ARCHIVED - Recommendations for use of Pneumococcal 23-Valent Polysaccharide Vaccine During Shortage
Canada Communicable Disease Report
Volume 30 • ACS-4
15 August 2004
An Advisory Committee Statement (ACS)
National Advisory Committee on Immunization (NACI)
4 Pages - 67 KB
The National Advisory Committee on Immunization (NACI) provides Health Canada with ongoing and timely medical, scientific, and public health advice relating to immunization. Health Canada acknowledges that the advice and recommendations set out in this statement are based upon the best current available scientific knowledge and is disseminating this document for information purposes. People administering or using the vaccine should also be aware of the contents of the relevant product monograph(s). Recommendations for use and other information set out herein may differ from that set out in the product monograph(s) of the Canadian licensed manufacturer(s) of the vaccine(s). Manufacturer(s) have sought approval of the vac-cine(s) and provided evidence as to its safety and efficacy only when it is used in accordance with the product monographs. NACI members and liaison members conduct themselves within the context of Health Canada's Policy on Conflict of Interest, including yearly declaration of potential conflict of interest.
Due to the temporary shortage of pneumococcal 23-valent polysaccharide vaccine in Canada, expected to last until approximately September 2004, the National Advisory Committee on Immunization (NACI) reviewed the options for stratifying risk groups for whom the vaccine is recommended to identify those whose immunization can be postponed until the supply is re-established. These recommendations take into account both the level of risk for invasive pneumococcal disease, as well as the likelihood of a protective immune response to the vaccine based on individual risk factors. While there are risk data to substantiate the selection of certain groups for priority vaccination, the committee's recommendations are also based on pragmatic issues such as the number of persons in the risk group, the ability of the health system to provide targeted vaccination to such persons and the potential for long-term missed vaccination associated with temporary disruption of a particular targeted program (i.e., long-term care facilities)1. For more detailed information related to the use of pneumococcal vaccines, readers are referred to the Canadian Immunization Guide and the statements on the recommended use of pneumococcal conjugate vaccine 2,3,4.
Persons at risk for pneumococcal disease
It is recognized that decisions related to supply and priorities are made at the provincial/territorial level, at which "gate keeping" and monitoring of usage also takes place.
Persons deemed at highest risk should be vaccinated as soon as possible and as vaccine supplies permit; the immunization of those at moderate-high and moderate risk can be postponed until supply is re-established. Re-immunization of those persons for whom this is indicated should be deferred until supply is re-established.
Persons at risk for pneumococcal disease
Highest risk (high attack rates; relatively small number of patients, potential for long-term missed vaccination)
Persons > = 2 years of age*, not previously immunized, in the following risk categories, especially those newly diagnosed and/or newly entering programs, should continue to receive high priority for vaccination:
- Sickle cell disease, congenital or acquired asplenia, or splenic dysfunction
- Dialysis - upon commencement of dialysis, nephrotic syndrome
- Multiple myeloma
- Residents of long-term care facilities
- Congenital immune deficiencies specifically IgG/IgG subclass and IgM deficiencies, Severe Combined Immunodefi-ciency (SCID) (Note: granulocyte and complement disorders are not at risk)
- Chronic cerebrospinal fluid leaks
- Induced immunosuppression for organ transplant or post-transplantation (bone marrow or stem cell and solid organ transplants)
- Persons receiving cochlear implants
Moderate-high risk (exact attack rates largely unknown; large numbers, many of whom do not present for vaccination, even when referred by their specialists)
Persons in the following risk categories should be vaccinated depending on supply of vaccine, but their immunization can generally be deferred until supply is re-established as their numbers are large:
- Persons >= 75 years of age
- Persons 65 to 74 years of age with the following chronic underlying illness:
- Chronic renal diseases - chronic renal insufficiency
- Chronic cardiac disease (particularly cyanotic congenital heart disease and cardiac failure)
- Chronic pulmonary disease (excluding asthma, except those treated with high-dose oral corticosteroid therapy)
- HIV infection/AIDS
- Chronic liver disease with or without ascites (cirrhosis, alcoholism)
- Diseases associated with immunosuppressive therapy or radiation therapy, including those with autoimmune diseases on high-dose steroids and chemotherapy agent(s)
- Malignancies - leukemia, Hodgkin's and non-Hodgkin's lymphomas, other malignancies
- Poorly controlled diabetes mellitus
Moderate risk (attack rates unknown or lower)
Persons in the following groups can generally be deferred for pneumococcal vaccination until the supply of vaccine is re-established:
- Healthy persons 65 to 74 years of age
- Persons 2 to 64 years of age with the chronic underlying illnesses identified in the preceding section, Moderate-high risk, second bullet*
*Note: Children from 2 to 5 years of age may receive pneumococcal poly-saccharide 23-valent vaccine, but the pneumococcal conjugate vaccine is generally preferred because of the age-dependent response. Polysaccharide vaccine may be used both as a booster dose in this age group and to increase the serotype coverage. Pneumococcal polysaccharide vaccine is not indicated for use in children < 2 years of age, in whom the pneumococcal conjugate vaccine should be used for routine prevention of invasive pneumococcal disease, commencing at 2 months of age.
McGeer A, Green K, Landry L, Talbot J, Goldenberg E, The Toronto Invasive Bacterial Diseases Network. Assessing the potential impact of vaccination programs on invasive pneumococcal disease: Data from population-based surveillance. Can J Infect Dis 1999;9(SuppA):24A-26A.
National Advisory Committee on Immunization. Statement on recommended use of pneumococcal conjugate vaccine. CCDR 2002;28(ACS-2):1-32.
National Advisory Committee on Immunization. Statement on recommended use of pneumococcal conjugate vaccine: Addendum. CCDR 2003;29(ACS-8):14-5.
Members: Dr. M. Naus (Chairperson), Dr. T. Tam (Executive Secretary), Dr. L. Bowmer, Dr. S. Dobson, Dr. J. Embree, Ms. A. Hanrahan, Dr. J. Langley, Dr. A. McGeer, Dr. P. Orr, Dr. M-N Primeau, Dr. B. Tan, Dr. B. Warshawsky, A. Zierler.
Liaison Representatives: S. Callery (CHICA), Dr. J. Carsley (CPHA), Dr. L. Chapman (CDC), Dr. A. Gruslin (SOGC), A. Honish (CNCI), Dr. B. Larke (CCMOH), Dr. B. Law (ACCA), Dr. A. McCarthy (CIDS), Dr. S. Rechner (CFPC), Dr. J. Salzman (CATMAT), Dr. L. Samson (CPS), Dr. D. Scheifele (CAIRE).
Ex-Officio Representatives: Dr. S. Deeks (CIDPC), Dr. A. Klein and Dr. H. Rode (BREC), Dr. M. Lem (FNIHB), Dr. M. Tepper (DND).
This statement was prepared by Dr. M. Naus, with assistance from Dr. S. Deeks and Dr. P. Varughese, and approved by NACI.
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