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Tuesday, June 15, 2021

SII receives ‘preliminary’ permission to make test batches of Sputnik V vaccine

The company on Friday received Drug Controller General of India Dr V G Somani's permission to manufacture batches of Sputnik V “for test and analysis”, a source close to the development told The Indian Express on condition of anonymity.

Written by Prabha Raghavan | New Delhi |
Updated: June 5, 2021 5:41:25 am
Sputnik VA health worker prepares to administer the Sputnik V coronavirus vaccine to a man during a soft launch of the Russian vaccine by inoculating employees and families of Dr Reddy’s Laboratories in Hyderabad. (AP Photo)

The Serum Institute of India (SII) has received a “preliminary” permission from the country’s drug top regulator to make test batches of Russia’s Sputnik V vaccine, The Indian Express has learnt.

If cleared, the Pune-headquartered vaccine maker may be able to add one more Covid-19 vaccine to its portfolio.

The company on Friday received Drug Controller General of India Dr V G Somani’s permission to manufacture batches of Sputnik V “for test and analysis”, a source close to the development told The Indian Express on condition of anonymity.

It is likely that SII will be able to use this permission to make test batches of Sputnik V to ensure that it is the same as the Russian vaccine that has received the DCGI’s restricted use permission. In doing so, the batches may also be tested by the regulator for aspects like quality and stability.

The batches produced with this permission cannot be used for commercial purposes, the source said.
Another source said that it is expected that SII would take “a few months” before it would be able to begin commercial production of Sputnik V.

It is unclear how many doses of the vaccine SII plans to manufacture on a monthly basis, as no agreement between the Pune company and the Russian Direct Investment Fund (RDIF) or Dr Reddy’s Laboratories has been announced.

Queries sent to SII and RDIF on Thursday about how many doses of Sputnik V are expected to be manufactured as per their agreement remained unanswered at the time of going to press on Friday.

Dr Reddy’s Laboratories said that there was “no comment” from the company on this “at this point”.

SII is currently in the process of ramping up its production capacity for Covishield, which accounts for nearly 90 per cent of the doses administered in India so far.

While the company was previously able to make around 60-70 million doses of the vaccine every month, its CEO had earlier said that the monthly production would hit 100 million doses by the end of July.

The Pune vaccine maker is also in the process of conducting bridging studies for Covovax, its version of Novovax’s protein-based Covid-19 vaccine. The government’s assessment is that SII would be able to supply 50 million doses of this vaccine every month starting September, as per parts of a presentation on vaccine availability that The Indian Express has viewed.

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