Russian Covid-19 vaccine Sputnik V production in India gets a shot in the arm as Serum Institute of India (SII) now partners with Russian Direct Investment Fund (RDIF) to make 300 million doses of the vaccine per year. The first batch of Sputnik V is expected to be produced at SII in September. With this partnership, the total manufacturing capacity for Sputnik V in India crosses 1.1 billion doses annually.
Moreover, as Kirill Dmitriev, CEO, RDIF, the Russian sovereign wealth fund, pointed out, SII will be in a position in the future to produce the mix-and-match dose combination of AstraZeneca-Oxford vaccine and Sputnik V. Speaking to reporters from Moscow, Dimitriev said that the trial of mix and match vaccines at Azerbaijan is expected to be over soon and the initial results could be out as early as end of this month.
Human trials of a Covid-19 vaccine combining the AstraZeneca-Oxford shot with Sputnik V had been approved in Azerbaijan, the United Arab Emirates and Belarus. Azerbaijan trials had begun around March this year.
Dimitriev told reporters that Sputnik V was the first in the world to suggest that the two shots should be different to give a stronger and longer immune response. Sputnik V is a heterogeneous vaccine–it uses two different components in two shots. The first shot uses human adenovirus vector Ad26 while the second one uses Ad5.
SII is already making Covishield, the AstraZeneca vaccine. Thus RDIF expects that once approved, SII is in a position to manufacture the combination dose vaccine of Sputnik V and AstraZeneca too, and it can also make the booster shots.
Adar Poonawalla, CEO of SII, said “We hope to make millions of doses in the coming months with trial batches starting in the month of September.”
The Pune-based vaccine maker, the world’s largest manufacturer in terms of doses, has already produced over 500 mn doses of Covid-19 vaccine, RDIF said. In addition to developing its own vaccine, it is currently manufacturing Covishield, Covovax (by Novavax) and conducting trials of Codagenix in the UK.
As part of the technical transfer process, SII has already received cell and vector samples from the Gamaleya Center. With their import approved by the Drug Controller General of India (DCGI), the cultivation process has begun.
India is the leading production hub for production of Sputnik vaccine. RDIF had earlier reached agreements with a number of pharmaceutical companies in India (Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and Morepen) for production of the Russian vaccine--more than 850 million doses per year. Around 250 million doses are planned for India at the moment.
Dimitriev said that some of these partners have already started manufacturing the Sputnik V, and the quality has been verified by the Gamaleya Research Institute of Epidemiology and Microbiology. The production from these partners is expected to be available by September, he added.
Indian production is critical for the commercial launch of Sputnik V, which is delayed thanks to shortage of the second dose component of the vaccine. Dr Reddy’s Laboratories (DRL), which is the distribution partner of RDIF for Sputnik V, launched a pilot on May 14. While the nation-wide soft launch has reached 50 cities, the vaccine is yet to be commercially launched.
DRL had said earlier that there was a ‘slight postponement in timeline of the commercial launch due to dependency on imported consignments’. DRL is the sole distributor of the first 250 mn doses of Sputnik V vaccine in India. The initial 50 mn doses are expected to be imported from Russia to ensure a faster roll-out in India as Indian manufacturing sites gear up to supply the vaccine.
The first consignment of imported doses of the Sputnik V vaccine, which landed in India on May 1, received regulatory clearance from the Central Drugs Laboratory, Kasauli, on May 13.
The imported doses of the vaccine are presently priced at a maximum retail price of Rs 948 plus 5 percent goods and service tax (GST) per dose, with the possibility of a lower price point when local supply begins, DRL said.
To date, Russian Sputnik V vaccine has been registered in 67 countries globally with a total population of over 3.5 billion people. The vaccine has shown an efficacy of 97.6 per cent based on the analysis of data on the Coronavirus infection rate among those in Russia vaccinated with both components of Sputnik V from December 5, 2020 to March 31, 2021.
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