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Valneva Announces Approval of an EB66®-based Prototype Influenza Vaccine in Japan

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Valneva SE has announced that the Chemo-Sero-Therapeutic Research Institute (Kaketsuken) has received manufacturing and marketing approval for a cell culture pandemic influenza vaccine (prototype) (General name: Emulsion Cell Culture Influenza HA Vaccine (Prototype)). This is a result of a co-development between GlaxoSmithKline and Kaketsuken.

In March 2014, Kaketsuken received a marketing authorization in Japan for a Pandemic Influenza Vaccine (H5N1), which was the first human vaccine ever produced in the EB66® cell line. This was followed by submission, for manufacturing and marketing approval, of the Prototype Vaccine in September 2014, which resulted in today’s approval. Prototype Vaccine is a model vaccine developed and manufactured using a model virus for pandemic vaccine production, and is a mock vaccine with immunogenicity and safety confirmed in humans.

Receiving approval for the Prototype Vaccine means that if a pandemic occurs in Japan, then any type of pandemic Influenza vaccine -once the actual virus strain responsible is identified- can be manufactured and supplied to the Ministry of Health in a short period of time.

Kaketsuken has recently completed the construction of a manufacturing facility in Kumamoto enabling the company to produce pandemic vaccine for more than 40 million people within six months after the virus strain for vaccine production is decided. This represents a production capacity of more than 80 million doses.

Thomas Lingelbach, President and Chief Executive Officer and Franck Grimaud, President and Chief Business Officer of Valneva, commented “This approval constitutes another major achievement and it will provide potential revenue stream for our EB66® platform.”

To date, Valneva has more than 35 license agreements with the world’s largest pharmaceutical companies for the use of its EB66® vaccine production platform in both human and animal health vaccines. Valneva’s proprietary platform has enabled three veterinary vaccines and one human vaccine to be commercialized.