New Delhi: The Central Drugs Laboratory (CDL), Kasauli, has cleared almost 6.5 crore doses of Biological E's COVID-19 vaccine Corbevax based on safety, quality and efficacy parameters, sources said on Tuesday.
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 the restricted use in an emergency situation for the 12-18 age group based on interim results (of the ongoing phase II/III clinical study).
Biological E said that Corbevax is administered through the intramuscular route with two doses scheduled 28 days apart and 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 the 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.
Earlier sources on condition of anonymity told ANI that the Central Government has placed an order for as many as five crores Biological E's vaccine Corbevax.
The Central government had placed an order for as many as 30 crore Corbevax doses in August 2021.
The Hyderabad-based pharmaceutical company Biological E on Monday received Emergency Use Authorization (EUA) approval from Drugs Controller General of India (DCGI) for its COVID-19 vaccine Corbevax to be administered between the age group of 12 to 18 years.
It is India's first indigenously developed Receptor Binding Domain (RBD) protein sub-unit vaccine against COVID-19.
The Corbevax will be the second vaccine after Covaxin which has received approval for those below 18 years of age.
Meanwhile, the health ministry said, "With the administration of more than 35.50 lakh doses (35,50,868) vaccine doses in the last 24 hours, India's COVID-19 vaccination coverage has exceeded 175.83 crore (1,75,83,27,441) as per provisional reports till 7 am today."
