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  • Covaxin trial data in...

Covaxin trial data in children submitted to CDSCO

Ruchika SharmaWritten by Ruchika Sharma Published On 2021-10-07T14:26:38+05:30  |  Updated On 7 Oct 2021 2:26 PM IST
Covaxin trial data in children submitted to CDSCO
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Hyderabad: Bharat Biotech, which completed the Phase 2/3 trials of COVID-19 vaccine Covaxin for use in children under 18 years of age, has submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for Emergency Use Authorisation for the jab, company sources said on Wednesday.

"Covaxin clinical trial data of 2-18 years age group has been submitted to CDSCO...This is feasible due to the safety of the manufacturing platform and empirical evidence from Phase 1,2 and 3 clinical trials in adults," sources told PTI.

Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella, had said on September 21 that the Paediatric Covaxin completed phase 2/3 trials with about 1,000 subjects and the data analysis was going on.

As part of the Phase II/III trial, the two-dose Covaxin was administered with 28 days apart.

"We will be submitting the data (to the regulator) by next week," he had said.

He also had said that Phase 2 trials of intranasal vaccine to prevent COVID-19 were going on and expected to be over in October.

If approved, Covaxin will be the first COVID-19 vaccine that can be administered to children in India.

COVAXIN, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility.

Medical dialogues team had earlier reported that the WHO would take a call on granting Emergency Use Listing (EUL) status for Bharat Biotech's COVID-19 vaccine Covaxin next week.

"WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin," the global health body had tweeted.

Read also: Covid-19: WHO to take final call on approval of Covaxin next week




bharat biotechbharat biotech newscovaxincoronaviruscoronavirus vaccinecdscoclinical trial
Source : with agency inputs
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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