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Published on: March 8, 2012
Postlicensure safety evaluation of human papilloma virus vaccines
1Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden. jerry.labadie@who-umc.org
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.
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