Biological E. and Intercell entered into a contract agreement in 2005 to develop, manufacture, commercialize, and distribute Intercell’s Japanese Encephalitis vaccine in India and the Indian subcontinent.
The approval was based on the positive pivotal Phase III safety and immunogenicity data and also on the primary endpoint.
Intercell CEO Thomas Lingelbach said the approval by the Indian authorities represents an important milestone in their strategy to roll out their Japanese Encephalitis vaccine in endemic countries with high medical need and to protect children and adults against this terrible disease.
Biological E.chairman & MD Vijay Kumar Datla said they are pleased that they are able to now manufacture the JEEV vaccine locally and will begin discussion with stakeholders to see how this vaccine can play a role in supporting India’s on-going fight against the dreadful disease.