Bharat Biotech's COVID-19 vaccine Covaxin was on Tuesday recommended by an expert panel for phase II/III clinical trial on those aged between two to 18 years, official sources said. 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 on Tuesday said it will continue the steady supply of its COVID-19 vaccine Covaxin, adding the jab has been directly supplied to 18 states since May 1. The states include Andhra Pradesh, Delhi, Bihar, Gujarat, Haryana, Uttar Pradesh and West Bengal, the Hyderabad-based firm added.
"COVAXIN has been directly supplied to 18 states since May 1st. Unflinching in our efforts, we will continue the steady supply of our #vaccine," Bharat Biotech said in a tweet. The company is supplying its vaccine to Andhra Pradesh, Assam, Bihar, Chhattisgarh, Delhi, Gujarat, Haryana, Jammu & Kashmir, Jharkhand, Karnataka, Madhya Pradesh, Maharashtra, Odisha, Tamil Nadu, Tripura, Telangana, Uttar Pradesh and West Bengal.
Bharat Biotech has commenced direct supply of Covaxin with effect from May 1 to several states based on the allocations received by the central government, the company's Joint Managing Director Suchitra Ella had earlier said.
On April 29, Bharat Biotech had announced a cut in the price of Covaxin for states to Rs 400 per dose from the earlier Rs 600. This followed widespread criticism of its pricing policy as it sold Covaxin to the central government at Rs 150 per dose. India has expanded its COVID-19 vaccination drive by allowing its large 18-plus population to get inoculated from May 1.