As dengue cases show a steep increase, particularly in Delhi, the World Health Organisation (WHO) has recommended introducing dengue vaccine in high burden countries like India.
Two months ago, the apex committee on health, headed by the health secretary, had denied approval to a multinational firm for its dengue vaccine when it sought a clinical trial waiver in India.
In May, the committee had concluded that the data presented by the company was inadequate to show the efficacy and immunogenicity of the vaccine in Indians. Immunogenicity is the ability of a substance to provoke an immune response in the body.
The government and the regulator are of the view that there is a need to test the vaccine on Indian patients.
Sources in the central drug regulator's office said data presented by the firm showed an efficacy rate of around 43%, against the requirement of 70%.
The vaccine is approved in four countries, including Mexico, Indonesia and Brazil. "However, the company wants a clinical trial waiver in India and sought approval based on data from its global studies involving 30,000 patients," a senior official in the office of Drugs Controller General of India said.
Dr Vikram Sanghi posted an update on eMediNexus
