Adverse events following immunization with the live-attenuated recombinant Japanese encephalitis vaccine (IMOJEV®) in Taiwan, 2017-18 BrowZine Journal Cover
Journal
Vaccine
Journal Volume
38
Journal Issue
33
Pages
5219-5222
Date Issued
2020
Author(s)
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. ? 2020 The Authors
Subjects
Adverse event; Chimeric; Live-attenuated recombinant Japanese encephalitis vaccine; National immunization program; Vaccine safety
SDGs
Other Subjects
diphtheria pertussis poliomyelitis tetanus Haemophilus influenzae type b vaccine; hepatitis A vaccine; Japanese encephalitis vaccine; live vaccine; measles mumps rubella vaccine; Pneumococcus vaccine; recombinant Japanese encephalitis vaccine; unclassified drug; Japanese encephalitis vaccine; virus antibody; acute kidney failure; adverse event; age distribution; Article; behavior change; child; conjunctivitis; decreased appetite; diarrhea; drug eruption; drug industry; drug monitoring; drug safety; drug surveillance program; eye discharge; fatigue; febrile convulsion; female; fever; focal glomerulosclerosis; headache; hematuria; human; immunization; injection site cellulitis; injection site edema; injection site erythema; injection site reaction; injection site swelling; male; preschool child; priority journal; rhinorrhea; school child; sex difference; side effect; tachypnea; Taiwan; throat disease; viral respiratory tract infection; vomiting; Asia; Japanese encephalitis; vaccination; Antibodies, Viral; Asia; Encephalitis, Japanese; Humans; Japanese Encephalitis Vaccines; Taiwan; Vaccination
Publisher
Elsevier Ltd
Type
journal article