@inbook{c756756e5f4a41b7b0e149d7a1360372,
title = "How Vaccine Safety is Monitored",
abstract = "Safety expectations for vaccines are high because they are administered to healthy and sometimes vulnerable populations. Also, vaccines are endorsed and required by most governments. Although no biologic or medical intervention is perfectly safe, vaccines are generally very safe and the risks of side effects are almost always greatly outweighed by the benefits derived from vaccination to prevent disease. Vaccine safety is evaluated at all stages of development, including preclinical animal and laboratory studies, phase 1-3 clinical trials, and after licensure. Regulatory authorities conduct in-depth reviews of investigational new vaccines prior to approval for licensure and usually require postlicensure surveillance and special studies. Many industrialized countries conduct clinical assessment of postlicensure adverse events and individual-level causality assessment. National authorities in many countries compensate persons who may have been injured by vaccines. Vaccine safety programs are coordinated in many countries and internationally. Questions about vaccine safety will undoubtedly continue to occur, and continuous monitoring will be needed to address these questions with rigorous scientific methods to help assure the public that vaccines are made as safe as possible.",
keywords = "IND application, Passive surveillance, Postmarketing surveillance, Vaccine development",
author = "Salmon, {Daniel A.} and Halsey, {Neal A.}",
note = "Funding Information: Health-care providers should report adverse events following immunizations to national health authorities. In the United States, this system is called the Vaccine Adverse Event Reporting System (VAERS), which is jointly maintained by the FDA and the Centers for Disease Control and Prevention (CDC). Canada has the Immunization Monitoring Program, ACTive (IMPACT) run by the Canadian Paediatric Society with funding from the Public Health Agency of Canada. European countries have surveillance systems, which are often integrated into drug safety surveillance, and all European member states report to the EMA. 5 For example, the United Kingdom has a system referred to as the “yellow card” administered by the Medicines and Healthcare Products Regulatory Agency. Argentina, Brazil, Mexico, Panama, and Venezuela use a passive system called SANEVA. A 2012 report from WHO indicates that about 80% of low- and middle-income countries (LMIC) report spontaneous or passive safety surveillance systems; however, only about half of these countries report detection of vaccine adverse event reports. 6 WHO has developed a multiphase plan for improved surveillance and investigation of vaccine safety in LMIC. 7 The WHO Collaborating Centre for International Drug Monitoring or the Uppsala Monitoring Center (UMC) is an independent foundation and center for service and research whose activities include improving passive safety surveillance internationally. Publisher Copyright: {\textcopyright} 2016 Elsevier Inc. All rights reserved. Copyright: Copyright 2016 Elsevier B.V., All rights reserved.",
year = "2016",
month = jul,
day = "11",
doi = "10.1016/B978-0-12-802174-3.00008-4",
language = "English (US)",
isbn = "9780128021743",
pages = "153--165",
booktitle = "The Vaccine Book",
publisher = "Elsevier Inc.",
}