Haryana: PGIMS to conduct Covid-19 vaccine trial

CHANDIGARH: The Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, is preparing to conduct a trial to evaluate the safety and efficacy of an inactivated vaccine for Covid-19.
In a press release issued on Wednesday, the institute said, “The safety of this vaccine has already been proven in animal studies by Bharat Biotech, a Hyderabad-based company who is also the developer of this vaccine. This trial is planned to be conducted in two phases: a seamless phase 1, followed by phase 2 randomised, double-blind, multicenter study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 vaccine in healthy volunteers.”
PGIMS stated clearance from the institute’s ethical committee had been taken. Approval from CDSCO, the apex body for ethical clearance for all studies in India, had also been taken for the study.
PGIMS stated 12 centres all over India had been given permission to conduct this study. The principle investigator for this study would be Dr Savita Verma, professor in the PGIMS department of pharmacology, while the Co-PIs would be Dr Dhruva Chaudhry, state nodal officer, Haryana for Cobid-19 along with Dr Ramesh Verma, professor in the department of community medicine.
The institute mentioned volunteers participating in the endeavour would be looked after well to manage any mild or serious side effects.