Coronavirus vaccine COVAXIN update: Human trial process starts at Hyderabad's NIMS
Hyderabad’s Nizam’s Institute of Medical Sciences was one of the trial sites that received the ICMR’s letterLast week, the drug regulator recently granted permission to initiate Phase I & II human clinical trials for COVID-19 Vaccine Covaxin
PremiumThe much-awaited trial process of India's first possible vaccine against COVID-19, Covaxin, has started on Tuesday at the Nizam's Institute of Medical Sciences (NIMS), a top official confirmed. Developed by Bharat Biotech, the Covaxin will be tested on over 1,100 people in two phases. The company had a plan to enroll 375 participants to test COVID-19 vaccine candidate this month.
Hyderabad’s Nizam’s Institute of Medical Sciences was one of the trial sites that received the Indian Council of Medical Research (ICMR)’s letter. "We will select healthy individuals and draw blood and send the blood samples to designated labs in New Delhi. They will give the green signal. Then the medicine people will examine and the first shot of the vaccine will be given due observation," NIMS director Dr K Manohar told PTI.
The ICMR has selected 12 institutes to conduct these trials, including AIIMS in Delhi and Patna. The apex medical body asked their principal investigators to ensure the enrolment process is initiated no later than by July 7.
"Everything will be sent to ICMR, where data is analysed. We have already started the screening of individuals. We will first take audio visual consent of the individual," the doctor added. For clinical human trial in Hyderabad's Nizams Institute of Medical Sciences, at least 30 people are required, said the medical officer.
Last week, the Drug Controller General of India granted permission to initiate Phase I & II human clinical trials for COVID-19 vaccine Covaxin. The drug regulator's nod to conduct human trials for Indian COVID-19 vaccine candidates COVAXIN and ZyCov-D marks the “beginning of the end" of the coronavirus pandemic, says the Ministry of Science and Technology.
The announcement of Covaxin by Bharat Biotech and ZyCov-D by Zydus Cadila was the "silver line in the dark clouds", the article by T V Venkateswaran, who is a scientist with Vigyan Prasar, said.
India's second possible vaccine against COVID-19, ZyCoV-D, is all set to start its human trial this month, the company said. The trials will be conducted on 1,000 volunteers across multiple sites in the country. Zydus Cadila group chairman Pankaj Patel said it would take three months to finish the trials.
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