Postlicensure safety evaluation of human papilloma virus vaccines.

OBJECTIVE: A summary of postlicensure safety information of HPV vaccines from three sources: VigiBase, the global database of WHO's Programme for International Drug Monitoring, the VAERS report on Gardasil and the RIVM report on Cervarix.

METHOD: all AEFI from the three sources were recalculated to a percentage of all AEFI reported for each of the two vaccines. And the safety profile was compared to the safety data in the SPC.

RESULTS: Comparison of relative AEFI reporting proportions in the global VigiBase database with VAERS for Gardasil and with RIVM for Cervarix shows a safety profile in VigiBase similar to the result of PMS on a national level in 2 countries.

CONCLUSION: The post licensure safety profile of both vaccines is consistent with the data in the SPC of these vaccines.