Dengue vaccine likely by 2019-end, says Panacea Biotec
Panacea Biotec has secured permission to conduct clinical trials on humans for the dengue vaccine in India
New Delhi: India could have a vaccine for the dreaded dengue as early as end 2019, according to drug maker Panacea Biotec, which has secured permission to conduct clinical trials for the vaccine in India.
Panacea Biotec will start clinical trials on humans by early 2018, a spokesperson said, adding that it has received permission to conduct phase I/II trials from the Drug Controller General of India (DCGI).
The vaccine for the mosquito-borne disease, which has killed at least 216 people in India so far this year, is critical to drive down the number of deaths caused by the disease and lower out-of-pocket costs of patients.
“As dengue is a big challenge for India and a vaccine is direly required, we have given a go-ahead for trials for dengue vaccine by TDB and Panacea Biotec,” said G.N. Singh, DCGI. “We are facilitating the trials in a speedy manner. As a regulator, we are ensuring that the vaccine is effective and safe for the people.”
TDB, short for Technology Development Board, part of the department of science and technology, and Panacea Biotec, are jointly investing Rs28.99 crore to develop the vaccine, a joint statement issued earlier this month said.
Panacea Biotec, in collaboration with the National Institutes of Health (NIH), US, has developed the advanced dengue vaccine with proven safety in pre-clinical studies.
Dengue is caused by four types of viruses and the proposed vaccine is designed to protect against all four.
The experimental vaccine is a single-dose shot and has been found to stimulate a strong immune response against all four types of viruses in all age groups, according to the results from clinical trials conducted by NIH.
Currently, some of the vaccines under development require 2-3 doses to achieve the desired immune response, while the published clinical data of the only licensed vaccine outside India has shown poor immune response against the Type-2 strain of dengue, besides being a three-dose vaccine which is effective only in the age group of 9-45 years.
Panacea Biotec’s vaccine is a live attenuated tetravalent vaccine.
“An efficient dengue vaccine must provide a balanced immune response against all four serotypes in all age groups, ideally in a single-dose regimen. The new dengue vaccine development programme would, therefore, represent a major advancement in the control of this life-threatening disease globally,” Rajesh Jain, joint managing director of Panacea Biotec, said in a statement.
According to the health ministry, a total of 140,910 cases and 216 deaths due to dengue have been reported in India this year, according to data available till 19 November.
The maximum number of cases was reported from Tamil Nadu (20,141), followed by Kerala (19,543), Karnataka (15,570), Punjab (14,049), West Bengal (10,697) and Delhi (8,549).
In 2016, the total number of dengue cases across India was 129,166 and in 2015 the recorded number was 99,913.
A total of 245 people died of dengue in 2016 and 220 the previous year.
Currently, there are no specific therapeutic options available and the treatment of dengue is primarily supportive. Prevention is currently limited to vector control measures only.