The expert panel that advises the Indian drug regulator has recommended phase II and III trials for Covaxin on children aged between two and 18 years.The nod from the subject expert committee (SEC) to conduct trials will allow the evaluation of the safety, reactogenicity and immunogenicity of Covaxin on kids. The trials will be conducted on over 500 children at multiple sites, including Delhi, Patna and Nagpur, according to sources.
The firm will have to submit interim safety data of the proposed phase II trial on children along with recommendations of the Data & Safety Monitoring Board (DSMB) to the Central Drugs Standard Control Organisation (CDSCO) before it will be allowed to proceed to the phase III of the study.
Covaxin has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). The indigenous, inactivated vaccine uses a whole-virion inactivated vero cell derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. The vaccine contain dead virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.
The company had initially applied for permission for conducting phase III clinical trials on children in the 5-18 years age group but in a meeting in late February 2021, the SEC asked the company to revise the study to a phase II/III and also submit efficacy and safety data of the phase III study on adults.