The Subject Expert Committee (SEC) of India's central drug authority on Monday, 14 February granted restricted emergency use authorisation to Biological E's COVID-19 vaccine Corbevax for children aged aged 12 to 18, news agency PTI quoted official sources as saying.
“The SEC on COVID-19 of the CDSCO which deliberated on the application recommended granting restricted emergency use authorisation to Biological E’s Corbevax for the 12 to less than 18 years age group subject to certain conditions," the source reportedly indicated.
The application has now been sent to the Drugs Controller General of India (DCGI) for approval.
The COVID-19 vaccine, which is India's first indigenously developed RBD protein sub-unit shot, had received the DCGI approval for emergency use in adults on 28 December.
Head of Quality and Regulatory Affairs of the Hyderabad-based pharmaceutical firm, Srinivas Kosaraju has apprised DCGI that it had received the assent to carry out phase 2/3 clinical studies of Corbevax among children and adolescents aged 5-18 years in September, PTI reported.
In his application to the authority on 9 February, he added,
“Based on the no-objection certificate, Biological E has initiated the clinical study in October 2021 and has evaluated the available safety and immunogenicity results of the ongoing phase 2/3 study which indicated that the vaccine is safe and immunogenic."
Further in his application, he noted that the proposal for restricted use comes during the ongoing pandemic and the widespread need of a COVID-19 vaccines.
(With inputs from PTI.)