Health Canada acting to alleviate confusion, concerns over H1N1 Special

Saying it is a part of Canada's good planning and preparedness for round two of the H1N1 virus, Health Canada confirmed Monday that it has started distributing the vaccine across Canada in anticipation of regulatory approval.

Two million doses were shipped across Canada Monday morning, and has said that approval of the vaccine is expected to be made this week. The doses were shipped out in order to make the vaccine available once approval was in place. Last week, Health Canada said it only had one million doses of vaccine available, and none for pregnant women and young children. At the same time, Health Canada said that the clinical tests were just being started. At a press teleconference Monday morning, Aglukkaq said the pre-distribution means the vaccination program can begin quickly once approval of the vaccine has been obtained. During the teleconference, Aglukkaq said it is normal to anticipate an increase in H1N1 cases, but at this time, Canada is only experiencing "low to moderate H1N1 levels." Aglukkaq later said that British Columbia and the North West Territories are experiencing a higher incidence of H1N1 than the rest of the country. This will not affect the distribution of the vaccine, said Dr. David Butler-Jones, Canada's Chief Public Health Officer, who also participated in the conference. If approved this week, the vaccine will be available a week earlier than Health Canada had scheduled. However, there still is concern because it takes apparently two weeks for the body to develop immunity after getting the flu shot, and the H1N1 outbreak is strong in British Columbia and growing in Ontario. A guide for British Columbia physicians states that the H1N1 vaccine is not expected to be available until mid-November, and this has not been updated as yet to reflect the distribution of the H1N1 vaccine or an earlier approval date. Dr. Butler-Jones clarified his advice for pregnant women. He said that because of the risks of serious complications caused by the virus, pregnant women in communities that are experiencing an outbreak of H1N1 should consult their doctors to decide on a course of action. He added that the risks to women from the virus far outweighed any risk from using the adjuvanted vaccine, which has fish oil, water and vitamin E added, so pregnant women should consider using the adjuvanted vaccine in that situation. Should any pregnant woman be experiencing flu-like symptoms, they should go to their doctor as soon as possible. None of the vaccines distributed Monday are non-adjuvanted, and Butler-Jones did not know when the non-adjuvanted vaccine would be available. Butler-Jones said that Canada was following the World Health Organization's (WHO) recommendations in the preparation of vaccines. In July, the WHO recommended that northern countries should complete production of seasonal flu vaccines before undertaking production of H1N1 vaccine, as the seasonal vaccine production would have been almost complete. Aglukkaq said "over 90% of first Nation communities have pandemic plans in place." Remote and isolated northern communities are designated as being at high risk, and those communities will receive vaccinations as soon as the vaccine has been approved. According to Health Canada, the vaccine approval process is as follows:

"... All vaccines intended for use by Canadians are subject to the provisions of the Food and Drugs Act and the Food and Drug Regulations. Prior to market authorization of a new vaccine, the manufacturer must file a submission with scientific and clinical evidence that demonstrates that the vaccine’s health benefits outweigh the risks and that the vaccine is effective and of suitable quality for Canadians. Leona Aglukkaq said Monday that the vaccines will not be used unless they have been deemed safe.

As part of the approval process, Health Canada experts conduct an on-site evaluation of the manufacturer’s facilities to assess the quality of the vaccine manufacturing process and to determine that the manufacturer is able to carry out the necessary quality controls for the vaccine. The manufacturer must also provide samples of at least three batches or “lots” of the vaccine for testing in Health Canada laboratories.

After Health Canada’s evaluation, if the conclusion is that the benefits of the vaccine outweigh its risks, then the vaccine is granted market authorization and can be sold in Canada. However the evaluation process for vaccines in Canada continues after authorization has been granted."

The WHO states that the process to create and approve a new influenza vaccine takes approximately five to six months. Aglukkaq said an H1N1 preparedness guide has been created and will be distributed, although copies can be found on Health Canada's website.