For the purposes of AVMA, ‘drug substance’ manufacture is defined as the process of manufacturing every constituent antigen of a vaccine. Manufacturing of adjuvants, conjugate carrier proteins, inactive ingredients and excipients, as well as lyophilisation and formulation of bulk vaccine, are not considered under this definition of ‘drug substance’ manufacture. For vaccines that contain multiple antigens, every constituent antigen must be manufactured in Africa for the vaccine to qualify for the AVMA ‘drug substance’ incentive levels. There is an exception for specific cases in which an antigen cannot be manufactured in Africa due to specific WHO requirements or similar reasons (e.g. polio, due to the requirement for a Containment Certification Scheme).
For the purposes of AVMA, ‘fill and finish’ is defined as the process of filling vials (or equivalent final container) with formulated drug substance, with or without subsequent intermediate and final packaging. The packaging of intermediate or final product without the process of filling is not sufficient to constitute ‘fill and finish’.
To achieve its ultimate objectives, AVMA aims to incentivise ‘drug substance’ manufacturing localisation in the long term and therefore provides higher incentives for ‘drug substance’ manufacturing. However, ‘fill and finish’ can serve as a pathway for new manufacturers, helping them generate revenue while expanding their technical capacity. Therefore, AVMA provides incentives for ‘fill and finish’ activities as well, although with lower incentive levels and with the majority of funding ringfenced for ‘drug substance’ manufacturing.