Bharat Biotech gets approval for phase 2/3 trials on 2-18 year olds | Fusion - WeRIndia

Bharat Biotech got approval for its vaccine, Covaxin, to conduct the next phase of clinical trials on children aged between 2 and 18 years.

Bharat Biotech, in association with the Indian Council of Medical Research (ICMR), developed the Covaxin vaccine. Currently, Covaxin is used in the COVID vaccination drive for adults.

The government wants to expand the vaccination drive to kids and adolescents also to protect them against COVID-19. In this context, the Subject Expert Committee recommended conducting phase II/III trials on those aged between 2 and 18 years.

The clinical trials will be conducted in 525 subjects at various sites like AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.

Earlier, Bharat Biotech submitted an application seeking permission to conduct the next phase of clinical trials on children aged two to 18 years. These trials will help the firm to assess the safety, reactogenicity and immunogenicity of Covaxin in children.

Hence, the Subject Expert Committee approved conducting phase II/III clinical trials of Covaxin.

However, before proceeding to Phase III trials, Bharat Biotech should submit the interim safety data of the phase II clinical trial to CDSCO.  Besides, the firm was asked to submit a revised clinical trial protocol.

Meanwhile, Bharat Biotech, in a tweet, said that Covaxin had been directly supplied to 18 states since May 1. These states include Andhra Pradesh, Telangana, Tamil Nadu, Karnataka, Assam, Bihar, Gujarat, Chhattisgarh, Delhi, Haryana, Jammu and Kashmir, Jharkhand, Maharashtra, Madhya Pradesh, Uttar Pradesh, Odisha, Tripura, and West Bengal.

The company had scaled up the production of Covaxin to meet the demands of the country. It said that the production capacity had been scaled up to 700 million doses from 200 million doses a year. It also partnered with Indian Immunologicals to produce the drug substance for Covaxin by way of technology transfer.

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