Coronavirus | WHO rejects SII proposal to extend Covishield shelf life from 6 to 9 months

The move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date

April 08, 2021 08:15 pm | Updated 10:33 pm IST - New Delhi

Covidshield. File.

Covidshield. File.

The WHO has 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, sources said.

Also read:Coronavirus | Serum Institute of India rejects charges by ‘Covishield’ volunteer, threatens to seek damages

The WHO has also sought a meeting with Drugs Controller General of India (DCGI) to discuss the matter, they said.

The move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date.

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 and/or implement a higher specification at release so that the minimum specification of ≥ 2.5 x 108 ifu/dose is fulfilled throughout the shelf life. 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.

Meanwhile, concerns have been raised about the vaccine as the European Union's health agency concluded a "possible link" between the vaccine and rare blood clots but stressed that the benefits of the vaccine to protect against COVID-19 continue to outweigh the risks.

The U.K.'s medicines regulator on Wednesday said that under-30s in the country will be offered an alternative to the Oxford-AstraZeneca vaccine due to "evolving evidence" linking it to rare blood clots. Developed by Oxford University and Swedish-British pharma major AstraZeneca, Covishield is being manufactured by SII.

0 / 0
Sign in to unlock member-only benefits!
  • Access 10 free stories every month
  • Save stories to read later
  • Access to comment on every story
  • Sign-up/manage your newsletter subscriptions with a single click
  • Get notified by email for early access to discounts & offers on our products
Sign in

Comments

Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.

We have migrated to a new commenting platform. If you are already a registered user of The Hindu and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.