Vaccine Production in Africa: A Feasible Business Model for Capacity Building and Sustainable New Vaccine Introduction

Africa has the highest incidence of mortality caused by infectious diseases, and remarkably does not have the capacity to manufacture vaccines that are essential to reduce mortality, improving life expectancy, and promoting economic growth. GAVI has significantly helped introduction of new vaccines in Africa but its sustainability is questionable, and new vaccines introduction post-graduation is rare. Conversely, Africa with its high population and economy growth is an increasing potential market for vaccines. This study aimed to investigate how investment for vaccine production in Africa could be triggered and in which way it could be affordable to most African governments or investors. The investigation was based on a literature review and supplemented by online questionnaires directed to global vaccine stakeholders, African governments and regulatory authorities. In-depth interviews with experts in manufacturing capacity implementation and regulatory capacity building in Africa complemented the study. We also developed business plan scenarios including facility costs calculations and a possible investment plan based on expert opinions and publicly available information from pertinent sources. We saw that, governments in Africa, show interest in vaccine production establishments but only with external support for investment. The common regulatory functionality gap was the quality control laboratories to test vaccine lots before regulatory release. The global vaccine stakeholders showed less preference in investment for vaccine production establishment in Africa. The diverse political ambitions among African governments make it difficult to predict and access the market, a prerequisite for competitive production. A feasible solution could be a small production facility that would use technologies with high yield at low costs of goods to cover the regional needs. A respective antigen production facility is estimated to cost USD 25 Million, an affordable dimension for investors or interested African governments. Attractiveness for the African market is deemed to be high when targeting diseases almost exclusively for Africa (e.g., malaria or invasive non-typhoidal salmonella). With a smart 5 years tangible implementation plan, marketing agreements within existing regional collaborations and with a strong political will, an African government alone or together with an investor could convince global vaccine stakeholders and investors to support

Berezinskii-Kosterlitz-Thouless transition and BCS-Bose crossover in the two-dimensional attractive Hubbard model

We study the two-dimensional attractive Hubbard model using the mapping onto the half-filled repulsive Hubbard model in a uniform magnetic field coupled to the fermion spins. The low-energy effective action for charge and pairing fluctuations is obtained in the hydrodynamic regime. We recover the action of a Bose superfluid where half the fermion density is identified as the conjugate variable of the phase of the superconducting order parameter. By integrating out charge fluctuations, we obtain a phase-only action. In the zero-temperature superconducting state, this action describes a collective phase mode smoothly evolving from the Anderson-Bogoliubov mode at weak coupling to the Bogoliubov mode of a Bose superfluid at strong coupling. At finite temperature, the phase-only action can be used to extract an effective XY model and thus obtain the Berezinskii-Kosterlitz-Thouless (BKT) phase transition temperature. We also identify a renormalized classical regime of superconducting fluctuations above the BKT phase transition, and a regime of incoherent pairs at higher temperature. Special care is devoted to the nearly half-filled case where the symmetry of the order parameter is enlarged to SO(3) due to strong ${\bf q}=(\pi,\pi)$ charge fluctuations. The low-energy effective action is then an SO(3) non-linear sigma model with a (symmetry breaking) magnetic field proportional to the doping. In the strong-coupling limit, the attractive Hubbard model can be mapped onto the Heisenberg model, from which we recover the Gross-Pitaevskii equation in the low-density limit.Comment: 31 pages, 12 figures, RevTex4; (v2) changes following referees' comments, references adde

Booster Vaccination With GVGH Shigella sonnei 1790GAHB GMMA Vaccine Compared to Single Vaccination in Unvaccinated Healthy European Adults: Results From a Phase 1 Clinical Trial

The investigational Shigella sonnei vaccine (1790GAHB) based on GMMA (generalized modules for membrane antigens) is immunogenic, with an acceptable safety profile in adults. However, pre-vaccination anti-S. sonnei lipopolysaccharide (LPS) antibody levels seemed to impact vaccine-related immune responses. This phase 1, open-label, non-randomized extension study (ClinicalTrials.gov: NCT03089879) evaluated immunogenicity of a 1790GAHB booster dose in seven adults with undetectable antibodies prior to priming with three 1790GAHB vaccinations 2–3 years earlier (boosted group), compared to one dose in 28 vaccine-naïve individuals (vaccine-naïve group). Anti-S. sonnei LPS serum IgG geometric mean concentrations and seroresponse (increase of ≥25 EU or ≥50% from baseline antibody ≤ 50 EU and ≥50 EU, respectively) rates were calculated at vaccination (day [D]1), D8, D15, D29, D85. Safety was assessed. Geometric mean concentrations at D8 were 168 EU (boosted group) and 32 EU (vaccine-naïve group). Response peaked at D15 (883 EU) and D29 (100 EU) for the boosted and vaccine-naïve groups. Seroresponse rates at D8 were 86% (boosted group) and 24% (vaccine-naïve group) and increased at subsequent time points. Across both groups, pain (local) and fatigue (systemic) were the most frequent solicited adverse events (AEs). Unsolicited AEs were reported by 57% of boosted and 25% of vaccine-naïve participants. No deaths, serious AEs, or AEs of special interest (except one mild neutropenia case, possibly vaccination-related) were reported. One 1790GAHB dose induced a significant booster response in previously-primed adults, regardless of priming dose, and strong immune response in vaccine-naïve individuals. Vaccination was well tolerated

Comparing Notes: Recording and Criticism

This chapter charts the ways in which recording has changed the nature of music criticism. It both provides an overview of the history of recording and music criticism, from the advent of Edison’s Phonograph to the present day, and examines the issues arising from this new technology and the consequent transformation of critical thought and practice

Wider Still and Wider: British Music Criticism since the Second World War

This chapter provides the first historical examination of music criticism in Britain since the Second World War. In the process, it also challenges the simplistic prevailing view of this being a period of decline from a golden age in music criticism