Canada Communicable Disease Report
Vol. 27 (ACS-1)
15 January 2001

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

SUPPLEMENTARY STATEMENT ON INFLUENZA VACCINATION: CONTINUED USE OF FLUVIRAL^® INFLUENZA VACCINE IN THE 2000-2001 SEASON

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PREAMBLE

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

BACKGROUND

Since mid-October, 2000, Health Canada has received reports of 1,191 cases being referred to as oculo-respiratory syndrome (ORS) following influenza immunization. The syndrome is characterized by ocular symptoms (red eyes, ocular pruritus, ocular discharge, lid edema), respiratory symptoms (cough, sore throat, difficulty breathing, wheezing), facial edema, or a combination of these symptoms developing within 2 to 24 hours of influenza immunization. Approximately 80% of the reactions have occurred in healthy adults < 60 years of age and approximately 75% in females. There have been at least 10 cases reported in children < 9 years of age. Most of the reactions in children occurred after receipt of the first dose of vaccine. The majority of cases have resolved completely within 48 hours. The syndrome is generally mild and self-limited, although a few cases have required hospitalization. There have been no deaths in association with this syndrome. Close to 98% (1,166/1,191) of cases occurred following receipt of Fluviral^® produced by BioChem Pharma. All but one of the distributed lots of Fluviral^® have been implicated (the non-implicated lot was distributed in very small quantities). Twenty-five cases have occurred following receipt of Fluzone^® or Vaxigrip^®, both produced by Aventis Pasteur Limited. To date, about 13 million doses of influenza vaccine have been distributed: nine million of the Aventis Pasteur Limited products and four million of the Biochem Pharma product. Results from studies done in settings in which Fluviral^® was administered show that the incidence rate of the syndrome of red eyes in combination with respiratory symptoms ranges from 2% to 3%. In one cohort study, in which Fluviral^® was offered, it was found that the relative risk of developing such a syndrome was close to infinity because no cases of red eyes and respiratory symptoms were identified among unimmunized individuals (Dr. D. Skowronski, BC Centre for Disease Control, Vancouver: personal communication, 2001).

RECOMMENDATIONS

To reduce the morbidity and mortality associated with influenza, the impact of illness in our communities and the societal costs associated with seasonal influenza and its complications, immunization programs should continue as planned among those at high risk of influenza-related complications, those capable of transmitting influenza to individuals at high risk of complications from influenza, and those who provide essential community services. Influenza programs in otherwise healthy children and adults, who may also experience significant morbidity associated with influenza illness⁽¹⁾, should also continue as planned. The benefits of influenza immunization for all recommended recipients, including healthy adults and children⁽²⁾, greatly outweigh any risks associated with receipt of all influenza vaccines currently licensed for use in Canada.

Previously unimmunized children < 9 years of age require a second dose of influenza vaccine 4 weeks after receipt of the first dose. In view of the unknown effect of re-immunization with the current year’s preparation of Fluviral^®, it is recommended that these children preferentially receive Vaxigrip^® or Fluzone^®. However, should neither of these alternate vaccines be available when re-immunization is due, health-care providers should offer Fluviral^®, with additional informed consent pertaining to what is presently known about the ORS in children < 9 years of age.

Recommended recipients of influenza vaccine, including healthy adults and children >= 9 years of age, should continue to be offered Fluviral^®, with additional informed consent pertaining to what is presently known about the ORS in older children and adults. Since influenza immunization is voluntary, appropriate informed consent, reviewing the newly identified adverse reaction is essential.

REFERENCES

1. Kilbourne ED, Arden NH. Inactivated influenza. In: Plotkin SA, Orenstein WA, eds. Vaccines. Philadelphia: WB Saunders, 1999; 531-51.

2. National Advisory Committee on Immunization. Statement on influenza vaccination for the 2000-2001. CCDR 2000; 26(ACS-2):1-16.

^† This statement was prepared by Dr. A. King with the assistance of Dr. E. Galanis and approved by NACI.

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