Bharat Biotech explains COVAXIN's 'vaccine to vaccination' process; says it takes 120 days

As India battles the second wave of COVID, COVAXIN-producer Bharat Biotech on Friday issued a statement on the production & supply of COVID-19 vaccines to the states and noted that the manufacturing, testing, release and distribution of vaccines is a complex and multifactorial process. Bharat Biotech's statement comes as states across the country are reporting a shortage of COVID vaccine doses and amid calls to ramp up the production of vaccine. Issuing a statement on Friday, the COVAXIN maker stated that there was a step-by-step process in place for scaling up the production of vaccines comprising of regulatory SOPs of GMP (Good Manufacturing Processes) and that there was a 4-month lag time for COVAXIN to translate into actual vaccination. 

COVAXIN maker issues statement on vaccine to vaccination

Bharat Biotech stated that highly coordinated efforts were required from the international supply chain, manufacturers, regulators and State and Central government agencies in order for vaccines to result in actual inoculation of the people. Noting that the timeline for manufacturing, testing and release for a batch of COVAXIN was approximately 120 days, the company said that the batches whose production was initiated in March would only be ready for supply in June. Further, it noted that it took two days for the supplies to reach the state & Centre govts' depots from Bharat Biotech’s facilities and that it would then be distributed by respective governments equitably across all sections of the population.

"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," COVAXIN maker Bharat Biotech's statement read. 

Here is the full statement from Bharat Biotech

"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.
 
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.
 
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.
 
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," Bharat Biotech's statement read.

Centre's big push to COVAXIN production

Weeks before, the Centre had announced an additional financial grant of Rs 65 crore to aid Bharat Biotech's new Bangalore facility. Setting clear targets, the Department of Biotechnology has said that the current production capacity of COVAXIN, developed by Hyderabad-based Bharat Biotech and ICMR, will be doubled by May-June 2021 and then increased to nearly 6-7 fold by August 2021. Providing numerical figures for context, the Union Ministry has said that the production of COVAXIN vials will be increased from the existing 1 crore doses in April to 6-7 crore doses in July and reach nearly 10 crore (100 million) doses per month by September this year. 

Apart from the three existing Bharat Biotech plants, Haffkine Biopharmaceutical Corporation Ltd, based in Mumbai, which is a state PSE under the Government of Maharashtra, has also been aided by the Union Government to produce COVAXIN. The Centre has informed that it will provide a financial grant to the tune of Rs 65 crore for the Haffkine facility to be made ready for manufacturing. The Central government has asked the institute to expedite and complete the task of setting up the unit within six months rather than the 12 months the manufacturer had sought. The unit is expected to have a production capacity of 20 million doses per month, once functional.

The Centre has also extended support to Indian Immunologicals Limited, based in Hyderabad, to prepare a facility to provide nearly 10-15 million dozes of COVAXIN per month by August-September 2021. To put things into perspective, up till Tuesday, India had administered just over 17 crore (170 million) vaccine doses overall.