n Vaccine development is a complex multistep process n From concept to licensure, it takes many years to develop a vaccine n Following authorisation to market, it may be necessary to provide evidence of economic value prior to governments approving the implementation of a new vaccination programme n Safety is a major issue for any vaccine; it is assessed at every step of vaccine development and safety surveillance continues indefinitely after licensure n Sometimes an adverse reaction is observed after a vaccination. It is important to determine whether a temporal association between the adverse event and the vaccination is causal, rather than a random chance occurrence (coincidental). Otherwise, vaccination programmes are halted for risks that are only theoretical, thus endangering people’s health through not being vaccinated n Clinical and epidemiological studies indicate that licensed vaccines have a benefiterisk profile where the benefits of vaccines clearly outweigh the risks of adverse effects

Vaccine development / G. Leroux-Roels; P. Bonanni; T. Tantawichien; F. Zepp. - STAMPA. - (2011), pp. 115-150. [10.1016/j.pervac.2011.05.005]

Vaccine development

BONANNI, PAOLO;
2011

Abstract

n Vaccine development is a complex multistep process n From concept to licensure, it takes many years to develop a vaccine n Following authorisation to market, it may be necessary to provide evidence of economic value prior to governments approving the implementation of a new vaccination programme n Safety is a major issue for any vaccine; it is assessed at every step of vaccine development and safety surveillance continues indefinitely after licensure n Sometimes an adverse reaction is observed after a vaccination. It is important to determine whether a temporal association between the adverse event and the vaccination is causal, rather than a random chance occurrence (coincidental). Otherwise, vaccination programmes are halted for risks that are only theoretical, thus endangering people’s health through not being vaccinated n Clinical and epidemiological studies indicate that licensed vaccines have a benefiterisk profile where the benefits of vaccines clearly outweigh the risks of adverse effects
2011
Perspectives in Vaccinology
115
150
G. Leroux-Roels; P. Bonanni; T. Tantawichien; F. Zepp
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Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/654947
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