Manufacturing to produce of COVID-19 vaccine Covaxin includes 4 months of lag time relying on expertise and regulatory approvals, Bharat Biotech mentioned on Friday.
“The timeline for manufacturing, testing and release for a batch of Covaxinis 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 mentioned in a press launch.
Bharat Biotech‘s clarification comes at a time when the nation is going through a scarcity of COVID-19 vaccines, resulting in disruptions within the nationwide inoculation programme.
“There is a four-month lag time forCovaxinto translate into actual vaccination,” it mentioned.
The manufacturing, testing, launch and distribution of vaccines are advanced and multi-factorial processes with lots of of steps, requiring a various pool of human sources, the agency mentioned.
For vaccines to lead to precise vaccination of individuals, extremely coordinated efforts are required from worldwide provide chains, producers, regulators and State and Central authorities companies, it mentioned.
Production scale-up of vaccines is a step-by-step course of, involving a number of regulatory SOPs of GMP (Standard Operating Procedures of Good Manufacturing Practices), Bharat Biotech mentioned.
Based on Central Drugs Standard Control Organisation (CDSCO) pointers, all vaccines equipped in India are mandated by regulation to be submitted for testing and launch to the Central Drugs Laboratory, Government of India.
All batches of vaccines equipped to State and Central Governments are primarily based on the allocation framework obtained from the Centre, the corporate mentioned.
The timeline forvaccine provides to succeed in the depots of the State and Central Governments from Bharat Biotechs services is round two days.
The vaccines obtained at these depots need to be additional distributed by the State Governments to numerous districts inside their respective states.