Phase 2 and 3 trials of Bharat Biotech’s paediatric Covaxin completed

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The phase-2 and 3 clinical trials of Bharat Biotech’s Covaxin for children below 18 years of age have been completed and the company will ramp up production from 35 million to 55 million doses at its Bengaluru facility in October, Managing Director, Krishna Ella said on the sidelines of Pharmaceutical Export Promotion Council Conference (Pharmexcil) on Tuesday. The company will share all the relevant clinical data with the Drugs Controller General of India (DCGI) by next week, he said, adding that Data generated from more than 1,000 volunteers is currently being analysed.

For ramping up production of Covaxin, Bharat Biotech has collaborated with Indian Immunologiclas and Hester Biosciences. Ella said that, if all safety parameters are in place then the firm could produce 100 million doses and the manufacturing partners are prepared. It is also prepared to export vaccine to other countries, he added.

Intranasal vaccine to come out soon

On the other hand, phase-2 trials of Bharat Biotech’s intranasal Covid-19 vaccines are expected to be completed by October, Ella said. He also said that the trials involved 650 volunteers and are conducted by dividing them into three groups.

The MD of the pharma company said that, volunteers in the first group are administered Covaxin and intranasal vaccine as second. In the second group, volunteers will get intranasal vaccine for both doses. The third group will get intranasal vaccine for the first dose and will get Covaxin as second dose, after 28 days, he said.

Ella also said that the intranasal immunisation can create an immune response in the nose, which is the entry point of the virus, would protect against the disease, infection and transmission as well.