Risk Management Plans and Periodic Safety Reports for COVID-19 Vaccines
Title | Risk Management Plans and Periodic Safety Reports for COVID-19 Vaccines PDF eBook |
Author | César Avalos (Of DIGEMID) |
Publisher | |
Pages | 11 |
Release | 2021 |
Genre | |
ISBN |
The continuous assessment of benefits and risks, as well as effective communication among stakeholders, is key for protecting and promoting public health, and for strengthening public trust in vaccines and the authorities that oversee the vaccination process. During the current COVID-19 pandemic, the private sector has played a critical role in the rapid development of vaccines. Moreover, primary responsibility for vaccine safety and efficacy monitoring rests with use authorization holders. National regulatory authorities have to make decisions based on limited safety and efficacy data at the time of authorization. Thus, constant monitoring is necessary as soon as a vaccine is authorized in order to detect and assess possible safety issues associated with its use. This document establishes recommendations and considerations to guide the development of strategies to assess the risk management plans and periodic safety reports required for use authorization of COVID-19 vaccines and for safety monitoring once their use is authorized. It is intended mainly for national regulatory authorities in the Region of the Americas, and may be considered by COVID-19 vaccine use authorization holders when preparing risk management plans and periodic safety reports for submission to health authorities.
COVID-19 vaccines
Title | COVID-19 vaccines PDF eBook |
Author | World Health Organization |
Publisher | World Health Organization |
Pages | 232 |
Release | 2020-12-22 |
Genre | Medical |
ISBN | 924001828X |
Crisis Communication Related to Vaccine Safety
Title | Crisis Communication Related to Vaccine Safety PDF eBook |
Author | W. H. O. Regional WHO Regional Office for Europe |
Publisher | Pan American Health Organization |
Pages | 76 |
Release | 2021-02-03 |
Genre | |
ISBN | 9789275123133 |
Vaccine- and vaccination-related crises require a communication response that is different from the communication strategies used to promote the benefits and importance of vaccines in general. This document presents the technical guidance needed to develop a communication plan that is appropriate for managing crises related to vaccine safety. This guidance will be useful for managers in the areas of immunization and vaccine and vaccination safety. They will also help preparedness and response teams working in safety crises to optimize their communication plans in order to regain, maintain, or strengthen trust in vaccines, vaccination, and immunization programs in general. Each chapter presents a phase (preparation, implementation, and evaluation) with suggested actions and support tools to prepare, implement, and evaluate a communication response in a crisis situation. Also, some sections can also be used to strengthen routine national communication activities such as interaction with media, message generation, spokespeople preparation among others. The current document complements the Manual for the surveillance of events supposedly attributable to vaccination or immunization (ESAVI) in the Region of the Americas. This document is published within the framework of a joint project that aims to promote communication-related to safe vaccination in the Region of the Americas and support health authorities that need to develop a communication plan to manage crises related to vaccine safety. Some of the sections in this publication are based on the guidance documents available in the WHO Regional Office for Europe's virtual library and can be consulted on their website.
COVID-19 vaccines
Title | COVID-19 vaccines PDF eBook |
Author | |
Publisher | World Health Organization |
Pages | 264 |
Release | 2021-08-04 |
Genre | Medical |
ISBN | 9240032789 |
CDC Yellow Book 2018: Health Information for International Travel
Title | CDC Yellow Book 2018: Health Information for International Travel PDF eBook |
Author | Centers for Disease Control and Prevention CDC |
Publisher | Oxford University Press |
Pages | 705 |
Release | 2017-04-17 |
Genre | Medical |
ISBN | 0190628634 |
THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad.
Canadian Immunization Guide
Title | Canadian Immunization Guide PDF eBook |
Author | Canada. Comité consultatif national de l'immunisation |
Publisher | |
Pages | 392 |
Release | 2006 |
Genre | Immunization |
ISBN | 9780660193922 |
The seventh edition of the Canadian Immunization Guide was developed by the National Advisory Committee on Immunization (NACI), with the support ofthe Immunization and Respiratory Infections Division, Public Health Agency of Canada, to provide updated information and recommendations on the use of vaccines in Canada. The Public Health Agency of Canada conducted a survey in 2004, which confi rmed that the Canadian Immunization Guide is a very useful and reliable resource of information on immunization.
Plotkin's Vaccines,E-Book
Title | Plotkin's Vaccines,E-Book PDF eBook |
Author | Walter A. Orenstein |
Publisher | Elsevier Health Sciences |
Pages | 2574 |
Release | 2022-12-21 |
Genre | Medical |
ISBN | 0323790593 |
From the latest vaccination evidence, recommendations, and protocols . . . to new vaccine development and the use of vaccines in reducing disease, Plotkin’s Vaccines, 8th Edition, covers every aspect of vaccination. Now completely revised and updated from cover to cover, this award-winning text continues to provide reliable information from global authorities, offering a complete understanding of each disease, as well as the latest knowledge of both existing vaccines and those currently in research and development. Described by Bill Gates as "an indispensable guide to the enhancement of the well-being of our world," Plotkin’s Vaccines is a must-have reference for current, authoritative information in this fast-moving field. Contains all-new chapters on COVID-19, vaccine hesitancy, and non-specific effects of vaccines, as well as significantly revised content on new vaccine technologies such as mRNA vaccines, emerging vaccines, and technologies to improve immunization. Presents exciting new data on evolution of adjuvants across the centuries, dengue vaccines, human papillomavirus vaccines, respiratory syncytial virus vaccines, tuberculosis vaccines, and zoster vaccines. Provides up-to-date, authoritative information on vaccine production, available preparations, efficacy and safety, and recommendations for vaccine use, with rationales and data on the impact of vaccination programs on morbidity and mortality. Provides complete coverage of each disease, including clinical characteristics, microbiology, pathogenesis, diagnosis, and treatment, as well as epidemiology and public health and regulatory issues. Keeps you up to date with information on each vaccine, including its stability, immunogenicity, efficacy, duration of immunity, adverse events, indications, contraindications, precautions, administration with other vaccines, and disease-control strategies. Covers vaccine-preventable diseases, vaccine science, and licensed vaccine products, as well as product technologies and global regulatory and public health issues. Analyzes the cost-benefit and cost-effectiveness of different vaccine options. Helps you clearly visualize concepts and objective data through an abundance of tables and figures.