INTRODUCTION: We carried out an active surveillance of common adverse events occurring among women (9 to 26 years old) receiving human papillomavirus vaccine (Gardasil® and Cervarix®) in 9 Italian Regions.
METHODS: Common adverse events occurring in the two weeks following each dose administration were collected using a structured diary.
RESULTS: From August 2008 to September 2011, 12,066 immunised women (9,084 receiving Cervarix® and 2,982 Gardasil®) were included in the surveillance for a total of 29,494 administered doses. 53% of women concluded the vaccination cycle (74% with Gardasil® and 47% with Cervarix®). 61% of women experienced an adverse event after the administration of the first dose. The high proportion of adverse events reported is mainly due to the design of the study, since women were requested to report all events occurring after the vaccination; however the majority of events were mild and transient.
DISCUSSION: As for all vaccines, and in particular for newly marketed ones, the surveillance of adverse events represents an essential step in the evaluation of a vaccination programme.
Republished from: Green Med Info