Analysis On Post-marketing Immunization Safety Of Hepatitis A Vaccine, Live And Hepatitis A Vaccine, Inactivated In China

Background Post-marketing surveillance of Adverse Events Following Immunization (AEFI) is the most important method to evaluate the safety of Hepatitis A Attenuated Live Vaccine(HepA-L) and Hepatitis A Inactivated Vaccine(HepA-I) in China. This study analyzed the data from the post-marketing surveillance from Beijing, Shanghai, Hebei, Guangdong, Guangxi, Shandong province to evaluate the safety of HepA-L and HepA-I.Objectives This study is to evaluate the post-marketing immunization safety of HepA-L and HepA-I in China.Methods Through National Surveillance System for Adverse Events Following Immunization (AEFI),AEFI for HepA during 2007-2008 were collected in 5 pilot provinces, and the occurrence features of AEFIs were analyzed by using descriptive methodology.Results In total,220 AEFI cases were reported from Jan.l 2007 to Dec.31 2008 in 6 pilot provinces. The over incidence rates of AEFIs for post-marketing HepA-L and HepA-I were 24.11 and 55.19 per million doses.106 Cases as serious adverse reactions had been reported (reported rate:19.93 per million). Serious adverse reactions includes: Fever (≥38.6℃)(53cases,9.97 per million), Allergic reactions(52 cases,9.78 per million), Sterile abscess(lcases,0.19 per million)。28 serious adverse reactions for HepA-L had been reported (reported rate:11.84 per million). Serious adverse reactions includes:Fever (≥38.6℃)(15cases,6.34 per million), Allergic reactions(13 cases,5.50 per million)。78 serious adverse reactions for HepA-I had been reported (reported rate: 26.41 per million). Serious adverse reactions includes:Fever (≥38.6℃)(38cases,12.87 per million), Allergic reactions(39 cases,13.20 per million), Sterile abscess(lcases, 0.34 per million)。 Analysis on the serious adverse reaction by Age, Sex, Manufactures and Cluster shows: Reported incidence rate of AEFIs and serious adverse reactions for male is higher than female. Reported incidence rate of AEFIs and serious adverse reactions is the highest form 2 to 6. The Chinese (5 provinces) vaccine reaction estimated reporting rate of HepA-L and HepA-I were 3.39-274.22 per million doses. According to the provinces analysis, serious reaction reporting rate of Hebei the highest, followed by Shanghai, Guangdong, Beijing and Guangxi Shandong. There is no cluster analysis show for HepA-L and HepA-I.97.2% serious adverse reactions were cured or better.2 death cases in AEFIs were coincidental illness.Conclusion Both HepA-L and HepA-I have good immunization safety. The study indicated that the safety of HepA-L was better than that of HepA-L.