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Tuesday, September 28, 2021

Sputnik too in Serum stable, plans 300 million doses a year

Russia's Sputnik V vaccine, developed by Gamaleya National Research Institute of Epidemiology and Microbiology in Moscow, was granted emergency use authorisation in India in May.

Written by Prabha Raghavan , Anuradha Mascarenhas | New Delhi |
Updated: July 14, 2021 7:25:32 am
Second batch of Russian COVID-19 vaccine reaches HyderabadThe Centre had fixed the price of the vaccine at Rs 1,145 per dose.

Covishield-maker Serum Institute of India (SII) has added yet another brand to its growing portfolio of Covid-19 vaccines, unveiling plans on Tuesday to manufacture Russia’s Sputnik V over the next two months.

SII’s addition to a growing list of Indian partners for Sputnik V would enable the country to churn out over a billion doses of the Russian vaccine every year. It is also likely to help improve supply of the vaccine in India, where a soft launch has already taken place through vials imported from Russia but doses from most domestic manufacturers are still awaited.

SII, through its partnership with the Russian Direct Investment Fund (RDIF), intends to produce over 300 million doses of Sputnik V per year, said Russia’s sovereign wealth fund in a statement. This takes India’s annual production capacity of this vaccine to nearly 1.2 billion doses a year.

The Pune-headquartered vaccine maker has already received samples of the cell and vector — crucial components to make the vaccine — from the Gamaleya Research Institute of Epidemiology and Microbiology as part of the technical transfer process. The cultivation process has already begun.

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

“We expect the ramp-up to be quite quick…we’ve actually been working with Serum for the last three months,” said RDIF CEO Kirill Dmitriev.

RDIF has tied up with six other companies to make over 850 million doses of Sputnik V in India. These include Gland Pharma, Stelis Biopharma, Panacea Biotec, Hetero Biopharma, Virchow Biotech and Morepen. It also has an agreement with Hyderabad’s Dr Reddy’s Laboratories to supply around 250 million doses to the Indian market.

DRL had conducted a “limited pilot soft launch” of Sputnik V in India on May 14, expecting commercial shipments by mid-June. Nearly a month after this expected timeline, the company is still in the soft launch phase, with domestic production from RDIF’s Indian partners yet to pick up.

“Neither the ongoing soft commercial launch nor work towards its ramp-up in India have been put on hold,” said DRL in a statement on Tuesday, adding that the soft launch rollout had been scaled up “speedily” and reached at least 51 cities. “Dr Reddy’s will strengthen the commercial rollout of Sputnik V in the coming weeks,” it said.

According to Dmitriev, “some” of the manufacturers have already produced batches of the vaccine that have been verified by the Gamaleya Research Institute in Moscow for their quality. These manufacturers are already in the process of commercially producing or will begin manufacturing Sputnik V on a commercial basis “in the next one or two months,” he said. “We believe September is a key month when Sputnik will really be scaled up in India,” he added.

Doses manufactured here will be provided on priority to India, which has recorded around 30.50 million cases of Covid-19 and over 410,000 deaths from the virus during the ongoing pandemic.

“We are in discussions with the Indian government to enable us to have some export, of course after the immediate needs of the Indian population have been met,” said Dmitriev. “We will see how it will be produced and for how many people,” he added.

According to him, the number of people receiving the vaccine could vary because of the possibility of RDIF receiving an emergency approval here through DRL to use Sputnik Light — its one-shot vaccine.

According to the government’s CoWIN portal, about 74.66 million people have been fully vaccinated in India, and 305.26 million have been partially vaccinated.

Expectations are that Sputnik V may also be used in mix-and-match scenarios with SII’s other Covid-19 vaccines in India, according to Dmitriev. The Russian vaccine has already been tested in mix-and-match studies with the AstraZeneca vaccine (on which Covishield is based) in countries like Azerbaijan and the results may be released “in the next two weeks, by the end of July,” he said.

“We are open to a mix-and-match approach with (the) Covishield vaccine in India. We believe it can produce great results…we believe that the trials in Azerbaijan will show high efficacy of this approach,” said Dmitriev.

This will be SII’s third agreement to contract manufacture a Covid-19 vaccine after its agreement to make the Indian version of the AstraZeneca-University of Oxford vaccine (Covishield) and Novavax’s protein vaccine (Covovax). The Pune vaccine maker is also in the process of developing a Covid-19 vaccine in the UK with Codagenix.

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