Author: A. R. Peters, P. Toye, P. Spooner, G. di Giulio, G. (Lieve) Lynen
About this Publication:
This paper describes the preparation and submission of the original registration dossier1 for the East Coast fever vaccine ECF ITM ‘Muguga cocktail’ in Kenya, Tanzania, Uganda and Malawi between 2007and 2009. The process faced a series of challenges in that the ‘vaccine’ unconventionally comprises a formulation of three stocks of the live virulent Theileria parva parasite administered together with a long-acting formulation of oxytetracycline. Only two batches had been manufactured and the dossier was based on the first, FAO-1. Since there were no official guidelines to follow for the relevant countries the dossier was constructed using the official European Union format and guidelines, following the universal principles of quality, safety and efficacy. Specific protocols (SOPs) were prepared to describe the production process. There was a complete lack of specifically designed clinical studies so the published and grey literature were searched for evidence to support safety and efficacy and these were used for the relevant sections of the dossier. Registrations were granted in three of the four countries in 2008-2009.
Subject Areas: Research and Development
Diseases: East Coast Fever