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HomeScienceICMR seeks nod for phase-3 trials of 1st dengue vaccine

ICMR seeks nod for phase-3 trials of 1st dengue vaccine


NEW DELHI : Looking for to develop the primary efficient vaccine in opposition to dengue, the Indian Council of Medical Analysis (ICMR) has sought the Medication Controller Normal of India’s (DCGI’s) go-ahead for phase-3 trials of a vaccine candidate it has developed with drugmakers Serum Institute and Panacea Biotec.

India is reeling beneath a dengue outbreak with 86 deaths and greater than 100,000 circumstances.

A vaccine developed by France is but get approval from many international locations, together with India, as a result of security causes.

An approval to the Indian shot from the DCGI may assist in the worldwide combat in opposition to dengue, for which there is no such thing as a particular remedy, with sufferers presently handled for signs.

“We’ve submitted section 3 protocol to DCGI. Presently we’re making progress with Panacea Biotec. How quickly we are going to begin, it is determined by approvals. Serum Institute of India will come slightly later as a result of they’re doing a little extra research earlier than going into section 3,” mentioned an ICMR scientist conscious of the matter.

“The Serum Institute is within the strategy of creating some check batches earlier than we provoke the method of section 3 scientific trial,” mentioned the particular person.

Queries despatched to the well being ministry, Serum Institute of India and Panacea Biotech didn’t elicit any response.

Dengue virus has 4 strains —DENV-1 that causes traditional dengue fever, DENV-2 that ends in haemorrhagic fever with shock, DENV-3 that causes fever with out shock, and DENV-4 that results in fever with out shock or profound shock. Scientists say that DENV-2, which is extra virulent in nature, is circulating this yr.

The worst hit states/UTs are Kerala, Haryana, Jammu & Kashmir, Bihar, Delhi, Rajasthan, Gujarat and Karnataka.

Takeda prescribed drugs on Wednesday mentioned the US Meals and Drug Administration has accepted and granted precedence evaluate of the Biologics License Software (BLA) for TAK-003, a dengue vaccine candidate developed by the Japanese agency.

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