Biological E (BioE) and European biotech company Valneva SE (Valneva) are now prequalified by the World Health Organization (WHO) for the global use in adults of the former Japanese Encephalitis vaccine. This is the first prequalification of a Japanese Encephalitis vaccine, and is a key step in ensuring the vaccine can be distributed to developing countries.

The company also expects the pediatric indication to be prequalified by the end of the year.

In 2005, Biological E and Valneva inked a partnership for the development and commercialization of a Japanese encephalitis vaccine for endemic regions, based on latter’s JEV technology. The vaccine, which was successfully developed under this partnership, is being marketed in India under the trade name JEEV and commercialization in other JE-endemic countries is planned.

Valneva is a new European biotech company focused on vaccine development and antibody discovery. It was created in 2013 through the merger between Intercell AG and Vivalis SA.

Mahima Datla, MD of Biological E Limited, said that it was an extremely important achievement for the vaccines community. Our vaccine’s prequalification is well in time to support GAVI’s plans of introducing the JE vaccine in several developing countries.

 “We share the excitement for this great achievement and are pleased that our technology used for IXIARO which is FDA and EMA approved will now help introducing an excellent vaccine in countries of substantial needs, stated Thomas Lingelbach, Valneva’s president and CEO and Franck Grimaud, Valneva’s president and chief business officer.

Biological E has emerged as a fast growing company. Early this year, the company also entered into a five year pentavalent supply arrangement with GAVI. In this regard, it has entered into a joint venture with GSK to develop a six-in-one paediatric vaccine combining the latter’s IPV It had also entered into a licensing pact with Novartis’s phase II typhoid conjugate vaccine.

Japanese encephalitis caused by a flavivirus that affects the membranes around the brain. Approximately one in 200 infections results in severe disease characterized by rapid onset of high fever, headache, neck stiffness, disorientation, coma, seizures, spastic paralysis and death. The case fatality rate can be as high as 60 per cent among those with disease symptoms; 30 per cent of those who survive suffer from lasting damage to the central nervous system. The severity of JE infections has been recognized by the medical community and the global health authorities have emphasized the need for routine vaccination, campaigns and travelers vaccine for endemic countries. The disease is endemic to many regions in Asia and South East Asia including in India, Bangladesh, Bhutan, Myanmar, Cambodia, Indonesia, Laos, Malaysia, Nepal, Pakistan, Philippines, Sri Lanka, Thailand and Vietnam.