Bharat Biotech's Chikungunya Vaccine enters Phase I trials
Hyderabad-based vaccine-maker Bharat Biotech announced on Monday that its Chikungunya Vaccine had entered Phase 1 clinical trials.
- Jun 5, 2017,
- Updated Jun 5, 2017 4:10 PM IST
Hyderabad-based vaccine-maker Bharat Biotech announced on Monday that its Chikungunya Vaccine had entered Phase 1 clinical trials. Though Phase I is an early stage in the development of a vaccine, however it stands out as an Indian company is working on a disease relevant to India and the developing world. Developing a vaccine for Chikungunya is not so important for the US, Europe or Japan but certainly critical for India.
How significant and efficacious is the drug and when will it actually be available as a product for patients are some questions, which need deeper understanding of the programme, since much depends on how the clinical trials progress.
"After successful completion of product development and pre-clinical testing, the candidate vaccine was approved by the DCG(I) for Phase 1 clinical trials in 2016," says a note issued by the company.
According to experts in the vaccine industry, while this is an important step, the development of the vaccine could still take time, which by some estimates could be as much as 4-5 years.
Typically, pre-clinical stage involves testing on animals, Phase I is to test for safety on healthy human volunteers. If it works well with no adverse reactions, then the regulator may allow testing on actual patients in phase II clinical trials. In the Phase III, then it is tested on an even larger patient population.
The note by the company says, "The candidate vaccine under development cross neutralized CHIKV isolates of the Asian genotype isolated in 1963 and isolates from the successive Indian epidemics caused by the East Central South African (ECSA) genotype since 2006. While Chikungunya (CHIKV) exists as three genotypes, there is only a single serotype of the virus. The candidate vaccine developed by Bharat Biotech effectively cross neutralized both the Asian and ECSA CHIKV genotypes." It also quotes Krishna Ella, Chairman & Managing Director of Bharat Biotech, saying, "Our pre-clinical studies were promising and we hope that the first-in -human clinical trials successfully meets with the clinical endpoints."
Bharat Biotech filed, what it calls "a globally pioneering patent", in 2007 for CHIKV and followed up with a second patent in 2011. Patents have been granted in USA, Europe, China, Indonesia, South Africa.
Chikungunya is a viral disease which is transmitted to humans by infected mosquitoes.
Hyderabad-based vaccine-maker Bharat Biotech announced on Monday that its Chikungunya Vaccine had entered Phase 1 clinical trials. Though Phase I is an early stage in the development of a vaccine, however it stands out as an Indian company is working on a disease relevant to India and the developing world. Developing a vaccine for Chikungunya is not so important for the US, Europe or Japan but certainly critical for India.
How significant and efficacious is the drug and when will it actually be available as a product for patients are some questions, which need deeper understanding of the programme, since much depends on how the clinical trials progress.
"After successful completion of product development and pre-clinical testing, the candidate vaccine was approved by the DCG(I) for Phase 1 clinical trials in 2016," says a note issued by the company.
According to experts in the vaccine industry, while this is an important step, the development of the vaccine could still take time, which by some estimates could be as much as 4-5 years.
Typically, pre-clinical stage involves testing on animals, Phase I is to test for safety on healthy human volunteers. If it works well with no adverse reactions, then the regulator may allow testing on actual patients in phase II clinical trials. In the Phase III, then it is tested on an even larger patient population.
The note by the company says, "The candidate vaccine under development cross neutralized CHIKV isolates of the Asian genotype isolated in 1963 and isolates from the successive Indian epidemics caused by the East Central South African (ECSA) genotype since 2006. While Chikungunya (CHIKV) exists as three genotypes, there is only a single serotype of the virus. The candidate vaccine developed by Bharat Biotech effectively cross neutralized both the Asian and ECSA CHIKV genotypes." It also quotes Krishna Ella, Chairman & Managing Director of Bharat Biotech, saying, "Our pre-clinical studies were promising and we hope that the first-in -human clinical trials successfully meets with the clinical endpoints."
Bharat Biotech filed, what it calls "a globally pioneering patent", in 2007 for CHIKV and followed up with a second patent in 2011. Patents have been granted in USA, Europe, China, Indonesia, South Africa.
Chikungunya is a viral disease which is transmitted to humans by infected mosquitoes.