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 effectsI documenti in FLORE sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.