Dengue vaccine awaits nod despite approval from FDA

The number of dengue cases has increased significantly over the years with about 90,000 people getting affected by the mosquito-borne disease across the country and leaving about 150 people dead in 2018. The number of cases and the deaths reported in the country were higher in 2017, around 1.88 lakh people were affected and 325 were reported dead, while in 2016, 1.29 lakh cases and 245 were reported deaths. Hence, the country has awaited for a dengue vaccine for many years now.

Though the dengue vaccines are in use in other countries after receiving approval, the vaccine in India has only remained in the review phase for about two years now.

Indian Council of Medical Research (ICMR) has stated that a study on epidemiology of dengue virus would be conducted in various zones in the country in 2017. “The approval of vaccines requires a clinical trial on a population of about 80,000 to further form the regulatory clearances. The other countries who have approved Dengavaxia vaccine for dengue prevention have a restricted usage, thus the clinical trial needs to be monitored,” said a senior official at ICMR.

The vaccine Dengvaxia has also been recommended by World Health Organization about three years back. The vaccine manufactured by Sanofi Pasteurs, is the first vaccine approved for the prevention of dengue. “The previous trial on dengue census and prevalence of the infection was rejected as the WHO guidelines were not implemented in the country.

However, expert committee has been formed to look into the possibility of approving the vaccine and enough number of manufacturing units should come up to take up the production of the vaccine positively,” said Dr Soumya Swaminathan, Deputy Director General of Programmes at the World Health Organization and former Director General of the Indian Council of Medical Research.