Canadian Immunization Guide: Part 4 - Active Vaccines

Pneumococcal Vaccine

Updated: October 2016

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 due to underlying medical conditions or lifestyle factors.
  • In children less than 5 years of age, effectiveness of conjugate vaccines against IPD due to serotypes contained in the vaccine is estimated to range from 86% to 97%.
  • Pneumococcal polysaccharide 23-valent (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
  • Pneumococcal vaccine is recommended for:
    • routine immunization of infants and children
    • immunization of children who missed pneumococcal immunization on the routine schedule
    • immunization of people at high risk of IPD due to underlying medical conditions
    • immunization of residents of long-term care facilities
    • immunization of adults who are at high risk of IPD due to lifestyle factors: smokers, persons with alcoholism, persons who are homeless
    • immunization of all adults 65 years of age and older
  • Pneumococcal vaccine should be considered for adults who use illicit drugs
How
  • Pneumococcal conjugate 13-valent (Pneu-C-13) vaccine
    • Routine infant immunization: Pneu-C-13 vaccine should be administered beginning at 2 months of age using a 3 or 4 dose schedule.
    • 12 to less than 24 months of age: 2 doses of Pneu-C-13 vaccine should be administered at least 8 weeks apart to children not previously vaccinated with a pneumococcal conjugate vaccine or who received only 1 dose before 12 months of age. Children who have received complete, age-appropriate pneumococcal vaccination but have not received Pneu-C-13 vaccine should receive 1 dose of Pneu-C-13 vaccine.
    • 24 to less than 36 months of age: 1 dose of Pneu-C-13 vaccine should be administered to children without pneumococcal vaccination or with incomplete vaccination schedules with any pneumococcal conjugate vaccine. Children who have received complete, age-appropriate pneumococcal vaccination but have not received Pneu-C-13 vaccine should receive 1 dose of Pneu-C-13 vaccine.
    • 36 to less than 60 months (5 years) of age: 1 dose of Pneu-C-13 vaccine should be administered to:
      • Healthy children who are of Aboriginal origin or who attend group child care, and who have received age-appropriate pneumococcal conjugate vaccination but have not received Pneu-C-13 vaccine. One dose of Pneu-C-13 vaccine should be considered for other healthy children.
      • Children at high risk of IPD due to underlying medical conditions who have received age-appropriate pneumococcal conjugate vaccination but have not received Pneu-C-13 vaccine.
      • Children without pneumococcal vaccination or with incomplete vaccination schedules with any pneumococcal conjugate vaccine.
    • 5 to less than 18 years of age: 1 dose of Pneu-C-13 vaccine should be administered to children and adolescents at high risk of IPD due to underlying medical conditions who have not received Pneu-C-13 vaccine.
    • Adults with immunocompromising conditions resulting in high risk of IPD: 1 dose of Pneu-C-13 vaccine should be administered at least 1 year after any previous dose of Pneu-P-23 vaccine.
    • Recipients of hematopoietic stem cell transplant [HSCT]: 3 doses of Pneu-C-13 vaccine administered at least 4 weeks apart should be administered starting 3 to 9 months after HSCT.
  • Pneumococcal polysaccharide 23-valent (Pneu-P-23) vaccine
    • One dose of Pneu-P-23 vaccine should be administered to all individuals 24 months of age and older who are at high risk of IPD due to an underlying medical condition or who are residents of long-term care facilities. People at highest risk of IPD should also receive 1 booster dose of Pneu-P-23 vaccine.
    • One dose of Pneu-P-23 vaccine is recommended for adults:
      • 65 years of age and older, regardless of risk factors or previous pneumococcal vaccination.
      • at high risk of IPD due to lifestyle factors: smokers, persons with alcoholism, persons who are homeless. Adults who use illicit drugs should be considered for Pneu-P-23 vaccination.
Why
  • S. pneumoniae is a common cause of invasive disease, such as bacteremia and meningitis.
  • The case fatality rate of bacteremic pneumococcal pneumonia is 5% to 7% and is higher among elderly persons.

Significant revisions included in this chapter are highlighted in the Table of Updates to the Canadian Immunization Guide.

Epidemiology

Disease description

Infectious agent

The bacterium Streptococcus pneumoniae is the cause of invasive pneumococcal disease (IPD) and a common cause of community acquired pneumonia (CAP). For additional information about S. pneumoniae, refer to the Public Health Agency of Canada (PHAC) website.

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 when 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 due to an underlying medical condition. 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. Susceptibility to S. pneumoniae infection and IPD is increased in smokers, persons with alcoholism and illicit drug users. Homeless populations have high rates of respiratory infections, including those caused by S. pneumoniae.

Medical conditions resulting in high risk of IPD

Table 1: Medical Conditions Resulting in High risk of IPD

  • Non-immunocompromising conditions
    • Chronic cerebrospinal fluid (CSF) leak
    • Chronic neurologic condition that may impair clearance of oral secretions
    • Cochlear implants, including children and adults who are to receive implants
    • Chronic heart disease
    • Diabetes mellitus
    • Chronic kidney diseaseTable Note 1
    • Chronic liver disease, including hepatic cirrhosis due to any causeTable Note 1
    • Chronic lung disease, including asthma requiring medical care in the preceding 12 months
  • Immunocompromising conditions
    • Sickle cell disease, congenital or acquired asplenia, or splenic dysfunctionTable 1 - Footnote 1,Table 1 - Footnote 2
    • Congenital immunodeficiencies involving any part of the immune systemTable Note 1, including B-lymphocyte (humoral) immunity, T-lymphocyte (cell) mediated immunity, complement system (properdin, or factor D deficiencies), or phagocytic functions
    • Immunocompromising therapyTable Note 1, including use of long-term corticosteroids, chemotherapy, radiation therapy, and post-organ transplant therapyTable 1 - Footnote 1
    • HIV infectionTable Note 1
    • Hematopoietic stem cell transplant (recipient)Table Note 1
    • Malignant neoplasmsTable Note 1, including leukemia and lymphoma
    • Nephrotic syndromeTable Note 1
    • Solid organ or islet transplant (candidate or recipient)Table Note 1

Seasonal and temporal patterns

IPD is more common in the winter and spring in temperate climates.

Spectrum of clinical illness

Although asymptomatic upper respiratory tract colonization is common, infection with S. pneumoniae may result in severe disease. IPD is a severe form of infection that occurs when S. pneumoniae invades normally sterile sites, such as the bloodstream or central nervous system. Bacteremia and meningitis are the most common manifestations of IPD in 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. In Canada, IPD is most common among the very young and adults over 65 years of age.

For additional information about IPD in Canada, including disease description and distribution, refer to the PHAC invasive pneumococcal disease website. Comprehensive updates on the epidemiology of IPD in Canada are published periodically in the Canadian Communicable Disease Report. Information on the epidemiology of IPD and CAP in Canada is also provided in previously published NACI Statements and Statement Updates.

Immunizing Agents Available for Use in Canada

Pneumococcal vaccines

Pneumococcal conjugate vaccines

  • Prevnar®13 (pneumococcal 13-valent conjugate vaccine, CRM197 protein), Pfizer Canada Inc. (licensee) (Pneu-C-13)

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

Pneumococcal polysaccharide 23-valent vaccine

  • PNEUMOVAX®23 (pneumococcal polysaccharide 23-valent 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
Pneu-C-7Table 2 - Footnote 1 serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine                                  
Pneu-C-10Table 2 - Footnote 1 serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine                            
Pneu-C-13 serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine                      
Pneu-P-23 serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine   serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine serotype included in the vaccine
Text Equivalent - Table 2

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

Immunogenicity, Efficacy and Effectiveness

Immunogenicity

Pneumococcal conjugate 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 pneumococcal conjugate or Pneu-P-23 vaccines. The immunogenicity of Pneu-C-7 vaccine has been demonstrated in children with immunodeficiency.

Pneu-C-10 and Pneu-C-13 vaccines were authorized by Health Canada 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 newer vaccines and Pneu-C-7 vaccine. Studies on Pneu-C-10 vaccine demonstrated an antibody response to all 10 vaccine serotypes. Studies on Pneu-C-13 vaccine demonstrated an antibody response to all 13 vaccine serotypes. There are no studies comparing the immunogenicity of Pneu-C-10 and Pneu-C-13 vaccines.

Pneumococcal polysaccharide vaccine

Pneumococcal polysaccharide vaccine is less immunogenic in children than pneumococcal conjugate vaccine. Following immunization with Pneu-P-23 vaccine, antibody concentrations decline after 5 to 10 years; the duration of immunity is not known.

Efficacy and effectiveness

Pneumococcal conjugate vaccines

In children less than 5 years of age, the effectiveness of pneumococcal conjugate vaccines is 86% to 97% against IPD serotypes whose antigens are contained in the vaccine (vaccine serotypes). Pneu-C-7 vaccine provides a 54% reduction in AOM and a 20% reduction in tympanostomy (tube placement) due to infection with vaccine serotypes.

Pneumococcal polysaccharide vaccine

Pneu-P-23 vaccine efficacy is more than 80% against IPD among healthy young adults and ranges from 50% to 80% in the elderly and high-risk groups. Immunogenicity and efficacy are decreased in certain groups at particularly high risk of pneumococcal infection, such as persons with kidney failure, sickle cell anemia, or impaired immune responsiveness, including HIV infection.

Recommendations for Use

Healthy children (2 months to less than 18 years of age)

Schedule

Routine schedule

Healthy infants (2 to less than 12 months of age)

For routine immunization of healthy infants, Pneu-C-13 vaccine may be provided using a 3 dose schedule at 2 months, 4 months and 12 months of age, or a 4 dose schedule at 2 months, 4 months and 6 months followed by a dose at 12 to 15 months of age.

Unimmunized healthy infants 7 to less than 12 months of age should receive 2 doses of Pneu-C-13 vaccine at least 8 weeks apart followed by a third dose at 12 to 15 months of age, at least 8 weeks after the second dose.

Catch-up and accelerated schedules

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. Table 3 summarizes the recommended schedules for Pneu-C-13 vaccine for healthy infants and children by pneumococcal conjugate vaccination history.

Children at high risk of IPD (2 months to less than 18 years of age)

Infants at high risk of IPD due to an underlying medical condition should receive Pneu-C-13 vaccine in a 4 dose schedule at 2 months, 4 months and 6 months followed by a dose at 12 to 15 months of age. Table 3 summarizes the recommended schedules for Pneu-C-13 vaccine for infants and children at high risk of IPD due to an underlying medical condition by pneumococcal conjugate vaccination history.

In addition to Pneu-C-13 vaccine, children at high risk of IPD due to an underlying medical condition should receive 1 dose of Pneu-P-23 vaccine at 24 months of age, at least 8 weeks after Pneu-C-13 vaccine. If an older child or adolescent at high risk of IPD due to an underlying medical condition has not previously received Pneu-P-23 vaccine, 1 dose of Pneu-P-23 vaccine should be administered, at least 8 weeks after Pneu-C-13 vaccine. Children and adolescents at highest risk of IPD should receive 1 booster dose of Pneu-P-23 vaccine; refer to Booster doses and re-immunization. Refer to Immunocompromised persons for information about immunization of HSCT recipients.

Table 3: Recommended Schedules for Pneu-C-13 Vaccine for Children 2 months to less than 18 years of age, by Pneumococcal Conjugate 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 1
2 to less than 7 monthsTable 3 - Footnote 2, Table 3 - Footnote 3 0 dose
1 dose
2 doses
7 to less than 12 monthsTable 3 - Footnote 5 0 doses
  • 2 doses +
  • 1 dose at 12-15 months of age
1 dose
  • 1 dose at 7 less than 12 months of age +
  • 1 dose at 12 to 15 months of age
2 doses 1 dose at 12 to 15 months of age
12 to less than 24 months, healthy or high risk of IPD due to an underlying medical conditionTable 3 - Footnote 5, Table 3 - Footnote 6 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 to less than 36 months,
healthy or
high risk of IPD due to an underlying medical conditionTable 3 - Footnote 5, Table 3 - Footnote 6
0 doses or incomplete vaccination schedule with any pneumococcal conjugate vaccine 1 dose
Complete, age-appropriate vaccination with Pneu-C-7 or Pneu-C-10 vaccine but 0 doses Pneu-C-13 vaccine
36 to less than 60 months (5 years), healthy 0 doses or incomplete vaccination schedule with any pneumococcal conjugate vaccine 1 dose
Complete, age-appropriate vaccination with Pneu-C-7 or Pneu-C-10 vaccine but 0 doses Pneu-C-13 vaccine
  • If of Aboriginal origin or attending group child care: 1 dose
  • All other children: consider 1 dose
36 to less than 60 months (5 years), high risk of IPD due to an underlying medical conditionTable 3 - Footnote 5, Table 3 - Footnote 6 0 doses or incomplete vaccination schedule with any pneumococcal conjugate vaccine 1 dose
Complete, age-appropriate vaccination with Pneu-C-7 or Pneu-C-10 vaccine but 0 doses Pneu-C-13 vaccine
5 to less than 18 years, high risk of IPD due to an underlying medical conditionTable 3 - Footnote 5, Table 3 - Footnote 6 0 dose Pneu-C-13 1 dose

Refer to Timing of Vaccine Administration in Part 1 for additional information about delayed immunization schedules and accelerated immunization schedules. Refer to additional information contained within the product monograph available through Health Canada’s Drug Product Database.

Healthy adults (18 years of age and older)

One dose of Pneu-P-23 vaccine should be administered to all adults aged 65 years of age and over, regardless of risk factors or previous pneumococcal vaccination. For adults who received Pneu-P-23 vaccine before 65 years of age, an additional dose of Pneu-P-23 vaccine should be administered at 65 years of age, at least 5 years after any previous dose.

Immunization with Pneu-C-13 vaccine may be considered on an individual basis for pneumococcal vaccine-naïve adults aged 65 years and older for the prevention of CAP and IPD caused by the 13 pneumococcal serotypes included in the vaccine. Pneu-C-13 vaccine should be provided first followed by Pneu-P-23 vaccine at least 8 weeks later. Adults aged 65 years and older who have previously received Pneu-P-23 can receive Pneu-C-13 vaccine if at least one year has passed since immunization with Pneu-P-23 vaccine.

Adults at high risk of IPD (18 years of age and older)

Adults with immunocompromising conditions resulting in high risk of IPD, except HSCT, should receive 1 dose of Pneu-C-13 vaccine followed at least 8 weeks later by 1 dose of Pneu-P-23 vaccine, if not previously received. The dose of Pneu-C-13 vaccine should be administered at least 1 year after any previous dose of Pneu-P-23 vaccine. Refer to Immunocompromised persons for information about immunization of HSCT recipients.

Immunocompetent adults with conditions or lifestyle factors (smokers, persons with alcoholism and homeless persons) resulting in high risk of IPD should receive 1 dose of Pneu-P-23 vaccine, if not previously received. One dose of Pneu-P-23 vaccine is also recommended for all adults who are residents of long-term care facilities and should be considered for individuals who use illicit drugs.

Some experts also suggest a dose of Pneu-C-13 vaccine, followed by Pneu-P-23 vaccine, for immunocompetent adults with conditions resulting in high risk of IPD as this may theoretically improve antibody response and immunologic memory. 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 included in the vaccine.

Adults at highest risk of IPD should also receive 1 booster dose of Pneu-P-23 vaccine; refer to Booster doses and re-immunization.

Table 4 - provides recommended schedules for adult immunization with pneumococcal vaccines.

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
Immunocompetent adults 18 to less than 65 years of age at high risk of IPD due to an underlying medical condition Pneu-P-23Table 4 - Footnote 1 1 dose +
1 booster dose of Pneu-P-23 vaccine at least 5 years later for people at highest risk of IPD
Immunocompetent adults 18 to less than 65 years of age who are residents of long-term care facilities, smokers, persons with alcoholism, homeless personsTable 4 - Footnote 2 Pneu-P-23 1 dose
Adults 65 years of age or older, regardless of risk factors or previous pneumococcal vaccination Pneu-P-23Table 4 - Footnote 3 1 doseTable 4 - Footnote 4
Adults with an immunocompromising condition (except HSCT)
  • Pneu-C-13;
  • Pneu-P-23
  • 1 dose of Pneu-C-13 vaccineTable 4 - Footnote 5
  • 1 dose of Pneu-P-23 vaccine at least 8 weeks after Pneu-C-13 vaccine +
  • 1 booster dose of Pneu-P-23 vaccine at least 5 years later
Adult HSCT recipients
  • Pneu-C-13
  • Pneu-P-23
  • 3 doses of Pneu-C-13 vaccine starting 3 to 9 months post-transplant, administered at least 4 weeks apart +
  • 1 dose of Pneu-P-23 vaccine 12 to 18 months post-transplant (6 to 12 months after the last dose of Pneu-C-13 vaccine) +
  • 1 booster dose of Pneu-P-23 vaccine recommended as early as 1 year later by some experts

Refer to Immunization of Adults in Part 3 for additional information about routinely recommended immunization for adults as well as vaccines recommended for adults in specific risk situations.

Booster doses and re-immunization

Pneumococcal conjugate vaccine

A second dose of Pneu-C-13 vaccine is not necessary because there is currently no evidence that a booster dose is beneficial.

Pneumococcal polysaccharide vaccine

A second dose of Pneu-P-23 vaccine is recommended for individuals of any age in whom antibody response is decreased due to: functional or anatomic hyposplenia or asplenia, including sickle cell disease; chronic liver disease, including hepatic cirrhosis; chronic kidney failure or nephrotic syndrome; and immunosuppression related to disease or therapy (i.e. individuals at highest risk of IPD). If a booster dose of Pneu-P-23 vaccine is recommended, it should be administered at least 5 years after any previous dose of Pneu-P-23 vaccine.

HSCT recipients over 2 years of age should receive a booster dose of Pneu-P-23 vaccine 1 year after the initial dose of Pneu-P-23 vaccine. Refer to Immunocompromised persons for recommendations for HSCT recipients.

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 been adequately immunized with Pneu-C-13 vaccine. Pneu-P-23 or Pneu-C-13 vaccine can be used in adults, if the outbreak is due to serotypes included in the vaccine.

Vaccination of Specific Populations

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. Pneumococcal vaccines may be given, regardless of possible previous receipt of the vaccines, 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 information about vaccination of people with inadequate immunization records.

Pregnancy and breastfeeding

If indicated, pregnant women can be vaccinated with Pneu-P-23 vaccine or Pneu-C-13 vaccine, as there is no evidence to suggest a risk to the fetus or to the pregnancy from immunization with pneumococcal vaccines. Women who are breastfeeding can be vaccinated with pneumococcal vaccines. Refer to Immunization in Pregnancy and Breastfeeding in Part 3 for additional information about vaccination of women who are pregnant or breastfeeding.

Infants born prematurely

Prematurity is associated with an increased risk of chronic lung disease which can increase the risk of IPD. Premature infants in stable clinical condition should be immunized with Pneu-C-13 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 compared to full-term infants. 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 information about vaccination of premature infants.

Patients in health care institutions

Residents of long-term care facilities should receive Pneu-P-23 vaccine. Refer to Recommendations for Use for information about pneumococcal vaccination of individuals at increased risk of IPD. Refer to Immunization of Patients in Health Care Institutions in Part 3 for additional information about vaccination of patients in health care institutions.

Persons with chronic diseases

Refer to Immunization of Persons with Chronic Diseases in Part 3 for additional information about vaccination of people with chronic diseases.

Asplenia or hyposplenia

Hyposplenic or asplenic individuals should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine, followed by a booster dose of Pneu-P-23 vaccine. Refer to Table 3, Table 4 and Booster doses and re-immunization for additional information.

Chronic kidney disease and patients on dialysis

Individuals with chronic kidney disease should receive age appropriate pneumococcal vaccines. Children less than 18 years of age with chronic kidney failure or nephrotic syndrome, should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine. Adults with chronic kidney failure should receive Pneu-P-23 vaccine. Adults with nephrotic syndrome should receive Pneu-C-13 and Pneu-P-23 vaccine. Due to the decreased immunogenicity and efficacy of Pneu-P-23 vaccine in children and adults with chronic kidney failure, 1 booster dose of Pneu-P-23 vaccine is recommended. Refer to Table 3, Table 4 and Booster doses and re-immunization for additional information.

Neurologic disorders

People with chronic CSF leak or chronic neurologic conditions that may impair clearance of oral secretions should receive pneumococcal vaccine. Children less than 18 years of age should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine. Adults should receive Pneu-P-23 vaccine. A booster dose of Pneu-P-23 vaccine is not recommended. Refer to Table 3 and Table 4 for additional information.

Chronic lung disease, including asthma

People with chronic lung disease, including individuals who required medical care for asthma in the past 12 months, should receive pneumococcal vaccine. Children less than 18 years of age should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine. Adults should receive Pneu-P-23 vaccine. A booster dose of Pneu-P-23 vaccine is not recommended. Asthma control should be optimized before receipt of pneumococcal vaccine. Refer to Table 3 and Table 4 for additional information.

Chronic heart disease

Individuals with chronic heart disease should receive age appropriate pneumococcal vaccines. Children less than 18 years of age should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine. Adults should receive Pneu-P-23 vaccine. A booster dose of Pneu-P-23 vaccine is not recommended. Refer to Table 3 and Table 4 for additional information.

Chronic liver disease

Individuals with chronic liver disease, including hepatic cirrhosis due to any cause, should receive pneumococcal vaccine. Children less than 18 years of age should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine. Adults should receive Pneu-P-23 vaccine. A booster dose of Pneu-P-23 vaccine is recommended for people with chronic liver disease, including hepatic cirrhosis. Refer to Table 3, Table 4 and Booster doses and re-immunization for additional information.

Endocrine and metabolic diseases

People with diabetes mellitus should receive pneumococcal vaccine. Children less than 18 years of age should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine. Adults should receive Pneu-P-23 vaccine. A booster dose of Pneu-P-23 vaccine is not recommended. Refer to Table 3 and Table 4 for additional information.

Non-malignant hematologic disorders

Individuals with sickle cell disease or other hemoglobinopathies resulting in splenic dysfunction should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine, followed by a booster dose of Pneu-P-23 vaccine. Refer to Table 3, Table 4 and Booster doses and re-immunization for additional information.

Cochlear implants

Individuals with cochlear implants, including children and adults who are to receive implants, should receive pneumococcal vaccine. Children less than 18 years of age should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine. Adults should receive Pneu-P-23 vaccine. A booster dose of Pneu-P-23 vaccine is not recommended. Refer to Table 3 and Table 4 for additional information.

Immunocompromised persons

Pneu-C-13 vaccine and Pneu-P-23 vaccine are recommended for individuals with immunocompromising conditions resulting in high risk of IPD. Because immunologic abnormalities may decrease the protection provided by pneumococcal vaccines, immunocompromised individuals should be counselled regarding the risk of fulminant pneumococcal sepsis, which may occur despite immunization.

When considering immunization of an immunocompromised person with pneumococcal vaccines, consultation with the individual’s attending physician may be of assistance. 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 receive Pneu-C-13 vaccine and Pneu-P-23 vaccine, followed by a booster dose of Pneu-P-23 vaccine. Refer to Table 3, Table 4 and Booster doses and re-immunization for additional information.

Acquired (secondary) immunodeficiency

Malignant neoplasms, including leukemia and lymphoma

Individuals with malignant neoplasms, including leukemia and lymphoma and malignant solid tumours, should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine, followed by a booster dose of Pneu-P-23 vaccine. Refer to Table 3, Table 4 and Booster doses and re-immunization for additional information.

Hematopoietic stem cell transplantation (HSCT)

HSCT recipients are at increased risk of pneumococcal diseases and Pneu-C-13 vaccine and Pneu-P-23 vaccine are recommended. Regardless of age, pneumococcal vaccination should be started at 3 to 9 months after HSCT with 3 doses of Pneu-C-13 vaccine administered at least 4 weeks apart, followed by 1 dose of Pneu-P-23 vaccine 12 to 18 months post-transplant (6 to 12 months after the last dose of Pneu-C-13 vaccine) or when the HSCT recipient reaches 2 years of age. Because antibody response to pneumococcal vaccination is known to be poor in HSCT recipients, HSCT recipients over 2 years of age should receive a booster dose of Pneu-P-23 vaccine 1 year after the initial dose of Pneu-P-23 vaccine.

Solid organ or islet transplantation

If possible, individuals being considered for solid organ or islet transplantation should receive age-appropriate pneumococcal vaccines at least 2 weeks before transplantation. If pneumococcal vaccination was not completed prior to transplant, in general, it should not be re-initiated until at least 3 to 6 months post-transplantation. Pneu-C-13 vaccine and Pneu-P-23 vaccine are recommended, followed by a booster dose of Pneu-P-23 vaccine. Refer to Table 3, Table 4 and Booster doses and re-immunization for additional information.

Immunosuppressive therapy

Vaccination status for pneumococcal disease should be reviewed for immunocompetent persons who might be anticipating initiation of immunocompromising treatments, individuals on immunosuppressive therapy, and in those who have diseases that might lead to immunodeficiency. Although pneumococcal vaccines can be safely administered at any time before, during or after immunosuppressive therapy, vaccination should be timed so that optimal immunogenicity is achieved. People undergoing immunosuppressive therapy should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine, followed by a booster dose of Pneu-P-23 vaccine. Refer to Table 3, Table 4 and Booster doses and re-immunization for additional information.

HIV-infection

When possible, pneumococcal vaccines should be given early in the course of HIV infection; however, there is no contraindication to the use of pneumococcal vaccines at any time. People with HIV infection should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine, followed by a booster dose of Pneu-P-23 vaccine. Refer to Table 3, Table 4 and Booster doses and re-immunization for additional information.

Refer to Immunization of Immunocompromised Persons in Part 3 for additional general information about vaccination of people who are immunocompromised.

Travellers

The primary series of pneumococcal conjugate 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 information about vaccination of travellers.

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, as necessary. 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. In many countries outside of Canada, pneumococcal conjugate vaccine is in limited use. Refer to Immunization of Persons New to Canada in Part 3 for additional information about vaccination of people who are new to Canada.

Serologic Testing

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

Administration Practices

Dose

Each dose of pneumococcal vaccine is 0.5 mL.

Route of administration

Pneumococcal conjugate 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 about pre-vaccination and post-vaccination counselling, vaccine preparation and administration technique, and infection prevention and control.

Interchangeability of vaccines

For routine infant immunization, Pneu-C-13 vaccine is the product of choice. Infants who have started an immunization schedule with a vaccine containing fewer serotypes should have their vaccine series completed with Pneu-C-13 vaccine.

Refer to Principles of Vaccine Interchangeability in Part 1 for additional information about interchangeability of vaccines.

Concurrent administration of vaccines

Pneumococcal vaccines may be administered concomitantly with other vaccines, with the exception of a different formulation of pneumococcal vaccine (i.e. concomitant use of Pneu-C-13 and Pneu-P-23). There should be at least an 8 week interval between a dose of pneumococcal conjugate vaccine and a subsequent dose of Pneu-P-23 vaccine, and at least a 1 year interval between a dose of Pneu-P-23 vaccine and a subsequent dose of pneumococcal conjugate vaccine; refer to Immunocompromised persons for information regarding administration of pneumococcal vaccines to HSCT recipients. Different injection sites and separate needles and syringes must be used for concurrent parenteral injections.
Refer to Timing of Vaccine Administration in Part 1 for additional information about concurrent administration of vaccines.

Storage and Handling of Immunizing Agents

Refer to Storage and Handling of Immunizing Agents in Part 1 for storage and handling recommendations for pneumococcal vaccines.

Safety and Adverse Events

Common and local adverse events

Pneumococcal conjugate vaccine

Studies of Pneu-C-13 vaccine indicated that irritability; decreased appetite; increased or decreased sleep; and pain, swelling and redness at the injection site; after the toddler dose and in older children, are common side effects. Low grade fever occurred in 20% to 30% or more of vaccine recipients. In adults over 50 years of age, the most commonly reported side effects included 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 vaccine recipients 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 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 injection site 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 concentrations. Anaphylaxis following vaccination with pneumococcal vaccine may occur but is very rare.

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 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 Reporting Adverse Events Following Immunization (AEFI) in Canada and 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. Refer to Contents of Immunizing Agents Available for Use in Canada in Part 1 for a list of vaccines available for use in Canada and their contents.

In situations of suspected hypersensitivity or non-anaphylactic allergy 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 the safety of pneumococcal conjugate vaccine for children less than 6 weeks of age. There are limited safety and immunogenicity data available regarding the use of Pneu-C-13 vaccine in children and adults in groups at high risk for IPD due to an underlying medical condition.

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

Selected References

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