POST-MARKETING PASSIVE SURVEILLANCE OFBIVALENT AND QUADRIVALENT HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINES

Objective: Cervical cancer and other Human papillomavirus associated malignancies might be prevented by Human papillomavirus vaccines namely Gardasil® (HPV4) - quadrivalent (Merck) and Cervarix™ (HPV2) - bivalent (GlaxoSmithKline) which are marketed internationally. The aim of this study is to analyze vaccines adverse events reporting system (VAERS) which is used for post-marketing passive surveillance (PMS) of licensed vaccines.Methods: We searched and analyzed reports of adverse events associated with HPV 2 and HPV4 vaccines from Vaccine Adverse Event Reporting System (VAERS). In United States, between the year2006-2013, total 24, 719 adverse events were reported after taking HPV2 and HPV4 vaccines. For HPV2 vaccine, we searched for reports from October 2009 to December 2013 and for HPV4 vaccine, we searched for reports from October 2006 to December 2013.Results: For HPV4 vaccine during 2006-2013, total 24, 460 adverse events and 84 deaths were reported while for HPV2 vaccine during 2009-2013, total 259 adverse events and 3 deaths were reported. Even after proper route of HPV vaccinesadministration i. e. intramuscular 13, 287 adverse events have been reported for HPV4 while 259 adverse events have been reported for HPV2 vaccine. The most frequently recorded adverse events due to HPV4 vaccine were found to be within the year 2006-2013 which included rash (2306 cases) followed by injection site erythrema (2245 cases) and pyrexia (2142 cases). However, adverse events recorded for HPV2 vaccine were within the period 2009-2013 which included dizziness (37 cases) followed by headache (34 cases) and malaise (19 cases).Conclusion: In future ongoing HPV vaccines safety surveillance and further studies may shed light on some of the hypothesized associations