Vaccine Development Process

The Government of Canada (GoC) is continually monitoring advances in science, research and knowledge that can strengthen our pandemic readiness capacity. The GoC has negotiated a long-term contract with Glaxo-Smith-Kline (GSK), a pharmaceutical company, to secure domestic capacity to develop and produce virus-specific vaccines in the event of an influenza pandemic.  This arrangement ensures Canadians will have timely access to vaccines in a pandemic, while reducing the risk of border delays or embargos that may result from relying on foreign suppliers in a crisis.  
 
Once a particular strain of virus has been identified, it can take about six months for an influenza vaccine to be developed and tested. The following outlines the steps necessary to develop a virus vaccine and the measures Canada has taken to date with regards to the H1N1 flu virus vaccine development process.

Timelines for Vaccine Production, Testing and Authorization in Canada

Step 1: Identification of virus (as soon as 24 hours)

The Public Health Agency of Canada’s National Microbiology Laboratory (NML) is internationally recognized as one of a handful of laboratories in the world with the capacity to work with highly pathogenic viruses. The NML has developed a test that enables researchers to determine within 24 hours whether a particular sample specimen of influenza being tested is the current H1N1 flu virus. The NML has shared this test with some provinces, which are now responsible for testing their own specimens.  The NML has completed the full genome sequencing on the Canadian and Mexican H1N1 viruses.
The sequencing will provide valuable insights that can allow researchers to better understand the virus and its impact on populations.   

Step 2: Development of a Primary Seed (approximately 4 weeks)

Development of the primary seed strain – the base material for the development of a vaccine – is the next step undertaken by WHO Collaborating Centres.  The WHO has developed a seed strain and is currently testing it for safety.  While this is underway, the WHO has distributed the seed strain to vaccine manufacturers, including GSK-Canada, for use in the preliminary development of an H1N1 vaccine.  The Government of Canada’s longstanding contract with GSK requires the company to develop and produce vaccines for every person in Canada in the event of a pandemic and gives Canada  priority access to GSK’s vaccine production over that of any other potential purchaser of vaccines. 

Step 3: Development and Production (approximately 12 additional weeks)

In accordance with the terms of the longstanding contract, the Government of Canada is in discussions with GSK about the development and production of the H1N1 vaccine.  After the safety testing and preliminary development work is completed, the production process for the H1N1 vaccine will take about 12 weeks.  In the meantime, GSK is working through potential production process issues by developing trial vaccines.  

Step 4: Testing (approximately 6 additional weeks)

Because the current H1N1 strain has not been a component of any previous influenza vaccine, it presents unknown factors that could require changes to the standard manufacturing process for vaccines.  Tests will be conducted to confirm basic information on the vaccine. A small clinical study with humans will also be conducted to establish the safety of the vaccine and that the vaccine produces an immune response.

Step 5: Review and Authorization (approximately 1 additional week)

Health Canada is working to ensure that mechanisms are in place for review and authorization of a safe and effective vaccine for use in Canada within the shortest time frame possible, and that trained staff is available for the timely testing and release of pandemic vaccine lots after it has been authorized for use in Canada. Their review of data would be concurrent with production.

Total Production and Testing Time

Total production and testing time from the initiation of the vaccine production (Steps 3 – 5 above) is approximately 19 weeks.  Based on these timelines and a best case scenario, an H1N1 vaccine may be available in November, if not sooner.