Valneva announced the signing of a new contract, lasting up to three years, with the U.S. government Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine IXIARO®.
The new contract spans a total of three years (one base year, plus two option years) with a base-year value of $61 million. The DoD has the option to purchase a total of $76 million - $105 million worth of IXIARO® across the two option years. Deliveries for the base-year will commence in the fourth quarter 2020.
“We are very pleased with this new contract including the longer duration of up to three years – a clear demonstration of the clinical need for personnel deployed to JE endemic areas. The U.S. military has been using IXIARO® for the past ten years and we are excited to continue to help protect military personnel, their families, civilian government service personnel, and government contractors from this potentially deadly disease,” Franck Grimaud, Chief Business Officer of Valneva said.
IXIARO® is the only JE vaccine approved by the U.S. Food and Drug Administration (FDA), having been developed through a cooperative research and development agreement with the Walter Reed Army Institute of Research. Valneva markets and distributes IXIARO® directly to the U.S. military and U.S. private market.
Valneva’s Japanese encephalitis vaccine is indicated for active immunization for the prevention of the disease for people who travel to, or live in, endemic areas. It has received marketing approval in the U.S., Europe, Canada, Hong Kong, Singapore, and Israel under the trade name IXIARO® and in Australia and New Zealand where it is marketed as JESPECT®. It is the only vaccine available to the U.S. military for Japanese Encephalitis. IXIARO® is approved for use in individuals two months of age and older in the U.S. and EU member states, Canada, Norway, Liechtenstein, Iceland, Singapore, Hong Kong, Japan, the Republic of Korea and Israel. In all other licensed territories, IXIARO®/JESPECT® is indicated for use in persons aged 18 years or more.
Japanese encephalitis is a deadly infectious disease found mainly in Asia. About 70,000 cases of JE are estimated to occur in Asia each year, although the actual number of cases is likely much higher due to underreporting in rural areas. JE is fatal in approximately 30 percent of those who show symptoms, and leaves half of survivors with permanent brain damage. The disease is endemic in Southeast Asia, India and China, a region with a population of more than three billion. In 2005, JE killed more than 1,200 children in only one month during an epidemic outbreak in Uttar Pradesh, India, and Nepal.