WHO Rejects Extending SII's Corona Vaccine Covishield Shelf Life From Six To Nine Months
This comes even as the DCGI has extended shelf life of Covishield, developed by Oxford University and Swedish-British pharma major AstraZeneca, from six to nine months from its manufacturing date.
Even as the country faces the Covid-19 challenge, the World Health Organisation (WHO) has cited insufficient data and rejected the proposal of Pune-based Serum Institute of India (SII) seeking extension of the shelf life of Oxford-AstraZeneca Covid-19 vaccine - Covishield - from six to nine months.
Sources, who confirmed the development in this regard, said the WHO has also sought a meeting with the Drugs Controller General of India (DCGI) to discuss the matter. This comes even as the DCGI has extended the shelf life of Covishield, developed by Oxford University and Swedish-British pharma major AstraZeneca, from six to nine months from its manufacturing date.
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The WHO had in a recent communique to the Serum Institute of India also asked the firm to formulate the doses with enough titer and/or implement a higher specification at release so that the minimum specification of 2.5 x 108 ifu/dose is fulfilled throughout the shelf life, PTI reported.
Earlier in February, India’s drug regulator had written to the Serum Institute of India stating it has no objection in respect of extension of shelf life of Covishield vaccine in a multi-dose glass vial (10 dose-5ml) from six months to nine months.
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The shelf-life, the length of time for which an item remains fit for use, of the AstraZeneca COVID-19 vaccine is six months, as per an update by the UK drug regulator earlier in February.
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