Covaxin kids trial over, Bharat Biotech to submit data to DCGI next week

HYDERABAD:

Bharat Biotech

, the developer of indigenously developed Covid-19 vaccine Covaxin, has completed the Phase II/III trials on children in the 2-18 years age group and is all set to submit the data to the drug regulator, Drugs Controller General of India (

DCGI

), soon, the company’s chairman & managing director Dr Krishna

Ella

said on Tuesday.

“The paediatric trial we have just completed. The Phase II/III is all completed. The data analysis is going on so we will be submitting (data) by next week to DCGI,” Ella said, adding that it was the same product and presentation as the vaccine being administered to adults.

Ella said this on the sidelines of the `Vanijya Saptah-Showcasing the strengths of India as a rising economic force & reinvigorating exports of Telangana’ organised by the department of commerce, Union ministry of commerce & industry, directorate general of foreign trade, Telangana government and

Pharmexcil

to commemorate as part of the `Azadi ka Amrit Mahotsav' celebrations to commemorate 75 years of independence.

As part of the Phase II/III trial, the two-dose Covaxin was administered to 525 children 28 days apart. Bharat Biotech had received the drug regulators’ nod to conduct the children’s trial in May this year.

Dr Ella had earlier indicated that if all goes well the vaccine for kids could be available by October. Covaxin has been developed by Bharat Biotech along with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV)-Pune.