WHO rejects SII’s proposal seeking Covishield’s shelf life extension: Report
- WHO has sought a meeting with DCGI regarding the matter
- The proposal was turned down citing insufficient data
- DCGI's decision will help health authorities in reducing vaccine wastage
The WHO, on Thursday, 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, news agency PTI reported, quoted sources.
Regarding this, the world health body has sought a meeting with Drugs Controller General of India (DCGI).
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. 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.
“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 said in the letter.
The DCGI’s decision will help health authorities in reducing vaccine wastage. According to an update by the UK drug regulator dated February 22, the shelf-life of the AstraZeneca COVID-19 vaccine is six months.
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