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Covaxin Production: March Batches to Be Ready for Shipping in June

Bharat Biotech said, the timeline for manufacturing, testing, and release for a batch of Covaxin is 120 days.

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COVID-19
2 min read
Bharat Biotech stated that the production batches of Covaxin initiated in March to be ready only in June.
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Bharat Biotech on Friday said that the timeline for manufacturing, testing, and release for a batch of Covaxin is approximately 120 days. In a statement, the company said that ‘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 the international supply chain, the manufacturers, the regulators, and the state and central government agencies,” it added.

The company said scaling up of vaccine production is a step-by-step process, involving several regulatory SOPs of GMP (Standard Operating Procedures of Good Manufacturing Practices).

There is a four-month lag for Covaxin to translate into actual vaccination. 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 in June, the company clarified.

Based on the 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.

“All batches of vaccines supplied to state and Central governments are based on the allocation framework received from the Centre. 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 added.

Moreover, the COVID vaccines are distributed by respective governments equitably across all sections of the population. Vaccines once available at the vaccination centres are then administered to recipients over a period of time, based on demand.

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