DCGI gives nod to Bharat Biotech's Covaxin for 6-12 age group in India
Apr 26, 2022, 14:34 IST
The Drugs Controller General of India (DCGI) on Tuesday approved the restricted emergency use authorisation (EUA) to Bharat Biotech's Covaxin for children between the age of 6-12 years, sources said.
The DGCI has asked vaccine manufacturer to submit safety data including the data on adverse event with due analysis every 15 days for the first two months and monthly thereafter upto 5 months, said the source familiar with the development.
This development comes after the Subject Expert Committee (SEC) discussed recommendations for the restricted emergency use of Covaxin in children aged between 2-12 years.
However, the SEC, after a meeting on Thursday, had recommended restricted emergency use of Biological E's Covid-19 vaccine, Corbevax, in children aged 5-12 years.
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The DGCI has asked vaccine manufacturer to submit safety data including the data on adverse event with due analysis every 15 days for the first two months and monthly thereafter upto 5 months, said the source familiar with the development.
This development comes after the Subject Expert Committee (SEC) discussed recommendations for the restricted emergency use of Covaxin in children aged between 2-12 years.
However, the SEC, after a meeting on Thursday, had recommended restricted emergency use of Biological E's Covid-19 vaccine, Corbevax, in children aged 5-12 years.
SEE ALSO:
Real-time payments are forecast to boost Indian GDP by US $45.9 billion in 2026
25-40% of people with COVID-19 develop long Covid, reporting symptoms that affect organs and cause mental health issues : Study