An example of integration of research into epidemic response.
This document builds on the Background document prepared for the September 4-5, 2014 Consultation. It includes proposed elements to consider during the development of a framework to assist decision-making at global and national level.
The aim of the document is to assist Member States and releva...nt partners in their discussions to identify the best approaches to ensure the accelerated evaluation and use of available or near-term therapies and vaccines for the treatment and prevention of EVD. The document calls for a coordinated effort by the international community to remove unnecessary obstacles towards this goal.
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This article was published on December 10, 2020, and updated on December 16, 2020, at NEJM.org. DOI: 10.1056/NEJMoa2034577
22 December 2020
The COVID-19 vaccine safety guidance manual has been developed upon recommendation and guidance of GACVS members, as well as by experts incorporating current and available information critical to all stakeholders when COVID-19 vaccines will be introduced.
For ease of use, the man...ual is available in a compiled form and in several separate modules that can be consulted individually. For each module, specific training material is also available to facilitate implementation.
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It will be updated continuously.
Details of COVID-19 availability in all ten ASEAN countries and another 30 Asian nations.
Due to the developing situation in China and Asia concerning the Coronavirus, we will be operating this article as a running live update service to keep businesses involved in... ASEAN and Asia updated with the latest relevant regional news.
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Interim Guidance October 2022. This addendum addresses some of the methodological aspects of VE evaluations that have been learned during the past year, as well as those that have become relevant in the current epidemiological setting of the COVID-19 pandemic. For some of the COVID-19 vaccine method...ology issues there are still insufficient data to make a recommendation, in which case different options for approaching VE evaluations are presented.
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COVID-19 Vaccines: 1 Safety Surveillance 2 Manual
While there is no indication that pregnant women have an increased susceptibility to infection with SARS-CoV-2, there is evidence that pregnancy may increase the risk of severe illness and mortality from COVID-19 disease in comparison with non-pregn...ant women of reproductive age. As seen with non-pregnant women, a high proportion of pregnant women have asymptomatic SARS-CoV-2 infection and severe disease is associated with recognized medical (e.g., high body-mass index (BMI), diabetes, pre-existing pulmonary or cardiac conditions) and social (e.g., social deprivation, ethnicity) risk factors. Pregnant women with symptomatic COVID-19 appear to have an increased risk of intensive care unit admission, mechanical ventilation and death in comparison with non-pregnant women of reproductive age, although the absolute risks remain low. COVID-19 may increase the risk of preterm birth, compared with pregnant women without COVID-19, although the evidence is inconclusive.
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“Guide to facilitate the implementation of the WHO/UNICEF “Guidance on developing a national deployment and vaccination plan for COVID-19 vaccines” for Africa
t contains action-oriented lists of critical topics to address and checklists tailored to the context of African Union Member States.
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The contents of this guide aim to guide the development of one comprehensive national deployment and vaccination plan, as proposed and outlined by the guidance – and underlines the need for countries to develop their vaccination plans.
This guide is not meant as a tool to assess deployment readiness. The recommendation to Member States is to use the VIRAT/VRAF 2.0 tool for that, which builds on the COVAX Vaccine Introduction Readiness Assessment Tool (VIRAT) and the World Bank’s Vaccine Readiness Assessment Framework (VRAF).
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Many critical questions remain about the effectiveness of COVID-19 vaccines in real-world settings. These questions can only be answered in post-introduction vaccine effectiveness studies.This guidance document outlines an approach to leverage existing surveillance systems for Severe Acute Respirato...ry Infection (SARI) to estimate COVID-19 vaccine effectiveness (VE) in preventing SARI associated with laboratory-confirmed SARS-CoV-2 using existing SARI surveillance systems. The approach uses the test-negative design to evaluate VE; cases are SARI patients who tested positive for SARS-CoV-2, and controls are SARI patients who tested negative for SARS-CoV-2.
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Development of one or more vaccines for Neisseria gonorrhoeae is an important objective for sexual and reproductive health worldwide, and for the fight against antimicrobial resistance.
WHO preferred product characteristics (PPCs) provide strategic guidance as to WHO’s preferences for new vacci...nes in priority disease areas. PPCs are intended to encourage innovation and development of vaccines for use in settings most relevant to the global unmet public health need.
Gonococcal vaccine PPCs describe global public health goals for gonococcal vaccines and preferred parameters pertaining to vaccine indications and target populations, safety and efficacy considerations, and immunization strategies.
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The roadmap describes the actions needed to
achieve the three development goals for TB
vaccines set by the WHO:
1. A safe, effective and affordable TB vaccine
for adolescents and adults.
2. An affordable TB vaccine for neonates and
infants with improved safety and efficacy.
3. A therapeutic v...accine to improve TB
treatment outcomes
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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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This document summarizes the results of the WHO-commissioned full value proposition for new tuberculosis (TB) vaccines. The assessment was commissioned to provide early evidence for national and global decision-makers involved in TB vaccine development and implementation, who include stakeholders in...volved in vaccine research, financing, regulation and policy-making, manufacturing, introduction and procurement. The goal is to accelerate development of effective vaccines against TB and their rapid introduction into countries.
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Geneva, 22 May 2023 – Gavi, the Vaccine Alliance today published a roadmap* outlining critical actions needed to ensure supply of oral cholera vaccine (OCV) is able to meet growing demand from countries. Released against a backdrop of a recent wave of cholera outbreaks around the world, the roadma...p forecasts the short-, mid- and long-term outlook for global cholera vaccine supply. Developed in consultation with a range of key Alliance partners, including WHO, UNICEF, the Global Taskforce for Cholera Control (GTFCC), and the Bill and Melinda Gates Foundation (BMGF), it describes how these organizations, manufacturers and countries can work together towards ensuring global OCV supply can support largescale preventive vaccination by 2026.
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