Russia’s Sputnik V to be produced at Serum Institute from September

New Delhi, July 13: The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund), and Serum Institute of India (SII), the world's largest vaccine manufacturer by volume, today announced cooperation to produce the Russian Sputnik vaccine against coronavirus.

SII is the world's largest company in terms of COVID vaccines production with over 500 million doses manufactured. Through several strategic associations, SII has been front running India's fight against the pandemic. In addition to developing its own vaccine, it is currently manufacturing Covishield (developed by AstraZeneca-Oxford), Covovax (by Novavax) and conducting trials of Codagenix in UK, said a release.

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.

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, the release also added.

To date, Russian Sputnik V vaccine has been registered in 67 countries globally with a total population of over 3.5 bn 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.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund said RDIF is delighted to cooperate with Serum Institute of India, the world's largest vaccine manufacturer. 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.

Adar Poonawalla, CEO of Serum Institute of India said I am delighted to partner with RDIF to manufacture the Sputnik vaccine. 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.

Advantages of Sputnik V:

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 December 5, 2020 to March 31, 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.