BackICMR seeks nod for phase-3 trials of 1st dengue vaccine
An approval to the Indian shot from the DCGI could help in the global fight against dengue, for which there is no specific treatment, with patients currently treated for symptoms
PremiumNEW DELHI : Seeking to develop the first effective vaccine against dengue, the Indian Council of Medical Research (ICMR) has sought the Drugs Controller General 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 under a dengue outbreak with 86 deaths and more than 100,000 cases.
A vaccine developed by France is yet get approval from many countries, including India, due to safety reasons.
An approval to the Indian shot from the DCGI could help in the global fight against dengue, for which there is no specific treatment, with patients currently treated for symptoms.
“We have submitted phase 3 protocol to DCGI. Currently we are making progress with Panacea Biotec. How soon we will start, it depends on approvals. Serum Institute of India will come a little later because they are doing some additional studies before going into phase 3," said an ICMR scientist aware of the matter.
“The Serum Institute is in the process of developing some test batches before we initiate the process of phase 3 clinical trial," said the person.
Queries sent to the health ministry, Serum Institute of India and Panacea Biotech did not elicit any response.
Dengue virus has four strains —DENV-1 that causes classic dengue fever, DENV-2 that results in haemorrhagic fever with shock, DENV-3 that causes fever without shock, and DENV-4 that leads to fever without shock or profound shock. Scientists say that DENV-2, which is more virulent in nature, is circulating this year.
The worst hit states/UTs are Kerala, Haryana, Jammu & Kashmir, Bihar, Delhi, Rajasthan, Gujarat and Karnataka.
Takeda pharmaceuticals on Wednesday said the US Food and Drug Administration has accepted and granted priority review of the Biologics License Application (BLA) for TAK-003, a dengue vaccine candidate developed by the Japanese firm.
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