Indian biotechnology company Bharat Biotech has been asked to submit efficacy data of its Covid-19 vaccine as the company intends to try its vaccine on children, Indian Express reported.
The report stated that an expert body under India’s top drug regulator has asked Bharat Biotech to submit the data before moving further with the trials.
The body also asked Dr. Reddy’s Laboratories to submit efficacy data of the Russian vaccine Sputnik V. The company recently sought emergency approval for the Russian Covid-19 vaccine.
Last month, Bharat Biotech’s Covaxin had received restricted use approval in an emergency situation for those who are aged above 18. Currently, the vaccine is being administered to healthcare and frontline workers “in clinical trial mode.” This is a part of the government’s mass inoculation campaign against Covid-19, as per media reports.
Also read: As demand for India’s Covid-19 vaccines rise, export of general vaccines slides
The company had sought the approval of the Central Drugs Standard Control Organisation (CDSCO). The company intends to carry out late-stage clinical trials of Covaxin in children aged 5-18, according to the Indian Express source who wished anonymity.
“They have to first bring the interim efficacy data in adults. They are yet to submit it. Without knowing about the efficacy in adults, the committee felt it was not advisable to (administer the vaccine in trials on) children yet,” the source said.
This comes as recently, at a conference organized by the state of Telangana, Bharat Biotech Chairman Krishna Ella had said that his company can make a product to tackle the Covid-19 variants in 15 days, as per media reports.
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