The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion for the marketing authorisation of Celvapan, the first cell culture-based H5N1 (avian flu) pandemic vaccine, in the EU. The vaccine is derived from the H5N1 strain A/Vietnam/1203/2004 and its antigen composition and structure are identical to the actual virus circulating in nature.

The positive opinion precedes the licensure of the “mock-up” vaccine, which allows Celvapan to be used if the WHO officially declares a pandemic [a “mock up” vaccine is identical to the future pandemic vaccine in composition and manufacturing; however, since the actual pandemic strain is not known, the vaccine contains another influenza strain not yet exposed to the general population. Once a pandemic is declared, this licensure allows for a fast track approval of the vaccine containing the actual pandemic strain].

The first peer-reviewed publication of study results for Celvapan appeared in the New England Journal of Medicine (NEJM) in 2007. These data indicated that the vaccine had met phase I/II trial endpoints for safety and immunogenicity. Since then, a phase III trial has demonstrated similar findings.