New Delhi: The phase-3 trial of a dengue vaccine developed by Panacea Biotech in collaboration with the Indian Council of Medical Research (ICMR) is likely to begin in August or September, a senior official said on Tuesday (May 16). Also, the phase 1/2 paediatric trials are underway for another dengue vaccine for which apex health research body ICMR has signed a Memorandum of Understanding with the Serum Institute of India (SII). Dr Nivedita Gupta, who heads the ICMR’s Division of Epidemiology and Communicable Diseases (ECD), said Panacea Biotech has already completed the phase 1/2 trials in India on healthy adults and the safety of the vaccine has been established.
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Phase 1/2 trials refer to a situation when the first and second phase of trials are conducted together.
At an event organised by ICMR to observe National Dengue Day, Dr Gupta said,
We have some preliminary immunogenicity results also. So all the paperwork has been done and the approval for phase-3 randomised double-blind, placebo controlled trial from the Drugs Controller General of India (DCGI) has also been obtained in January. The trial will be conducted on 10,335 healthy adults aged 18-80 years at 20 sites.
Panacea Biotech, meanwhile, is now trying to upscale vaccine production and the phase-3 trial is likely to begin in August or September, Dr Gupta stated.
The Serum Institute of India has completed its phase 1 trial on 60 adults in Australia during which the safety and preliminary immunogenicity of the vaccine were established. Now it is conducting a phase 1/2 trial in children in India.
Dr Gupta said,
The ICMR has also got into an MoU with Serum Institute for developing this dengue vaccine. Once the phase 1/2 trial is completed, based on the results, we will start the phase 2/3 trial in paediatric population.
She said immediately after Covid, the ICMR prioritised dengue vaccine development in India.
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Serum Institute and Panacea Biotech had applied after an expression of interest was floated on the website of ICMR in February 2022 inviting manufacturers in India who have a potential vaccine and are ready to go to phase 3 trials.
Dr Rajiv Bahl, Director General of ICMR said on Tuesday,
Dengue is a big challenge for the country and a vaccine is definitely required. This is a disease because of which needless lives are lost every year and we should and could do better than what we are doing now.
“If we have to be a developed country in 25 years, one of the things we need to get rid of is vector-borne diseases like Lymphatic filariasis, Kala azar, malaria and also dengue,” Dr Bahl said.
Vector-borne disease control will be one of the 10 most important priorities of the ICMR in the coming years along with the same level as EMR (Emergency Medical Response), one Health and Tuberculosis, Dr Bahl said.
He said,
We will launch a series of research studies in all different ways to address various aspects where innovations are required whether it’s vector control strategies of different types or others.
“Vector Control research is extremely important with changing vector behaviour and many of the known things we used to read in textbooks changing. We need not only be abreast with whatever is happening but also find solutions to those problems that how we enhance vector control,” he said.
Dr Bahl said,
We are also working on vaccines and waiting for the vaccine trial to start.
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(This story has not been edited by NDTV staff and is published from a syndicated feed.)
NDTV – Dettol have been working towards a clean and healthy India since 2014 via the Banega Swachh India initiative, which is helmed by Campaign Ambassador Amitabh Bachchan. The campaign aims to highlight the inter-dependency of humans and the environment, and of humans on one another with the focus on One Health, One Planet, One Future – Leaving No One Behind. It stresses on the need to take care of, and consider, everyone’s health in India – especially vulnerable communities – the LGBTQ population, indigenous people, India’s different tribes, ethnic and linguistic minorities, people with disabilities, migrants, geographically remote populations, gender and sexual minorities. In wake of the current COVID-19 pandemic, the need for WASH (Water, Sanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign will continue to raise awareness on the same along with focussing on the importance of nutrition and healthcare for women and children, fight malnutrition, mental wellbeing, self care, science and health, adolescent health & gender awareness. Along with the health of people, the campaign has realised the need to also take care of the health of the eco-system. Our environment is fragile due to human activity, which is not only over-exploiting available resources, but also generating immense pollution as a result of using and extracting those resources. The imbalance has also led to immense biodiversity loss that has caused one of the biggest threats to human survival – climate change. It has now been described as a “code red for humanity.” The campaign will continue to cover issues like air pollution, waste management, plastic ban, manual scavenging and sanitation workers and menstrual hygiene. Banega Swasth India will also be taking forward the dream of Swasth Bharat, the campaign feels that only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diarrhoea and the country can become a Swasth or healthy India.
