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Valneva Scotland Ltd

2. 地点(通信地址):
Oakbank Park Road, Livingston, EH53 0TG
3. 所针对疾病类型概述:

Valneva manufactures Japanese Encephalitis Viral vaccine (IXIARO®/JESPECT®) at its cGMP facilities in Livingston, Scotland. The site is licensed and operates under a Manufacturing Authorisation granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The vaccine is designed to protect travellers and military against Japanese encephalitis (JE), the leading cause of viral neurological disease & disability in Asia. 

IXIARO® is a purified, inactivated aluminum-adjuvanted JE vaccine, based on the SA14–14–2 virus strain, and is available in North America, Europe, Canada, Switzerland, Singapore, Hong Kong and Israel as well as in Australia & New Zealand (as JESPECT®). 

Marketing approval from the European Medicines Agency is held by Valneva Austria GmbH.  

Valneva supplies Japanese Encephalitis Vaccine in other territories including Taiwan, through commercial partner Adimmune (JEVAL) and in India through commercial partner Biological E (JEEV). 

Investigational Medicinal Product (IMP) licence for clinical trial manufacture granted by MHRA in a fully segregated, multi-purpose clinical trial material manufacturing facility (“CTM Unit“) allows the bulk production of viral products intended to undergo clinical investigations including: 

Zika vaccine VLA1601 

VLA1601 is a highly purified inactivated vaccine candidate against the Zika virus, developed using the same manufacturing platform as Valneva’s IXIARO® (JESPECT®) JE vaccine. In pre-clinical development, VLA1601 demonstrated excellent purity and had an overall biological, chemical and physical profile comparable to the commercially produced JE vaccine. Valneva has an established manufacturing process in its dedicated clinical JE vaccine facility.  

Chikungunya vaccine VLA1553 

A potential single-shot vaccine against a severe, growing threat, VLA1553 is a monovalent, single dose, live-attenuated vaccine candidate for protection against chikungunya. The vaccine candidate is designed for prophylactic, active, single-dose immunization against chikungunya in humans over one year old. The vaccine aims for long-lasting protection and an anticipated safety profile similar to licensed vaccines for active immunization in adults and children.