Pneumococcal vaccines: Canadian Immunization Guide

For health professionals

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This information is captured in the Table of Updates.

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 or environmental invasive pneumococcal disease 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 or environmental invasive pneumococcal disease (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 at increased risk of invasive pneumococcal disease, by pneumococcal conjugate vaccine history
  • Adults without medical or environmental invasive pneumococcal disease risk factors (18 years of age and older)
  • Adults with medical or environmental invasive pneumococcal disease (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
  • Travellers
  • Persons new to Canada
• Serologic Testing
• Administration Practices
• Storage and Handling of Immunizing Agents
• Safety and Adverse Events
  • Common and very common adverse events
  • Uncommon, rare and very rate adverse events
  • Guidance on reporting adverse events following immunization (AEFI)
  • Contraindications and precautions
• Chapter Revision Process and 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, the elderly and persons at increased risk due to underlying medical, environmental or living conditions.

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.
• Individuals at increased risk for IPD (Table 1) and adults 65 years of age and older are preferentially recommended the higher valent Pneu-C-20 vaccine.
• Pneu-C catch-up vaccine schedules aim to provide increased pneumococcal serotype coverage in individuals previously vaccinated with lower valent vaccines and in those whose schedule is incomplete for age.
• For adults, Pneu-C-15 followed by Pneu-P-23 may be offered as an alternative if Pneu-C-20 is unavailable or inaccessible.

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, the elderly, and groups at increased risk due to an underlying medical, environmental or living condition (Table 1). Susceptibility to S. pneumoniae infection and IPD is also increased in people who smoke, persons with alcohol use disorders, persons with substance use disorders (i.e., cocaine use and injection drug use) and people who are underhoused or experiencing homelessness who have high rates of respiratory infections, including those caused by S. pneumoniae. 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. Pneumococci cause 50% of all cases of bacterial meningitis. 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 elderly persons 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 aged less than 5 years were attributable to pneumococcal disease. In Canada, IPD is most common among the very young and adults 65 years of age and older.

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 previously published 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)

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)

Table 2: S. pneumoniae serotype antigens included in pneumococcal vaccines

Vaccine	Serotypes in pneumococcal vaccines
	1	4	6B	9V	14	18C	19F	23F	5	7F	3	6A	19A	22F	33F	8	10A	11A	12F	15B	2	9N	17F	20
PNEU-C-10											no data	no data	no data	no data	no data	no data	no data	no data	no data	no data	no data	no data	no data	no data
PNEU-C-13														no data	no data	no data	no data	no data	no data	no data	no data	no data	no data	no data
PNEU-C-15																no data	no data	no data	no data	no data	no data	no data	no data	no data
PNEU-C-20																					no data	no data	no data	no data
PNEU-P-23												no data

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. 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.

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 older adults and high-risk groups. Efficacy is decreased in certain groups such as persons with kidney failure, sickle cell anemia, or impaired immune responsiveness, including HIV infection.

Recommendations for Use

Children without medical 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 medical or environmental 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 early 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 in the province or territory 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 medical or environmental 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 medical or environmental 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 previously received pneumococcal conjugate vaccine doses	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 medical 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 at increased risk of IPD (Table 1) 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 age that includes at least one dose of Pneu-C-20 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 or environmental IPD risk factors, by pneumococcal conjugate vaccine history^{Footnote 1Footnote 2}

Age at presentation for immunization	Number of previously received pneumococcal conjugate vaccine doses	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 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. 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. Return to footnote 3 referrer

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

One dose of Pneu-C-20 should be offered to all adults 65 years of age regardless of their pneumococcal vaccination status with Pneu-C-13 or Pneu-P-23. In previously immunized adults 65 years of age and older, Pneu-C-20 should be provided at least 1 year from either the last Pneu-C-13 dose or the last Pneu-P-23 dose. However, a longer interval of 5 years between Pneu-P-23 and Pneu-C-20 may maximize the total duration of protection against pneumococcal infection by taking advantage of the estimated effectiveness duration of Pneu-P-23 and the boosting anticipated with Pneu-C-20. An interval of 1 year between Pneu-C-13 and Pneu-C-20 is meant to expand serotype coverage offered by Pneu-C-13 in a time-effective manner.

Immunization with Pneu-C-15 followed by Pneu-P-23 may be offered as an alternative to Pneu-C-20. Pneu-C-15 vaccine should be provided first, followed by Pneu-P-23 vaccine at least 8 weeks later. For adults 65 years of age and older who have received Pneu-P-23 alone, when Pneu-C-20 is not available, there may be benefit to offering immunization with Pneu-C-15 at least 1 years after the receipt of Pneu-P-23.

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

Regardless of their Pneu-C-13 or Pneu-P-23 vaccination status, one dose of Pneu-C-20 is recommended for all adults 65 years of age and older, and adults 18 to 64 years of age living with specific IPD risk factors (Table 1).

For vaccine-naïve adults in whom Pneu-C-20 is recommended, Pneu-C-15 followed by Pneu-P-23 may be offered as an alternative. For adults 65 years of age and older who have received Pneu-P-23 alone, there may be a benefit to offering Pneu-C-15 if Pneu-C-20 is not available.

While the recommended interval between Pneu-C-15 and Pneu-P-23 is 1 year, when a rapid completion of a vaccine series in vulnerable population is required, the recommended interval is 8 weeks. The minimum interval between Pneu-C-20 and Pneu-C-13 is 8 weeks.

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 do not require further doses; adults for whom Pneu-C-20 is indicated should only receive one dose of Pneu-C-20).

Children who have medical or environmental risk conditions 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 Pneu-C-13 or Pneu-C-15. Individuals at increased risk of IPD who have received at least one dose of Pneu-C-20, 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 hospitalized. 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 12-15 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 Pneu-C-13 or Pneu-P-23 vaccination status, all individuals who live in communities or settings experiencing sustained high IPD rates, including those residing in long term care facilities, should receive Pneu-C-20. Children who are in residential care for their complex medical needs should also receive Pneu-C-20 vaccine.

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

Chronic medical conditions that lead to increased risk of IPD are listed in Table 1. All children with chronic medical conditions that lead to increased risk for IPD should receive Pneu-C-20 vaccine.

Immunization with Pneu-C-20 is also recommended for:

• all adults with chronic kidney disease, chronic liver disease, conditions leading to splenic dysfunction (including sickle cell disease and other hemoglobinopathies, and congenital or acquired asplenia), chronic CSF leaks and cochlear implants (including those who are to receive implants)
• adults 50 years and older with other chronic medical conditions listed in Table 1.

Adults less than 50 years of age with chronic lung disease, chronic heart disease, diabetes mellitus and chronic neurologic conditions that impair clearance of oral secretions may be considered for vaccination with Pneu-C-15 or Pneu-C-20 at clinical discretion.

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

Children who have chronic medical or environmental 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-13 and at least 1 year since a dose of Pneu-P-23. In adults, the minimum interval between Pneu-C-13 and Pneu-C-20 is 8 weeks and between Pneu-P-23 and Pneu-C-20 is one year. In adults for whom Pneu-C-20 is indicated, when Pneu-C-20 is unavailable or inaccessible, the use of Pneu-C-15 in series with Pneu-P-23 can be considered.

Refer to Children at increased risk of IPD (2 months to less than 18 years of age), Adults at increased risk of IPD (18 years of age and older), Table 4 and Booster doses and re-immunization for additional information.

Immunocompromised persons

Individuals with immunocompromising conditions should receive Pneu-C-20 vaccine. These include adults and children with:

• 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;
• immunosuppression due to therapy, including use of long-term corticosteroids, chemotherapy, radiation therapy, and post-organ transplant therapy;
• HIV infection;
• hematopoietic stem cell transplant (recipient);
• malignant neoplasms, including leukemia and lymphoma;
• 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 Pneu-C and at least 1 year since a dose of Pneu-P-23. Adults previously immunized with Pneu-P-23 or Pneu-C-13 should receive Pneu-C-20 at least 8 weeks after Pneu-C-13 and at least one year after Pneu-P-23. In adults, when Pneu-C-20 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 at increased risk of IPD (2 months to less than 18 years of age), Adults at increased risk of IPD (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)

HSCT recipients should be immunized with Pneu-C-20 vaccine. The specific timing of Pneu-C-20 for HSCT recipients should be determined in consultation with the recipient's transplant specialist.

Pneumococcal vaccination should be started at 3 to 9 months after HSCT with 3 doses of Pneu-C-20 vaccine administered at least 4 weeks apart, followed by 1 dose of Pneu-C-20 vaccine 12 to 18 months post-transplant (6 to 12 months after the last dose of Pneu-C-20 vaccine) or when the HSCT recipient reaches 2 years of age.

In adults, the use of Pneu-C-15 with Pneu-P-23 may be considered if Pneu-C-20 is unavailable or inaccessible to ensure HSCT recipients receive optimal protection.

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

Refer to Children at increased risk of IPD (2 months to less than 18 years of age), Adults at increased risk of IPD (18 years of age and older), Table 4 and Booster doses and re-immunization 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 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.

Concurrent administration with other vaccines

Pneumococcal vaccines may be administered concurrent with other vaccines, with the exception of a different formulation of pneumococcal vaccine (i.e., concurrent use of pneumococcal conjugate and polysaccharide vaccines. 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 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 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 vaccines Pneu-C-15 and Pneu-C-20, 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. There are limited safety data available regarding the use of Pneu-C-15 and Pneu-C-20 vaccine in children and adults in groups at increased risk for IPD due to an underlying medical condition.

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

Chapter Revision Process and Acknowledgments

This chapter was updated to incorporate guidance on the use of new conjugate pneumococcal vaccine products, including the use of 15-valent and 20-valent conjugate vaccines.

This chapter was prepared with the support of O Baclic, F Crane, W Siu, R Pless, A Wierzbowski, KJ Hildebrand, A Haynes, and N Islam. CIG gratefully acknowledges the contribution of N Mohamed and M Salvadori.

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). 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=

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