Post-Authorization Safety Study of Papilloguard (A Domestically Manufactured Bivalent (16,18) HPV Vaccine in Iran

Background: In recent years, various vaccines, including Papilloguard, have been introduced to prevent transmission of this virus. This vaccine has shown good immunogenicity and efficacy profile in phase III study; however, its safety remains controversial. This study aimed to investigate the complications and adverse events associated with the Papilloguard vaccine in the Iranian population. Methods: In this survey study, 1,028 volunteers (690 (67.1%) female and 338 (32.9%) males, mean age 33.8±7.01), who had received the Papilloguard vaccine and whose basic information was recorded in the Papilloguard vaccine registration system by call center team of Arta Pharmed Company (Tehran, Iran) were examined. Cumulative vaccine-related complications were assessed and recorded by Arta Pharmed Company’s call center team 7 days, 1 month, and 6 months after receiving each dose of vaccine during the 6 months following vaccination. Patient evaluations were conducted over the phone. Any complication leading to hospitalization or requiring medical interventions was defined as a serious complication. Result: The cumulative incidence of at least one complication immediately after injection, 7 days, 1 month, and 6 months after injection was reported in 272 (26.5%), 101 (9.8%), 74 (7.2%), and 29 (2.8%) of the participants, respectively. Post-injection pain was the most common complication after vaccination, 227 (22.1%). The cumulative incidence of injection site pain 7 days, 1 month, and 6 months after injection was 8.4%, 5.7%, and 0.7%, respectively. In terms of severity of complications, complications were reported as mild in 253 (24.6%), moderate in 15 (1.5%), and severe in 4 (0.4%) recipients. Only 0.4% of recipients experienced severe complications. Conclusion: In a mid-term follow-up, in the Iranian population, Papilloguard vaccine had few side effects and was well tolerated. Papilloguard vaccine can be included in national vaccination guidelines for the prevention of HPV and its consequences.