Bharat Biotech, in a statement, said “the company plans to produce 200 million doses of Covaxin per annum in the GMP facilities that are already operational for the production of vaccines based on Inactivated Vero Cell Platform Technology, under stringent levels of GMP and biosafety.”
The additional doses would be produced at its wholly-owned subsidiary Chiron Behring Vaccines situated in Ankleshwar, Gujarat and the product availability will commence from Q4 2021.
“This effectively takes the volumes up to around 1 billion doses per annum, with its own established campuses specialised for manufacturing inactivated viral vaccines under the highest levels of biosafety,” added the statement.
Bharat Biotech is also working on Covaxin’s Phase II/III clinical trials for the age group of 2 to 18 years and is expected to begin in 10 to 12 days. Dr VK Paul, Member, NITI Aayog, during a press briefing on COVID-19 this week said, “I have been told that trials will begin in the next 10-12 days.”
The national regulator Drugs Controller General of India (DCGI) had last week given its nod to Bharat Biotech in this matter. The trial will be conducted on 525 healthy volunteers.
This would be the first time in the country when a COVID-19 vaccine will be tested on children. The clinical trials will involve two COVID vaccine shots injected on day 0 and day 28 and will take place at several sites — AIIMS, Delhi; AIIMS, Patna; and Meditrina Institute of Medical Sciences, Nagpur.
