As India starts vaccinating its teenagers from Monday, Bharat Biotech, the maker of Covaxin, has started to pick up un-used stock from private hospitals to re-label the shelf life. Covaxin is the only vaccine available for vaccination drive for teenagers now.
The company got a shelf life extension in December, when the country’s drug regulator allowed a shelf life of 12-months for Covaxin.
Therefore, upon receiving the order from the Central Drugs Standard Control Organisation (CDSCO) the company started lifting unused stock from hospitals to re-label the shelf life from nine months to 12 months.
“The company, after receiving the approval from the regulator on the extension of shelf life to 12 months, has already begun lifting the unused stock from private hospitals a few weeks ago at its own expense for re-labelling. It will also conduct testing and inspection before re- labeling,” a company source said.
The person added that all hospitals that have placed new orders have also started receiving fresh stocks.
Covid-19 vaccine shelf lives have been extended from time to time as more stability data was generated and manufacturers were able to submit it with the Drugs Controller General of India (DCGI).
“Approval of shelf-life extension is based on the availability of additional stability data, which was submitted to CDSCO. With the shelf-life extension, hospitals can now utilise the stock which was nearing the expiry and avoid vaccine wastage,” the company had said in December.
Moreover, the CDSCO had also noted that an opened vial of Covaxin can be stored at 2-8 degree Celsius for up to 28 days and is not required to be discarded immediately in a day or at the end of immunisation session.
Some hospitals, however, have not opted for re-labelling as they are confident of using the stock within the stipulated shelf life mentioned.
A Bengaluru-based hospital said it was confident of using the stock by March (the expiry date mentioned on vaccine stocks) and thus it was not going for re-labelling. The hospital has ordered fresh stock instead.
Several hospitals like Manipal Hospitals Group, Fortis Healthcare, Rainbow Hospitals etc have placed orders for fresh stock of Covaxin.
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