SII to begin manufacturing Sputnik V in India by September, targets 300 million doses a year

Pune-based vaccine manufacturer SII has already received cell and vector samples for the production of Sputnik V from Russia's Gamaleya Center, the developer of the vaccine.

Vials of Russia's Sputnik V Covid vaccine | Twitter/@sputnikvaccine

New Delhi: Pune-based Serum Institute of India (SII), the world’s largest vaccine manufacturer in terms of volume, will start manufacturing the Russian Covid-19 vaccine Sputnik V by this September.

SII and the Russian Direct Investment Fund (RDIF, the global distributor of the vaccine) Tuesday announced cooperation to produce the Sputnik vaccine.

“The first batch of Sputnik vaccine is expected to be produced at SII’s facilities by  September. The parties intend to produce over 300 million doses of the vaccine in India per year,” the companies said in the joint press statement.

The move could help India increase the supply of Sputnik V, which is still not fully available in the market due to a delay in its commercial launch.

“We hope to make millions of doses in the coming months with trial batches starting in the month of September,” Adar Poonawalla, CEO, SII said in the press statement.

“With high efficacy and a good safety profile, it is critical that the Sputnik vaccine is accessible in full measure for people across India and the world. Given the uncertainty of the virus, it is important for international institutes, and governments to collaborate and further bolster up our fight against the pandemic,” he added.

According to the RDIF, India is the leading production hub for the manufacturing of the Sputnik vaccine.

The RDIF had earlier, over the past six months, entered into agreements with a number of pharmaceutical companies in India including Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and Morepen for the production of the vaccine in India, but these companies haven’t started manufacturing the vaccine yet.

Hyderabad-based drugmaker, Dr Reddy’s is the brand custodian of Sputnik V in India, which means it is the sole distributor of the vaccine in the country. The company, however, does not manufacture the vaccine and has only been distributing what it imported from Russia.

Sputnik received emergency use authorization in India from the Drugs Controller General of India (DCGI) on 12 April 2021. Its use in the country started on 14 May.

Delayed rollout of Sputnik in India

In India, the use of the vaccine — which is based on the common cold-causing human adenoviral vectors — has been delayed by Dr Reddy’s Laboratories due to various reasons.

While the vaccine first reached India on 1 May, it was deployed under a ‘limited pilot soft launch’ on 14 May. Under the pilot phase initiated by Dr Reddy’s, the vaccine was made available in a few hospitals in selected cities.

The company had earlier told ThePrint that there is a “slight postponement in the timeline of the commercial launch due to dependency on imported consignments, and quality testing in India”.

Now, supplies of the vaccine in India are expected to increase with the SII manufacturing Sputnik V in the country. The SII has already received cell and vector samples (needed for the production of the vaccines) from Russia’s Gamaleya Center, the developer of the vaccine, as part of the technology transfer process.

“With the import approved by the Drug Controller General of India (DCGI), the cultivation process (of viruses, for the manufacturing of the vaccine) has begun,” the statement issued by the SII and RDIF explained.

(Edited by Poulomi Banerjee)