The Drugs Controller General of India (DGCI) approved emergency use authorization to Covaxin for the age group of 6-12 years.
The Hyderabad-based pharma company Bharat Biotech has been asked to submit safety data including the data on adverse events with due analysis every 15 days for the first two months and monthly thereafter up to 5 months by the Drug Controller General of India (DGCI), said sources as quoted by news agency ANI.
Sources further informed that Corbevax COVID-19 vaccines for 5-12 years children will also get nod from DGCI for emergency use authorization.
Earlier, DCGI's Subject Expert Committee (SEC) recommended the restricted emergency use of Biological E's Corbevax COVID-19 vaccine for children aged 5-12, on Thursday.
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The subject expert committee has asked for additional data from Bharat Biotech for Covaxin below 12 yrs, no recommendations as of now, Sources added.
The Corbevax is currently being administered to children in the age group of 12-14.
COVID-19 vaccinations for minors in India were started from January 3 onwards with those in the 15-18 age group for Bharat Biotech's Covaxin.
The drive later expanded on March 16 to include children aged above 12 for Corbevax.
Overall India is currently administering two COVID-19 vaccines for children above 12.
Meanwhile, informing about the DCGI's nod to Covaxin for the 6-12 age group and Corbevax for 5-12 age group, Union Health Minister Mansukh Mandaviya tweeted, "India's fight against COVID becomes stronger @CDSCO_INDIA_INF gives nod to 'Covaxin' for 6-12 age group and 'Corbevax' for 5-12 age group for 'Restricted Use in Emergency Situations' ".
