Tests on children: Expert panel asks Bharat Biotech to submit Covaxin efficacy data

5 months ago 26
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So far, the DCGI has approved Covaxin as well as Covishield (the Indian version of the vaccine developed by the University of Oxford and AstraZeneca) for restricted use in vaccinations against Covid-19.

AN EXPERT body under India’s top drug regulator has asked Bharat Biotech to submit data of Covaxin’s efficacy to consider the company’s request to test the Covid-19 vaccine on children, The Indian Express has learnt.

It has also directed Dr Reddy’s Laboratories, which sought emergency approval for Russian-made Sputnik V, to submit final data on the vaccine’s safety and ability to prompt an immune response from Indian clinical trials.

Bharat Biotech’s Covaxin received restricted use approval in an emergency situation on January 3 for use in those aged above 18. So far, the vaccine has been administered to healthcare and frontline workers “in clinical trial mode” as part of the government’s mass vaccination campaign against the virus.

The company had approached the Central Drugs Standard Control Organisation (CDSCO) for approval to conduct late-stage clinical trials of Covaxin in children aged 5-18, according to a source close to the development.

The Subject Expert Committee (SEC) that was looking into the request on Wednesday told the Hyderabad vaccine-maker to submit data on Covaxin’s efficacy — a marker of how well the vaccine prevents symptomatic cases of Covid-19 — in adults.

“They have to first bring the interim efficacy data in adults. They are yet to submit it,” the source told The Indian Express on condition of anonymity. “Without knowing about the efficacy in adults, the committee felt it was not advisable to (administer the vaccine in trials on) children yet.”

Earlier this week, Bharat Biotech chairman and managing director Dr Krishna Ella said the company was expecting interim data on the efficacy of Covaxin in two weeks.

The SEC also told Dr Reddy’s to submit “the complete safety and immunogenicity data” of Sputnik V “as per the protocol approved” in order to be considered for a restricted emergency use approval, said the source. The Hyderabad company on February 19 announced that it had approached the Drug Controller General of India (DCGI), who heads CDSCO, for an emergency approval of the vaccine, which it has been testing on around 1,500 participants in mid- to late-stage trials in India.

The company had submitted interim data on the vaccine’s immunogenicity (its ability to provoke an immune response) as well as Russian data on its efficacy in support of its application, according to the source.

Queries to Dr Reddy’s and Bharat Biotech about when they may be able to submit the data sought by the SEC remained unanswered by press time on Wednesday.

So far, the DCGI has approved Covaxin as well as Covishield (the Indian version of the vaccine developed by the University of Oxford and AstraZeneca) for restricted use in vaccinations against Covid-19.

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