Advancing vaccine development and manufacture in Africa

Emerging and known infectious diseases pose a constant threat to the health and prosperity of Africa and its people. Africa, like other regions of the world with a high burden of vaccine preventable diseases, has benefited immensely from vaccines and Africa’s growing population means an increase in the continuing need for vaccines. By 2050, Africa’s population will be 2.5 billion and one in four people in the world will be African. However, Africa has limited capacity to produce vaccines, yet is the most in need of routine vaccines. Currently less than 1% of vaccines used in Africa is made in Africa while Unicef supplies more than 60% of its global demand for vaccines to Africa. Dependency on external vaccines supply has rendered Africa vulnerable in epidemics and pandemics, and poorly prepared to respond adequately to emergency situations during disease outbreaks. Local vaccine development and production in Africa is therefore essential to support Africa’s growing needs and specific disease burdens as well as boost socio-economic development and the development of skills in biotechnology, and positively impact industrial and life science development. However, building local capacity would require the right level of political and technical support, including a clear, well-funded and coherent regional policymaking and planning approach, allowing development of the necessary ecosystem to establish a viable, competitive and sustainable vaccine manufacturing capability. An overview of the work of the African Vaccine Manufacturing Initiative (AVMI) and its mission of advancing vaccine development and manufacturing capacity in Africa will be provided. Collaborative efforts with partners, progress to date and the need for an African vaccine manufacturing policy will be discussed. Please click Additional File below for the presentation

Development of a pentavalent Group B Streptococcus (GBS) glycoconjugate vaccine in Africa

A vaccine against Group B Streptococcus (GBS), utilized in a maternal immunization strategy to reduce the burden of GBS mortality and morbidity in infants, has potential for use all over the world, but would have the greatest impact in low-resource countries that have limited access to interventions. Currently there is no vaccine against GBS. The Biovac Institute (Biovac), a private public partnership in South Africa, is developing a pentavalent, polysaccharide-protein conjugate vaccine (PCV) against GBS — using state-of-the-art technology and targeting the most common strains. A vaccine providing more than 90 % coverage against GBS infection would need to include at least 5 serotypes including serotypes Ia, Ib, II, III and V. Production of a low-cost pentavalent vaccine would require optimization of unit processes to achieve high yields without compromising product quality. The presentation will describe (1) the selection of high capsular polysaccharide (CPS) producing isolates; (2) development of manufacturing processes to produce CPS for serotypes Ia, Ib, II, III and V; (3) development of a glycoconjugate process, which involves covalently linking the CPS to a carrier protein; (4) results of a monovalent conjugate vaccine mouse study; and (5) further animal and clinical studies planned. While the GBS project affords Biovac the opportunity to establish end-to-end vaccine product development capability, equally importantly, it will also begin to shift the paradigm regarding Africa by demonstrating that vaccine projects of this complexity and magnitude can be done in Africa by Africans. It will contribute significantly to advancing Africa’s capability to respond to vaccine epidemics and infectious diseases of regional relevance

Development of a pentavalent Group B Streptococcus (GBS) glycoconjugate vaccine in Africa

A vaccine against Group B Streptococcus (GBS), utilized in a maternal immunization strategy to reduce the burden of GBS mortality and morbidity in infants, has potential for use all over the world, but would have the greatest impact in low-resource countries that have limited access to interventions. Currently there is no vaccine against GBS. The Biovac Institute (Biovac), a private public partnership in South Africa, is developing a pentavalent, polysaccharide-protein conjugate vaccine (PCV) against GBS — using state-of-the-art technology and targeting the most common strains. Please click Download on the upper right corner to see the full abstract. Please click Additional File below for the presentation

Immune responses against group B Streptococcus monovalent and pentavalent capsular polysaccharide tetanus toxoid conjugate vaccines in Balb/c mice

Summary: Immunization of pregnant women with Group B Streptococcus (GBS) capsular polysaccharide (CPS) conjugate vaccine (CV) could protect young infants against invasive GBS disease. We evaluated the immunogenicity of investigational five GBS monovalent (serotypes Ia, Ib, II, III, and V) CPS-tetanus toxoid (TT)-CV with adjuvant and GBS pentavalent CPS-TT-CV with adjuvant (GBS5-CV-adj) and without adjuvant (GBS5-CV-no-adj), in Balb/c mice. Aluminum phosphate was the adjuvant in the formulations, where included. The homotypic immunoglobulin G (IgG) geometric mean concentration (GMC) and opsonophagocytic activity (OPA) geometric mean titer (GMT) did not differ after the third dose of the GBS5-CV-adj vaccine compared with the monovalent counterparts for all five serotypes. The GBS5-CV-adj induced higher post-vaccination serotype-specific IgG GMCs and OPA GMTs compared to GBS5-CV-no_adj. The GBS5-CV with and without adjuvant should be considered for further development as a potential vaccine for pregnant women to protect their infants against invasive GBS disease