The national drugs controller has not given a go-ahead to clinical trials on children to test a Coronavirus disease (Covid-19) vaccine in India.
The two approved vaccines for use in the country currently are for adults only.
The subject expert committee of the national drugs regulator, Central Drugs Standards Control Organisation, heard an application by Hyderabad-based Bharat Biotech International on Wednesday that sought approval for Phase 3 clinical trial on children between the ages of 5 and 18 years for its anti-Covid vaccine, Covaxin.
The committee, however, asked the company to produce efficacy data on adults for its vaccine before seeking permission to test Covaxin on children.
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“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,” the official cited above added.
Covaxin is already approved for use in India for adults in a clinical trial mode based on the safety and immunogenicity data the company submitted.
{{/usCountry}}Covaxin is already approved for use in India for adults in a clinical trial mode based on the safety and immunogenicity data the company submitted.
{{/usCountry}}The company is yet to submit the Phase 3 efficacy data.
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.
“…We discussed potential timelines for the supply of COVAXIN® to Ukraine on a priority and the prospects of a partnership for our BBV 154 intranasal vaccine. There is a lot of interest in COVAXIN® worldwide. ..,” said Krishna Ella, chairman and managing director of Bharat Biotech.
Bharat Biotech has co-developed Covaxin along with the Indian Council of Medical Research.