The Drugs Controller General of India (DGCI) has approved Bharat Biotech’s COVID-19 vaccine Covaxin for phase II/III clinical trial on those aged between two to 18 years. The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
“The DCGI, after careful examination, has accepted the recommendation of Subject Expert Committee and accorded permission to conduct the Phase II/III clinical trial of Covaxin in the age group 2 to 18 years, to its manufacturer Bharat Biotech,” the government said in a press note.
It added that the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) had on Tuesday deliberated upon Bharat Biotech’s application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years. The committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions.
Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India’s ongoing COVID-19 vaccination drive. Covishield — the local version of Oxford-AstraZeneca COVID-19 vaccine, which is being manufactured by Pune-based Serum Institute of India is also being given to adults. Recently, Sputnik V was approved to be imported from Russia by Dr Reddy’s, but is yet to be widely available in the country.
Meanwhile, Bharat Biotech has submitted to the Centre its production plan for the next four months, informing that it can ramp it up to 7.8 crore doses by August.