Corbevax is currently being administered to children in the age group 12-14 years. Hyderabad based Biological E had approached the drug regulator earlier this week for granting Emergency Use Authorisation (EUA). However, the SEC sought more data.
In a meeting held on April 11, the SEC reviewed Biological E’s application and asked for updated safety data which should be 2-3 months post second dose, immunogenicity data and virus neutralising antibody data against a variant of concern.
The SEC has also sought additional data from Bharat Biotech for using Covaxin in kids between 5-12 age group.