Indian firm gets regulator’s nod to start Zika vaccine trials
19 Dec 2017
The Drugs Controller General (India) has granted permission to an Indian firm to conduct the phase-I clinical trial of a Zika virus vaccine.
Zika virus disease is a mosquito-borne disease caused by a virus transmitted primarily by the Aedes egypti mosquito. Infections in pregnant women can cause children to be born with brain deficiencies.
The signs and symptoms of Zika virus infection can include mild fever, skin rash, conjunctivitis, muscle and joint pain, malaise or headaches. These symptoms normally last for 2-7 days.
Union minister of state for health and family welfare Ashwini Kumar Choubey told the Lok Sabha on Monday that an Indian firm had submitted an application to the drugs controller.
"The application was on the Zika virus vaccine, along with non-clinical (animal) toxicity data, claiming 100 per cent efficacy in animals for grant of permission to conduct the Phase-I clinical trial," he said in a written reply to a question.
"Based on the evaluation of the application, in consultation with the Experts Committee, the DCG (I) has granted permission to conduct the Phase-I clinical trial," Choubey said.
Anupriya Patel, also union minister of state for health and family welfare, said in another written reply that the World Health Organisation (WHO) had declared the Zika virus disease to be a Public Health Emergency of International Concern (PHEIC) on 1 February 2016, following the Zika outbreak in Brazil and other Latin countries and its association with birth defects (microcephaly) in newborns.
"Further, the WHO declared that it ceased to be a Public Health Emergency on November 18, 2016," she said.
She also said that the ministry has a three-pronged action plan on combating the disease, and there are 27 laboratories in the government sector that can test the Zika virus disease.
While there is scientific consensus that Zika virus is a cause of microcephaly and Guillain-Barré syndrome, links to other neurological complications are also being studied.
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