The subject expert committee for Covid-19 has given permission for restricted use of Bharat Biotech's Covid-19 vaccine Covaxin in emergency situation for children in 2-18 years group, India Today reported on Tuesday.
The Hyderabad-based drug maker's two-dose vaccine is already been used in the country's immunisation programme against Covid-19 for those above 18 years of age.
"The firm should submit safety data including the data on AEFI (adverse events following immunisation) and AESI (adverse events of special interest), with due analysis, every 15 days for the first two months and monthly thereafter and also as per requirement of New Drugs & Clinical Trials Rules, 2019," the committee was reported as saying.
The vaccine will be administered in two doses, with a gap of 20 days between the first and second dose, the report said.
Bharat Biotech had submitted the interim safety and immunogenicity data of Phase II/III clinical trials of the vaccine in 2-18 years age group for seeking emergency approval. The company is also awaiting approval of the vaccine from the World Health Organization (WHO).
With this approval, Covaxin is the only vaccine in India approved for use in children who are as young as two years. Earlier, drug maker Zydus Cadila's ZyCoV-D was the only vaccine to be approved for use in those below 18 years in the country. The vaccine has been permitted for use in 12-18 years age group.
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