Bharat Biotech completes phase 2/3 trials of Covaxin for children under 18yrs

In a significant development, Hyderab-based Bharat Biotech completed Phase 2/3 trials of its COVID-19 vaccine- 'Covaxin' for use in pediatric population of country. Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella stated that data analysis for Phase 2/3 trials was currently going on. All data pertaining to use of Covaxin for children under 18 years of will be submitted to DGCI by next week, as per company.  number of subjects in phase 2/3 trials was over 1000, Dr Ella said. 

“Paediatric Covaxin just completed phase 2/3 trials. data analysis is going on. We will be submitting data ( to regulator) by next week. number of subjects ( volunteers) is touching 1000,” Ella said.

On June 3. Bharat Biotech h started its phase-2 trials of COVAXIN at Patna's AIIMS hospital in Bihar. trial took place at various sites, including AIIMS, Delhi, AIIMS, Patna, and Meditrina Institute of Medical Sciences, Nagpur with two doses ministered in an interval of 28 days. d to conduct trials on pediatric population was given by DGCI on May 13. If approved by DGCI, Covaxin will be first such vaccine in India that would cater to iculating children.

Covaxin production to touch 55 million doses

ditionally, Bharat Biotech MD also opened up on current production of Covaxin for ult population saying that it would touch 55 million doses in October as against 35 million in September. He also said Phase 2 trials of firm’s intranasal vaccine against COVID-19 is expected to be over by end of October. “We are supplying 35 million this month. Next month we will be definitely supplying 55 million doses. Production at Bangalore is catching up very fast,” he said replying to a query.

Speaking about Intranasal vaccine, Dr Ella remarked that  trials are conducted on three cohorts in which one group is ministered Covaxin as first dose and intranasal as second. Trials are expected to be conducted on about 650 volunteers for Intranasal Covaxin.

(With ncy Inputs)