WHO has additionally sought a gathering with Drugs Controller General of India (DCGI) VG Somani to have a look at the info formalities that had been fulfilled earlier than SII was given clearance to increase its shelf life in India.
PUBLISHED ON APR 09, 2021 07:07 AM IST
The World Health Organization (WHO) has turned down Serum Institute of India’s (SII) proposal to hunt extension of the shelf lifetime of Covishield vaccine from six to 9 months owing to inadequate knowledge, in accordance with officers conscious of the matter mentioned on Thursday.
SII is domestically manufacturing the Covid-19 vaccine developed by Oxford University and AstraZeneca beneath the model title Covishield. WHO has additionally sought a gathering with Drugs Controller General of India (DCGI) VG Somani to have a look at the info formalities that had been fulfilled earlier than SII was given clearance to increase its shelf life in India.
While SII refused to remark, trade insiders mentioned it’s not a rejection of the appliance. “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,” mentioned individual quoted above mentioned.
WHO has additionally requested the corporate to formulate the doses with sufficient titer and/or implement a better specification at launch in order that the minimal specification of ≥ 2.5 x 100000000 ifu/dose is fulfilled all through the shelf life.
The DCGI in a letter to SII in February mentioned 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 9 months. “You are permitted to apply the shelf life of nine months to unlabelled vials available on hand…,” Somani had mentioned.
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