Bharat Biotech Gets Approval To Start Next Phase Of Clinical Trials Of 'Covaxin' On Children Aged 2-18 Years

The Subject Expert Committee (SEC) on Tuesday recommended that Bharat Biotech be granted permission to conduct the phase 2/3 clinical trials of Covaxin on Children aged between 2-18 years.

Covaxin

Hyderabad: With the third wave of deadly Coronavirus expected to hit children this time, an expert panel has recommended Bharat Biotech's Covid-19 vaccine 'Covaxin' for phase II/III clinical trial on those aged between 2-18 years.

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday recommended that Bharat Biotech be granted permission to conduct the phase 2/3 clinical trials of Covaxin on Children.

The SEC deliberated upon Hyderabad-based vaccine maker'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.

As reported by news agency PTI, the panel after a detailed deliberation observed that Bharat Biotech be allowed to conduct the proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in children between age group pf 2-18 years.

The committee noted that the recommendation is 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.

According to the report, the clinical trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.

At present, the indigenously developed Covaxin drug against novel Coronavirus, is  being administered to people above 18 years of age.