Post-marketing safety surveillance for inactivated and live-attenuated Japanese encephalitis vaccines in China, 2008–2013

Wu, Wendi; Liu, Dawei; Li, Keli; Nuorti, J. Pekka; Nohynek, Hanna; Xu, De‐Hai; Ye, Jiakai; Zheng, Jingshan; Wang, Huaqing

doi:10.1016/j.vaccine.2017.05.021

Cited by 12 publications

(5 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The live-attenuated vaccine is immunogenic, induces long term immunity, and requires one or two doses in childhood [143]. In China and Nepal, two dose regimens in children led to seroconversion in 97.5% and 98% of recipients, respectively, with high levels of antibody persisting for up to five years following immunisation [144,145]. While initially only available in China, it is now the recommended vaccine for many endemic countries in Asia [146].…”

Section: Jev Vaccinationmentioning

confidence: 99%

The Ecology and Evolution of Japanese Encephalitis Virus

et al. 2021

View full text Add to dashboard Cite

Japanese encephalitis virus (JEV) is a mosquito-borne flavivirus mainly spread by Culex mosquitoes that currently has a geographic distribution across most of Southeast Asia and the Western Pacific. Infection with JEV can cause Japanese encephalitis (JE), a severe disease with a high mortality rate, which also results in ongoing sequalae in many survivors. The natural reservoir of JEV is ardeid wading birds, such as egrets and herons, but pigs commonly play an important role as an amplifying host during outbreaks in human populations. Other domestic animals and wildlife have been detected as hosts for JEV, but their role in the ecology and epidemiology of JEV is uncertain. Safe and effective JEV vaccines are available, but unfortunately, their use remains low in most endemic countries where they are most needed. Increased surveillance and diagnosis of JE is required as climate change and social disruption are likely to facilitate further geographical expansion of Culex vectors and JE risk areas.

show abstract

Section: Jev Vaccinationmentioning

confidence: 99%

The Ecology and Evolution of Japanese Encephalitis Virus

et al. 2021

View full text Add to dashboard Cite

show abstract

“…Safety data from clinical trials showed SA14-14-2 JE vaccine to be well-tolerated and established the vaccine’s good safety profile [ 3 , 6 , 7 , 10 , 18 ]. Available post-marketing surveillance data primarily have been collected through routine passive AEFI surveillance systems and during the vaccine’s use in routine immunization programs [ 19 – 21 ]. It is difficult to compare AEFI rates from post-marketing surveillance conducted in diverse settings with different methodologies, and when SA14-14-2 JE vaccine is used in routine immunization programs when it is often co-administered with measles or other vaccines.…”

Section: Discussionmentioning

confidence: 99%

An evaluation of adverse events following an immunization campaign with the live, attenuated SA14-14-2 Japanese encephalitis vaccine in Cambodia

et al. 2022

View full text Add to dashboard Cite

Introduction Japanese encephalitis (JE) virus is the most common cause of vaccine-preventable encephalitis in Asia. The SA14-14-2 JE vaccine manufactured by Chengdu Institute of Biological Products has been shown to be safe and effective in clinical trials and childhood routine immunization programs. However, there are few published reports describing results of surveillance for adverse events following immunization (AEFI) when the vaccine is used in mass campaigns. We describe the results of AEFI surveillance following a 2013 vaccination campaign among almost 310,000 children aged 9 months–12 years in Battambang Province, Cambodia. Methods Routine AEFI surveillance was strengthened by staff training and supplemented by active hospital surveillance. An AEFI was defined as any sign, symptom, or disease temporally associated (i.e., within 4 weeks) with receipt of the vaccine, irrespective of whether it was considered related to immunization. Data were collected on standardized forms and causality assessments were conducted for serious AEFI. Results Passive and active surveillance detected 28 AEFI for an overall incidence of 9.0 AEFI per 100,000 doses administered. The most frequent events were vasovagal episodes (n = 7, 25%) and rash (n = 6, 21%), and most other events were common childhood conditions such as fever and vomiting. Three AEFI were classified as serious, including one hypersensitivity reaction and two meningoencephalitis cases. Of these, the hypersensitivity event was the only serious AEFI classified as being consistent with a causal association to immunization. Conclusions Most reported adverse events were conditions that commonly occur after other childhood vaccinations or independently of vaccination, and in the context of careful monitoring for serious AEFI only one serious event consistent with a causal association with immunization was identified. These results support the good safety profile of the SA14-14-2 JE vaccine, and provide reassuring data as the vaccine’s use expands.

show abstract

“…It may be composed of entire virions or bacterial cells or only their fragments. Inactivated virus vaccines that are currently used include the inactivated polio vaccine [ 201 ], inactivated Japanese encephalitis vaccine [ 202 ], inactivated hepatitis A vaccine [ 203 ], inactivated rabies vaccine [ 204 ], hand-foot-and-mouth disease vaccine [ 205 ], cholera vaccine [ 206 ], leptospirosis vaccine, bleeding heat vaccine, and forest encephalitis vaccines. For obvious reasons, inactivated vaccines are intrinsically much safer than live vaccines, and they generally have a more complete molecular spatial structure.…”

Section: Concepts and Methods Of Vaccine Developmentmentioning

confidence: 99%

Advances in the design and development of SARS-CoV-2 vaccines

et al. 2021

View full text Add to dashboard Cite

Since the end of 2019, coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread worldwide. The RNA genome of SARS-CoV-2, which is highly infectious and prone to rapid mutation, encodes both structural and nonstructural proteins. Vaccination is currently the only effective method to prevent COVID-19, and structural proteins are critical targets for vaccine development. Currently, many vaccines are in clinical trials or are already on the market. This review highlights ongoing advances in the design of prophylactic or therapeutic vaccines against COVID-19, including viral vector vaccines, DNA vaccines, RNA vaccines, live-attenuated vaccines, inactivated virus vaccines, recombinant protein vaccines and bionic nanoparticle vaccines. In addition to traditional inactivated virus vaccines, some novel vaccines based on viral vectors, nanoscience and synthetic biology also play important roles in combating COVID-19. However, many challenges persist in ongoing clinical trials.

show abstract

Post-marketing safety surveillance for inactivated and live-attenuated Japanese encephalitis vaccines in China, 2008–2013

Abstract: While our analysis did not find apparent safety concern of JE vaccines in China, further study should consider JE-I vaccines and febrile convulsion, and taking more sensitive methods to detect signals.

Cited by 12 publications

References 29 publications

The Ecology and Evolution of Japanese Encephalitis Virus

The Ecology and Evolution of Japanese Encephalitis Virus

An evaluation of adverse events following an immunization campaign with the live, attenuated SA14-14-2 Japanese encephalitis vaccine in Cambodia

Advances in the design and development of SARS-CoV-2 vaccines

Contact Info

Product

Resources

About