Delhi: Dr Dangs Lab to be 1st central lab to hold human trials of Covaxine
Delhi: A Delhi-based private laboratory has claimed that it has been selected as the central lab for human clinical trials of Covaxin, India's indigenous COVID-19 vaccine candidate. The vaccine is being developed and manufactured by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology.
Dr. Dangs Lab said on Wednesday that it has partnered with Bharat Biotech for conducting the trials."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; India's indigenous COVID-19 vaccine being developed and manufactured by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology " it said in a statement.
This is a "randomised, double blind, placebo controlled multi-centric clinical trial in India", it added."Dr. Dangs Lab is currently processing all samples for screening and safety for the various phases of this clinical trial, whereas all the efficacy studies will be performed in NIV (Pune)," the statement said.
The lab has already started receiving 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, it added.
"Stringent quality norms driven by good clinical laboratory practice (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 fulfil the imminent need of an effective and safe COVID19 vaccine," the statement said.
This is a "randomised, double blind, placebo controlled multi-centric clinical trial in India", it added."Dr. Dangs Lab is currently processing all samples for screening and safety for the various phases of this clinical trial, whereas all the efficacy studies will be performed in NIV (Pune)," the statement said.
The lab has already started receiving 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, it added.
"Stringent quality norms driven by good clinical laboratory practice (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 fulfil the imminent need of an effective and safe COVID19 vaccine," the statement said.
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