Hsuan-Yin Ma1, Chung-Chih Lai2, Nan-Chang Chiu3, Ping-Ing Lee4. 1. Sanofi Pasteur, Taiwan, 7F., No.3, Songren Rd., Xinyi Dist., Taipei City 11010, Taiwan. 2. Medical Affairs, Asia & JPAC, Sanofi Pasteur, 38 Beach Road, #18-11 South Beach Tower, Singapore 189767, Singapore. 3. Department of Pediatrics, Mackay Children's Hospital, No. 92, Section 2, Zhongshan N Rd, Zhongshan District, Taipei City 10449, Taiwan; Department of Medicine, MacKay Medical College, No. 46, Section 3, Zhongzheng Road, Sanzhi District, New Taipei City 252, Taiwan. Electronic address: ncc88@mmh.org.tw. 4. Department of Pediatrics, National Taiwan University Hospital, and National Taiwan University College of Medicine, No.8, Chung Shan S. Rd., Taipei 10041, Taiwan. Electronic address: pinging@ntu.edu.tw.
Abstract
BACKGROUND: Japanese encephalitis (JE) is a significant public health concern in the Asia-Pacific region, with a case-fatality rate of around 20% for those who develop encephalitis. Mouse-brain derived vaccines against JE have been used in the publicly funded national immunization program (NIP) in Taiwan since 1968. They were replaced with a live-attenuated recombinant vaccine (JE-CV, IMOJEV®) in May 2017. We assessed reports of adverse events (AE) following the introduction of JE-CV into the Taiwan NIP to characterize its post-licensure safety profile. METHODS: AEs reported between 1 May 2017 and 31 December 2018 post vaccination with JE-CV were extracted from the National Adverse Drug Reactions (ADR) Reporting System, a passive surveillance system run by the Taiwan Food and Drug Administration. The report rates were calculated based on the number of doses distributed by the manufacturer during the assessment period. RESULTS: There were 51 AEs reported among 30 subjects (12 girls and 18 boys; mean age 25 months), with a reporting rate of 4.7 AEs per 100,000 doses distributed. The AEs occurred after a median of. 1-day post vaccination. Eight subjects had received concomitant vaccination with another vaccines. There were four serious AEs reported: febrile seizure, acute renal failure, viral respiratory tract infection, and injection site cellulitis. None of these serious AEs were classified as being causally related to JE-CV vaccination. CONCLUSION: These post-licensure AE surveillance data confirm the favorable safety profile of JE-CV.
BACKGROUND:Japanese encephalitis (JE) is a significant public health concern in the Asia-Pacific region, with a case-fatality rate of around 20% for those who develop encephalitis. Mouse-brain derived vaccines against JE have been used in the publicly funded national immunization program (NIP) in Taiwan since 1968. They were replaced with a live-attenuated recombinant vaccine (JE-CV, IMOJEV®) in May 2017. We assessed reports of adverse events (AE) following the introduction of JE-CV into the Taiwan NIP to characterize its post-licensure safety profile. METHODS: AEs reported between 1 May 2017 and 31 December 2018 post vaccination with JE-CV were extracted from the National Adverse Drug Reactions (ADR) Reporting System, a passive surveillance system run by the Taiwan Food and Drug Administration. The report rates were calculated based on the number of doses distributed by the manufacturer during the assessment period. RESULTS: There were 51 AEs reported among 30 subjects (12 girls and 18 boys; mean age 25 months), with a reporting rate of 4.7 AEs per 100,000 doses distributed. The AEs occurred after a median of. 1-day post vaccination. Eight subjects had received concomitant vaccination with another vaccines. There were four serious AEs reported: febrile seizure, acute renal failure, viral respiratory tract infection, and injection site cellulitis. None of these serious AEs were classified as being causally related to JE-CV vaccination. CONCLUSION: These post-licensure AE surveillance data confirm the favorable safety profile of JE-CV.