The Drugs Controller General of India ( DCGI)) has given emergency use authorisation (EUA) to vaccine maker Biological E Limited’s (BE), Covid-19 vaccine Corbevax for the 12 to 18 years age group.
Union Health Minister Mansukh Mandaviya on Monday tweeted that the Central Drugs Standard Control Organisation(CDSCO) has granted the authorisation.
“It is the first indigenously developed Receptor Binding Domain Protein sub-unit vaccine against COVID-19. This will further strengthen our fight against COVID–19,” he said.
The vaccine is administered through an 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 and 10 mL (20 doses) vial pack.
Biological E Managing Director Mahima Datla said in a statement: “We are pleased with this significant development, which 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.’’
Last September, Biological E got permission to conduct phase II and III clinical trials of Corbevax in children and adolescents aged 5 to 18 years. Based on the no–objection certificate, BE initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results of the ongoing phase II/III study, which indicated that the vaccine is safe and immunogenic,” the company said.
India has been administering Bharat Biotech’s Covaxin to those between 15 and 18 years old since January 3. The DCGI has already approved Corbevax for restricted use in emergency situations among adults on December 28, 2021. “The BE conducted phase I/II, II/III clinical trials of its Corbevax vaccine for adults in the country,’’ the company said in its statement.