Long-term polio vaccine security – the timely, sustained, and uninterrupted supply of suitable types of affordable, quality-assured polio vaccines – is essential in the global effort to achieve and maintain a polio free world. However, fragmented approaches and short-term planning pose considera...ble challenges to securing long-term polio vaccine security.
This framework is designed to enhance the efforts of existing structures and workstreams within the Global Polio Eradication Initiative (GPEI) and other stakeholders by improving communication and coordination on vaccine security. Ensuring vaccine security is crucial for maintaining a timely, sustained, and uninterrupted supply of affordable, quality-assured polio vaccines in the global fight to achieve and sustain a polio-free world. However, challenges such as fragmented approaches, short-term planning, a dynamic policy environment, and a diverse product pipeline present significant risks to long-term vaccine security. This framework emphasizes the need for alignment and coordination across key polio operational domains, including Poliovirus Containment, Research and Development, and Vaccine Manufacturing and Supply. It also underscores the critical role of normative frameworks and policies in shaping long-term vaccine strategies that guide these operational areas. Additionally, it highlights the importance of cross-cutting elements such as financing and access to resources, along with the integration of communication, coordination, and advocacy efforts, as essential enablers for achieving vaccine security. To secure long-term vaccine supply, it is imperative to enhance alignment and strengthen coordinated efforts across workstreams and with stakeholders, including vaccine manufacturers.
Recognizing that vaccine security is an ongoing endeavor, requiring continuous monitoring and adaptation, this framework will undergo regular updates and revisions. Initially, the management of the framework will be carried out by the GPEI Vaccine Supply Group (VSG).
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PNAS 119 (8) e2113947119 | https://doi.org/10.1073/pnas.2113947119
Environmental exposure to active pharmaceutical ingredients (APIs) can have negative effects on the health of ecosystems and humans. While numerous studies have monitored APIs in rivers, these employ different analytical methods, m...easure different APIs, and have ignored many of the countries of the world. This makes it difficult to quantify the scale of the problem from a global perspective. Furthermore, comparison of the existing data, generated for different studies/regions/continents, is challenging due to the vast differences between the analytical methodologies employed. Here, we present a global-scale study of API pollution in 258 of the world’s rivers, representing the environmental influence of 471.4 million people across 137 geographic regions. Samples were obtained from 1,052 locations in 104 countries (representing all continents and 36 countries not previously studied for API contamination) and analyzed for 61 APIs. Highest cumulative API concentrations were observed in sub-Saharan Africa, south Asia, and South America. The most contaminated sites were in low- to middle-income countries and were associated with areas with poor wastewater and waste management infrastructure and pharmaceutical manufacturing. The most frequently detected APIs were carbamazepine, metformin, and caffeine (a compound also arising from lifestyle use), which were detected at over half of the sites monitored. Concentrations of at least one API at 25.7% of the sampling sites were greater than concentrations considered safe for aquatic organisms, or which are of concern in terms of selection for antimicrobial resistance. Therefore, pharmaceutical pollution poses a global threat to environmental and human health, as well as to delivery of the United Nations Sustainable Development Goals.
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Guidance for the preparation and submission of dossiers
Cet article fait partie d’une série d’explications à propos de la mise au point et de la distribution des vaccins.
Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie...s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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Access to medical personal protective equipment (PPE) is essential for routine healthcare delivery, and a critical tool for containing outbreaks, as well as preventing and responding to pandemics. It is one of our most effective tools against COVID-19, and an undervalued tool more generally in infec...tion control.
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a full range of completely free GxP training courses. They do not provide certificates but give you a quick and easy access to quality training resources wrapped in a pleasant, interactive and easy to digest form.
A.55 Medicines and Related Substances Act, 2013 | No. 8 of 2013 | An Act to provide for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances, and matters incidental thereto.
Ensuring Access to Simple, Safe and Effective First-Line Medicines for Tuberculosis.
Accessed in November 2017.
COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator
The ACT Accelerator is a ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines.
COVAX is co-led by Gavi, the Coalition for Epide...mic Preparedness Innovations (CEPI) and WHO. Its aim is to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.
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This document outlines the working structure and guiding principles for collaboration of COVAX, the Vaccines pillar of the Access to COVID-19 Tools Accelerator (ACT-A). The working structure of COVAX continues to adapt to emerging needs and the changing trajectory of the pandemic. Some components of... the pandemic response capabilities united under COVAX may eventually be integrated into regional, national and sub national health systems, routine immunization programmes and future global pandemic preparedness and response (PPR) structures. Therefore, the working structures outlined in this document continue to evolve and the document provides a snapshot of the COVAX ways of working in the first half of 2022.
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