WHO rejects proposal seeking extension of Covishield's shelf life

The WHO has rejected Serum Institute of India's proposal seeking extension of the shelf life of Oxford-AstraZeneca Covid-19 vaccine, Covishield, from six to nine months, citing insufficient data, sources said. The WHO has also sought a meeting with Drugs Controller General of India (DCGI) to discuss the matter, they said. The move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date.

In a recent communique to Pune-based Serum Institute of India (SII), the WHO has 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. Shelf life is the length of time for which an item remains fit for use. The DCGI in a letter to SII in February said it has no objection in respect of 'extension of shelf life of Covishield vaccine' in multi-dose glass vial (10 dose-5ml) from six months to nine months.

According to an update by the UK drug regulator dated February 22, the shelf-life of the AstraZeneca Covid-19 vaccine is six months. The UK's medicines regulator on Wednesday said that under-30s in the country will be offered an alternative to the Oxford-AstraZeneca vaccine due to "evolving evidence" linking it to rare blood clots..Developed by Oxford University and Swedish-British pharma major AstraZeneca, Covishield is being manufactured by SII.