India’s drug regulator DCGI has given a go-ahead to Bharat Biotech to conduct phase 2 and phase 3 clinical trials on those belonging to the age group of 2 to 18 years. The Hyderabad-based vaccine maker will conduct the trial on 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur, news agency PTI reported.
The approval came after the subject expert committee on Covid-19 deliberated upon Hyderabad-based 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.
“After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study,” news agency PTI reported quoting sources.
During the trial, the vaccine will be administered through muscles in two doses in a gap of 28 days, the government .
Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol. 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.
Bharat Biotech’s Covaxin has been found to neutralise the 617 variant of the deadly virus. Developed by the Hyderabad-based firm in partnership with National Institute of Virology and the Indian Council of Medical Research, Covaxin was approved for emergency use on January 3. Trial results later showed the vaccine has an efficacy of 78 per cent.
After widespread criticism over vaccine pricing, the company reduced the price of its Covaxin for state governments from ₹ 600 to ₹ 400 per dose, the vaccine-maker said in a statement today. The cost of the COVID-19 vaccine for private hospitals is changed at ₹ 1,200 per dose.