The Pharmacovigilance team in WHO aims to assure the safety of medicines and vaccines by ensuring reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug... Monitoring. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring.
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Interim guidance. 12 May 2021. The Continuity of essential health services: Facility Assessment Tool can be used by countries to rapidly assess the capacity of health facilities to maintain the provision of essential health services during the COVID-19 pandemic. It can help to alert the authorities ...and other stakeholders about where service delivery and utilization may require modification and/or investment. This assessment tool covers the following aspects of essential health services:
health workforce (numbers, absences, COVID-19 infections, health workforce management, training and support);
financial management and barriers;
service delivery and utilization (facility closures, changes in service delivery, community communication campaigns, changes in service utilization and catch-up strategies);
IPC capacities (protocols, safety measures, guidelines and the availability of personal protective equipment (PPE) for staff);
availability of therapeutics, diagnostics and supplies, and vaccine readiness; and
provision of COVID-19 primary care services.
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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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The PQS on-line catalogue includes details of all immunization-related products currently pre-qualified by WHO for procurement by United Nations agencies. The catalogue is produced and maintained by the Quality, Safety and Standards group in the Immunization, Vaccine and Biologicals Department of WH...O, Geneva. It replaces the old WHO/UNICEF Product Information Sheets (PIS), the last edition of which was published in 2000. Only products included in the PQS catalogue are now recommended to be purchased by UN agencies.
Large File: 120 MB
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15 January 2021
This Aide Memoire is for policy makers, immunization programme managers, infection prevention and control (IPC) focal points at national, sub-national, and facility level, as well as for health workers involved in COVID-19 vaccination delivery. This document summarizes the key IPC p...rinciples to consider and the precautions to take for safely delivering COVID-19 vaccines. The principles and recommendations provided in this document derive from World Health Organization (WHO) IPC and immunization standards and other guidance in the context of COVID-19. WHO will update these recommendations as new information becomes available. All technical guidance for COVID-19 is available online.
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1 March 2021
This article is part of a series of explainers on vaccine development and distribution. Learn more about vaccines – from how they work and how they’re made to ensuring safety and equitable access – in WHO’s Vaccines Explained series.
This global guidance provided the framework for over 100 countries to develop their NDVPs. This updated (second) version supersedes the previous version published in 16 November 2020. New information has been added on the following areas:
the COVID-19 Partners Platform;
the use of COVID...-19 simulation exercises to test deployment strategies;
the indemnity agreement and no-fault compensation programme for vaccines secured through the COVAX Facility in the Advance Market Commitment (AMC) eligible economies;
the availability and use of the WHO-UNICEF COVID-19 Vaccine Introduction and deployment Costing (CVIC) tool;
the COVAX Facility’s humanitarian buffer that enables allocation of vaccine to cover high-risk populations in humanitarian settings;
recommendations for vaccination of pregnant and lactating women;
supplementary information on infection prevention and control (IPC) measures to be used to deliver COVID-19 vaccines safely;
the WHO licensed COVID-19 vaccines product-specific information;
use of geospatial data and digital micro plans for equitable access and delivery of COVID-19 vaccines;
lessons learned from the development of NDVPs and early experiences in COVID-19 vaccine deployment in countries; and
updated additional resources at the end of each chapter.
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Since the release of the first volume in May 2020, the COVID-19 pandemic has continued to rage around the world. By mid-March, 2021, countries around the globe had reported over 123 million cases—a nearly five-fold increase since this report’s previous volume—and over 2.7 million deaths attrib...uted to the disease. And while new case loads are currently on the rise again, the global health community has already administered almost 400 million doses of vaccines, at last offering some signs of hope and progress.
Economic impacts threaten to undo decades of recent progress in poverty reduction, child nutrition and gender equality, and exacerbate efforts to support refugees, migrants, and other vulnerable communities. National and local governments—together with international and private-sector partners—must deploy vaccines as efficiently, safely and equitably as possible while still monitoring for new outbreaks and continuing policies to protect those who do not yet have immunity.
More than ever, the world needs reliable and trustworthy data and statistics to inform these important decisions. The United Nations and all member organizations of the Committee for the Coordination of Statistical Activities (CCSA) collect and make available a wealth of information for assessing the multifaceted impacts of the pandemic. This report updates some of the global and regional trends presented in Volume I and offers a snapshot of how COVID-19 continues to affect the world today across multiple domains.
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When situations occur in which unwanted events are rightly or wrongly connected with vaccination, they may erode confidence in vaccines and the authorities delivering them. This document presents the scientific evidence behind WHO’s recommendations on building and restoring confidence in vaccines ...and vaccination, both in ongoing work and during crises. The evidence draws on a vast reserve of laboratory research and fieldwork within psychology and communication. It examines how people make decisions about vaccination; why some people are hesitant about vaccination; and the factors that drive a crisis, covering how building trust, listening to and understanding people, building relations, communicating risk and shaping messages to the audiences may mitigate crises. This document provides a knowledge base for stakeholders who develop communication strategies or facilitate workshops on communication and trust-building activities in relation to vaccines and immunization, such as immunization programme units, ministries of health, public relations and health promotion units, vaccine safety communication trainers and immunization advisory bodies.
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Tackling COVID-19 misinformation. Ensuring communities have access to lifesaving public health information from trusted sources and are not misled by misinformation is essential to ending the COVID-19 pandemic.
In an effort to empower doctors and nurses – some of the most effective and trusted... messengers of public health information – to actively address COVID-19 misinformation and build vaccine confidence globally, the WHO welcomes this social media toolkit for healthcare practitioners, developed by the Government of the United Kingdom.
This toolkit aims to provide healthcare workers with the tools, skills and content needed to effectively share authentic and reliable information online. Centered around three core vaccine confidence messages, Vaccine Safety, Vaccine Development and Vaccine Reducing Risk of Sickness; this toolkit sets out three approaches: creating your own posts, posting the images and videos provided in the toolkit, or resharing vaccine information from trusted sources.
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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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Child and adolescent vaccine safety report
This report on the safety of COVID-19 vaccination in children and adolescents in Argentina includes data from the start of the adolescent campaign
in Argentina, includes data reported since the start of the campaign in adolescents (28 July 2021) and in ch...ildren aged 3-11 years (12 October 2021) until 6 AM on 31 October 2021.
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Position paper on vaccination with Sputnik V vaccine | National Commission on Vaccine Safety (CoNaSeVa) | 12 May 2021
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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1.0 PURPOSE
To define the procedure for the conduct of in-person meetings in both healthcare and community settings in response to COVID-19 and with respect to Public Health and Social Measures (PHSMs) to reduce the risk of disease transmission. A general risk assessment must be conducted to inform... context specific recommendations.
2.0 SCOPE
The procedure in this document is applicable to all meetings that require convening people
together physically.
3.0 SAFETY AND HYGIENE PROCEDURE
Before entry into the meeting room/venue:
• Presentation of evidence for complete doses of COVID-19 vaccination (depending on COVID-19 vaccine taken) or negative COVID-19 PCR test done within the last 72 hours, or where applicable proof of daily negative RDT result. The Africa Union Trusted Travel platform, with technical support from the PanaBIOS Consortium has implemented an online system that allows Airlines and Port Health services to authenticate and verify traveler’s COVID-19 results certificates in line with international standards, across Africa and beyond.
• Hand hygiene stations should be available at the points of entry.
• All participants must wear a well fitted mask that covers the nose and mouth. Medical masks should be provided all meeting participants.
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Dengue is the fastest spreading, mosquito-borne viral infectious disease worldwide, with remarkable morbidity and mortality. In the past decades, profound contributions have been made towards understanding its epidemiology, including disease burden and distributions, risk factors, and control and pr...evention practices. Dengue continues to disseminate to new areas, including high latitude regions, and a new serotype (dengue virus serotype 5) has been identified. Vaccine research has made new progress, in which the licensed yellow fever and dengue virus quadrivalent chimeric vaccine is now under further safety assessment. In disease surveillance, because of its operational simplicity, rapidity, capability, and utility as an indicator of disease severity, dengue virus NS1 antigen detection has great promotion and application value among primary health care institutions. Vector control progress has driven new breakthroughs in biotechnology, including Wolbachia-infected Aedes and genetically modified Aedes. Both Aedes variants have been used to block transmission of the dengue virus through population replacement and suppression. In the future, vector control should still be pursued as a key measure to prevent transmission, along with anti-viral drug and vaccine 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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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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Introduction Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan
Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV.
Objective The objective of this initiative was to improve reporting of adverse events (A...Es) by strengthening passive safety
surveillance via PV training and mentoring of local PV stakeholders and healthcare providers (HCPs) at their own healthcare
facilities (HCFs).
Methods An 18-month PV training and mentoring programme was implemented in collaboration with national stakeholders,
and in partnership with the Ministry of Health, GSK and PATH. Two-day training was provided to Expanded Programme on
Immunisation coordinators, identified as responsible for AE reporting, and four National Regulatory Authority representa-
tives. Abridged PV training and mentoring were provided regularly to HCPs. Support was given in upgrading the national
PV system. Key performance indicators included the number of AEs reported, transmission of AE forms, completeness of
reports, serious AEs reported and timeliness of recording into VigiFlow.
Results In 18 months, 443 HCPs at 61 HCFs were trained. The number of reported AEs increased from 22 (January 2000 to
October 2016) to 228 (November 2016 to May 2018), enabling Malawi to become a member of the World Health Organization
Programme for International Drug Monitoring. Most (98%) AE report forms contained mandatory information on reporter,
event, patient and product, but under 1% were transmitted to the national PV office within 48 h.
Conclusion Regular PV training and mentoring of HCPs were effective in enhancing passive safety surveillance in Malawi,
but the transmission of reports to the national PV centre requires further improvement.
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This dataset contains data from WHO's data portal covering the following categories:
Air pollution, Antimicrobial resistance (AMR), Assistive technology, Child mortality, Dementia diagnosis, treatment and care, Dementia policy and legislation, Environment and health, Foodborne Diseases Estimates,... Global Dementia Observatory (GDO), Global Health Estimates: Life expectancy and leading causes of death and disability, Global Information System on Alcohol and Health, Global Patient Safety Observatory, HIV, Health financing, Health systems, Health taxes, Health workforce, Hepatitis, Immunization coverage and vaccine-preventable diseases, Malaria, Maternal and reproductive health, Mental health, Neglected tropical diseases, Noncommunicable diseases, Nutrition, Oral Health, Priority health technologies, Resources for Substance Use Disorders, Road Safety, SDG Target 3.8 | Achieve universal health coverage (UHC), Sexually Transmitted Infections, Tobacco control, Tuberculosis, Vaccine-preventable communicable diseases, Violence against women, Violence prevention, Water, sanitation and hygiene (WASH), World Health Statistics.
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