After three months of working together, the Russian Direct Investment Fund (RDIF) and Serum Institute of India (SII) have made it official. The Pune-based vaccine-maker will produce 300 million doses of the Sputnik V vaccine, annually.

The first batch of Sputnik V is expected from SII in September, said Kirill Dmitriev, RDIF Chief Executive. September, he said, will be a key month for the scale up of Sputnik in India, as the other manufacturing tie-ups would also begin to deliver by then.

The RDIF Chief’s statement comes even as reports in India suggest a shortfall in the supply of the second dose of Sputnik V. While the RDIF head did not address the issue, Dr Reddy’s Laboratories clarified late on Monday: “Neither the ongoing soft commercial launch nor work towards its ramp up in India have been put on hold.” DRL inked the first deal with the Russian sovereign wealth fund, last year, to market the vaccine in India.

Also read: Dr Reddy’s to strengthen commercial roll-out of Sputnik V

Dmitriev said the SII alliance would serve India’s vaccine requirement first, and then take up exports, to the 66 countries where Sputnik V is approved. Talks are on with the Indian authorities to facilitate exports, he said. There was, however, little clarity on the percentage of the doses that would be supplied to India, or the pathway for RDIF’s single-dose Sputnik Light.

Mix and match

Sputnik V pioneered the use of heterogeneous boosting in Covid-19 vaccines, he said, with two different vectors for the two-shot vaccine. This approach leads to longer immunity.

With many countries exploring a “mix and match” of vaccines, he said, they too were open to combining Sputnik and Covishield. In fact, results from the use of Sputnik and the AstraZeneca vaccine would be out by this month end, he said.

Tech-transfer

As part of the technical-transfer process, SII has received cell and vector samples from Russia’s Gamaleya Center. With their import approved by the Drug Controller General of India (DCGI), the cultivation process has begun, he said. The RDIF chief said, “This will substantially increase our production capabilities.”

Reiterating the timeline, SII Chief Executive Adar Poonawalla said, “We hope to make millions of doses in the coming months with trial batches starting in September.”

Serum Institute has a manufacturing and marketing tie-up for the AstraZeneca-Oxford University Covid-19 vaccine (Covishield), besides alliances with Novavax and Codagenix.

 

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