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

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

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

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

Covaxin production to touch 55 million doses

Additionally, the Bharat Biotech MD also opened up on the current production of Covaxin for the adult population saying that it would touch 55 million doses in October as against 35 million in September. He also said the Phase 2 trials of the firm’s intranasal vaccine against COVID-19 is expected to be over by the 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 the Intranasal vaccine, Dr Ella remarked that the trials are conducted on three cohorts in which one group is administered Covaxin as the first dose and intranasal as the second. Trials are expected to be conducted on about 650 volunteers for Intranasal Covaxin.

(With Agency Inputs)