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The virulent “bird flu” strain H5N1 has spread from South East & Central Asia to Europe and Africa and this increased prevalence, together with its particular genetic characteristics, has increased concern about its potential to start a human pandemic.
Building on its routine work in support of seasonal influenza vaccination, NIBSC plays a central role as an Essential Regulatory Laboratory in planning and preparing for pandemic influenza. NIBSC advises the UK’s Department of Health on appropriate vaccine strategies, and works with regulators and manufacturers to develop new approaches for quality assurance and batch release of vaccines in the event of a pandemic, and for continued provision of reference viruses and reagents to support vaccine manufacture.
The NIBSC IRC prepares candidate influenza vaccine viruses (H5N1) for supply to manufacturers and other bona fide research groups around the world to:
These candidate influenza vaccine viruses are available free of charge, with the exception of third party shipping costs, and NIBSC receives no royalties from their use. The strains are made within NIBSC’s own high containment laboratory using reverse genetics technology and the Institute receives no funding for this work other than its core grant-in-aid from the UK Department of Health.
NIBSC also routinely prepares reagents for influenza vaccine standardisation (potency testing) of manufactured influenza vaccine batches. NIBSC is the leading WHO International Laboratory for Biological Standardisation, holding and distributing over 2000 different standards around the world. Reagents for these candidate influenza vaccine viruses (H5N1) have been prepared and are available (http://www.nibsc.ac.uk/spotlight/influenza_resource_centre/reagents.aspx). NIBSC recovers costs for this service from manufacturers in line with its policy for provision of other standards and reference materials. These reagents for influenza vaccine standardisation are available free of charge to all National Control Laboratories.
Materials Transfer Agreements
These candidate influenza vaccine viruses are developed at NIBSC using materials that are subject to third party rights. All recipients of the materials covered by the accompanying MTA must respect the rights of the owners of the plasmids on which NIBRG materials are based, and the reverse genetics engineering processes used to make these strains safe.
Please click below for a template MTA for:
A list of Organisations who have received one of these candidate vaccine viruses.
All shipments of these viruses have been documented on the WHO Influenza Virus Tracking System (interim).