Selected disease areas are identified as WHO priorities for product development. In the case of Lassa virus, target product profile development followed prioritization of Lassa fever as part of the WHO R&D Blueprint for Action to Prevent Epidemics. The target audience includes vaccine scientists, product developers, manufacturers and funding agencies.
All the requirements contained in WHO guidelines for WHO policy recommendations and prequalification will also apply. The criteria below lay out some of the considerations that will be relevant in WHO’s case-by-case assessments of Lassa virus vaccines in the future.
None of the characteristics in the tables below dominates over any other. For certain vaccine characteristics, footnotes are added to provide the rationale and assumptions made. Therefore, should a vaccine’s profile be sufficiently superior to the critical characteristics under one or more categories, this may outweigh failure to meet another specific critical characteristic. Vaccines which fail to meet multiple critical characteristics are unlikely to achieve favourable outcomes from WHO’s processes.
A generic description of WHO’s Vaccine Prequalification process can be found at the end of this document.