Serum Institute to Produce Sputnik V in India From September: RDIF CEO

SII has already received cell and vector samples from the Gamaleya Center, as per the RDIF.

The RDIF has signed a deal to produce 750 million doses of Sputnik V in India.

(Photo: Altered by The Quint)

The Serum Institute of India (SII) will begin producing Russian COVID-19 vaccine Sputnik V in India in September, Kirill Dmitriev, CEO, Russian Direct Investment Fund (RDIF) said on Tuesday, 13 July.

He added that some other manufactures are also ready to produce the vaccine in India.

STATEMENT BY RDIF

Sharing the news of collaboration with SII, “the world’s largest vaccine manufacturer by volume”, the RDIF, on Tuesday, said in a statement:

• The first batch of Sputnik vaccine is expected to be produced at SII’s facilities in September

• The parties intend to produce over 300 million doses of the vaccine in India per year

Further, as per the statement, SII has already received cell and vector samples from the Gamaleya Center, as part of the technical transfer process.

“With their import approved by the Drug Controller General of India (DCGI), the cultivation process has begun,” the RDIF further said, adding that it had earlier reached agreements with a number of pharmaceutical companies in India.

The Sputnik V vaccine has, as per RDIF, already been registered in 67 countries globally with a total population of over 3.5 billion people.

“The data obtained by regulators of a number of countries during the vaccination of the population, including in Argentina, Serbia, Bahrain, Hungary, Mexico, San Marino, UAE and others, demonstrates that Sputnik V is one of the safest and most effective vaccines against coronavirus.”

RDIF

WHAT DID THE RDIF CEO SAY?

Meanwhile, Kirill Dimitriev, CEO of the RDIF, in his comment, quoted in the statement, said that RDIF is delighted to cooperate with SII.

“This strategic partnership is a major step to substantially increase our production capabilities demonstrating a perfect example of joining forces and expertise to save lives both in India and around the world. With technology transfer underway we expect the first batches of the vaccine to be produced jointly with SII in coming months.”

Kirill Dimitriev, CEO of the RDIF

WHAT SII CEO SAID

SII CEO Adar Poonawalla, in his comment, was quoted as sharing his own delight at the partnership with RDIF for the manufacturing of the jab.

“We hope to make millions of doses in the coming months with trial batches starting in the month of September. 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.”

SII CEO Adar Poonawalla

KEY ADVANTAGES OF SPUTNIK V, AS PER THE RDIF

Key advantages of the vaccine, as listed out in the RDIF-SII statement, are:

• Efficacy of Sputnik V is 97.6% based on the analysis of data on the coronavirus infection rate among those in Russia vaccinated with both components of Sputnik V from 5 December, 2020 to 31 March, 2021

• The Sputnik V vaccine is based on a proven and well-studied platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years

• Sputnik V has pioneered the use of heterogeneous boosting (two different vectors for the two shots in a course of vaccination among COVID vaccines). This approach provides for immunity with a longer duration than vaccines using the same delivery mechanism for both shots

• The safety, efficacy and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades

• There are no strong allergies caused by Sputnik V

• The storage temperature of Sputnik V at +2+8 C means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure

BACKGROUND

On 4 June, the DCGI had granted SII the permission to manufacture ‘Sputnik V’ for examination test and analysis at its licensed facility at Hadapsar, reported ANI, citing sources.

SII, which makes the Covishield vaccine, had earlier applied to the DCGI seeking permission to manufacture Russia's COVID-19 vaccine Sputnik V.

SII’s application had come amid an acute shortage of vaccine doses across the country.

Meanwhile, Sputnik V is also being imported by Dr Reddy's Laboratories and will be manufactured locally by the pharmaceutical major in the coming months.

On Monday, the pharma major stated that the nationwide soft launch of the Russian vaccine has reached over 50 cities and town across India.

It said it will strengthen the commercial roll-out of Sputnik V in the coming weeks.

Starting initially in Hyderabad on Monday, the soft launch roll-out of Sputnik V has scaled up speedily and reached cities and towns all India.

The Russian vaccine had been approved for emergency use authorisation in India in April, making it the third COVID-19 vaccine to be approved in the country, the other two being Covishield and Bharat Biotech's Covaxin.

Since then, the DCGI has also granted permission to Mumbai-based pharmaceutical firm Cipla to import the Moderna COVID-19 vaccine for restricted emergency use in India.

(With inputs from ANI)