Drugs Controller Rejects Bharat Biotech's Request for Covid Vaccine Trials on Kids, Seeks Efficacy Data First

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Rejecting Bharat Biotech’s request to conduct clinical trials of Covaxin on children, the national drugs controller has asked the company to submit its report on efficacy of the Covid-19 vaccine.

Hearing an application by Hyderabad-based Bharat Biotech International on Wednesday that sought approval for Phase 3 clinical trials of Covaxin on children between 5-18 years of age, the subject expert committee of Central Drugs Standards Control Organisation asked the company to produce efficacy data on adults for its vaccine before seeking permission to test Covaxin on children.

“The efficacy data is top priority and they will also have to produce that data that has been asked for by the experts before more permissions are granted,” Hindustan Times quoted an official as saying.

Bharat Biotech is yet to submit its Phase 3 efficacy data on Covaxin which has already been approved for use in the country for adults in a clinical trial mode based on the safety and immunogenicity data the company had previously submitted.

The two vaccines, Covaxin and Covishield (developed by the University of Oxford and AstraZeneca, approved for use in the country, are currently for adults only.

Meanwhile, a three-member delegation from Ukraine led by the country’s health minister, Dr Maksym Stepanov, visited Bharat Biotech’s manufacturing facility in Hyderabad.

During the meeting, potential timelines for the supply of Covaxin to Ukraine were discussed on a priority basis and the prospects of a partnership for the country’s BBV 154 intranasal vaccine were also talked about. “There is a lot of interest in Covaxin worldwide,” said Krishna Ella, chairman and managing director of Bharat Biotech.

Covaxin has been developed by Bharat Biotech along with the Indian Council of Medical Research (ICMR).