The Drug Controller General of India on Monday granted approval to a pharmaceutical company in Hyderabad to conduct clinical human trials of a potential vaccine for the coronavirus, NDTV reported. The first two phases of human trials for the vaccine, called Covaxin, are scheduled to start across the country in July.
It is the first indigenous vaccine to have received the drug regulator’s approval for trials.
Covaxin was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology.
It is an inactivated vaccine created from a strain of the infectious SARS-CoV-2 virus. Inactivated vaccines use the killed version of the germ that causes a disease. It helps the immune system mount an antibody response towards virus.
Permission to conduct its clinical trial was granted after the company submitted results from pre-clinical studies of the vaccine, which demonstrated its safety and immune response.
“The collaboration with the ICMR and NIV was instrumental in the development of this vaccine,” Bharat Biotech Chairperson and Managing Director Dr Krishna Ella said, according to The Indian Express. “The proactive support and guidance from the Central Drugs Standard Control Organisation have enabled approvals to this project.”
Last week, the World Health Organization said the experimental vaccine AstraZeneca vaccine was probably the leading candidate and most advanced in terms of development, Reuters reported. The vaccine was developed by researchers at University of Oxford in United Kingdom and the British firm has already begun large-scale human trials for it.
In May, the NITI Aayog had said that 30 groups in the country were working on developing a vaccine against the coronavirus. Principal Scientific Advisor K Vijay Raghavan had said that India is on the right track to develop a vaccine. “There are about a total of 30 groups in India, big industry to individual academics, who are trying to develop vaccines, of around 20 are keeping a good pace,” Raghavan said.