An Advisory Committee Statement (ACS)
National Advisory Committee on Immunization (NACI)*

UPDATE ON HEPATITIS A VACCINE
(AVAXIM®, AVENTIS PASTEUR)

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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. Persons 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 only sought approval of the vaccine(s) and provided evidence as to its safety and efficacy when used in accordance with the product monographs.

The manufacturer of one of the hepatitis A vaccines licensed in Canada, (Avaxim^®, Aventis Pasteur) has provided revised information on the content of this vaccine. Each dose (0.5 mL) of Avaxim^® contains:

• HAV antigen units (as defined by the manufacturer)      160
• Aluminum hydroxide                                                              0.3 mg
• 2-phenoxyethanol                                                                   2.5 µg
• formaldehyde                                                                        12.5 µg
• medium 199, water for injection up to                               0.5 mL
• neomycin                                                                   trace amounts

This update is a revision of the Supplementary Statement on Hepatitis A Vaccine (ACS-4), published on 1 July, 2000.

* Members: Dr. V. Marchessault (Chairperson), Dr. J. Spika (Executive Secretary), J. Brousseau (Administrative Secretary), Dr. I. Bowmer, Dr. G. De Serres, Dr. S. Dobson, Dr. J. Embree, Dr. I. Gemmill, Dr. J. Langley, Dr. M. Naus, Dr. P. Orr, Dr. B. Ward, A. Zierler.

Liaison Representatives: S. Callery (CHICA), Dr. J. Carsley (CPHA), Dr. V. Lentini (DND),Dr. M. Douville-Fradet (ACE), Dr. T. Freeman (CFPC), Dr. R. Massé (CCMOH), Dr. J. Salzman (CATMAT), Dr. L. Samson, (CIDS), Dr. D. Scheifele (CAIRE), Dr. M. Wharton (CDC).

Ex-Officio Representatives: Dr. A. King (CIDPC), Dr. L. Palkonyay (BBR), Dr. P. Riben (MSB).

This statement was prepared by Dr. Ian Gemmilll and approved by NACI.

[Canada Communicable Disease Report]