Hyderabad-based pharmaceutical company Biological E Ltd on Monday said its coronavirus vaccine Corbevax, also India’s third homegrown vaccine, has received an emergency use approval in India for use in children aged 12 to 18 years.
The approval is likely to significantly ramp up the government’s ongoing drive to vaccinate children between 15 and 18 years of age, and later for those between 12 and 14 years of age.
It comes at a time when schools across the country are opening up as Covid cases are witnessing a considerable decline.
“With this approval, we are closer to finishing our global fight against the COVID-19 pandemic. Once fully vaccinated, children can resume their activities and educational pursuits in schools and colleges without any apprehension,” said Mahima Dada, Managing Director, Biological E. Limited.
Biological E had sought the emergency use authorisation of Corbevax on February 13. The expert panel of India’s central drug authority had later recommended granting restricted Emergency Use Authorisation (EUA) to Biological E’s vaccine. The recommendation was sent to the Drugs Controller General of India (DCGI) for final approval.
Corbevax is India’s first indigenously developed RBD protein sub-unit vaccine against Covid-19. The Drugs Controller General of India had approved the vaccine for restricted use in adults on December 28, but it was incorporated in the country’s vaccine drive.
In a statement, the pharmaceutical company said that it initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results of the ongoing phase 11/11 study, which indicated that the vaccine is safe and immunogenic.
Corbevax is India’s first indigenously developed RBD protein sub-unit vaccine against Covid-19. The Drugs Controller General of India had approved the vaccine for restricted use in adults on December 28, but it was incorporated in the country’s vaccine drive.
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.
Read all the Latest News India and Breaking News here
Comments
0 comment