Abstract
The Public Health Agency of Canada has a mandate to prepare and respond to public health events, including influenza pandemics. Pandemic preparedness requires a multifaceted approach with collaboration from all levels of government. The Canadian Pandemic Influenza Preparedness: Planning Guidance for the Health Sector (CPIP) is a guidance document that outlines key health sector preparedness activities designed to ensure Canada is ready to respond to the next influenza pandemic. This article, the first in a series, outlines Canada's pandemic influenza vaccine strategy as described in the CPIP annex on vaccines. The strategy encompasses all elements of a vaccine program including prioritization of the initial vaccine distribution, securing a pandemic vaccine supply, regulatory approval of a pandemic vaccine, vaccine safety, distribution and storage of the vaccine, allocation and vaccine uptake.
Highlights
Influenza pandemics are recurring but unpredictable events that arise when a novel influenza A virus spreads widely and causes a worldwide event
Pandemic preparedness necessitates a multifaceted approach with collaboration from all levels of government
The Extraordinary Use New Drugs (EUND) regulations, enacted in 2011 after pH1N1, may be used (9). These regulations allow Health Canada to expedite authorization of a pandemic vaccine based on animal data supplemented by any available human data as long as a complete “quality package” is available and a rigorous postmarket surveillance plan is in place
Summary
Influenza pandemics are recurring but unpredictable events that arise when a novel influenza A virus spreads widely and causes a worldwide event. The Extraordinary Use New Drugs (EUND) regulations, enacted in 2011 after pH1N1, may be used (9) These regulations allow Health Canada to expedite authorization of a pandemic vaccine based on animal data supplemented by any available human data as long as a complete “quality package” (information on manufacturing the vaccine) is available and a rigorous postmarket surveillance plan is in place. Possible actions include updates to the product monograph, revisions to vaccine recommendations, changes to administration practices and quarantine or recall of a vaccine lot by Health Canada Key needs for such enhanced safety monitoring and case report assessment include protocols for rapid field investigations, analytical capacity and knowledge of background rates of potential adverse events to compare observations with expectations. Gap in vaccination coverage and uptake monitoring, work is underway to develop provincial and territorial registries for both seasonal and pandemic influenza surveillance
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