“The timeline for manufacturing, testing and release for a batch of Covaxin is approximately 120 days, depending on the technology framework and regulatory guidelines to be met. Thus, production batches of Covaxin that were initiated during March this year will be ready for supply only during the month of June,” the vaccine maker said in a press release.
Bharat Biotech’s clarification comes at a time when the country is facing a shortage of Covid-19 vaccines, leading to disruptions in the nationwide inoculation programme. “There is a four-month lag time for Covaxin to translate into actual vaccination,” it said.
The manufacturing, testing, release and distribution of vaccines are complex and multi-factorial processes with hundreds of steps, requiring a diverse pool of human resources, the firm said.
For vaccines to result in actual vaccination of people, highly coordinated efforts are required from international supply chains, manufacturers, regulators and state and Central government agencies, it said.
Production scale-up of vaccines is a step-by-step process, involving several regulatory SOPs of GMP (Standard Operating Procedures of Good Manufacturing Practices), Bharat Biotech said. PTI