Bharat Biotech’s Covid-19 vaccine Covaxin has been recommended by an expert panel for phase II/III clinical trial on those aged between two and 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.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday 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,” a source said.
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 said earlier this week that it was disheartening to listen to some states complaining about their intentions regarding supply of Covaxin. “18 states have been covered though in smaller shipments. Quite disheartening to the teams to hear some states complaining about our intentions. 50 of our employees are off work due to covid, yet we continue to work under pandemic lockdowns 24×7 for U,” Joint Managing Director Suchitra Ella said in a tweet. The Hyderabad-based firm is supplying Covaxin to 18 states, including Andhra Pradesh, Haryana, Odisha, Assam, Jammu & Kashmir, Tamil Nadu, Bihar, Jharkhand and Delhi. Other states are Chhattisgarh, Karnataka, Telangana, Tripura, Madhya Pradesh, Uttar Pradesh, Gujarat, Maharashtra and West Bengal.
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