The Drugs Controller General of India (DCGI) gives restricted emergency use authorisation to Covaxin for the 6-12 age group.
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 (DCGI), Sources told ANI.
The DCGI to give emergency use authorisation to Corbevax COVID-19 vaccines for 5-12 age group soon, sources said.
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.
The subject expert committee has asked for additional data from BharatBiotech 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' ". (ANI)