Pneumococcal vaccines: Canadian Immunization Guide

For health professionals

• Previous page
• Part 4 table of contents
• Next page

Last partial content update: April 2025

This chapter was updated based on the following guidance from the National Advisory Committee on Immunization (NACI):

• November 2024: Recommendations on the use of pneumococcal vaccines in adults, including PNEU-C-21

This information is captured in the table of updates.

Last complete chapter revision: May 2024

On this page

• Key information
• Epidemiology
  • Table 1: Conditions resulting in increased risk of IPD
• Preparations authorized for use in Canada
  • Table 2: S. pneumoniae serotypes included in pneumococcal vaccines
• Immunogenicity, efficacy and effectiveness
• Recommendations for use
  • Children without medical, social, behavioral or environmental IPD risk factors (2 months to less than 18 years of age)
  • Table 3: Recommended schedules for Pneu-C-15 or Pneu-C-20 vaccine for children 2 months to less than 18 years of age without IPD risk factors, by pneumococcal conjugate vaccine history
  • Children with medical, social, behavioral or environmental IPD risk factors (2 months to less than 18 years of age)
  • Table 4: Recommended schedules for Pneu-C-20 vaccine for children 2 months to less than 18 years of age with medical, social, behavioral or environmental IPD risk factors, by pneumococcal conjugate vaccine history
  • Adults without medical, social, behavioral or environmental IPD risk factors (18 years of age and older)
  • Adults with medical, social, behavioral or environmental IPD (18 years of age and older)
  • Booster doses and re-immunization
  • Outbreak control
• Vaccination of specific populations
  • Persons with inadequate immunization records
  • Pregnancy and breastfeeding
  • Infants born prematurely
  • Residents of health care institutions
  • Persons with chronic diseases
  • Immunocompromised persons
  • Hematopoietic stem cell transplantation (HSCT)
  • Travellers
  • Persons new to Canada
• Serologic testing
• Administration practices
• Storage requirements
• Safety and adverse events
  • Common and very common adverse events
  • Uncommon, rare and very rare adverse events
  • Guidance on reporting adverse events following immunization (AEFI)
  • Contraindications and precautions
• Chapter revision process
• Acknowledgments
• Selected references

Key information

What

• Streptococcus pneumoniae infections are a major cause of illness and death worldwide.
• Invasive pneumococcal disease (IPD), which includes bacteremia and meningitis, is most common in the very young, older adults and persons at increased risk due to underlying medical, social, behavioral, or environmental risk factors.

Who

• Pneumococcal vaccines are recommended for routine immunization of infants, children and adults, as well as those at increased risk of IPD (Table 1).

How

• Pneu-C vaccine schedules vary by age, pneumococcal vaccine history and risk for IPD.
• Either Pneu-C-15 or Pneu-C-20 may be used for routine immunization of healthy infants and children less than 5 years of age.
• Adults 65 years of age and older, as well as adults under 65 years of age with risk factors for IPD (Table 1) should receive 1-dose of Pneu-C-20 or Pneu-C-21 vaccine.
• Pneu-C catch-up vaccine schedules aim to provide increased pneumococcal serotype coverage in individuals previously vaccinated with lower valent vaccines.

Why

• S. pneumoniae is a common cause of pneumonia and IPD.
• Severe infections such as IPD can lead to significant mortality and morbidity with lifelong complications.
• Vaccination is the most effective way to prevent IPD.

Epidemiology

Disease description

Infectious agent

The bacterium Streptococcus pneumoniae is the cause of invasive pneumococcal disease (IPD) and a common cause of respiratory infections including community acquired pneumonia (CAP) and acute otitis media (AOM). For additional information about S. pneumoniae, refer to the Pathogen Safety Data Sheet.

Reservoir

Humans carry S. pneumoniae in their nasopharynx.

Transmission

S. pneumoniae is transmitted by direct contact and respiratory droplets or indirect contact with respiratory secretions of infected or colonized persons. The incubation period for IPD 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, older adults, and groups at increased risk due to underlying medical, social, behavioral, or environmental conditions (Table 1). The incidence rate of IPD in pediatric populations under 19 years of age is significantly higher in northern Canada compared to the rest of Canada.

Seasonal and temporal patterns

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

Spectrum of clinical illness

Asymptomatic upper respiratory tract colonization with S. pneumoniae is common. Infection with S. pneumoniae may result in bronchitis, otitis media, sinusitis or invasive disease when S. pneumoniae invades normally sterile sites, such as the blood or central nervous system.

Bacteremia and meningitis are the most common manifestations of IPD in children 2 years of age and younger. The case-fatality rate of pneumococcal meningitis is 8% among children and 22% among adults. Permanent neurologic damage is common among survivors. Pneumococcal pneumonia with or without bacteremia is the most common presentation among adults and is a common complication following viral infections. The case fatality rate of bacteremic pneumococcal pneumonia is 5% to 7% and is higher among older adults and those with multiple co-morbidities.

Disease distribution

Worldwide, pneumococcal disease is a major cause of morbidity and mortality. In 2019, the World Health Organization (WHO) estimated that more than 700,000 deaths among children under 5 years of age were attributable to pneumococcal disease. In Canada, IPD is most common among the very young and adults 65 years of age and older. The serotype distribution of IPD cases varies by age group, risk factors and geographic region.

For additional information about IPD in Canada, including disease description and distribution, refer to the Public Health Agency of Canada 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 NACI Statements and Statement Updates.

Preparations authorized for use in Canada

Pneumococcal vaccines

Pneumococcal conjugate vaccines

• SYNFLORIX^® (pneumococcal 10-valent conjugate vaccine, non-typeable Haemophilus influenzae protein D, diphtheria or tetanus toxoid conjugates, adsorbed) GlaxoSmithKline Inc. (Pneu-C-10)
• Prevnar^®13 (pneumococcal 13-valent conjugate vaccine, diphtheria CRM₁₉₇ protein), Pfizer Canada ULC. (licensee) (Pneu-C-13)
• VAXNEUVANCE^® (pneumococcal 15-valent conjugate vaccine, CRM₁₉₇ protein, adsorbed), Merck Canada Inc. (Pneu-C-15)
• PREVNAR 20^™ (Pneumococcal 20-valent conjugate vaccine, diphtheria CRM₁₉₇ protein), Pfizer Canada ULC. (Pneu-C-20)
• CAPVAXIVE^™ (Pneumococcal 21-valent conjugate vaccine) Merck Canada Inc. (Pneu-C-21)

Refer to the product monograph available through Health Canada's Drug Product Database (DPD) for more information regarding the use of these vaccines.

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 vaccine

• PNEUMOVAX^®23 (pneumococcal polysaccharide 23-valent vaccine), Merck Canada Inc. (Pneu-P-23)

Preparations authorized for use in Canada may not be currently available for sale. Refer to Health Canada's Drug Product Database (DPD) for its drug status. Definitions of drug status can be found under DPD Terminology.

For complete prescribing information, consult the product leaflet or information contained within the product monograph available through Health Canada's DPD.

Refer to Contents of immunizing agents authorized for use in Canada in Part 1 for a list of vaccines and passive immunizing agents authorized for use in Canada and their contents.

Immunogenicity, efficacy and effectiveness

Immunogenicity

Pneumococcal conjugate vaccines

At one month following the completion of the recommended schedule, the majority of immunocompetent infants immunized with Pneu-C vaccines will develop antibodies that are protective against vaccine-contained antigens. The immunogenicity of lower valent pneumococcal conjugate vaccines (Pneu-C-7 and Pneu-C-13) has also been demonstrated in children with immunodeficiency. Higher valent pneumococcal conjugate vaccines (Pneu-C-15 and Pneu-C-20) have been authorized by Health Canada based on the demonstration of immunological non-inferiority to Pneu-C-13 for most of the shared vaccine serotypes. It is currently unknown how lower immune responses to some vaccine-contained antigens following immunization with Pneu-C-15 and Pneu-C-20 (compared to Pneu-C-13) may impact vaccine effectiveness, duration of protection, carriage, and herd immunity. In adults with and without risk factors for IPD, Pneu-C-21 vaccine produced similar immune responses as Pneu-C-20 for shared serotypes. Anamnestic responses against vaccine-contained antigens are induced upon boosting with all conjugate pneumococcal vaccines.

Pneumococcal polysaccharide vaccine

Pneumococcal polysaccharide vaccine is less immunogenic than pneumococcal conjugate vaccine. Following immunization with Pneu-P-23 vaccine, antibody concentrations begin to decline after 5 years in immunocompetent individuals.

Efficacy and effectiveness

Pneumococcal conjugate vaccines

In children less than 5 years of age, the effectiveness of Pneu-C-13 following the completion of recommended schedules has been reported to range from 67% to 96% against IPD (vaccine serotypes) and 20% to 77% against pneumonia. There are currently no efficacy or effectiveness data available for Pneu-C-15 or Pneu-C-20 vaccines.

Recommendations for use

Children without medical, social, behavioral or environmental IPD risk factors (2 months to less than 18 years of age)

Routine and delayed infant schedule (children less than 12 months of age)

The routine immunization of infants 2 to less than 7 months of age without risk factors (Table 1), should follow the relevant provincial or territorial schedule administering Pneu-C-15 or Pneu-C-20 vaccine 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. The minimum interval between doses is 8 weeks. Immunization programs for infants that use a 3-dose schedule should offer the third dose at 12 months of age to allow for earlier protection.

Unimmunized infants presenting for vaccination at 7 to less than 12 months of age should receive 2 doses of Pneu-C-15 or Pneu-C-20 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.

Infants with an interrupted or incomplete schedule who are less than 12 months of age when they re-present should complete their immunization schedule as if no interruption had occurred.

During the transition to Pneu-C-15 or Pneu-C-20 immunization programs, if Pneu-C-15 or Pneu-C-20 are unavailable or inaccessible, any pneumococcal conjugate vaccine available may be used to complete the recommended vaccine series. Table 3 summarizes the recommended schedules for Pneu-C-15 or Pneu-C-20 vaccine for infants by pneumococcal conjugate vaccination history.

Children without risk factors who have completed a full series with Pneu-C-13 do not need an additional dose of Pneu-C-15 or Pneu-C-20.

Catch-up schedules (children 12 months to less than 18 years of age)

The number of doses required to complete a pneumococcal conjugate vaccination series for children with interrupted or incomplete schedules varies with the age of the child. Children 12 to less than 60 months of age with interrupted or incomplete vaccination schedules should be assessed to determine the number of doses required to complete the series. Immunization with pneumococcal vaccine is not recommended for children 5 years of age and older without risk factors for IPD. Table 3 summarizes the recommended schedules for Pneu-C-15 or Pneu-C-20 vaccine for children by pneumococcal conjugate vaccination history.

Table 3: Recommended schedules for Pneu-C-15 or Pneu-C-20 vaccine for children 2 months to less than 18 years of age without IPD risk factors, by pneumococcal conjugate vaccine history

Age at presentation for immunizationFootnote 1	Number of pneumococcal conjugate vaccine doses previously received	Recommended schedule for Pneu-C-15 or Pneu-C-20Footnote 2
2 to less than 7 months	0 doses	2 or 3 doses + 1 dose at 12 to 15 months of ageFootnote 3
	1 dose	1 or 2 doses + 1 dose at 12 to 15 months of ageFootnote 3
	2 doses	0 or 1 dose + 1 dose at 12 to 15 months of ageFootnote 3
7 to less than 12 months	0 doses	2 doses + 1 dose at 12 to 15 months of age
	1 dose	1 dose + 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	0 doses	2 doses
	1 dose at less than 12 months of age
	2 or more doses at less than 12 months of age	1 dose
	0 or 1 dose at less than 12 months of age AND 1 dose at 12 months of age or older
24 to less than 60 months (5 years)	0 doses or incomplete vaccination schedule	1 dose
5 to less than 18 years	0 doses	0 doses
Footnotes Footnote t3-1 Follow relevant provincial or territorial schedule. Return to footnote 1 referrer Footnote t3-2 The minimum interval between doses of pneumococcal conjugate vaccine is 8 weeks. Return to footnote 2 referrer Footnote t3-3 Immunization programs for children using a 3-dose schedule should offer the third dose at 12 months of age to allow for early complete protection. Return to footnote 3 referrer

Children with additional medical, social, behavioral or environmental IPD risk factors (2 months to less than 18 years of age)

Routine and delayed infant schedule (children less than 12 months of age)

Infants with risk factors for IPD (Table 1) who are 2 to less than 7 months of age should receive the Pneu-C-20 vaccine administered using a 4-dose schedule at 2 months, 4 months and 6 months, followed by a dose at 12 to 15 months of age. The minimum interval between doses is 8 weeks. Unimmunized infants at increased risk of IPD presenting for vaccination at 7 to less than 12 months of age should receive 2 doses of Pneu-C-20 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. Infants with an interrupted or incomplete schedule who are less than 12 months of age when they re-present should complete their immunization schedule as if no interruption had occurred.

Infants who have started their pneumococcal vaccine series with Pneu-C-13 or Pneu-C-15 should receive Pneu-C-20 vaccine to complete their vaccine series. Table 4 summarizes the recommended schedules for Pneu-C-20 vaccine for infants at increased risk of IPD by pneumococcal conjugate vaccination history.

Refer to Immunocompromised persons for additional information about the immunization of hematopoietic stem cell transplant (HSCT) recipients.

Catch-up schedules (children 12 months to less than 18 years of age)

The number of Pneu-C-20 doses required to complete a vaccination series for children with interrupted or incomplete schedules varies with the age of the child. Children 12 months of age and older with interrupted or incomplete vaccination schedules should be assessed to determine the number of Pneu-C-20 doses required to complete the series. Table 4 summarizes the recommended schedules for Pneu-C-20 vaccine for infants and children at increased risk of IPD by pneumococcal conjugate vaccination history.

All children who are at increased risk of IPD and have previously completed their recommended immunization schedule with Pneu-C-13 or Pneu-C-15 should receive 1 dose of Pneu-C-20. Pneu-C-20 should be provided at a minimum interval of 8 weeks since the last dose of Pneu-C-13 or Pneu-C-15, or at least 1 year since a dose of Pneu-P-23. Children at increased risk of IPD who have completed a vaccine series appropriate for their age that includes at least one dose of Pneu-C-20 after 12 months of age, do not require any additional doses of Pneu-C-20 or Pneu-P-23.

Table 4: Recommended schedules for Pneu-C-20 vaccine for children 2 months to less than 18 years of age with medical, social, behavioral or environmental IPD risk factors, by pneumococcal conjugate vaccine history^{Footnote 1Footnote 2}

Age at presentation for immunization	Number of pneumococcal conjugate vaccine doses previously received	Recommended schedule for Pneu-C-20Footnote 3
2 to less than 7 months	0 doses	3 doses + 1 dose at 12 to 15 months of age
	1 dose	2 doses + 1 dose at 12 to 15 months of age
	2 doses	1 dose + 1 dose at 12 to 15 months of age
7 to less than 12 months	0 doses	2 doses + 1 dose at 12 to 15 months of age
	1 dose	1 dose + 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	0 doses	2 doses
	1 dose at less than 12 months of age
	2 or more doses at less than 12 months of age	1 dose
	0 or 1 dose at less than 12 months of age AND 1 dose at 12 months of age or older
24 to less than 60 months (5 years)	0 doses of Pneu-C-20	1 dose
5 to less than 18 years	0 doses of Pneu-C-20	1 dose
Footnotes Footnote t4-1 Refer to Immunocompromised persons for information about immunization of HSCT recipients. Return to footnote 1 referrer Footnote t4-2 All children who previously completed their recommended immunization schedule but have not received Pneu-C-20 after 12 months of age should receive 1 dose of Pneu-C-20. Return to footnote 2 referrer Footnote t4-3 The minimum interval between doses of pneumococcal conjugate vaccine is 8 weeks. Return to footnote 3 referrer

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.

Adults without medical, social, behavioral or environmental IPD risk factors (18 years of age and older)

One (1) dose of Pneu-C-20 or Pneu-C-21 should be offered to all adults 65 years of age regardless of their pneumococcal vaccination status with Pneu-C-13, Pneu-C-15 or Pneu-P-23. In previously immunized adults 65 years of age and older, Pneu-C-20 or Pneu-C-21 should be provided at least 1 year from either the last dose of Pneu-C-13, Pneu-C-15 or Pneu-P-23. An interval of 1 year between pneumococcal conjugate vaccines is meant to expand serotype coverage offered by immunization in a time-effective manner. However, a minimal interval as short as 8 weeks may be considered in those who might be anticipating initiation of immunosuppressive treatments or who have diseases that might lead to immunodeficiency.

Immunization with Pneu-C-15 and Pneu-P-23 should be used only when Pneu-C-20 or Pneu-C-21 are unavailable or inaccessible. In those cases, Pneu-C-15 should be provided first, followed by Pneu-P-23 vaccine at least 8 weeks later.

Adults with medical, social, behavioral or environmental IPD risk factors (18 years of age and older)

Regardless of their pneumococcal vaccination history with Pneu-C-13, Pneu-C-15 or Pneu-P-23, one dose of Pneu-C-20 or Pneu-C-21 is recommended for adults with IPD risk factors (Table 1). The recommended interval between Pneu-P-23 and either Pneu-C-20 or Pneu-C-21 is 1 year, but an interval as short as 8 weeks may be considered in those who might be anticipating initiation of immunosuppressive treatments or who have diseases that might lead to immunodeficiency. The minimum interval between pneumococcal conjugate vaccines is 8 weeks.

For vaccine-naïve adults who are recommended pneumococcal vaccination, Pneu-C-15 followed by Pneu-P-23 may be offered as an alternative to Pneu-C-20 or Pneu-C-21 only when these vaccines are unavailable or inaccessible. In those cases, Pneu-C-15 should be provided first, followed by Pneu-P-23 vaccine at least 8 weeks later.

For additional information on the immunization of HSCT recipients, refer to the Hematopoietic stem cell transplantation (HSCT) section. 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

Re-immunization using a same-valency conjugate vaccine following the completion of an age-appropriate schedule is not currently recommended since it is not known whether additional doses will confer an added benefit (e.g., children at increased risk of IPD who have completed a vaccine series that includes at least one dose of Pneu-C-20 after 12 months of age, do not require further doses; adults for whom Pneu-C-20 or Pneu-C-21 is indicated should only receive one dose of either one of the vaccines).

Children who have risk factors for IPD and have never received Pneu-C-20, should receive one dose of Pneu-C-20. For children that have previously been immunized with Pneu-C-13, Pneu-C-15 or Pneu-P-23 and for whom Pneu-C-20 is indicated, the minimal interval is 1 year since Pneu-P-23 and 8 weeks since a Pneu-C vaccine. Children at increased risk of IPD who have received at least one dose of Pneu-C-20 after 12 months of age, do not require Pneu-P-23.

For immunization guidance pertaining to HSCT recipients, including booster doses are re-immunization, refer to the Hematopoietic stem cell transplantation (HSCT) section below.

Outbreak control

During outbreaks of pneumococcal infection due to Pneu-C vaccine serotypes, immunization with Pneu-C vaccine should be provided according to the recommended schedule to children who have not been adequately immunized with Pneu-C vaccine. Pneu-P-23 or a Pneu-C 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; refer to Tables 3 and 4. 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, women and individuals who are pregnant or breastfeeding can be vaccinated with pneumococcal vaccines, as there is no evidence to suggest a risk to the infant, fetus or to the pregnancy from immunization. Refer to Immunization in pregnancy and breastfeeding in Part 3 for additional information about vaccination of women and individuals who are pregnant or breastfeeding.

Infants born prematurely

Prematurity is associated with a risk of chronic lung disease which can increase the risk of IPD. Premature infants in stable clinical condition should be immunized with Pneu-C-15 or Pneu-C-20 vaccine at the same chronological age and according to the same schedule as full-term infants. The first dose of pneumococcal conjugate vaccine should be given at 2 months of age, even if the infant is still in hospital. Children with chronic lung disease are at high risk of IPD and should be immunized using a 4-dose Pneu-C-20 vaccine schedule (at 2, 4, 6 and 12 to 15 months of age).

Refer to Immunization of infants born prematurely in Part 3 for additional information about vaccination of premature infants.

Residents of health care institutions

Regardless of their pneumococcal vaccination history with Pneu-C-13 or Pneu-P-23, individuals who live in communities or settings experiencing sustained high IPD rates, including those residing in long term care facilities (or children in residential care for complex medical needs), should receive pneumococcal vaccination. Adults should receive either Pneu-C-20 or Pneu-C-21. Children should receive Pneu-C-20.

Refer to Recommendations for use for information about pneumococcal vaccination of individuals at high 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. Refer to Table 4 and Booster doses and re-immunization for additional information, including situations when Pneu-C-20 and Pneu-C-15 are unavailable or inaccessible.

Persons with chronic diseases

Individuals with chronic medical conditions that lead to increased risk of IPD (listed in Table 1) are recommended to receive pneumococcal vaccination. Children with medical risk factors for IPD should receive Pneu-C-20 vaccine, and adults should receive either Pneu-C-20 or Pneu-C-21.

Vaccine-naïve infants and children with incomplete immunization schedules who have medical risk factors for IPD should receive Pneu-C-20 according to their age-appropriate schedule (Table 4).

Children who have chronic medical conditions and who previously completed their recommended immunization schedule with Pneu-C-13 or Pneu-C-15 should receive one dose of Pneu-C-20, at a minimum interval of 8 weeks since the last dose of Pneu-C vaccine and at least 1 year since a dose of Pneu-P-23.

In adults, one dose of either Pneu-C-20 or Pneu-C-21 should be provided regardless of pneumococcal vaccination history with Pneu-C-13, Pneu-C-15 or Pneu-P-23. The recommended interval between Pneu-P-23 and either of Pneu-C-20 or Pneu-C-21 is 1 year, but an interval as short as 8 weeks may be considered in those who might be anticipating initiation of immunosuppressive treatments or who have diseases that might lead to immunodeficiency. The minimum interval between Pneu-C vaccines is 8 weeks.

Refer to Children with medical, social, behavioral, or environmental IPD risk factors (2 months to less than 18 years of age), Adults with medical, social, behavioral, or environmental IPD risk factors (18 years of age and older), Table 4 and Booster doses and re-immunization for additional information.

Immunocompromised persons

Children with immunocompromising conditions should receive Pneu-C-20 and adults with immunocompromising conditions should receive either Pneu-C-20 or Pneu-C-21 vaccine. Immunocompromising conditions include:

• 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
• immunocompromising conditions or immunosuppressive therapy, within the last 2 years, including use of long-term corticosteroids, chemotherapy, radiation therapy, and immunosuppressive biologics
• HIV infection
• hematopoietic stem cell transplant (HSCT) recipient
• active malignant neoplasms, including leukemia and lymphoma
• candidates and recipients of solid organ or islet transplant (recipient)
• nephrotic syndrome

Vaccine-naïve infants and children with incomplete immunization should receive Pneu-C-20 according to their age-appropriate schedule (Table 4). Children who previously completed their recommended immunization schedule with Pneu-C-13 or Pneu-C-15 should receive one dose of Pneu-C-20 at a minimum interval of 8 weeks since the last dose of the pneumococcal vaccine. Adults previously immunized with Pneu-C-13, Pneu-C-15 or Pneu-P-23 should receive one dose of either Pneu-C-20 or Pneu-C-21 at least 8 weeks after the last dose of pneumococcal vaccine. In adults, when Pneu-C-20 or Pneu-C-21 is unavailable or inaccessible, the use of Pneu-C-15 in series with Pneu-P-23 can be considered.

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.

Refer to Children with medical, social, behavioral, or environmental IPD risk factors (2 months to less than 18 years of age), Adults with medical, social, behavioral, or environmental IPD risk factors (18 years of age and older), Table 4 and Booster doses and re-immunization for additional information about the use of pneumococcal vaccine in immunocompromised individuals. Refer to Immunization of immunocompromised persons in Part 3 for additional information about the immunization of immunocompromised individuals.

Hematopoietic stem cell transplantation (HSCT)

Pediatric HSCT recipients should be immunized with Pneu-C-20 vaccine. Adult HSCT recipients should be immunized with both Pneu-C-20 and Pneu-C-21. A primary series of 3 doses starting 3 to 9 months after transplant should be administered at least 4 weeks apart, followed by a booster dose 12 to 18 months post-transplant (6 to 12 months after the last dose). The specific timing of the Pneu-C vaccines for HSCT recipients should be determined in consultation with the recipient's transplant specialist.

Adult HSCT recipients will benefit from broader serotype coverage, therefore, the higher valency vaccine that was not given as part of the primary series can be offered as the booster dose at 12 to 18 months post-transplant (i.e., 3 doses of Pneu-C-20 + 1 dose of Pneu-C-21, or 3 doses of Pneu-C-21 + 1 dose of Pneu-C-20). In adults, the use of Pneu-C-15 with Pneu-P-23 may be considered only if Pneu-C-20 or Pneu-C-21 is unavailable or inaccessible.

Pediatric HSCT recipients who have completed their recommended immunization schedule with Pneu-C-13, Pneu-C-15 or Pneu-P-23 vaccine post-transplant should receive one dose of Pneu-C-20 at a minimum interval of 8 weeks since the last received dose of a pneumococcal vaccine. Adult HSCT recipients who have completed their recommended immunization schedule with Pneu-C-13, Pneu-C-15 or Pneu-P-23 vaccine post-transplant should receive one dose of Pneu-C-20 or Pneu-C-21 at a minimum interval of 8 weeks since the last received dose of a pneumococcal vaccine, followed at a minimum interval of 8 weeks by a dose of the other higher valency vaccine not given previously.

Refer to Children with medical, social, behavioral, or environmental IPD risk factors (2 months to less than 18 years of age), Adults with medical, social, behavioral, or environmental IPD risk factors (18 years of age and older), Table 4, Booster doses and re-immunization and Immunocompromised persons for additional information about the use and timing of pneumococcal vaccine in immunocompromised individuals including those initiating immunosuppressive therapy, solid organ or islet transplantation, and individuals with HIV infection.

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 common, 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 and route of administration

Each dose of pneumococcal vaccine is 0.5 mL.

Pneumococcal conjugate vaccine should be administered intramuscularly (IM). Pneu-P-23 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.

Concurrent administration with other vaccines

Pneumococcal vaccines may be administered concurrent with other vaccines, with the exception of a different formulation of pneumococcal vaccine. Different injection sites and separate needles and syringes must be used for concurrent parenteral injections.

Fever and shivering were more commonly reported in adults 50 years of age and older when Pneu-P-23 was co-administered with Shingrix.

Refer to Timing of vaccine administration in Part 1 for additional information about concurrent administration of vaccines.

Storage requirements

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 very common adverse events

Pneumococcal conjugate vaccine

Studies of pneumococcal conjugate vaccines 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% or more of vaccine recipients. In adults over 18 years of age, the most commonly reported side effects included pain at the injection site, fatigue, headache, arthralgia, and myalgia. There was little or no difference in the frequency of adverse events between the newer Pneu-C-vaccines, and Pneu-C-13.

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. Refer to Booster doses and re-immunization.

Uncommon, rare and very rare adverse events

Serious adverse events are rare following immunization and, in most cases, data are insufficient to determine a causal association. Very few vaccine-related serious adverse events were reported in clinical trials with any of the authorized pneumococcal vaccines. Anaphylaxis following vaccination with pneumococcal vaccine may occur but is very rare.

Guidance on reporting adverse events following immunization (AEFI)

To ensure the ongoing safety of vaccines in Canada, reporting of AEFIs by vaccine providers and other clinicians is critical, and in some jurisdictions, reporting is mandatory under the law. Vaccine providers are asked to report AEFIs through local public health officials and to check for specific AEFI reporting requirements in their province or territory. In general, any serious or unexpected adverse event felt to be temporally related to vaccination should be reported.

For additional information about AEFI reporting, please refer to Reporting adverse events following immunization (AEFI) in Canada. For general vaccine safety information, refer to Vaccine safety and pharmacovigilance in Part 2.

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 authorized for use in Canada in Part 1 for a list of vaccines 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.

Refer to Contraindications and precautions in Part 2 for additional information.

Chapter revision process

This chapter was updated to incorporate guidance on the use of the new 21 valent conjugate pneumococcal vaccine product.

Acknowledgments

This chapter was updated with the support of O Baclic, F Crane, E Wong, M Salvadori, C Jensen, and R Harrison.

The CIG gratefully acknowledges the contribution of N Haddad.

Selected references

• American Academy of Pediatrics. Kimberlin DW, Barnett ED, Lynfield R, et al. (editors). Red Book: 2021-2024 Report of the Committee on Infectious Diseases. 32nd ed. Elk Grove Village, IL: American Academy of Pediatrics; 2021.
• Bennett JE, Dolin R, Blaser MJ. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases 9th Ed. Philadelphia, PA: Elsevier Inc; 2020.
• Centers for Disease Control and Prevention (United States). Pneumococcal Disease, For Clinicians, Risk Factors. Accessed July 2023 from: https://www.cdc.gov/pneumococcal/clinicians/risk-factors.html
• GlaxoSmithKline Inc. Product Monograph - SYNFLORIX^™. November 09, 2023.
• Golden A, Griffith A, Demczuk W, et al. Invasive pneumococcal disease surveillance in Canada, 2020 Can Commun Dis Rep 2022;48(9):396-406. https://doi.org/10.14745/ccdr.v48i09a04 Accessed on December 13, 2022 at: Invasive pneumococcal disease surveillance in Canada, 2020, CCDR 48(9) - Canada.ca
• Merck Canada Inc. Product Monograph - PNEUMOVAX^®23 (pneumococcal polysaccharide 23-valent vaccine), (Pneu-P-23) September 07, 2023.
• Merck Canada Inc. Product Monograph - VAXNEUVANCE^® (pneumococcal 15-valent conjugate vaccine, CRM197 protein, adsorbed), (Pneu-C-15) July 07, 2023.
• National Advisory Committee on Immunization. An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI). Statement on the recommendations on the use of pneumococcal vaccines in adults, including PNEU-C-21. November 2024.
• National Advisory Committee on Immunization. An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI). Recommendations for public health programs on the use of pneumococcal vaccines in children, including the use of 15-valent and 20-valent conjugate vaccines. February 2024.
• National Advisory Committee on Immunization. An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI). Public health level recommendations on the use of pneumococcal vaccines in adults, including the use of 15-valent and 20-valent conjugate vaccines. February 2023. (Catalogue no. HP5-153/1-2023E-PDF)
• Pfizer Canada Inc. Product Monograph - Prevnar^® 13. August 08, 2019.
• Pfizer Canada ULC. Product Monograph - PREVNAR 20^™ (Pneumococcal 20-valent conjugate vaccine, diphtheria CRM197 protein), (Pneu-C-20). November 16, 2023.
• Public Health Agency of Canada. Invasive Pneumococcal Disease. For Health Professionals. Accessed July 2023 at https://www.canada.ca/en/public-health/services/immunization/vaccine-preventable-diseases/invasive-pneumococcal-disease/health-professionals.html
• World health Organization. Pneumococcal vaccination coverage. Accessed on July 14, 2023 at: https://immunizationdata.who.int/pages/coverage/pcv.html?CODE=SEAR&ANTIGEN=PCV3&YEAR=

• Previous page
• Part 4 table of contents
• Next page