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Volume 31 • ACS-3
15 April 2005
An Advisory Committee Statement
National Advisory Committee on Immunization (NACI)*?
4 Pages - 205 KB
The National Advisory Committee on Immunization (NACI) provides the Public Health Agency of Canada with ongoing and timely medical, scientific, and public health advice relating to immunization. The Public Health Agency of 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 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 vaccine(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 the Public Health Agency of Canada?s Policy on Conflict of Interest, including yearly declaration of potential conflict of interest.
Since the publication on 15 October 2001, of the National Advisory Committee on Immunization Statement on Recommended Use of Meningococcal Vaccines(1) and on 1 September 2003, of the Supplementary Statement on Conjugate Meningococcal Vaccines(2), information has been published that details the experience in England regarding the effectiveness of the conjugated meningococcal C vaccines 4 years after their introduction(3). In addition, a third meningococcal C conjugate vaccine (Meningitec®, Wyeth) has been approved for use in Canada, and the dosage schedule has been changed for NeisVac-C® (ID Biomedical Corporation). Finally, advice has been requested about the safety and efficacy of concomitant administration of the meningococcal C conjugate vaccines with the 7-valent pneumococcal conjugate vaccine (Prevnar®, Wyeth). This update will address these four issues. For more detailed information related to the use of meningococcal vaccines and the epidemiology of meningococcal infections in Canada, readers are referred to the original statements(1,2) as well as the most recent enhanced surveillance report(4).
Recently, information has become available about the effectiveness of the meningococcal C conjugate vaccine program 4 years after its introduction in England(3). The vaccine was introduced into the routine schedule in November 1999 with the recommendation that all children receive three doses of the vaccine at ages 2, 3, and 4 months. All children from 5 months to 18 years of age were vaccinated as part of a catch-up campaign. This involved two doses at least 4 weeks apart for children aged 5 months to 1 year, and a single dose for children> 1 year of age. Assessment of the immunization program in its first year showed that vaccine effectiveness ranged from 87% to 98%. There was no significant difference in effectiveness between age groups. Specifically, effectiveness after 1 year was 93% for the infants who had received three doses of the vaccine given as part of the routine schedule. For children who were part of the catch-up program, the effectiveness after 1 year was 87% among infants vaccinated at 5 to 11 months of age, 88% among children vaccinated at 1 to 2 years, 98% among children vaccinated at 3 to 4 years, and 96% among adolescents. However, after 4 years of follow-up, the vaccine effectiveness among children who had received the routine infant immunization declined significantly to 66% and was lower than in the catch-up cohorts, in whom it remained high, ranging from 83% to 100%. Therefore, it would appear that while a dosage schedule of 2, 3, and 4 months provides adequate protection against infection for at least 1 year after the immunization series, it does not provide sustained protection in subsequent years compared with a schedule that includes administration of vaccine to children>= 5 months of age.
NACI recommends that infants receive at least one dose of their primary immunization series AFTER 5 months of age. Infants who complete their primary series before 5 months should receive an additional dose of vaccine. NACI also recommends that infants 4 to 11 months of age who have not previously received the vaccine should be immunized with two doses given at least 4 weeks apart. Regardless of the vaccine chosen, unimmunized children>= 12 months, adolescents, and adults require only a single 0.5 mL dose.
There are no published data related to the interchangeability of the three conjugated meningococcal C vaccines, but the vaccines have been used safely in this manner without a noticeable decrease in efficacy (Dr. David Salisbury, Principal Medical Officer, Communicable Disease Branch, Department of Health, London, UK: personal communication, 2003). When possible, the infant series should be completed with the same vaccine.
The safety of the meningococcal C conjugate vaccines has not been established during pregnancy. The decision to use these vaccines during pregnancy should weigh the risk of meningococcal group C illness with the theoretical risk of adverse effects to the fetus.
Meningitec® is composed of Neisseria meningitidis group C oligosaccharide (MnCO) conjugated to CRM197, a non-toxic mutant of diphtheria toxin. The vaccine is supplied as a sterile, ready-to-use single dose suspension in a glass vial for intramuscular injection. Each 0.5 mL dose contains 10 µg of Neisseria meningitidis group C oligosaccharide conjugated to approximately 15 µg of Corynebacterium diphtheriae CRM197 protein. The vaccine contains aluminum phosphate, sodium chloride, and sterile water. It does not contain thimerosal. A white deposit and a clear supernatant may become apparent with storage. The vaccine should be stored between 2° C and 8° C; it should not be frozen. The vaccine should be shaken well and inspected before use to ensure that it is a homogenous white suspension. It should not be administered if it cannot be resuspended, if there is particulate matter present, if the suspension is discoloured, or if the vaccine has been frozen.
For infants, three doses are recommended beginning at no earlier than 2 months of age and separated by at least 1 month. At least one dose of the primary immunization series should be given after 5 months of age. Infants aged 4 to 11 months who have not previously received the vaccine should be immunized with two doses given at least 4 weeks apart. For children> 12 months, adolescents, and adults, a single dose is required.
The recommended dosage schedule for children aged < 12 months receiving NeisVac-C® has been changed to two doses of vaccine, which should be administered at least 2 months apart; the first dose should not be administered before 2 months of age. NACI recommends that at least one dose of the primary immunization series be given after 5 months. Previous recommendations were that children < 12 months should receive three doses of NeisVac-C®, administered at least 4 weeks apart.
There have been no changes in the recommended dosage schedule for Menjugate®, Chiron Corporation. For infants, three doses are recommended beginning at no earlier than 2 months of age and given at least 4 weeks apart. At least one dose of the primary immunization series should be given after 5 months of age. Infants 4 to 11 months who have not previously received the vaccine should be immunized with two doses given at least 4 weeks apart. For persons> 12 months a single dose is required.
There are no published data detailing the effect on antibody production and protection against disease of simultaneous administration of the conjugated pneumococcal and meningococcal C vaccines currently licensed in Canada. Anecdotally, the vaccines have been administered simultaneously without identification of any increase in the incidence of adverse events. The two vaccines must be given using separate syringes and at separate sites. Currently, there is no information indicating any adverse effect on the efficacy of either vaccine if given in this manner. Practitioners should weigh the benefits of administering the two vaccines at the same time (decreased missed opportunities for immunization and earlier protection from vaccine-preventable disease) with the potential risks of decreased efficacy of one or the other vaccine with co-administration and the need to administer the vaccines using two injections at one health care visit. Research should be conducted to assess the efficacy of simultaneous administration of these two vaccines.
National Advisory Committee on Immunization. Statement on recommended use of meningococcal vaccines. CCDR 2001;27(ACS-6):2-36.
National Advisory Committee on Immunization. Supplementary statement on conjugate meningococcal vaccines. CCDR 2003;29(ACS-6):10-11.
Trotter CL, Andrews NJ, Kaczmarski EB et al. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet 2004;364:365-7.
Squires SG, Deeks SL, Tsang RSW. Enhanced surveillance of invasive meningococcal disease in Canada, 1 January, 1999, through 31 December, 2001. CCDR 2004;30(3):17-28.
*Members: Dr. M. Naus (Chairperson), Dr. T. Tam (Executive Secretary), Dr. I. Bowmer, Dr. S. Dobson, Dr. B. Duval, 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. Salvadori (AMMI Canada), 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. J. Embree with assistance from Dr. Shelley Deeks and approved by NACI.