Vaccine
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Despite the remarkable power of immunization reducing morbidity and mortality due to vaccine preventable diseases, one in five African children still does not receive all the basic, necessary vaccines. This is particularly true of the 10 middle-income countries (MICs) in the WHO African Region, where data demonstrates that immunization coverage is decreasing. These countries are not eligible for Gavi support in accessing new vaccines because of their relatively high per capita income level and will gradually increase with the transitioning of countries out of Gavi support. ⋯ The meeting brought together 17 low, middle and upper middle income countries in the African Region. Immunization partners and other WHO Regions also participated in the consultation to share experiences and explore ways of increasing access to affordable vaccines in MICs in the African Region. At the end of the meeting a number of solutions and action points were proposed for implementation in the Region.
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Randomized Controlled Trial
Safety and immunogenicity of a respiratory syncytial virus fusion glycoprotein F subunit vaccine in healthy adults: Results of a phase 1, randomized, observer-blind, controlled, dosage-escalation study.
Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory tract infections in infants. An investigational vaccine using an engineered recombinant RSV fusion glycoprotein in its post-fusion conformation (RSV F subunit vaccine) has been developed to protect young infants via maternal immunization. This first-in-human, phase I, observer-blind study (NCT02298179) evaluated the safety and immunogenicity of different dosages and formulations of RSV F subunit vaccine in healthy non-pregnant women and men aged 18-45 years. ⋯ A single dose of each formulation of RSV subunit F vaccine was well-tolerated and enhanced preexisting NAb titers through six months of follow-up.
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Although major reductions in maternal and child mortality were achieved in the Millennium Development Goals era, progress must be accelerated to meet Sustainable Development Goals health targets by 2030. An estimated 2.7 million neonatal deaths and 2.6 million stillbirths still occur annually. Over the past several years there has been renewed global interest in innovative approaches to maternal immunization to potentially decrease mortality and severe morbidity in neonates, and in the pregnant woman and her fetus. ⋯ Meeting participants identified priority actions including (1) establishing background rates to better evaluate emerging safety signals and vaccine effectiveness, (2) identifying potential sentinel vaccine surveillance sites, (3) developing data sharing capabilities, (4) creating guidance documents and protocols, and (5) the advanced preparation of culturally-appropriate communication plans and risk management plans. Integrating MIV across the routine obstetric and neonatal health care delivery continuum and all relevant programs and data systems could result in fundamental improvements in maternal, neonatal and child health. Improved pregnancy pharmacovigilance platforms may strengthen other vaccine and drug product safety systems and improve maternal and child research capabilities in LMICs.
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Persons who inject drugs (PWID) are at highest risk for acquiring and transmitting hepatitis C (HCV) infection. The recent availability of oral direct-acting antiviral (DAA) therapy with reported cure rates >90% can prevent HCV transmission, making HCV elimination an attainable goal among PWID. The World Health Organization (WHO) recently proposed a 90% reduction in HCV incidence as a key objective. However, given barriers to the use of DAAs in PWID, including cost, restricted access to DAAs, and risk of reinfection, combination strategies including the availability of effective vaccines are needed to eradicate HCV as a public health threat. This study aims to model the cost and efficacy of a dual modality approach using HCV vaccines combined with DAAs to reduce HCV incidence by 90% and prevalence by 50% in PWID populations. ⋯ The modeling results underscore the importance of developing an effective HCV vaccine and augmenting DAAs with vaccines in HCV intervention strategies in order to achieve efficient reductions in incidence and prevalence.