NEW 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 (ICMR) and the National Institute of Virology. (NIV).
Dr. Dangs Lab said 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 Covaxine, being developed and manufactured by Bharat Biotech in collaboration with the ndian Council of Medical Research and NIV,” it said in a statement.
This is a “randomised, double blind, placebo controlled multi-centric clinical trial,” it added.
“The 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,” 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 country over this month, it added.
“Stringent quality norms driven by good clinical laboratory practice guidelines are being followed. The lab has renowned experts who are working tirelessly to provide quality and timely results to fulfil the imminent need of an effective and safe vaccine,” the statement said.