The approval, given to a licensed model of the drug made by the Serum Institute of India (SII) and exported to dozens of international locations, might assist well being authorities minimise vaccine wastage and higher plan their inoculation programmes.
Some African international locations have solely till the center of subsequent month to make use of up greater than one million doses of the vaccine – branded Covishield by SII – if the shelf life isn’t prolonged.
“You are permitted to apply the shelf-life of 9 month to unlabelled vials available on hand,” India’s medication controller-general, V.G. Somani, wrote late final month in reply to a request from the SII.
AstraZeneca stated in an announcement final week that its product may very well be saved, transported and dealt with at regular refrigerated circumstances for at the very least six months. The World Health Organization (WHO) web site additionally provides the shelf-life of Covishield and the South Korean-made AstraZeneca shot as six months.
Reuters has reviewed Somani’s approval, which has been communicated to some African international locations, however couldn’t decide if his advice utilized to unused vials. Each vial sometimes comprises 5 millilitre of vaccine, or 10 doses.
The supply, with direct data of the matter however not authorised to debate it publicly, stated the approval was given based mostly on knowledge submitted by the SII. The supply didn’t specify what variety of knowledge was shared by the corporate, the world’s largest vaccine maker.
Somani, the SII and AstraZeneca didn’t instantly reply to requests for remark.
India has up to now administered 55 million Covishield doses at residence and exported almost 64 million. India can also be utilizing one other vaccine developed domestically by Bharat Biotech.
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