Citing insufficient data, WHO has rejected Serum Institute of India’s proposal seeking extension of the shelf life of the Oxford-AstraZeneca Covid-19 vaccine, Covishield, from six to nine months, sources said.
The WHO has also sought a meeting with the Drugs Controller General of India (DCGI) to discuss the matter, they said.
The move comes even as the DCGI has extended Covishield’s shelf-life from six to nine months from its manufacturing date.
In a recent communique to Pune-based Serum Institute, the WHO also asked the firm to formulate doses of a higher specification so that the minimum specification of ≥2.5×108 ifu/dose is fulfilled throughout the shelf-life.
The DCGI, in a letter to SII in February, had said: “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 VG Somani had said in the letter.
The DCGI’s decision will help health authorities reduce vaccine wastage. According to a February 22 update by the UK drug regulator, the shelf-life of the AstraZeneca vaccine is six months.
EU concerns
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 UK’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.
African Union says no to SII
Reuters adds: The African Union has dropped plans to secure Covid-19 vaccines from SII and is exploring options with Johnson & Johnson, the head of the Africa Centres for Disease Control and Prevention said on Thursday.
