Hyderabad-based pharmaceutical company Biological E on Monday received final approval from Drugs Controller General of India (DCGI) for its COVID-19 vaccine Corbevax, for the age group 12 to 18 years.
It is India's first indigenously developed Receptor Binding Domain (RBD) protein sub-unit vaccine against COVID-19.
The country's central drug authority has already approved COVID-19 vaccine Corbevax for restricted use in emergency situations among adults on December 28, 2019. Biological E received the approval for restricted use in an emergency situation in adolescents aged 12 to less than 18 years based on interim results (of the ongoing phase II/III clinical study).
According to Mahima Datla, Managing Director, Biological E Limited, "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. 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.''
An official statement from the pharmaceutical firm stated that in September 2021, it received approval to conduct a Phase II/III clinical trial on Corbevax in children and adolescents aged 5 to 18 years.
"Based on the no-objection certificate, Biological E 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 statement read.
Biological E said that Corbevax is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees' Celsius temperature and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial and 10 mL (20 doses) vial pack.
"Biological E conducted phase I/II, II/III clinical trials of its Corbevax vaccine for adults in the country. In addition, it conducted a Phase III active comparison clinical trial to evaluate superiority over Covishield vaccine," it said.
The Corbevax will be the second vaccine after Covaxin which has received approval for those below 18 years of age.
( With inputs from ANI )
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