Covaxin manufacturing to vaccination takes 4 months, says Bharat Biotech

Bharat Biotech says that the time taken for manufacturing, testing and release of a batch of Covaxin is about 120 days

As the glaring shortage of the Covid-19 vaccines continues to drag the country's mass immunisation programme, Bharat Biotech, the maker of Covaxin, has defended its slow and low output.

The bio-tech firm, which had earlier stated its vaccine manufacturing as highly expensive and low yielding, has now stated that “the time lag for Covaxin to translate into actual vaccination is four months.”

Covaxin and Serum Institute of India-produced Covishield are part of the ongoing vaccination under which over 20.5 crore doses have been administered till Friday morning. However, the number of beneficiaries who availed both the doses are only about 4.39 crore out of an estimated nearly 140 crore population.

The share of Covaxin in the vaccination numbers is just around 10 per cent.

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Covaxin, the first indigenous vaccine developed in collaboration with ICMR - National Institute of Virology last year was approved for emergency use in January.

While Covishield is mRNA based, Covaxin is an inactivated whole virion, highly purified vaccine which requires Bio Safety Level -3 facilities for production.

“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,” Bharat Biotech said in a statement on Friday.

While the nation is facing a severe shortage in Covid-19 vaccine supply, an apparent pressure is building on the company to scale up the supplies to the states.

Earlier this month, Andhra Pradesh chief minister Jaganmohan Reddy wrote to Prime Minister Narendra Modi asking for Bharat Biotech to transfer its vaccine production technology to other vaccine firms, keeping the emergency requirement in consideration.

“The manufacturing, testing, release and distribution of vaccines is a complex and multi-factorial 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 chain, manufacturers, regulators and state and central government agencies,” the company states.

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Bharat Biotech has last week announced that it would be able to deliver up to one billion doses of Covaxin annually by the end of 2021. As of April, the firm's Covaxin production capacity was pegged at 500 million doses per annum.

“Production scale-up of vaccines is a step-by-step process, involving several regulatory Standard Operating Procedures of Good Manufacturing Practices,” the firm said.

Based on Central Drugs Standard Control Organisation (CDSCO) guidelines, all batches of vaccines supplied in India are mandated by law to be submitted for testing and release to the Central Drugs Laboratory at Kasauli. The supply to state and centre are based on the allocation framework received from the Union government.

Bharat Biotech said that the time taken for vaccines to reach the state and central government depots from its facilities is around two days.

While SII is supplying Covishield to the state governments at Rs 300 per dose, Bharat Biotech revised price for the same is Rs 400. Covaxin is made available for private hospital supply at Rs 1200 per dose, and Covishield at Rs 600.