Biological E's Corbevax has got emergency use authorisation, or EUA
A second COVID-19 vaccine for children and teens has received emergency use authorisation in India. Biological E Ltd's Corbevax has got EUA for adolescents between 12 and 18 years, the vaccine-maker said in a statement today.
Till now India has been administering Bharat Biotech's Covaxin to teens between 15 and 18 years old since January 3.
The EUA, short for emergency use authorisation, for Corbevax's restricted use in emergency among adults was cleared by the regulator Drugs Controller General of India in December 2019.
"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)," Biological E said in the statement today.
Corbevax is being billed as India's first homegrown "receptor-binding domain protein sub-unit vaccine against COVID-19". A receptor-binding domain is a key part of a virus located on its "spike" domain that allows it to dock to body receptors to enter and infect cells. These are also the primary targets in the prevention and treatment of viral infections.
"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," Biological E Managing Director Mahima Datla said in a statement.
Last September, Biological E got permission to conduct phase II and III clinical trials on 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 in the statement.
Corbevax is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degree Celsius. It comes in 0.5 ml (single dose), 5 ml (10 doses) and 10 ml (20 doses) vial packs, BE said.
The Hyderabad-based firm was founded in 1953 and is the first private sector biological products company in India and the first pharmaceutical company in southern India. In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets.