New Delhi: Hyderabad-based Bharat Biotech on Tuesday announced that the phase 2/3 trials of Covaxin for inoculation in children under the age of 18 have been completed and it expects to submit the data to the Drug Controller General of India (DCGI) by next week.
What’s the status of the Covaxin trial in children?
Bharat Biotech’s chairman and managing director Krishna Ella informed that the data analysis following the trials is currently underway and the report would be submitted soon, according to the news agency PTI.
“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,” said Ella.
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Apart from this, 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 on intranasal vaccine are being conducted on about 650 volunteers, who have been grouped into three cohorts. While 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.
Updating 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.
While the government said that it would resume the 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.