India inching closer to launching its first dengue vaccine
India is likely to get its first vaccine for Dengue soon as the Indian Council of Medical Research (ICMR) is all set to submit its clinical trial protocol to the country's drug regulator CDSCO by June. Moreover, the vaccine's phase-3 trials are expected to begin by October. ICMR is also in the process of roping in two pharmaceutical companies to manufacture the vaccine.
Why does this story matter?
Notably, dengue has been identified as one of the top 10 global health threats by the World Health Organization (WHO) in 2019. It is a viral disease that is spread by mosquitoes, predominantly in tropical and subtropical regions in the world. While there is no specific treatment available, a vaccine would help protect against the same and control the spread of the infection.
Department is working on the final protocol: ICMR
Dr. Nivedita Gupta, the head of virology at ICMR, told News18 that the department is still "working on the trial protocol" and will submit it to the Central Drugs Standard Control Organisation (CDSCO) for clearance once it is finalized. She further added that the ICMR is expected to submit the trial protocol in the next six to eight weeks.
What is clinical trial protocol?
A trial protocol is a detailed plan on how a clinical trial will be conducted. It includes all the necessary information such as the number of participants, number of trial locations, dosages of vaccine, follow-up plan, efficacy, and safety profile of the vaccine.
Who will manufacture the vaccine?
ICMR is reportedly in the process of signing agreements with Panacea Biotec and the Serum Institute of India for vaccine manufacture. "ICMR has already signed the memorandum of understanding (MoU) with Panacea... the process of signing with SII is already underway," Gupta said. Notably, partnership with vaccine makers will be on a royalty basis for a fixed-term contract condition for conducting phase-3 clinical trials.
What will be ICMR's role?
As per the ICMR's expression of interest, the council will provide infrastructure for further research and development activities and conducting clinical trials. ICMR will also provide technical support through a team of experienced scientists. The team will help in the planning of the study, developing a clinical trial protocol, implementing phase-3 clinical trials, generating results, data analysis, outcome assessment, safety, immunogenicity, and efficacy assessment.
What causes dengue?
Dengue is caused by mosquitoes, primarily those belonging to the Aedes aegypti variety. There is no specific treatment for dengue currently, and in extreme cases, it may also in a patient's death. Its symptoms include fever, nausea, vomiting, aches, and muscle, joint, or bone pain. If it gets severe it may also cause shock, internal bleeding, and organ failure.
