SSA TB AND HIV MITIGATION PROGRAMME

A loan to support the research and development of a vaccine for the prevention of tuberculosis in infants and broadly neutralising antibodies for prevention and treatment of HIV in high-risk populations.

The project will support up to 50% of the Promoter's planned expenditures into research and development (R&D), clinical trials and capital expenditure activities to develop: i) VPM1002, a novel vaccine for the prevention of tuberculosis in infants (TB) and ii) several monoclonal antibodies (mAb) for the prophylaxis and treatment of HIV. During the project, VPM1002 will be compared for efficacy and safety against the current tuberculosis vaccine BCG in a large, multi-centric clinical trial, implemented in several sub-Saharan African countries (Uganda, Gabon, Kenya, Tanzania, Lesotho, etc.) eligible under the Cotonou Agreement.

The project mainly concerns investments in R&D (process development, clinical studies, regulatory development/production capacity, etc.) that are expected to be carried out in existing facilities already authorised for the same purpose and would therefore not require an environmental impact assessment (EIA) under the Directive 2014/52/EU amending the EIA Directive 2011/92/EU. Full environmental details will be verified during the appraisal.

The Promoter has been assessed by the EIB as being a private company not subject to EU rules on public procurement or concessions. However, if after the project appraisal the EIB were to conclude that the promoter is after all subject to EU public procurement legislation (Directive 2014/24/EU), then the Bank would require the Promoter to ensure that contracts for the implementation of the project will be tendered in accordance with the relevant applicable EU procurement legislation (Directives 2014/24/EU as well as Directive 89/665/EEC) as interpreted by the Court of Justice of the EU, with publication of tender notices in the Official Journal of the EU, as and where required.