July 23, 2020 1:44:38 am
The lab has already started processing samples from 50 to 100 subjects per day from various trial sites for safety testing, and will be increasing operations as per assigned timelines to cover 12 sites across the length and breadth of the country over this month.
While the efficacy studies will be performed in National Institute of Virology in Pune, samples for screening will be sent to the lab.
“We are extremely privileged to announce that Dr. Dangs Lab, New Delhi, has been provided the opportunity to serve the nation by being selected as the central lab for the human clinical trials of Covaxin. This is a randomised, double blind, placebo controlled multi-centric clinical trial in India,” Dr. Dangs Lab said in a statement.
Drug Controller General of India (DCGI) had recently gave a green signal for human clinical trials for Covid-19 vaccine candidate Covaxin, which has been developed by Bharat Biotech in collaboration with ICMR and the NIV.
“Stringent quality norms driven by GCLP guidelines are being followed as mandated by regulatory authorities. The lab has renowned experts in each field who are working tirelessly and collectively to provide quality and timely results to fulfill the imminent need of an effective and safe Covid-19 vaccine,” it said.
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