New Delhi:
A private Delhi-based laboratory, Dr Dangs Lab, claimed it had been selected as the central laboratory for human clinical trials of Covaxin, India’s indigenous COVID-19 vaccine candidate. The vaccine is developed and manufactured by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV) in Pune.
Dr Dangs Lab said on Wednesday it had partnered with Bharat Biotech to conduct the trials.
“We are extremely privileged to announce that Dr Dangs Lab, New Delhi has had the opportunity to serve the nation by being selected as the central laboratory for the human clinical trials of Covaxin; India’s native COVID-19 vaccine is developed and manufactured by Bharat Biotech in collaboration with ICMR, NIV, ”Dr Dang’s Lab said in a statement.
It is a “multicenter, randomized, double-blind, placebo-controlled clinical trial in India,” he added.
“Dr. Dangs Lab is currently processing all samples for screening and safety for the various phases of this clinical trial, while all efficacy studies will be performed in NIV,” the statement said.
The lab has already started receiving samples of 50 to 100 subjects per day from various test sites for safety testing and will scale up operations on schedule to cover 12 sites across the length and breadth of the country at during this month.
“Strict quality standards, based on Good Clinical Laboratory Practice (GCLP), are followed in accordance with regulatory authority requirements.” The laboratory has renowned experts in each field who work tirelessly and collectively to provide quality and timely results in order to respond to effective and safe COVID19 vaccine, ”the statement said.