GlaxoSmithKline Biologicals' Arepanrix H1N1 vaccine delisted from the WHO list of prequalified vaccines
According to domestic vaccine regulations on 13 October 2010 the special pandemic specific market authorization, designated as "Interim Order", has expired for the Arepanrix H1N1 vaccine of GlaxoSmithKline Biologicals in Canada. Arepanrix H1N1 is a Canadian made vaccine indicated for active immunization against the 2009 pandemic H1N1 influenza strain. Due to the expired market authorization Canadian Authorities will no longer perform any batch release for Arepanrix H1N1. (In Canada current seasonal influenza vaccines contain a 2009 pandemic H1N1 influenza like strain.)
As a consequence, the WHO has removed Arepanrix H1N1 from its prequalified list of monovalent H1N1 vaccines. This decision is not related to any quality issue or other problem with the vaccine, it is rather a consequence of the expiry of the market authorization in Canada. According to the prequalification procedure requirements, only appropriately licensed vaccines can be prequalified. In addition, vaccines must be released to the market by the responsible National Regulatory Authority which for this vaccine is the Canadian Authority.