Covaxin production. Covaxin takes 120 days from manufacturing to release: Bharat Bio

The timeline for manufacturing, testing and release for a batch of Covaxin is approximately 120 days, Bharat Biotech has said on Friday.

In a detailed explanation of timelines involved from making of vaccine to vaccination, the Hyderabad-based company said the manufacturing, testing, release and distribution of vaccines is a “complex and multifactorial process”' with hundreds of steps, requiring a diverse pool of human resources.

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, the company said. Production scale-up of vaccines was a step-by-step process, involving several regulatory SOPs of GMP (Standard Operating Procedures of Good Manufacturing Practices). “There is a four-month lag time for Covaxin to translate into actual vaccination,'' it added.

Based on Central Drugs Standard Control Organisation(CDSCO) guidelines, all vaccines supplied in India are mandated by law to be submitted for testing and release to the Central Drugs Laboratory, Government of India.

All batches of vaccines supplied to State and Central Governments are based on the allocation framework received from the Government of India.

The timeline for vaccine supplies to reach the depots of the State and Central Governments from Bharat Biotech’s facilities is around two days.

The vaccines received at these depots have to be further distributed by the State Governments to various districts within their respective states. “This requires an additional number of days,”' the company said in a release.

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