Global Vaccine Safety Blueprint


Book Description

"WHO is developing a global vaccine safety blueprint to improve existing vaccine safety systems in low- and middle-income countries (LMIC). In preparation for the blueprint, information on the perception of vaccine safety experts about the performance of vaccine safety systems in LMIC, as well as their expectations and recommendations, was sought. To outline local experience, available infrastructures, needs and priorities of vaccine safety monitoring expressed in LMIC, we performed a survey of vaccine safety stakeholders with different professional backgrounds in LMIC. Experts were randomly sampled by country economic status, WHO region and population size. Their relevant perspectives were elicited via questionnaire by four scientific areas of vaccine safety monitoring. Follow-up clarifications were implemented when appropriate. Of the 182 professionals who initially agreed to participate, 78 (43%) coming from 28 LMIC, returned the survey. Of these, 89% coming from 26 LMIC, expressed the need to improve the capacity and quality of vaccine safety monitoring in their countries. The main needs expressed were support for training (80% from 27 LMIC) and harmonized methods, including standardized case definitions (74% from 26 LMIC). Eighty-two percent of professionals coming from 24 countries report to have spontaneous reporting systems. Of these, 52% coming from 20 countries, indicate actual detection of reports. Fifty-six percent, coming from 19 countries, indicated the existence of at least basic health databases. However, only 15%, coming from six countries, reported conducting epidemiological studies using these resources. Forty-five percent, coming from 14 countries, wish to achieve the ability to link health-care databases. Forty-five percent, coming from 18 countries, indicate that they are partially relying on vaccine safety information from other countries. Thirty percent, coming from 15 countries, requested improved international collaboration and, as high as 93%, coming from 26 LMIC, expressed the need for support from an international consortium. Ensuring the safety of vaccines is considered important by public-health experts from LMIC. There is a need to improve the quality of existing vaccine safety data, to enhance local analytic capacity, to establish health-care databases and to enhance information sharing within and across countries. This could best be accomplished through a concerted effort to provide training and harmonized tools, and an international support structure, so that countries can perform vaccine safety functions effectively."--Page 1.




COVID-19 vaccines


Book Description




Ranking Vaccines


Book Description

As a number of diseases emerge or reemerge thus stimulating new vaccine development opportunities to help prevent those diseases, it can be especially difficult for decision makers to know where to invest their limited resources. Therefore, it is increasingly important for decision makers to have the tools that can assist and inform their vaccine prioritization efforts. In this first phase report, the IOM offers a framework and proof of concept to account for various factors influencing vaccine prioritization-demographic, economic, health, scientific, business, programmatic, social, policy factors and public concerns. Ranking Vaccines: A Prioritization Framework describes a decision-support model and the blueprint of a software-called Strategic Multi-Attribute Ranking Tool for Vaccines or SMART Vaccines. SMART Vaccines should be of help to decision makers. SMART Vaccines Beta is not available for public use, but SMART Vaccines 1.0 is expected to be released at the end of the second phase of this study, when it will be fully operational and capable of guiding discussions about prioritizing the development and introduction of new vaccines.







Making Markets for Vaccines


Book Description

A legacy of our generation -- Ch. 1. We need to invest more in vaccines -- Ch. 2. Promoting private investment in vaccine development -- Ch. 3. A market not a prize -- Ch. 4. Design choices -- Ch. 5. $3 billion per disease -- Ch. 6. Meeting industry requirements -- Ch. 7. How sponsors can do it.




Neonatal Tetanus Elimination


Book Description

This publication is one of a series of practical field guides produced by the Pan American Health Organization with best practice guidance for immunisation programmes in the region. This guide describes the strategies that have made the elimination of neonatal tetanus in the Americas possible, highlighting the progress made in surveillance to identify and monitor high-risk areas as well as immunisation activities geared towards women of childbearing age who live in those areas. Sections cover: epidemiology, clinical aspects, case definitions and investigations, surveillance, data analysis, control in high risk areas, programme monitoring, vaccine storage and supply.




Definition and Application of Terms for Vaccine Pharmacovigilance


Book Description

This report from the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with WHO covers the activities and outputs of the CIOMS/WHO Working Group on Vaccine Pharmacovigilance (2005-2010). This working group brought together experts from both industrialized and emerging countries representing regulatory agencies, vaccine industry, national and international public health bodies including WHO and CIOMS, academia and clinical care, contributing from their different perspectives. The report covers general terms and definitions for vaccine safety and discusses the application of such harmonized tools in vaccine safety surveillance and studies. As well, the report highlights case definitions for adverse events typically reported for vaccines. The report is addressed to those engaged in vaccine safety data collection and evaluation, and will also make a useful reading for others who want to familiarize themselves with vaccine safety terminology.




Immunization Safety Review


Book Description

The Immunization Safety Review Committee was established by the Institute of Medicine (IOM) to evaluate the evidence on possible causal associations between immunizations and certain adverse outcomes, and to then present conclusions and recommendations. The committee's mandate also includes assessing the broader societal significance of these immunization safety issues. While all the committee members share the view that immunization is generally beneficial, none of them has a vested interest in the specific immunization safety issues that come before the group. The committee reviews three immunization safety review topics each year, addressing each one at a time. In this fifth report in a series, the committee examines the hypothesis that exposure to polio vaccine contaminated with simian virus 40 (SV40), a virus that causes inapparent infection in some monkeys, can cause certain types of cancer.




Mann's Pharmacovigilance


Book Description

Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.