Little progress has been made since the 1960s and 1970s to widen the therapeutic arsenal against Trypanosoma cruzi, the causative pathogen of Chagas disease, which remains a frustrating and perplexing infectious disease. This chapter focuses on the strategic and operational challenges in the clinica...l drug development of a novel antitrypanosomal agent for Chagas disease. The various elements that contribute to a robust assessment of treatment effect including dose selection, choice of patient population, trial methodology, endpoint measures, and regulatory perspectives are discussed. The learnings herein should serve as resource to help researchers and other stakeholders optimize their clinical development plans and speed delivery of new medicines to patients with Chagas disease.
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As vaccines get approved by national authorities, learn about National and WHO approval processes for vaccines and how safety is ensured during emergency approval of vaccines. Dr Mariângela Simão explains in Science in 5.
As vaccines get approved by national authorities, learn about National and WHO approval processes for vaccines and how safety is ensured during emergency approval of vaccines. Dr Mariângela Simão explains in Science in 5.
Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries (LMICs). However, sufficient information on the safety of drugs and vaccines in pregnant women is rarely available at the time of product licensure... or approval. To account for this, active safety surveillance efforts are needed during the post-licensure and post-approval
phase to assess the safety of drugs and vaccines in pregnant women and their offspring. Pregnancy exposure registries (PER) are used to monitor the safety of vaccines and drugs. PERs are observational studies that systematically collect health information on exposure to medical products such as drugs and vaccines during pregnancy. This review demonstrates that a number of resources presently exist in LMICs that perform active safety surveillance in pregnant populations. These results indicate such systems employ a wide variety of approaches, each with their own set of strengths and challenges, as summarized in the final section of the report.
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Scientists and researchers managed to produce vaccines to protect against COVID-19. Vaccine candidates have recently been approved in some countries and are in the approval process in others, yet misinformation about the safety and effects of any future vaccine is already threatening its rollout. In... this report, we catalogue the top myths about a COVID-19 vaccine that have appeared in NewsGuard’s ratings of more than 6,000 news and information sites worldwide.
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COVAXINTM, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) h...igh containment facility.
The vaccine received DCGI approval for Phase I & II Human Clinical Trials and the trials commenced across India from July, 2020.
After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXINTM, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.
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This page serves to provide up to date information on serology tests that are in development or available for use. Importantly, many of these tests have been approved for research use only, which indicates that they are not yet approved for use as a public health diagnostic tool or for at-home diagn...osis. Some of these tests may move forward to approval for diagnostic use, while others may be appropriate for research only.
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The report provides a brief introduction to patents and licences and their effect on the market for antiretroviral (ARV) medicines. It gives an overview of the patent landscape with respect to a select number of ARV medicines in developing countries as of April 2014. The focus is primarily on those ...ARVs that are recommended by the World Health Organization (WHO) as well as new ARVs that have either recently obtained regulatory approval or are in phase III clinical trials.
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27 September 2022
These WHO interim recommendations for use of the Novavax NVX-CoV2373 vaccine were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document and annexes referenced below.
6 June 2022
These WHO interim recommendations on the use of the Janssen Ad26.COV2.S (COVID-19) vaccine were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document referenced below.
Th...is document has been updated: Version 6 June 2022.
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Estas orientaciones provisionales se han elaborado a partir de las recomendaciones que hizo el Grupo de Expertos de la OMS en Asesoramiento Estratégico en materia de inmunización (SAGE) en su reunión extraordinaria del 15 de marzo de 2021 [1], y que fueron actualiza...das en su reunión extraordinaria del 27 de mayo de 2021 [2].
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Это временное руководство было разработано на основе рекомендаций Стратегической консультативной группы экспер-тов (СКГЭ) по иммунизации на ее внеочередном засе...ании 15 марта 2021 г. (
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An overview of COVID-19 Vaccine AstraZeneca and why it is authorised in the EU. Available in 22 languages
18 Febr. 2021
Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety and efficacy.
In view of the ongoing political, peace and reconciliation, administrative and economic reforms as well as plans to establish the United Nations Development Assistance Framework (UNDAF) in 2018, WFP extended the current Protracted Relief and Recovery Operation (PRRO 200299), launched in January 2...013, by two years to include 2016 and 2017, with approved budget USD 343 million. To echo this extension and provide a more appropriate response to the country's rapid and multi-pronged transition, WFP adopted a transition strategy with gradually reduced emphasis on humanitarian assistance and greater focus on early recovery and development interventions. WFP's strategic engagement in-country was driven by the overarching goal to assist Myanmar to achieve the national Zero Hunger Challenge by 2025, and was guided by three priorities: emergency preparedness and response; nutrition; and provision of social safety nets.
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