Well, for the children from the age gap between 12-18 years the second COVID-19 vaccine has received emergency use authorization in India.
Till now, India has been managing Bharat Biotech’s Covaxin to teens between 15 and 18 years old since January 3.
The EUA, short for emergency use authorization, for Corbevax’s limited use in an emergency, amid adults, was voided by the regulator Drugs Controller General of India in December 2019.
Today Biological E said in the statement, “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).”
Corbevax is being advertised as India’s first homegrown “receptor-binding domain protein sub-unit vaccine against COVID-19”. A receptor-unbreakable domain is a key role of a virus located on its “spike” domain that permits it to dock to body receptors to enter and infect cells. These are also the main targets in the prevention and treatment of viral infections.
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 closer to finishing our global fight against the COVID-19 pandemic.”
Last September, Biological E got authorization to perform phase II and III detached trials on Corbevax in children and adolescents aged 5 to 18 years.
The company added, “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.”
Corbevax is managed by an intramuscular route with two doses scheduled 28 days aside and is stored at 2 to 8 degrees 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 section biological products company in India and the first pharmaceutical company in southern India. In current years, BE has launched new enterprises for organizational growth such as developing general injectable products for the controlled markets.