Takes Covaxin 4 months to reach end user from start of production: Bharat Biotech - Times of India

HYDERABAD: It takes about four months for indigenously developed vaccine Covaxin to reach the end user from the manufacturing stage, its developer Bharat Biotech said on Friday.
The timeline for manufacturing, testing and release for a batch of indigenously developed Covid-19 vaccine Covaxin is approximately 120 days, depending on the technology framework and regulatory guidelines to be met, it said.
“There is a four-month lag time for Covaxin to translate into actual vaccination. Thus, production batches of Covaxin that were initiated during March this year will be ready for supply only during the month of June,” the company said.
Pointing out that the production scale-up of vaccines is a step-by-step process involving several regulatory SOPs of GMP (Standard Operating Procedures of Good Manufacturing Practices), it 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's statement comes as several states continue to cite shortage of Covaxin with reports questioning the production capacity of the vaccine manufacturer.
It also said that 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 at Kasauli.
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, which requires an additional number of days, it explained.
Also all the batches of vaccines supplied to state and central governments are based on the allocation framework received from the Indian government, it added.

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Takes Covaxin 4 months to reach end user from start of production: Bharat Biotech - Times of India
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