Covid-19 vaccine Covaxin manufacturer Bharat Biotech has submitted the trial data for children in the 2-18 years age group to the Drugs and Comptroller General of India (DCGI), the company’s chairman and managing director Dr Krishna Ella told on Saturday.
“We have submitted the data from trials on volunteers in the age group of 2-18 to the DCGI,” Dr Krishna Ella, the Hyderabad-based firm’s chairman and managing director, told India Today on Saturday.
The development comes after the biotechnology company, last month, completed phase 2/3 trials of Covaxin on kids. Bharat Biotech was expected to submit data to the drugs regulator “very soon.”
The Hyderabad-based company, the maker of India’s first indigenous Covid-19 vaccine, completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September. Covaxin is yet to be given the EUL (emergency use listing) by WHO.
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So far, only drugmaker Zydus Cadila’s DNA Covid-19 vaccine has received emergency use approval in India to be used in adults and children aged 12 years and above.
Meanwhile, the country’s drug regulator on September 28 allowed Serum Institute to enrol kids between 7 and 11 years for its trial of US drugmaker Novavax’s coronavirus 19 vaccine.
(With agency inputs)
