NEW DELHI: India’s drug regulator has allowed AstraZeneca The Covid-19 vaccine will be used for up to nine months from its date of manufacture, as opposed to the prescribed six months, according to a document reviewed by Reuters and a source.
Approval, granted to an authorized version of the drug manufactured by the Serum Institute of India (SII) and exported to dozens of countries, it could help health authorities minimize vaccine waste and better plan their inoculation programs.
Some African countries only have until the middle of next month to consume more than a million doses of the brand-name vaccine. Covishield by IBS – if the shelf life is not extended.
“You are allowed to apply the 9-month shelf life to unlabeled vials available by hand,” India’s general drug controller VG Somani wrote late last month in response to a request from SII.
AstraZeneca said in a statement last week that its product could be stored, transported and handled under normal refrigeration conditions for at least six months. The World Health Organization The website also shows the shelf life of Covishield and the South Korean-made AstraZeneca injection of six months.
Reuters has reviewed Somani’s approval, which has been communicated to some African countries, but could not determine whether its recommendation applies to unused vials. Each vial typically contains 5 milliliters of vaccine or 10 doses.
The source, with direct knowledge of the matter but not authorized to discuss it publicly, said that the approval was given based on the data presented by the SII. The source did not specify what kind of data the company, the world’s largest vaccine maker, shared.
Somani, the SII and AstraZeneca did not immediately respond to requests for comment.
India has so far administered 55 million doses of Covishield at home and has exported almost 64 million. India is also using another vaccine developed domestically by Bharat Biotech.
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