Postlicensure safety evaluation of human papilloma virus vaccines

Issue title: Special Issue: Vaccines

Article type: Research Article

Authors: Labadie, Jerry

Affiliations: Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden

Note: [] Address for correspondence: Jerry Labadie, MD, Vaccine Safety Specialist, Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Box 1051, 751 40 Uppsala, Sweden. Visiting address: Bredgränd 7, Uppsala. Tel.: +46 18 65 60 60; +46 18 65 16 59 (direct); Website: www.who-umc.org; E-mail: [email protected]

Abstract: 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.

DOI: 10.3233/JRS-2011-0529

Journal: International Journal of Risk & Safety in Medicine, vol. 23, no. 2, pp. 103-112, 2011