Genome Valley (Hyderabad)-based vaccine and bio-therapeutic innovator, Bharat Biotech recently launched its vero cell-derived purified inactivated JE vaccine ‘JENVAC’ which received manufacturing and marketing approvals from Drug Controller General (India) (DCGI). It is a fully indigenous vaccine commercialised using strain, identified, characterised, manufactured and tested in India.
The uniqueness of JENVAC is its strength to provide increased immunogenicity and long-term protection as a result of unique manufacturing technologies. The virus strain for this vaccine was isolated in Kolar, Karnataka during the early 1980s and characterised by the National Institute of Virology, Pune and the strains were later transferred to Bharat Biotech for further vaccine development. The vaccine candidate strain was adapted to vero cell substrate and is manufactured using novel purification, inactivation techniques with advanced bioreactor technology. The most significant benefit JENVAC brings over live attenuated vaccines is that it can be administered during disease epidemics because it is a highly purified and inactivated vaccine.
Dr VM Katoch, Secretary Department of Health Research, Government of India, said, “JENVAC not only represents a successful example of developing a totally Indian product of immense public health importance by public-private partnership but also will prove to be a good stimulus to Indian Council of Medical Research (ICMR) institutes and other institutions to move fast with their leads to fully developed products by following this route.”
In clinical trials, JENVAC showed superior safety and immunogenicity, in head-to-head comparison with the live SA14-14-2 vaccine. JENVAC met all its primary and secondary endpoints, in the age group of one to 50 years, after one or two doses of 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 dose 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. The added benefit of JENVAC is its ability to provide long-term sero-protection.
Dr Krishna M Ella, Chairman and Managing Director, Bharat Biotech, said ,“JENVAC is a product of years of committed R&D. It is yet another clone to clinic milestone for the Bharat Biotech team. JENVAC has the potential to reduce disease burden and reduce India’s import of JE vaccines. Bharat Biotech has a long history of developing novel healthcare solutions through public private partnerships, we hope to continue the same in years to come.”
Japanese encephalitis is the most common cause of viral encephalitis in Asia-Pacific. It causes inflammation of the brain, symptoms include high fever, headache, sensitivity to light, stiff neck and back, vomiting, confusion and, in severe cases, seizures, paralysis and coma. The disease which is transmitted via mosquitoes, with pigs and water birds acting as amplifying hosts for the virus, is the leading cause of viral encephalitis in Asia with ~50,000 clinical cases reported annually.
The numbers of JE cases are vastly under-reported due to the lack of good surveillance infrastructure in affected countries. According to estimates, JE has infected approximately 10 million children globally, killing three million and causing long-term disability in four million children. JENVAC has the potential to prevent millions of infections, thereby saving lives and preventing long-term disability in millions, not just in India, but also in South East Asia, and Asia at large.
According to a press release, Bharat Biotech will pursue a dual pricing strategy for JENVAC to cater to the needs of government agencies and those of the private market. 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 five dose presentations.”
EP News Bureau – Mumbai
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