Missing Covaxin doses! Bharat Biotech clears air

While official data shows 2.1 crore doses of Covaxin had been administered across the country till Thursday, based on statements from Bharat Biotech and Centre, at least 6 crore doses should have been produced and available for vaccination

A Bharat Biotech BSL-3 facility being used to produce Covaxin A Bharat Biotech BSL-3 facility being used to produce Covaxin

Bharat Biotech, manufacturer of indigenously made COVID-19 vaccine Covaxin, has said its vaccine has a lag time of four months, from production in its factories to come out as a vaccine ready for 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 during the month of June.

"Production scale-up of vaccines 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 time for Covaxin to translate into actual vaccination," said the company.

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Its clarification comes in the wake of reports on the mismatch between actual vaccinations done so far and on monthly production targets revealed by the government and the company. Reports said while official data shows 2.1 crore doses of Covaxin had been administered across the country till Thursday, based on statements from the company and the Centre, production should have been at least 6 crore doses and available for vaccination, said a report. Unlike live viral vaccines and m-RNA vaccines that can be produced and scaled up quickly, Bharat Biotech's vaccine uses a traditional technology of killed viruses, in which virus is cultured, killed and purified to make the vaccine. Scale up of production is also a difficult process, said experts.

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 chain, manufacturers, regulators and state and central government agencies, said the company.

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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 additional number of days. Pandemic vaccines are distributed by respective governments equitably across all sections of the population. Vaccines once available at the vaccination centers are then administered to recipients over a period of time, based on demand, elaborated Bharat Biotech.

More than 22.46 crore vaccine doses have been provided to states and union territories and of this, the total consumption, including wastages, is 20.48 crore doses as of today morning, the government today said. The Centre in at least two separate affidavits, to the Supreme Court and to the Kerala Government, had said 2 crore Covaxin doses are made every month. Krishna Ella, the company's CMD, in April said the company produced 1.5 crore each in March and April and plans to make 3 crore doses in May. That was interpreted as at least 6 crore doses of production happened in the three month period, while actual vaccination with Covaxin was just 2.1 crore in India.

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