Home / Science / Health /  India set to carry out phase 3 clinical trials for vaccine against dengue

NEW DELHI : The Indian Council of Medical Research (ICMR) has invited domestic companies to collaborate on the development of the first Indian vaccine for dengue, a top official said.

Pharmaceutical companies and vaccine makers who have developed potential vaccine candidates against dengue and have successfully completed phase 1 and 2 clinical trials can submit their expressions of interest (EoI) to ICMR by 11 March. The phase-3 clinical trials will be conducted in India.

Currently, there is no specific treatment for the mosquito-transmitted disease and patients are treated for their symptoms. India reported 1,23,106 dengue cases and 90 deaths in 2021, shows data from the National Centre for Vector Borne Diseases Control, a body under the Ministry of Health and Family Welfare (MoHFW). According to the World Health Organization (WHO), dengue was as one of the top ten global health threats in 2019.

“We all know that dengue is a major public health disease and till date, India does not have safe and effective vaccine against dengue virus disease. The ICMR has been mandated to address the growing demands of scientific advances in biomedical research and find practical solutions to the health problems of the country. Therefore, we have invited pharmaceutical companies/vaccine manufactures to collaborate with us for phase 3 clinical trial to develop a safe and effective dengue vaccine," said Dr. Samiran Panda, additional director general, ICMR said.

ICMR will provide technical expertise in terms of study planning, development and implementation of phase-3 clinical trial protocol. While France and Mexico have developed dengue vaccines, they are not approved in India. Other nations are also making attempts to develop a dengue vaccine.

“Under this EoI, ICMR offers institutional infrastructure for undertaking further research & development (R&D) and vaccine clinical trial for evaluation of efficacy along with safety and immunogenicity as per regulatory requirement," said an ICMR document seen by Mint.

The collaboration will be on a 5% royalty basis for a fixed-term contract for the phase-3 trials. ICMR will provide technical support to the companies through its team of experienced scientists in study planning, development of clinical trial protocol, implementation of phase-3 clinical trial of tetravalent dengue vaccine, generating results, data analysis, outcome assessment, safety, immunogenicity and efficacy assessment and product improvement.

“Presently, we provide symptomatic treatment to dengue patients in India as we do not have any vaccine against dengue virus. Some of the western countries like Mexico and France have developed dengue vaccine but they are still not approved in our country. ICMR has taken a great step in developing dengue vaccine," said Dr. Atul Gogia, senior consultant, internal medicine at Sir Ganga Ram Hospital in New Delhi.

ABOUT THE AUTHOR

Priyanka Sharma

Priyanka Shamra is a health and pharma journalist with nearly nine years of field reporting experience. She is a special correspondent with Mint. Her beat includes covering the Ministry of Health and Department of Pharmaceuticals. She also covers the Ministry of Women and Child Development and the Department of Biotechnology.
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