Vaccine maker Biological E Ltd (BE) said in a statement on Monday, 21 February, that its Corbevax vaccine had received emergency use authorisation (EUA) from the Drugs Controller General of India (DCGI) for the age group of 12-18 years.
The Hyderabad-based pharmaceutical firm's COVID-19 vaccine is India's first indigenously developed RBD protein sub-unit shot.
Mahima Datla, the company's managing director, told The Times of India, "This significant development helps extend the reach of our vaccine to the age group of 12 to 18 years in our country. We truly believe that with this approval, we are even more closer to finishing our global fight against the COVID-19 pandemic."
She added that once children were fully vaccinated, they could resume offline classes and activities without any apprehension.
Corbevax is the second COVID vaccine for children in India. India had started administering Bharat Biotech's Covaxin to teens between 15 and 18 years from 3 January.
Restricted Emergency Use Approval
The DGCI's Subject Expert Committee (SEC) had granted restricted emergency use authorisation to the Corbevax vaccine for children aged 12 to 18 on 14 February, news agency PTI had 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 drug controller had granted restricted emergency use of the vaccine on adults in December last year.
Biological E's Head of Quality and Regulatory Affairs, Srinivas Kosaraju, apprised the DCGI that it had received the permission to carry out phase 2/3 clinical studies of Corbevax among children and adolescents aged 5-18 years in September, PTI reported.
(With inputs from PTI, The Indian Express.)