Covaxin which had earlier been developed in Hyderabad at the Genome Valley plant, in collaboration with the Indian Council of Medical Research, is all geared up to start its first phase of human trials. Bharat Biotech, a leading vaccine and bio-therapeutics manufacturers, has developed Covaxin with ICMR’s Pune-based National Institute of Virology.
According to sources, volunteers at 14 different locations across India are undergoing what is termed as “safety and screening” study to evaluate all the parameters, including infections, liver functions, possible exposure to the coronavirus or similar infectious diseases. The trials are touted to have a considerable sample size of 1,500 people. The locations include New Delhi, Patna, Chennai, Kanpur, Goa, Gorakhpur, Bhubaneswar, Rohtak, Visakhapatnam and Hyderabad.
In the past, on June 29, the Hyderabad-based firm announced that the Drug Controller General of India (DGI) gave the green light for phase-1 and phase-2 human clinical trials of the indigenously developed drug. The company had earlier submitted results generated from pre-clinical (animal) studies to get approval to conduct human clinical trials. These trials are meant to demonstrate safety and immune responses.
The SARS-CoV-2 strain was isolated at National Institute of Virology (Pune), an institute under the ICMR, and was transferred to Bharat Biotech. The company has a biosafety level-3 plant in the city of Hyderabad. These type of plants are conducive for work involving microbes, which could cause serious and potentially lethal diseases, through the inhalation route.
According to media reports, AIIMS-Patna has already started testing the candidate vaccine on 10 volunteers picked by the hospital authority for the trial, as reported by AIR. According to the report, the first dose of the vaccine has been administered to the study participants, who will be given the second dose after an interval of 14 days.
Meanwhile, Maharashtra has 2,60,924 cases of coronavirus with 94,146 cases in Mumbai only.
Share
Tweet
