses and re-immunization

Conjugate pneumococcal vaccine
Re-immunization with conjugate pneumococcal vaccine after age and risk appropriate childhood vaccination is not necessary.

Pneumococcal polysaccharide vaccine
Immunity induced by Pneu-P-23 vaccine decreases over time. Routine re-immunization of healthy individuals who have been vaccinated with Pneu-P-23 vaccine is not recommended. However, re-immunization is recommended for those of any age at highest risk of IPD, including those with: functional or anatomic asplenia or sickle cell disease; hepatic cirrhosis; chronic renal failure; nephrotic syndrome; HIV infection; and immunosuppression related to disease or therapy. For solid organ transplant recipients, there is evidence that antibody titers decline after 3 years. Experience with re-immunization after solid organ transplant is limited.

If re-immunization is carried out, a single re-immunization after 5 years is recommended. Because there are insufficient data to recommend repeated administration of Pneu-P-23 vaccine, re-vaccination following a second dose is not routinely recommended.

Individuals who have previously received Pneu-P-23 vaccine and who require re-immunization following immunization with Pneu-C-13 vaccine, should receive Pneu-P-23 no sooner than 8 weeks after Pneu-C-13 vaccine and no sooner than 5 years after the initial dose of Pneu-P-23.

Refer to Immunocompromised persons for considerations for persons undergoing HSCT.

Serologic Testing

Serologic testing is not necessary before or after receiving pneumococcal vaccine.

Storage Requirements

All pneumococcal vaccines should be stored in a refrigerator at +2°C to +8°C. Do not freeze.

Refer to Storage and Handling of Immunizing Agents in Part 1 for additional information.

Simultaneous Administration with Other Vaccines

Conjugate pneumococcal vaccine may be administered concomitantly with routine childhood vaccines at different injection sites using separate needles and syringes. 

Conjugate pneumococcal vaccine and Pneu-P-23 vaccine should be administered at least 8 weeks apart. However, for adults with immunocompromising conditions (except HSCT), Pneu-C-13 dose should be administered at least one year after any previous dose of Pneu-P-23. Pneumococcal 23-valent polysaccharide vaccine and HZ vaccine may be administered together.

Refer to Timing of Vaccine Administration in Part 1 for additional general information.

Vaccine Safety and Adverse Events

Refer to Vaccine Safety in Part 2 for additional general information.

Common and local adverse events

Conjugate pneumococcal vaccine
Clinical trials of Pneu-C-10 vaccine have found that irritability, decreased appetite, drowsiness, pain, swelling and redness at the injection site, or low-grade fever occur in 29% to 37% of vaccinees. Fever above 39°C occurs in 2% to 3% of vaccines. An increase in reactogenicity was reported after booster vaccination, compared to the doses of the primary series.

Studies of Pneu-C-13 vaccine indicate that irritability, decreased appetite, increased or decreased sleep, pain, swelling and redness at the injection site, after the toddler dose and in older children, are common side effects. Low-grade fever occurs in 20% to 30% or more of vaccinees. In adults over 50 years of age, the most commonly reported side effects include pain at the injection site, fatigue, headache and new onset of myalgia, with fever above 38°C occurring in approximately 3% of vaccine recipients.

Pneumococcal polysaccharide vaccine
Reactions to Pneu-P-23 vaccine are usually mild. Soreness, redness and swelling at the injection site occur in 30% to 60% of vaccinees and more commonly follow SC administration than IM administration. Occasionally, low grade fever may occur. Re-immunization of healthy adults less than 2 years after the initial dose is associated with increased local injection site and systemic reactions. Studies have suggested that re-vaccination after an interval of at least 4 years is not associated with an increased incidence of adverse side effects. However, severe local reactions, including reports of injection site cellulitis and peripheral edema in the injected extremity, have been documented rarely with Pneu-P-23 vaccine in post-marketing surveillance, even with the first dose. Multiple re-vaccinations are not recommended. Refer to Booster doses and re-immunization.

Less common and serious or severe adverse events

Serious adverse events are rare following immunization and, in most cases, data are insufficient to determine a causal association. Few serious adverse events were reported in clinical trials with any of the pneumococcal vaccines, and consisted mainly of reports of afebrile and febrile seizure. Arthus-like reactions (causing a local vasculitis from deposition of immune complexes) are very rare and mainly occur in persons with high initial pneumococcal antibody levels. Anaphylaxis following vaccination with pneumococcal vaccine may occur but is very rare. Refer to Vaccine Safety in Part 2 for additional general information.

Guidance on reporting Adverse Events Following Immunization (AEFI)

Vaccine providers are asked to report, through local public health officials, any serious or unexpected adverse event felt to be temporally related to vaccination. An unexpected AEFI is an event that is not listed in available product information but may be due to the immunization, or a change in the frequency of a known AEFI. Refer to User Guide to completetion and submission of the AEFI reports or consult Vaccine Safety in Part 2 for additional information about AEFI reporting.

Contraindications and precautions

Pneumococcal vaccines are contraindicated in persons with a history of anaphylaxis after previous administration of the vaccine and in persons with proven immediate or anaphylactic hypersensitivity to any component of the vaccine or its container. For pneumococcal vaccines, potential allergens include:

  • Prevnar®13: diphtheria CRM197 carrier protein
  • SYNFLORIX®:  latex in plunger stopper of pre-filled syringe, diphtheria toxoid carrier protein, tetanus toxoid carrier protein, non-typeable Haemophilus influenzae protein D carrier protein

In situations of suspected hypersensitivity or allergy not associated with anaphylaxis to vaccine components, investigation is indicated, which may involve immunization in a controlled setting. Consultation with an allergist is advised.

Administration of pneumococcal vaccine should be postponed in persons suffering from severe acute illness. Immunization should not be delayed because of minor acute illness, with or without fever.

There are currently no data available regarding safety for children below the age of 6 weeks of age. There are limited safety and immunogenicity data on Pneu-C-13 vaccine for children or adults in groups at higher risk for IPD (e.g., children or adults with splenic dysfunction, HIV infection, malignancy, nephrotic syndrome).

Refer to Contraindications, Precautions and Concerns in Part 2 for additional general information.

Other Considerations

Interchangeability of vaccines

Infants who have started an immunization schedule with one conjugate pneumococcal vaccine may continue their immunization schedule with a different conjugate pneumococcal vaccine. For example, infants who started a series with Pneu-C-7 or Pneu-C-10 vaccine can complete it with Pneu-C-13 vaccine. Refer to Principles of Vaccine Interchangeability in Part 1 for additional general information.

Selected References

  • American Academy of Pediatrics. In: Pickering LK, Baker CJ, Kimberlin DW, et al. (editors). Red Book: 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009.
  • American Academy of Pediatrics. Technical report: prevention of pneumococcal infections, including the use of pneumococcal conjugate and polysaccharide vaccines and antibiotic prophylaxis. Pediatrics 2000;106:367-76.
  • Black S, Shinefield H, Fireman B, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J. 2000;19:87-95.
  • Butler JC, Breiman RF, Campbell JF, et al. Pneumococcal polysaccharide vaccine efficacy: an evaluation of current recommendations. JAMA;1993;270:1826-31.
  • Centers for Disease Control and Prevention. Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of invasive pneumococcal disease – United States, 1998-2003. MMWR Morb Mortal Wkly Rep 2005;54(36):893-7.
  • Centers for Disease Control and Prevention. Licensure of a 13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Recommendations for Use Among Children - Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep 2010;59(09):258-61.
  • Centers for Disease Control and Prevention. Updated Recommendations for Prevention of Invasive Pneumococcal Disease Among Adults Using the 23-Valent Pneumococcal Polysaccharide Vaccine. MMWR Morb Mortal Wkly Rep t 2010;59(34):1102-6.
  • DeStefano F, Pfeifer D, Nohynek H. Safety profile of pneumococcal conjugate vaccines: systematic review of pre- and post-licensure data. Bull World Health Organ 2008;86:373-80.
  • Eskola J, Anttila M. Pneumococcal conjugate vaccines. Pediatr Infect Dis J. 1999;18:543-51.
  • Eskola J, Kilpi T, Palmu A, et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001;334:403-9.
  • Esposito S, Tansey S, Thompson A et al. Safety and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared to Those of a 7-Valent Pneumococcal Conjugate Vaccine Given as a Three-Dose Series with Routine Vaccines in Healthy Infants and Toddlers. Clin Vaccine Immunol 2010;17(6):1017-26.
  • Fine MJ, Smith MA, Carson CA, et al. Efficacy of pneumococcal vaccination in adults: a meta-analysis of randomized clinical trials. Arch Intern Med. 1994;154:2666-77.
  • GlaxoSmithKline Inc. Product Monograph - SYNFLORIX™. May 2009.
  • Jackson L et al. Safety of Revaccination with Pneumococcal Polysaccharide Vaccine. JAMA. 1999;281:243-48.
  • Johnstone J, Eurich DT, Minhas JK et al. Impact of the pneumococcal vaccine on long-term morbidity and mortality of adults at high risk for pneumonia. Clin Infect Dis 2010;5:15-22.
  • Kellner JD, Church DL, MacDonald J, et al. Progress in the prevention of pneumococcal infection. Can Med Assoc J. 2005;173(10):1149-51.
  • Merck Frosst Canada Ltd.  Product Monograph - PNEUMOVAX® 23. January 2011.
  • National Advisory Committee on Immunization. Statement on the recommended use of pneumococcal 23-valent polysaccharide vaccine in homeless persons and injection drug users. Can Commun Dis Rep. 2008;34(ACS-5):1-12.
  • National Advisory Committee on Immunization. An Advisory Committee Statement (ACS). National Advisory Committee on Immunization (NACI): Statement on the Use of Conjugate Pneumococcal Vaccine – 13 Valent in Adults (Pneu-C-13). Can Commun Dis Rep. 2013:39(ACS-5).
  • National Advisory Committee on Immunization. An Advisory Committee Statement (ACS). National Advisory Committee on Immunization (NACI): Update on the Use of Pneumococcal Vaccines: Addition of Asthma as a High-Risk Condition. Public Health Agency of Canada. February 2014 (Catalogue no. HP40-94/2014E-PDF).
  • National Advisory Committee on Immunization. Update on pediatric invasive pneumococcal disease and recommended use of conjugate pneumococcal vaccines. Can Commun Dis Rep. 2010:36(ACS-3):1-30.
  • National Advisory Committee on Immunization. Update on the use of conjugate pneumococcal vaccines in childhood. Can Commun Dis Rep. 2010:36(ACS-12):1-21.
  • Pfizer Canada Inc.  Product Monograph – Prevnar® 13. October 2010.
  • Rodriguez R. Safety of pneumococcal revaccination. J Gen Intern Med. 1995;10:511-2.
  • Sanofi Pasteur Ltd.  Product Monograph – PNEUMO 23®. July 2008.
  • Scheifele D, Halperin S, Pelletier L, et al. Invasive pneumococcal infection in Canadian children 1991-1998: implications for new vaccination strategies. Clin Infect Dis. 2000;31:58-64.
  • Shapiro ED, Berg AT, Austrain R, et al. The protective effect of polyvalent pneumococcal polysaccharide vaccine. N Engl J Med. 1991;325:1453-60.
  • Shinefield HR, Black S, Ray P, et al. Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers. Pediatr Infect Dis J. 1999;18:757-63.
  • Tseng HF, Smith N, Sy LS et al. Evaluation of the incidence of herpes zoster after concomitant administration of zoster vaccine and polysaccharide pneumococcal vaccine. Vaccine 2011; 29:3628–32.
  • van Gils EJ, Veenhoven RH, Hak E et al. Pneumococcal Conjugate Vaccination and Nasopharyngeal Acquisition of Pneumococcal Serotype 19A Strains. JAMA 2010;304(10):1099-1106.
  • World Health Organization. Pneumococcal conjugate vaccine for childhood immunization – WHO position paper. Wkly Epidemiol Rec 2007; 12(83): 93-104.
  • World Health Organization. 23-valent pneumococcal polysaccharide vaccine – WHO position paper. Wkly Epidemiol Rec 2008; 42(83): 373-84.
  • Yeh SH, Gurtman A, Hurley DC et al. Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine in Infants and Toddlers. Pediatrics 2010;126(3):e493-e505.

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