Source: http://healthycanadians.gc.ca/publications/healthy-living-vie-saine/4-canadian-immunization-guide-canadien-immunisation/index-eng.php?page=16
Timestamp: 2016-09-29 20:23:03
Document Index: 486532774

Matched Legal Cases: ['art 1', 'art 3', 'art 3', 'art 3', 'art 3', 'art\n1', 'art 2', 'art 2']

Updated: March 2015 Key Information
Table 1: Conditions resulting in high risk of IPD
Table 3: Recommended schedules for conjugate pneumococcal vaccine for children 2 months up to and including 17 years of age, by conjugate pneumococcal vaccination history
Routine infant immunization: administer three doses of Pneu-C-13 vaccine at minimum 8-week intervals beginning at 2 months of age, followed by a fourth dose at 12 to 15 months of age. For healthy infants, a three-dose schedule may be used, with doses at 2 months, 4 months, and 12 months of age.
12 to 23 months of age: administer two doses of Pneu-C-13 vaccine at least 8 weeks apart to children not previously vaccinated with a conjugate pneumococcal vaccine or who received only 1 dose before 12 months of age.
Healthy children who are of aboriginal origin or who attend group child care who have received age-appropriate pneumococcal conjugate vaccination but have not received Pneu-C-13 vaccine. Consider one dose of Pneu-C-13 vaccine for other healthy children.
Children at high risk of IPD who have received age-appropriate pneumococcal conjugate vaccination but have not received Pneu-C-13 vaccine.
Administer one dose of Pneu-P-23 vaccine after pneumococcal conjugate vaccine to children 24 months of age and older, adolescents and adults who are at high risk of IPD (refer to Table 1).
Administer one dose of Pneu-P-23 vaccine to all adults 65 years of age and older and to immunocompetent adults less than 65 years of age in long-term care facilities. Immunocompromised adults should be immunized with Pneu-C-13 and Pneu-P-23 as indicated in the preceding bullet.
Pneumococcal disease is caused by a bacterium, Streptococcus pneumoniae (S. pneumoniae or pneumococcus), of which 15 serotypes cause the majority of disease.
IPD is most common in the very young, the elderly and groups at high risk (refer to Table 1). Persons with a cochlear implant appear to be at increased risk of pneumococcal meningitis. Attendance at a child care center has been shown to increase the risk of IPD and acute otitis media (AOM) 2-fold to 3-fold among children under 5 years of age. Homeless populations have high rates of respiratory infections, including those caused by S. pneumoniae.
Pneumonia with secondary bacteremia, bacteremia, and meningitis are the most common IPDs. Bacteremia is the most common manifestation of IPD among children 2 years of age and younger. Bacteremic pneumococcal pneumonia is the most common presentation among adults and is a common complication following influenza. The case fatality rate of bacteremic pneumococcal pneumonia is 5% to 7% and is higher among elderly persons. Bacterial spread within the respiratory tract may result in AOM, sinusitis or recurrent bronchitis.
SYNFLORIX® (pneumococcal 10-valent conjugate vaccine, non-typeable Haemophilus influenzae protein D, diphtheria or tetanus toxoid conjugates adsorbed), GlaxoSmithKline Inc. (Pneu-C-10).
The tetanus, diphtheria and non-typeable Haemophilus influenzae carrier proteins used in conjugate pneumococcal vaccines do not confer protection against diphtheria, tetanus or Haemophilus influenzae type b disease.
Pneumococcal 23-valent polysaccharide vaccines
PNEUMOVAX®23 (pneumococcal 23-valent polysaccharide vaccine), Merck Canada Inc. (Pneu-P-23)
Pneu-C-7 vaccine is no longer available.
Icon checkmark
Serotype included in the vaccine
For complete prescribing information, consult the product leaflet or information contained within Health Canada's authorized product monograph available through the Drug Product Database. Refer to Contents of Immunizing Agents Available for Use in Canada in Part 1 for a list of all vaccines available for use in Canada and their contents.
In children, the efficacy of Pneu-C-7 vaccine is 89% to 97% against IPD serotypes whose antigens are contained in the vaccine. Pneu-C-7 vaccine provides a 54% reduction in AOM and a 20% reduction in tympanostomy tube placement due to vaccine serotypes. There are no efficacy data available for Pneu-C-13 vaccine for any indication and no efficacy data available for Pneu-C-10 vaccine for its primary indication against IPD. However, preliminary estimates from an unpublished case control study that was conducted in the US suggest 79% to 95% vaccine effectiveness among 2-59 month old children against Pneu-C-13 serotype IPD.
Pneu-P-23 vaccine efficacy is more than 80% against IPD among healthy young adults and ranges from 50% to 80% among the elderly and in high-risk groups. Effectiveness in preventing community-acquired pneumonia in the elderly remains a challenge. Immunogenicity and efficacy are decreased in certain groups at particularly high risk of pneumococcal infection, such as persons with renal failure, sickle cell anemia, or impaired immune responsiveness, including HIV infection. Following immunization with Pneu-P-23 vaccine, antibody levels decline after 5 to 10 years and decrease more rapidly in some groups than others. The duration of immunity is not known.
Infants immunized with Pneu-C-7 vaccine develop a 3.4-fold to 20-fold increase in serum antibodies against vaccine serotypes. Anamnestic responses are induced upon boosting with either conjugate pneumococcal or Pneu-P-23 vaccines. The immunogenicity of Pneu-C-7 vaccine has been demonstrated in children with immunodeficiency.
New conjugate pneumococcal vaccines Pneu-C-10 and Pneu-C-13 were authorized based on identifying an immune response to all serotypes in the vaccine and demonstrating non-inferiority to each of the 7 serotypes common to the new vaccine and Pneu-C-7 vaccine. Studies on Pneu-C-10 vaccine demonstrated an antibody response to all 10 serotypes. Studies on Pneu-C-13 vaccine demonstrated an antibody response to all 13 serotypes. There are no studies comparing the immunogenicity of Pneu-C-10 and Pneu-C-13 vaccines.
In healthy young adults, a single dose of pneumococcal polysaccharide vaccine stimulates an antibody response to each of the serotypes in the vaccine. Polysaccharide vaccine is less immunogenic in children than the conjugate pneumococcal vaccine.
Children with no pneumococcal vaccinations or interrupted or incomplete vaccination schedules should be assessed to determine the number of doses required to complete the series; children who have received complete, age-appropriate pneumococcal vaccination but have not received Pneu-C-13 vaccine should receive one dose of Pneu-C-13 vaccine (refer to Table 3). Children at high risk of IPD (refer to Table 1) should also receive one dose of Pneu-P-23 vaccine when they reach 24 months of age.
Children (24 to 35 months of age)
Children at high risk of IPD (refer to Table 1) should also receive one dose of Pneu-P-23 vaccine, at least 8 weeks after Pneu-C-13 vaccine.
Children (36 to 59 months of age)
Healthy children who have received age-appropriate pneumococcal vaccination but have not received Pneu-C-13 vaccine and who are of aboriginal origin or who attend group child care.
Children at high risk of IPD (refer to Table 1) who have received age-appropriate pneumococcal vaccination but have not received Pneu-C-13 vaccine.
Children with no or incomplete vaccination schedules with any conjugate pneumococcal vaccine product (refer to Table 3).
Healthy children and adolescents in this age group do not need pneumococcal vaccine.
Pneu-P-23, Pneu-C-13 or both vaccines are recommended for pregnant women who are at high risk of IPD (refer to Recommendations for Use - Adults). There is no evidence to suggest a risk to the fetus or to the pregnancy from maternal immunization with inactivated vaccines. Women who are breastfeeding can be vaccinated with Pneu-P-23 or Pneu-C-13 vaccine. Refer to Immunization in Pregnancy and Breastfeeding in Part 3 for additional general information.
Refer to Immunization of Patients in Health Care Institutions in Part 3 for additional general information.
Conjugate pneumococcal vaccine (Pneu-C-13) followed by polysaccharide pneumococcal vaccine (Pneu-P-23) is recommended for individuals aged 2 years and over with immunocompromising conditions due to underlying disease or therapy (refer to Table 1). Immunologic abnormalities may decrease the protection provided by either type of pneumococcal vaccine and those at highest risk should be counselled regarding the risk of fulminant pneumococcal sepsis, which may occur despite immunization. When considering immunization of an immunocompromised person, consultation with the individual's attending physicians may be of assistance, in addition to the guidance provided below. For complex cases, referral to a physician with expertise in immunization or immunodeficiency is advised.
Individuals with congenital immunodeficiencies involving any part of the immune system should be immunized against pneumococcal disease. Both Pneu-C-13 and Pneu-P-23 vaccines are recommended along with a single re-immunization with Pneu-P-23 (refer to Table 3 and Table 4).
Hematopoietic stem cell transplantation (HSCT-autologous or allogeneic)
HSCT are at increased risk of pneumococcal diseases and pneumococcal vaccine is recommended for all persons. Regardless of age, pneumococcal vaccination should be started at 3 to 9 months after HSCT with three doses of Pneu-C-13 vaccine provided at least 4 weeks apart, followed by a dose of Pneu-P-23 vaccine 6 to 12 months later or when recipient reaches age 2 years. Because antibody response to pneumococcal vaccination is known to be poor in these persons, some experts recommend that all transplant recipients over 2 years of age receive a booster dose of Pneu-P-23 vaccine 1 year after their initial Pneu-P-23 immunization.
If possible, individuals being considered for solid organ transplantation should receive age-appropriate pneumococcal vaccines at least 2 weeks before transplantation. If the vaccination was not completed prior to transplant, in general, it should not be re-initiated until at least 3 to 6 months after transplantation. Both Pneu-C-13 and Pneu-P-23 vaccines are recommended along with a single re-immunization with Pneu-P-23 (refer to Table 3 and Table 4).
Immunocompromising therapy
If immunocompromising therapy cannot be stopped, pneumococcal vaccine should be given when the person is least immunosuppressed. Both Pneu-C-13 and Pneu-P-23 vaccines are recommended along with a single re-immunization with Pneu-P-23 (refer to Table 3 and Table 4).
When possible, pneumococcal vaccine should be given early in the course of HIV infection; however, there is no contraindication to the use of pneumococcal vaccines at any time. Both Pneu-C-13 and Pneu-P-23 vaccines are recommended along with a single re-immunization with Pneu-P-23 (refer to Table 3 and Table 4). Refer to Booster doses and re-immunization for reason and schedule for re-vaccination. Refer to Immunization of Immunocompromised Persons in Part 3 for additional general information.
Hyposplenic or asplenic individuals should receive pneumococcal vaccine, as they are at risk of serious pneumococcal infections. When elective splenectomy is planned, all recommended vaccines should ideally be administered at least 2 weeks before surgery. In the case of an emergency splenectomy, vaccines should be given 2 weeks after surgery or before discharge, particularly if it is suspected that the person might not return for vaccination after discharge. Both Pneu-C-13 and Pneu-P-23 vaccines are recommended, along with a single re-immunization with Pneu-P-23 (refer to Table 3 and Table 4).
Refer to Immunization of Persons New to Canada in Part 3 for additional general information.
During outbreaks of pneumococcal infection due to Pneu-C-13 vaccine serotypes, immunization with Pneu-C-13 vaccine is recommended for children who have not previously received adequate vaccination with Pneu-C-13. Pneu-P-23 vaccine has also been used to control outbreaks of pneumococcal infection due to Pneu-P-23 vaccine serotypes in adults. Pneu-C-10 or Pneu-13 vaccine can be used in adults if the serotype of the outbreak is prevented by the vaccine.
Children who are at high risk of IPD should also receive one dose of Pneu-P-23 vaccine at 24 months of age with possible re-immunization depending on the condition (refer to Booster doses and re-immunization). Refer to Table 3 and Recommendations for Use.
Return to footnote Ʊ referrer
2-6 monthsTable 3 - Footnote †, Table 3 - Footnote **
If of aboriginal origin or attending group child care, 1 dose
All other children, consider 1 dose
60 months - 17 years, high risk of IPDTable 3 - Footnote ¥ 0 dose Pneu-C-13
Immunocompetent adults 18-64 years of age at high risk of IPD (refer to Table 1)
Pneu-P-23Table 4 - Footnote *
1 dose of Pneu-C-13Table 4 - Footnote **
1 dose of Pneu-P-23 at least 8 weeks after Pneu-C-13
a single re-immunization with Pneu-P-23 recommended 5 years later
3 doses of Pneu-C-13 starting 3-9 months after transplant, administered at least 4 weeks apart
1 dose of Pneu-P-23 12 to 18 months post transplant (6 to 12 months after the last dose of Pneu-C-13)
a single re-immunization with Pneu-P-23 recommended as early as 1 year later by some experts
Re-immunization with conjugate pneumococcal vaccine after age and risk appropriate childhood vaccination is not necessary.
Immunity induced by Pneu-P-23 vaccine decreases over time. Routine re-immunization of healthy individuals who have been vaccinated with Pneu-P-23 vaccine is not recommended. However, re-immunization is recommended for those of any age at highest risk of IPD, including those with: functional or anatomic asplenia or sickle cell disease; hepatic cirrhosis; chronic renal failure; nephrotic syndrome; HIV infection; and immunosuppression related to disease or therapy. For solid organ transplant recipients, there is evidence that antibody titers decline after 3 years. Experience with re-immunization after solid organ transplant is limited.
If re-immunization is carried out, a single re-immunization after 5 years is recommended. Because there are insufficient data to recommend repeated administration of Pneu-P-23 vaccine, re-vaccination following a second dose is not routinely recommended.
Individuals who have previously received Pneu-P-23 vaccine and who require re-immunization following immunization with Pneu-C-13 vaccine, should receive Pneu-P-23 no sooner than 8 weeks after Pneu-C-13 vaccine and no sooner than 5 years after the initial dose of Pneu-P-23.
All pneumococcal vaccines should be stored in a refrigerator at +2°C to +8°C. Do not freeze.
Conjugate pneumococcal vaccine may be administered concomitantly with routine childhood vaccines at different injection sites using separate needles and syringes.
Conjugate pneumococcal vaccine and Pneu-P-23 vaccine should be administered at least 8 weeks apart. However, for adults with immunocompromising conditions (except HSCT), Pneu-C-13 dose should be administered at least one year after any previous dose of Pneu-P-23. Pneumococcal 23-valent polysaccharide vaccine and HZ vaccine may be administered together.
Serious adverse events are rare following immunization and, in most cases, data are insufficient to determine a causal association. Few serious adverse events were reported in clinical trials with any of the pneumococcal vaccines, and consisted mainly of reports of afebrile and febrile seizure. Arthus-like reactions (causing a local vasculitis from deposition of immune complexes) are very rare and mainly occur in persons with high initial pneumococcal antibody levels. Anaphylaxis following vaccination with pneumococcal vaccine may occur but is very rare. Refer to Vaccine Safety in Part 2 for additional general information.
Vaccine providers are asked to report, through local public health officials, any serious or unexpected adverse event felt to be temporally related to vaccination. An unexpected AEFI is an event that is not listed in available product information but may be due to the immunization, or a change in the frequency of a known AEFI. Refer to User Guide to completion and submission of the AEFI reports or consult Vaccine Safety in Part 2 for additional information about AEFI reporting.
Centers for Disease Control and Prevention. Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of invasive pneumococcal disease - United States, 1998-2003. MMWR Morb Mortal Wkly Rep 2005;54(36):893-7.
National Advisory Committee on Immunization. An Advisory Committee Statement (ACS). National Advisory Committee on Immunization (NACI): Statement on the Use of Conjugate
Pneumococcal Vaccine - 13 Valent in Adults (Pneu-C-13). Can Commun Dis Rep. 2013:39(ACS-5).
Pfizer Canada Inc. Product Monograph - Prevnar®13. October 2010.
Sanofi Pasteur Ltd. Product Monograph - PNEUMO 23®. July 2008.
Tseng HF, Smith N, Sy LS et al. Evaluation of the incidence of herpes zoster after concomitant administration of zoster vaccine and polysaccharide pneumococcal vaccine. Vaccine 2011; 29:3628-32.
World Health Organization. Pneumococcal conjugate vaccine for childhood immunization - WHO position paper. Wkly Epidemiol Rec 2007; 12(83): 93-104.
World Health Organization. 23-valent pneumococcal polysaccharide vaccine - WHO position paper. Wkly Epidemiol Rec 2008; 42(83): 373-84.