The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international GMP standards, technological advan...cements, industry practices and regulatory expectations specific to the vaccine manufacturing context. Some of the topics include computer system validation, data integrity, challenges in lyophilization and others. Real world examples and case studies will be used to show how to interpret current and recently new good manufacturing practices requirements from a practical point of view and to implement appropriate approaches.
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Essais cliniques, autorisation d’utilisation d’urgence, production, transport, stockage et finalement administration par les soignants locaux : suivez le parcours d’un vaccin.
La stratégie continentale commune africaine pour COVID-19 est sous-tendue par la nécessité de limiter la transmission, de prévenir les décès et de réduire les dommages associés. La participation des nations africaines aux essais cliniques est une étape essentielle pour garantir la productio...n de données suffisantes sur la sécurité et l'efficacité des candidats vaccins les plus prometteurs parmi les populations de la région.
Bien que l'activité actuelle des essais cliniques COVID-19 sur le continent soit limitée, l'Afrique possède une expérience et des capacités considérables pour mener des essais cliniques de vaccins préventifs contre toute une série de maladies, et de nombreuses organisations du continent travaillent sans relâche pour aider à préparer des essais supplémentaires sur des vaccins COVID-19 potentiels.
Disponible en anglais, français et portugais
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An interactive tool for partners, manufacturers, and countries to follow the developments of the COVID-19 vaccine market with up-to-date information.
As the designated COVAX procurement coordinator and procurement agent, UNICEF has launched the COVID-19 Vaccine Market Dashboard – an interactive ...tool for countries, partners and industry to follow the developments of the rapidly evolving COVID-19 vaccine market and the efforts of the COVAX Facility to ensure fair and equitable access for every country in the world.
In this first release, the dashboard provides a regularly updated overview of the global research and development pipeline, the projected production capacity, publicly announced bilateral and multilateral supply agreements, as well as reported price points.
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Every country has been affected by COVID-19, with nearly a quarter
of a billion cases and almost 5 million deaths reported globally as of
end of September 2021. Despite the stunning speed with which highly
effective and safe vaccines have been developed, new waves of disease
are still pushin...g health systems to the breaking point, increasingly
transmissible variants are emerging, some survivors are suffering
serious long-term sequelae, and the International Monetary Fund
estimates that global economic losses could exceed US$5.3 trillion
by 2026, if COVID-19 becomes endemic.
Although over 6 billion doses of COVID-19 vaccine have already been
administered, and global production is now reaching 1.5 billion doses
per month, the world is not positioned to end the pandemic. In areas of
high vaccine coverage, there have been massive reductions in serious
disease, hospitalization and death but, globally, vaccine access is highly
inequitable with coverage ranging from 1% to over 70%, depending
largely on a country’s wealth. Consequently, SARS CoV-2 variants
continue to emerge, causing surges of disease and slowing or even
reversing the reopening of societies and economies.
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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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Dengue is a significant public health problem. There are four dengue virus serotypes identified; however, its diagnosis is difficult due to the existence of many viruses, bacteria, and parasites producing the same clinical presentation, being present in the same geographical area and even producing ...coinfections. Therefore, determining whether a person has, had, or is infected with dengue virus is of great importance. In order to do so, direct and indirect laboratory tests have been developed to identify the virus or part of its structure that generally detects the antibody response. These techniques are used for diagnosis, epidemiological studies, monitoring, assessment and production of vaccines and antivirals, etc. They range from the use of cell cultures, animal models, inoculation by insects, and serology tests to the use of detection molecular tests and quantification of genetic material that are described in this chapter herein, a brief explanation of this methodology, its strengths and weaknesses, and its application in the dengue research.
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Antimicrobial resistance (AMR) is a global human, animal, plant and environment health threat that needs to be addressed by every country. The impacts of AMR are wide-ranging in terms of human health, animal health, food security and safety, environmental effects on ecosystems and biodiversity, and ...socioeconomic development. Just like the climate crisis, AMR poses a significant threat to the delivery of the 2030 Agenda for Sustainable Development. The response to the AMR crisis has been spearheaded through the global action plan on antimicrobial resistance (GAP-AMR), developed by the World Health Organization (WHO) in 2015, in close collaboration with the Food and Agriculture Organization of the United Nations (FAO) and the World Organisation for Animal Health (WOAH), and formally endorsed by the three organizations’ governing bodies and by the Political Declaration of the high-level meeting of the United Nations General Assembly on AMR in 2016. In 2022, the three organizations officially became the Quadripartite by welcoming the United Nations Environment Programme (UNEP) into the alliance “to accelerate coordination strategy on human, animal and ecosystem health”.
The aim of the GAP-AMR is to ensure the continuity of successful treatment with effective and safe medicines.
Its strategic objectives include:
• improving the awareness and understanding of AMR;
• strengthening the knowledge and evidence base through surveillance and research;
• reducing the incidence of infection through effective sanitation, hygiene and infection prevention measures; optimizing the use of antimicrobial medicines in human and animal health; and
• developing the economic case for sustainable investment that takes account of the needs of all countries and increasing investment in new medicines, diagnostic tools, vaccines and other interventions.
With the adoption of the GAP-AMR, countries agreed to develop national action plans (NAPs) aligned with the GAP-AMR to mainstream AMR interventions nationally. Individually, the Quadripartite took action to advance AMR interventions in their respective sectors. FAO adopted a resolution on AMR recognizing that it poses an increasingly serious threat to public health and sustainable food production, and developed an AMR action plan to support the resolution’s implementation. For its part, WOAH developed a strategy on AMR aligned with the GAP-AMR, acknowledging the importance of a One Health approach to AMR. Similarly, more recently, UNEP’s governing body, the United Nations Environment Assembly, recognized that AMR is a current and increasing threat and a challenge to global health, food security and the sustainable development of all countries, and welcomed the GAP-AMR and the NAPs developed in accordance with its five overarching strategic objectives
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The African Centers for Disease Control and Prevention and the African Union together have called for a New Public Health Order which will safeguard the health and economic security of the continent as it strives to meet the aspirations of the Agenda 2063. A key pillar of this mandate seeks to expan...d the local manufacture of vaccines, diagnostics, and therapeutics. Presently, less than one percent of vaccines administered on the continent are manufactured locally. This places a great burden on the health systems of African countries and reduces their ability to respond to pandemics and other health crises.
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The report aims to capture lessons from the COVID-19 pandemic and to highlight the opportunity for more ambitious global action: expanding sustainable access to vaccines for all towards
the Immunization Agenda 2030 and pandemic prevention, preparedness and response efforts. The report is organized ...in two sections: the first section provides WHO insights on global vaccine market dynamics, drawing from data provided by Member States, which are, in turn, analysed and displayed in the second section.
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Despite high regional demand for vaccines valued at over US$ 1 billion annually, Africa’s vaccine industry provides only 0.1% of global supply. Vaccine inequity and hoarding at the start of the pandemic, which resulted in delays in obtaining COVID-19 doses, stimulated new resolve to address future... supply security. In 2021, the AU set a target to produce and supply more than 60% of the vaccine doses on the continent by 2040.
In the last 18 months alone, more than 30 new African manufacturing projects have been announced and estimates indicate that the African vaccine market across all existing and projected novel products could range between US$ 2.8 billion and US$ 5.6 billion by 2040*, demonstrating the potential for a thriving regional industry to emerge.
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22 Sept. 2021
The rapid development of effective Covid-19 vaccines in 2020 gave hope to the world in the darkest days of the deadly pandemic. However, the vaccine roll-out has been massively skewed towards wealthy nations. While rich states have hoarded vaccines, companies have also played a decisi...ve role in restricting fair access to a life-saving health product. This report focuses on six leading vaccine developers, AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax and Pfizer, assessing each company’s human rights policy, pricing structure, records on intellectual property, knowledge and technology sharing, allocation of available vaccine doses and transparency.
Available in Arabic, English, French, German and Spanish
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PHARMA’S RESPONSE TO THE COVID-19 VACCINES CRISIS. Update Feb., 14, 2022. In September 2021, Amnesty International published A Double Dose of Inequality, which assessed the extent to which the pharmaceutical industry was restricting access to Covid-19 vaccines. This report updates that assessment ...of five leading vaccine manufacturers, AstraZeneca plc, BioNTech SE, Johnson & Johnson, Moderna Inc., and Pfizer Inc. It also includes for the first time an assessment of the two largest Chinese vaccine producers, China National Pharmaceutical Group Co., Ltd. (Sinopharm) and Sinovac Biotech Ltd. (Sinovac).
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A handbook for district and health facility staff
A handbook for district and health facility staff
The COVID-19 Vaccine (Whole Virion Inactivated) BBV152, COVAXIN® vaccine explainer includes key information on the vaccine specific requirements.
WHO Vaccine Management Handbook