The World Health Organization 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 today.
The WHO has also sought a meeting with the Drugs Controller General of India (DCGI) to discuss the matter as the DGCI recently cleared the SII's proposal to extend Covishield's shelf life from six to nine months from its date of manufacturing, sources said, our New Delhi correspondent reports.
In a letter to the SII, the DGCI head VG Somani said the company is permitted to apply the shelf life of nine months to unlabelled vials available on hand.
In a recent communique to Pune-based SII, WHO has also asked the pharma major to formulate the doses with enough titer and/or implement a higher specification at release so that the minimum specification of the dose is maintained throughout the shelf life.
The DCGI had justified its decision to extend Covishield's shelf life to help cut vaccine wastage.