تحميل

Valneva Scotland Ltd

2. الموقع (العنوان البريدي):
Oakbank Park Road, Livingston, EH53 0TG
3. وصف عام لأنواع الأمراض التي يغطيها:

Japanese Encephalitis Viral Vaccine

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).

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).

An Investigational Medicinal Product (IMP) licence for clinical trial manufacture granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in a fully segregated, multi-purpose clinical trial material manufacturing facility (“CTM Unit“) for the bulk production of viral products intended to undergo clinical investigations is in place and currently a manufacturing campaign for the following vaccine candidate is ongoing;

 

Chikungunya vaccine VLA1553

A 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.

Valneva successfully completed a Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine candidate

SARS CoV-2 Inactivated Viral Vaccine VLA2001

The vaccine candidate is produced using the manufacturing platform of Valneva’s commercial Japanese encephalitis (JE) vaccine using a Vero-cell based process to generate a highly-purified and inactivated whole virus vaccine candidate adjuvanted with Alum and CpG 1018.

Valneva initiated Phase 1/2 clinical study in December 2020

Positive Phase 3 results from a randomized, observer-blind controlled immunogenicity trial

Cov-Compare comparing the vaccine candidate VLA2001 to AZD12221 have been generated

Rolling submissions for initial approval of the VLA2001 vaccine candidate with the European Medicines Agency and the UK MHRA are ongoing and Valneva expects further regulatory approvals in the first quarter of 2022.

Batch manufacture at commercial scale was initiated in 2021 in a licenced CL3 Production Facility