Phase 2/3 trials of `Covaxin' for use in children completed: Bharat Biotech MD

The company is expected to submit the data by next week to the DCGI, chairman and managing director of Bharat Biotech International Ltd Krishna Ella said.

By Newsmeter Network  Published on  22 Sep 2021 4:11 AM GMT
Phase 2/3 trials of `Covaxin for use in children completed:  Bharat Biotech MD

Hyderabad: Bharat Biotech has completed the Phase 2 and 3 trials of Covaxin for use in children below 18 years of age. The company is expected to submit the data by next week to the DCGI, chairman and managing director of Bharat Biotech International Ltd Krishna Ella said.

He was speaking on the sidelines of a two-day conference organized by the Union Ministry of Commerce, DGFT, Telangana government, and Pharmexcil to commemorate 75-years of independence.

"The data analysis is going on. We will be submitting the data by next week," he said.

Ella said Covaxin output will be ramped up to 5.5 crore doses from October. "We are supplying 3.5 crore doses this month. Next month, we will definitely be able to supply 5.5 crore doses," he said

The company chief said the production from Bengaluru will increase from next month as they have got the licence recently for one more facility. "We have two facilities in Bengaluru. One of them is fully ramped up and producing 2.25 crore doses. The second unit will start producing from next month," he said.

Ella said the company is currently producing almost 30 million doses in Hyderabad. "Covaxin output could reach 100 million doses by the end of the year with the help of its four partners – IIL (Indian Immunological Ltd), Haffkine Institute, Bibcol, and Hester Lifesciences," he said.

He said the company was ready to export Covaxin doses if the government allows it. He however said currently, the centre is focusing on the domestic market He also said that the Intranasal Vaccine developed by Bharat Biotech can create an immune response in the nose, which is the point of entry for the virus.

According to Ella, the intranasal vaccine trials are conducted on three cohorts in which one group is administered Covaxin as the first dose and intranasal as the second. Similarly, intranasal for the second group and intranasal vaccine for the third cohort are administered, 28 days apart. He said the trials will be conducted on about 650 volunteers.

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