WHO rejects SII’s proposal seeking extension of Covishield shelf life

WHO has also sought a meeting with Drugs Controller General of India (DCGI) VG Somani to look at the data formalities that were fulfilled before SII was given clearance to extend its shelf life in India.

The World Health Organization (WHO) has turned down Serum Institute of India’s (SII) proposal to seek extension of the shelf life of Covishield vaccine from six to nine months owing to insufficient data, according to officials aware of the matter said on Thursday.

SII is locally manufacturing the Covid-19 vaccine developed by Oxford University and AstraZeneca under the brand name Covishield. (HT file photo)

SII is locally manufacturing the Covid-19 vaccine developed by Oxford University and AstraZeneca under the brand name Covishield. WHO has also sought a meeting with Drugs Controller General of India (DCGI) VG Somani to look at the data formalities that were fulfilled before SII was given clearance to extend its shelf life in India.

While SII refused to comment, industry insiders said it is not a rejection of the application. “In an evolving situation that we are seeing during this pandemic, applications keep going back and forth. It is not that big a concern for companies as all they have to do is submit more data that has been sought,” said person quoted above said.

WHO has also asked the company to formulate the doses with enough titer and/or implement a higher specification at release so that the minimum specification of ≥ 2.5 x 100000000 ifu/dose is fulfilled throughout the shelf life.

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 to nine months. “You are permitted to apply the shelf life of nine months to unlabelled vials available on hand...,” Somani had said.