Bharat Biotech is also initiating the process to obtain an approval from the World Health Organisation for Covaxin.
Bharat Biotech, the Hyderabad-based COVID-19 vaccine maker, recently received approval from the Drugs Controller General of India to conduct clinical trials on children between the age of 2 and 18 (Representative image: PTI)
Bharat Biotech plans to start the pediatric trial of its indigenously-made COVID-19 vaccine Covaxin in June. The Hyderabad-based vaccine maker recently received approval from the Drugs Controller General of India (DCGI) to conduct clinical trials on children between the age of 2 and 18.
Speaking at a FICCI Ladies Organisation (FLO) meeting in Hyderabad on May 22, Bharat Biotech’s head of business development and international advocacy, Raches Ella said the trial will commence on June 1, as per an Economic Times report.
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“Bharat Biotech may get the license in the third quarter of this year,” Ella said.
Ella further said that Bharat Biotech has also initiated the process to obtain approval from the World Health Organisation (WHO) for Covaxin.
“A few of our products in the past got their approval. We expect approval for Covaxin (from WHO) by the end of Q3 or Q4,” Ella added.
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Earlier in May, an expert panel had recommended that phase 2/3 clinical trials of Covaxin on the 2-18 age group should be started.
Health experts have been seeking effective and safe doses for children before a possible third wave of infections arrives. India has so far approved Covishield, Covaxin and Sputnik V.
Covaxin is indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
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