DCGI approves Biological E's COVID-19 vaccine Corbevax for 12-18 age group
DCGI has already approved Corbevax for restricted use in emergency situation in adults on December 28.
- Feb 21, 2022,
- Updated Feb 21, 2022 11:43 PM IST
India's drug regulator on Monday granted final approval to Biological E's COVID-19 vaccine Corbevax, which is India's first indigenously developed RBD protein sub-unit vaccine against COVID-19, for children between 12-18 years of age.
This is the third COVID-19 vaccine to be approved for children between 12 and 18 years of age after Bharat Biotech's Covaxin and Cadila Healthcare’s ZyCoV-D.
"Biological E Limited's Corbevax vaccine, India's first indigenously developed Receptor Binding Domain (RBD) Protein sub-unit vaccine against COVID-19, has received emergency use authorisation (EUA) from India's drug regulator for the 12 to 18-year age group," the company said in a statement.
Commenting on the emergency use approvall (EUA), Mahima Datla, Managing Director, Biological E. Limited, said, "...We truly believe that with this approval, we are even more closer to finishing our global fight against the COVID-19 pandemic. Once fully-vaccinated, children can resume their activities and educational pursuits in schools & colleges without any apprehension. We thank all the participants in the clinical trials, Biotechnology Industry Research Assistance Council (BIRAC) and Department of Biotechnology, Govt of India, Translational Health Science and Technology Institute (TSTHI) and the principal investigators and clinical site staff who have extended their support during the last several months."
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 in adults on December 28.
Earlier, in an application sent to the DCGI on February 9, Srinivas Kosaraju, the 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.
The Corbevax vaccine is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees Celsius and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack.
According to the Health Ministry, the company has conducted phase 1/2, 2/3 clinical trials of its COVID-19 vaccine in the country. Further, it has conducted a phase 3 active comparator clinical trial to evaluate superiority against Covishield vaccine, it said.
Meanwhile, over 70 per cent of India's adolescents in the 15-18 age group have received the first dose of COVID-19 vaccine so far, Union Health Minister Mansukh Mandaviya had said earlier this month.
''Young India further strengthening the world's largest vaccination drive. Over 70% of our youngsters between 15-18 age group have received their 1st dose of COVID19 vaccine,'' Mandaviya said.
Vaccination of children aged between 15 and 18 began from January 3 across the country.
India's drug regulator on Monday granted final approval to Biological E's COVID-19 vaccine Corbevax, which is India's first indigenously developed RBD protein sub-unit vaccine against COVID-19, for children between 12-18 years of age.
This is the third COVID-19 vaccine to be approved for children between 12 and 18 years of age after Bharat Biotech's Covaxin and Cadila Healthcare’s ZyCoV-D.
"Biological E Limited's Corbevax vaccine, India's first indigenously developed Receptor Binding Domain (RBD) Protein sub-unit vaccine against COVID-19, has received emergency use authorisation (EUA) from India's drug regulator for the 12 to 18-year age group," the company said in a statement.
Commenting on the emergency use approvall (EUA), Mahima Datla, Managing Director, Biological E. Limited, said, "...We truly believe that with this approval, we are even more closer to finishing our global fight against the COVID-19 pandemic. Once fully-vaccinated, children can resume their activities and educational pursuits in schools & colleges without any apprehension. We thank all the participants in the clinical trials, Biotechnology Industry Research Assistance Council (BIRAC) and Department of Biotechnology, Govt of India, Translational Health Science and Technology Institute (TSTHI) and the principal investigators and clinical site staff who have extended their support during the last several months."
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 in adults on December 28.
Earlier, in an application sent to the DCGI on February 9, Srinivas Kosaraju, the 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.
The Corbevax vaccine is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees Celsius and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack.
According to the Health Ministry, the company has conducted phase 1/2, 2/3 clinical trials of its COVID-19 vaccine in the country. Further, it has conducted a phase 3 active comparator clinical trial to evaluate superiority against Covishield vaccine, it said.
Meanwhile, over 70 per cent of India's adolescents in the 15-18 age group have received the first dose of COVID-19 vaccine so far, Union Health Minister Mansukh Mandaviya had said earlier this month.
''Young India further strengthening the world's largest vaccination drive. Over 70% of our youngsters between 15-18 age group have received their 1st dose of COVID19 vaccine,'' Mandaviya said.
Vaccination of children aged between 15 and 18 began from January 3 across the country.