VACCINE FOR H1N1 FLU VIRUS

With a second, potentially more severe wave of the H1N1 flu virus expected to arrive in North America later this fall, the federal government and the provinces and territories have been working together in a collaborative and coordinated manner to deliver a safe and effective H1N1 flu vaccine. 

Protecting Canadians against the H1N1 flu virus:

• A vaccine is any preparation intended to produce immunity to a disease by stimulating the production of antibodies. Vaccines are the primary means to prevent illness and death from influenza. They stimulate the production of antibodies against the flu virus components included in the vaccine, providing immunity against the virus.
• Immunization is the safest and most effective way to protect against infectious disease and is the cornerstone of the public health response to the H1N1 flu virus pandemic in Canada. 

Vaccine Regulation:

• Health Canada’s Biologics and Genetic Therapies Directorate (BGTD) is the regulatory authority responsible for working to maximize the safety, efficacy, and quality of all vaccines for human use, including the vaccines for the seasonal flu virus and the H1N1 flu virus. 
• Canada exercises tight regulatory oversight over vaccines. Prior to market authorization of a new vaccine, the manufacturer must file a submission with scientific and clinical evidence that demonstrates that the vaccine is safe, efficacious and of suitable quality. Following vaccine approval, the Public Health Agency of Canada, in association with Health Canada, monitors the safety of vaccines on an ongoing basis.
• Public safety is paramount: we will strike the right balance between the need to have an H1N1 vaccine available quickly, and the imperative to help ensure that vaccine is safe and effective.
• Because it is anticipated that all data regularly required for the market authorization of a new vaccine will not be available at the time of approval, the routine regulatory processes cannot be used for authorization of a pandemic vaccine because of the urgent need for the vaccine.
• Because of the urgent need for the vaccine, a special regulatory approach is being used to ensure that vaccine is available when needed. The situation with the pandemic vaccine is unique as Health Canada has been proactively preparing for an influenza pandemic for several years.
• Health Canada experts are reviewing data on the vaccine’s safety and efficacy as it becomes available.  The regulatory evaluation process will continue concurrent with production.  

Vaccine Availability:

• The Government of Canada has a longstanding contract with GlaxoSmithKline to maintain vaccine production capacity in Canada in order to meet Canada’s pandemic vaccine needs promptly and effectively.
• The Government of Canada has announced plans to order for 50.4 million doses of H1N1 vaccine, on behalf of all provinces and territories, which will be available to Canadians in time for the winter flu season.  This vaccine order will be sufficient to meet the needs of every Canadian likely to need and want protection.
• Although the delivery of immunization is a provincial and territorial responsibility, given the exceptional circumstances of a pandemic, the Government of Canada intends to cover 60 per cent of this purchase on a one-time basis. 
• Decisions on vaccine delivery and the administration of flu clinics is a provincial and territorial government responsibility.  Each province and territory will have to assess their capacity to deliver immunization clinics and will have to make decisions around cost of the vaccine.
• Data from clinical studies are expected to be available in late  October followed soon afterwards if all goes well  by regulatory authorization.

Priorities for Vaccines:

• In Canada we are fortunate that the issue is not whether we will have enough vaccines for everyone: it is how quickly everyone will get vaccinated.  The Government of Canada has made a commitment to secure enough H1N1 vaccine for every person in Canada who will need and want a vaccine.
• Those who need it most will get it first. Decisions about program implementation for the pandemic vaccine will be based on a number of factors, including scientific evidence, ethical, legal and logistical considerations.
• A vaccine prioritization framework is guiding the work by federal, provincial and territorial government as vaccine priority guidelines are being developed. Several factors must be weighed in developing vaccine priority guidelines, such as the characteristics of the illness and the vaccine, its spread and severity among different populations and the logistics of administering the vaccine.
• The guidelines will be informed by the latest scientific and epidemiological evidence, legal and ethical considerations, WHO guidelines and international comparisons, as well as other key stakeholder and public perspectives.
• It is anticipated that the vaccine priority guidelines will be released in September.

Meeting Canadian Needs:

• While we would aim to vaccinate 100 per cent of the population, from observing seasonal flu shot campaigns, we know that even in provinces with free universal access vaccination programs, usually less than 50 per cent of the population will choose to be immunized.  Ordering 50.4 million doses of pandemic vaccine amounts to ordering 50 per cent more than we would expect to use for a normal seasonal vaccination campaign.
• The Government of Canada is confident that 50.4 million vaccine doses will be sufficient to meet the needs of every Canadian likely to need and want protection

Seasonal flu shot and the H1N1 vaccine:

• The seasonal flu shot is not made to protect against the H1N1 flu virus..
• It is expected that the vaccines will be administered separately, at least a few weeks apart. 

Adjuvanted vaccine:

• There are two parts of an adjuvanted vaccine: the antigen and the adjuvant.  Antigen is the active ingredient in the vaccine that provides protection against the virus. 
• Adding an “adjuvant” to the vaccine allows for a larger amount of vaccine to be produced (dose-sparing) and still be effective.    Adjuvant-based vaccine also has the potential to provide better cross-protection against mutating flu virus strains.  

The World Health Organization (WHO) urges the use of dose-sparing formulations that use adjuvant to maximize antigen-sparing, permitting more vaccine to be available.