covaxin: Private hospitals in Bengaluru confused over Covaxin shelf life extension | Bengaluru News – Times of India


BENGALURU: A recent letter from Bharat Biotech to stakeholders saying it was extending the shelf life of Covaxin from the existing six months to a year has left hospitals in Bengaluru confused. However, experts say there is no cause for worry.
There are six lakh doses of Covaxin with private hospitals in Karnataka, all of whom were worried that the doses would go to waste since the original six-month expiry was nearing. Now though, doses which were to expire between September 2021 and June 2022 can be used anywhere from March to September next year depending on the date of manufacture.
In its communique, Bharat Biotech said the extension was approved by Central Drugs Standard Control Organisation (CDSCO), the drugs controller in India.
Bharat Biotech tweeted: “CDSCO has approved the extension of shelf life of Covaxin up to 12 months from the date of manufacture. This approval of shelf life expansion is based on availability of additional stability data, which was submitted to CDSCO. The shelf life extension has been communicated to our stakeholders.”
But hospitals say potential vaccine seekers could reject doses since the labels would show old expiry dates. “Transporting vials to change the label may break the cold chain. Perhaps, hospitals can display a certificate from the company on their premises. However, convincing people may be tough,” said Dr HM Prasanna, president, Private Hospitals and Nursing Homes Association (PHANA).
Of the six lakh Covaxin doses with private hospitals, Apollo hospitals has stock of over four lakh. “We have not yet received any communication from the manufacturer so far. Our stock expires in November,” said Dr Yateesh Govindaiah, unit head, Apollo hospitals, Jayanagar.
Dr Sharan Patil, chairman, Sparsh Hospital, who received a letter from the manufacturer, said they will seek the opinion of pharmacologists and related experts. Dr R Ravindra, who owns Suguna hospital, said he would prefer a communication from the drugs controller instead of the manufacturer.
But Dr Rajshekar YL, secretary, PHANA, said, “When we upload the batch number on the CoWin portal, it shows the revised expiry date. It should not be an issue.”
TOI’s queries to Bharat Biotech did not elicit replies till the time of going to print.
Virologists say the extension is not a problem. Renowned virologist Dr T Jacob John said Covaxin is a ‘killed virus’ vaccine, which normally has a one-year shelf life.
However, Dr John said increasing the shelf life of drugs with retrospective effect is very rare. “I guess that the company had earlier said six months as the shelf life, because they had not tested it beyond six months. They may have kept the stock and tested it further. The problem is that Indians suspect Indians all the time,” said Dr Jacob. He said to clear the confusion, it’s better to change the label on vials.
Dr Gagandeep Kang, top vaccine scientist, said the DCGI is the authority to extend the shelf life of a drug and they would not have done it without adequate data. “There are multiple measurements based on which a chart is prepared showing the rate at which the active ingredients of the vaccine decline over time. This shows vaccine potency. Shelf life being extended is not new,” said Dr Kang.
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Sagar Biswas

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