Post-marketing Surveillance on Safety of Japanese Encephalitis Vaccine SA 14-14-2 in Burdwan District of West Bengal, India.

Abstract

Background- Japanese Encephalitis with high mortality and disability is serious public health menace in South-East Asia including India. Successful JE control of other S.E.Asian countries and the largest epidemic in Uttar Pradesh, led India to initiate mass vaccination campaign, in 2006, for immunizing 1-15 years children of eleven hyperendemic districts of five states with SA-14-14-2 JE vaccine. Methodology-Community based Active Postmarketing Surveillance for one year was conducted, in randomly selected villages of a randomly selected block of Burdwan district, West Bengal, involving 720 target children with objective to explore the safety of SA-14-14-2 vaccine, in Indian perspective. Results- About 15% and ≤1% participants suffered from pain and swelling and/or redness at injection site. Fever was the most prominent general systemic reaction developed by about 10-15% subjects, < 5% children reported reactions like headache, bodyache, nausea-vomiting, listlessness, loss of appetite, pain abdomen and loose motions etc. whereas almost 5-8% vaccinees affected by cough and runny nose. No serious AEs was reported up to one year after vaccination. Conclusion- Being consistent with results of other studies, present findings led to conclude that short term safety of vaccine appeared satisfactory requiring long term monitoring of AEFIs to explore its remote serious AEs.