Biological E’s COVID jab gets emergency use approval for 12 to 18 age group

Biological E’s Corbevax has got emergency use authorisation (EUA) from the Government of India for administering COVID vaccine to children in the 12 to 18 age group.

This is the second COVID vaccine for children to get EUA in India after Bharat Biotech’s Covaxin received government nod in January for the 15 to 18 years category.

The Drugs Controller General of India (DCGI) has already approved Corbevax, which is India’s first indigenously developed RBD protein sub-unit vaccine against COVID-19, for restricted use in emergency situation among adults on December 28.

In an application sent to DCGI on February 9, Srinivas Kosaraju, head of Quality and Regulatory Affairs of Biological E Limited, said the firm had received approval for conducting phase 2/3 clinical study of Corbevax among children and adolescents aged 5-18 years in September.

Also read: India logs 22,270 fresh COVID-19 cases, active tally down to 2.53 lakh

On Monday (February 21), the Hyderabad-based company issued a statement confirming emergency use approval. “BE received the approval for restricted use in an emergency situation in adolescents aged 12 to 18 years based on interim results (of the ongoing phase II/III clinical study),” the statement read.

Biological E Managing Director Mahima Datla said, “We truly believe that with this approval, we are even more closer to finishing our global fight against the COVID-19 pandemic.”

The Corbevax vaccine is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees Celsius temperatures and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack.