Bharat Biotech completes phase 2/3 trials of Covaxin in children, to submit data by next week

“Paediatric Covaxin just completed phase 2/3 trials. The data analysis is going on. We will be submitting the data by next week,” Bharat Biotech’s chairman and managing director Krishna Ella said.
Briefing on the production of Covaxin, Krishna Ella said that it would reach 55 million doses in October.(AP)
Briefing on the production of Covaxin, Krishna Ella said that it would reach 55 million doses in October.(AP)
Published on Sep 21, 2021 04:19 PM IST
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Written by Srivatsan K C | Edited by Avik Roy, Hindustan Times, New Delhi

Bharat Biotech, the Hyderabad-based biotechnology company and the makers of Covaxin Covid-19 vaccine, on Tuesday said that the phase 2/3 trials of Covaxin for inoculation in children under the age of 18 are over. The company also said that it expects to submit the data to the Drug Controller General of India (DCGI) by next week.

Bharat Biotech’s chairman and managing director Krishna Ella also said that the data analysis following the trials is currently underway and the report would be submitted soon. “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 1,000,” news agency PTI quoted him as saying.

Also read | Covaxin's wait continues, WHO ‘delays’ emergency use nod till October 5

Further, Ella also announced that the phase 2 trials of the company’s intranasal vaccine against Covid-19 is expected to conclude by the end of September. The intranasal vaccine creates an immune response in the nose, an entry point for the virus into the human body, thus offering protection against the infection and transmission of the virus, he noted.

The trials for the intranasal vaccine are being conducted on about 650 volunteers, who have been grouped into three cohorts. The first group received Covaxin as the first dose and the intranasal as the second, the second group got intranasal shots for both doses while the third group received it for the first dose and Covaxin for the second, Ella said. Each dose has been administered following a 28-day gap, he added.

Briefing on the production of Covaxin, Ella said that it would reach 55 million doses in October against the 35 million doses in September. “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,” PTI quoted him as saying.

The Union government on Monday said that it would resume export of Covid-19 vaccine doses to other countries under the Vaccine Maitri initiative from October. Commenting on this, Ella said that the company is ready to export the shots if the Centre permits, but is currently not in a hurry to look for overseas markets.

(With PTI inputs)

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Thursday, December 02, 2021