India on Friday launched its first indigenous vaccine to protect children from Japanese encephalitis. Until now, the country has been importing the vaccine from China.
The Vero cell-derived purified inactivated JE vaccine–JENVAC, which received manufacturing and marketing approvals from the Drug Controller General of India, is the first vaccine to be manufactured in the public-private partnership mode between the Indian Council of Medical Research and Bharat Biotech.
The vaccine will provide increased immunogenicity and long-term protection as a result of unique manufacturing technologies.
Japanese encephalitis, a mosquito-borne viral infection, is the most common cause of viral encephalitis in eastern Uttar Pradesh (U.P.), affecting 171 districts and claiming hundreds of lives every year. Mortality is higher among children and thousands of them in this area have been rendered disabled by it.
The virus strain for this vaccine was isolated in Kolar, Karnataka, during the early 1980s and characterised by the National Institute of Virology at Pune. The strains were transferred to Bharat Biotech for further vaccine development.
The most significant benefit JENVAC brings over live attenuated vaccines (those that reduce the harmful effects of pathogens but keep them viable) is that it can be administered during an epidemic as it is a highly purified and inactivated vaccine.
In the clinical trials, JENVAC showed superior safety and immunogenicity, in comparison to live vaccine. It met all its primary and secondary endpoints in the age group of 1-50 years, after 1 or 2 doses in vaccination. Phase III trials showed 98.7 per cent sero-protection 28 days after the first dose, and 99.8 per cent sero-protection 28 days after the second dose.
The results proved that JENVAC can be administered as a single dose during epidemics for mass vaccination campaigns and also as a two-dose schedule during routine immunisation as part of the National immunisation programme in endemic regions.
Bharat Biotech will pursue a dual pricing strategy for JENVAC to cater to the needs of government and private agencies. While the price is expected to be around Rs 160 per dose in the open market, the price for government agencies is still being negotiated.
Describing the vaccine as an “Indian solution for an Indian problem”, Union Health and Family Welfare Minister Ghulam Nabi Azad said this completely indigenous vaccine was an outstanding example of public-private partnership and a remarkable milestone in the emergence of India as an innovative and self-sufficient technology hub.
“Since we were using a vaccine imported from China, availability was certainly an issue for comprehensive and quick augmentation of the national programme,” he said, adding that the need for this vaccine was immense since the birth cohort in the affected 171 districts was about 40 lakh annually, requiring about 1 crore doses for a comprehensive coverage.
The current manufacturing capacity of JENVAC is 20 million doses, expandable to 60 million doses based on market requirements. The vaccine is available in both single dose and 5 dose presentations, Krishna M. Ella, Chairman and Managing Director of Bharat Biotech said. “It is yet another milestone for Bharat Biotech.”