Covaxin gets approval for phase II/III trials on two to 18-year-olds

Hyderabad: Even as Pfizer-BioNTech vaccine has become the first vaccine globally to get approval from US drug regulator for use on children aged 12-15 years, 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.

According to sources, the trials will be conducted on over 500 kids at multiple sites, including Delhi, Patna and Nagpur. The nod from the subject expert committee (SEC) has been granted for conducting trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin on kids.

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 leg of the study.

In fact, Covaxin was the first Covid-19 vaccine globally to begin testing on children as young as 12 years in September 2020.

The phase II trials of Covaxin, which was a double-blinded study on 380 volunteers, included participants in the 12 to 65 years age bracket. Covaxin has been developed along with ICMR-NIV, Pune.

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.