Supplies of Covaxin were disrupted as the initial batches from Bharat Biotech's new fermentation plant at Bengaluru faced some stability issues and were rejected for supply in the month of July. The rejected batches were then not utilized.
As per the experts, it is a regular phenomenon when batches of drugs and vaccines fail to qualify for stability tests.
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Various stability studies have been conducted on vaccines and other pharmaceutical products. These studies were conducted to determine the storage period of intermediates and to modify the shelf-life of the vaccine.
Reportedly, disruption at Bharat Biotech’s plant assumed significance because a slowdown in the vaccine was witnessed. Meanwhile, for now, there is no quality issue with the vaccine.
An official said, “It is a new facility with a large-scale fermentation plant. The trial batches were disrupted during the standardization process and therefore, the supply of Covaxin was less than expected. It has been sorted out now and supplies have also started. It will be full-scale very soon.”
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Covaxin is one of the three covid-19 vaccines approved by the Indian government. Covaxin is an indigenous vaccine, manufactured by Bharat BioTech. Recently, the government told that it has received 5.45 crore doses of Covaxin in over six months, till July 16 and the company had the orders to supply 8 crores more Covaxin doses by the end of July month.