DCGI Has Agreed, But WHO Rejects Serum Institute Proposal To Extend Covishield Shelf Life
World Health Organization (WHO) cited insufficient data in rejecting the proposal of Serum Institute of India (SII), seeking extension of shelf life of Oxford-AstraZeneca’s COVID-19 vaccine, Covishield, from six to nine months.
Sources told Hindustan Times that WHO has sought a meeting with Drugs Controller General of India (DCGI) to further discuss the matter.
Interestingly, DCGI has agreed to extend Covishield’s ‘use by’ date from six to nine months from the manufacturing date.
In a letter to SII in February, India’s regulator made it clear that it has no objection to extending shelf life of Covishield vaccine in multi-dose glass vial (10 dose-5ml) from six months to nine months.
“You are permitted to apply the shelf life of nine months to unlabelled vials available on hand, subject to the condition that the details of such stock, batch-wise, shall be submitted to this office and Central Drugs Laboratory, Kasauli,” DCGI Dr V G Somani had stated.
It will help in reducing vaccine wastage, but the UK drug regulator said on February 22 that the shelf life of the AstraZeneca COVID vaccine is six months.
SII is manufacturing the vaccine developed by Oxford University and Swedish-British pharma major AstraZeneca under the brand name of Covishield.