Corbevax is a receptor-binding domain (RBD) protein sub-unit Covid-19 vaccine and is India’s first indigenously developed Covid-19 vaccine
Biological E’s Corbevax approved in India. (Credit: Arek Socha from Pixabay)
Indian vaccine manufacturer Biological E has received the Drugs Controller General of India (DCGI) authorisation for Corbevax for emergency use in people aged 12 to 18 years.
Corbevax is a receptor-binding domain (RBD) protein sub-unit Covid-19 vaccine, already approved for restricted use in emergencies among adults.
The vaccine is India’s first indigenously developed Covid-19 vaccine and is the third vaccine to be approved in people aged 12 to 18 years, following ZyCoV-D and Covaxin.
BE received the approval for restricted use in an emergency in adolescents aged 12 to less than 18 years based on interim results (of the ongoing phase II/III clinical study).
Biological E managing director Mahima Datla said: “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 close 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.”
In September last year, the Indian vaccine maker has secured regulatory approval to conduct a Phase 2/3 trial of Corbevax in children and adolescents aged five to 18 years.
The company has evaluated the available safety and immunogenicity results from the ongoing Phase 2/3 study and found that the vaccine is safe and immunogenic.
Corbevax is administered through an intramuscular route with two doses scheduled 28 days apart and is stored at 2º to 8º Celsius temperature.
Biological E has conducted Phase 1/2, and 2/3 clinical trials of Corbevax in adults, along with a Phase 3 active comparison clinical trial to evaluate compared to Covishield.
The Hyderabad-based pharmaceuticals and biologics company is engaged in developing, manufacturing and supplying vaccines and therapeutics.
In October last year, Biological E filed an application with the DCGI, seeking regulatory approval to conduct the Phase 3 study of its Corbevax vaccine as a booster dose.