PremiumNEW DELHI: The Russian Direct Investment Fund has signed a pact with Serum Institute of India through which the world’s largest vaccine manufacturer by volume will produce over 300 million doses of the Sputnik V vaccine annually.
“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," Serum Institute chief executive officer Adar Poonawalla was quoted as saying in a statement Tuesday.
For Pune-based SII, this is the third covid-19 vaccine it will contract manufacture at its facilities in Pune, following the production of Covishield, which is a version of AstraZeneca’s and University of Oxford’s jointly-developed jab Vaxzevria, and Covovax, a version of the jab developed by US-based Novavax.
Serum Institute is also developing and conducting trials in the UK for a jab with Codagenix.
For RDIF, the global commercialising partner for the Russian vaccine Sputnik V, Serum Institute becomes the seventh contract manufacturer in India after Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and Morepen Laboratories.
With Serum Institute producing 300 million, the total number of Sputnik V doses annually produced in India now goes beyond 1.1 billion.
“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," RDIF CEO Kirill Dmitriev said.
Besides the manufacturing pacts, RDIF also has an exclusive distribution pact in India for Sputnik V with Hyderabad-based drugmaker Dr Reddy’s Laboratories. Under the pact, Dr Reddy’s can sell 250 million doses in India.
However, Dr Reddy’s is struggling to kickstart its commercial launch as most of the companies, barring Panacea Biotec, are yet to start commercial production and there is a high dependence on imports from Russia.
The company was expected to start commercial launch of the vaccine country-wide in mid-June but one month since that timeline, it is still in the ‘soft-launch’ phase, although the ‘soft-launch’ has been expanded to multiple cities across India, including Mumbai, Delhi, Bengaluru, Kolkata, Chennai, among others. The ‘soft-launch’ had initially started in Hyderabad and Vishakhapatnam on 14 May.
In a statement on Tuesday, Dr Reddy’s spokesperson said, “neither the ongoing soft launch nor work towards its ramp-up in India have been put on hold" and that it will strengthen the commercial launch in the coming weeks.
Based on real-world data from Russia between December and March, Sputnik V was found to be 97.6% effective in preventing covid-19 and has been found to be safe. While the current version of the vaccine requires a storage temperature of -19 degree Celsius, the developers are working on another version which can be stored at normal refrigeration temperatures of 2-8 degree Celsius.
The Sputnik V vaccine is a two-dose vaccine given three weeks apart. The vaccine comprises of human adenovirus that act as a vector for the gene that produces the spike protein of the coronavirus in the human body, which then tricks the immune system into providing protection.
However, unlike other covid-19 vaccines like Covishield, the two doses of Sputnik V use different strains of adenovirus, and each dose is produced separately, which has complicated the manufacturing process.
RDIF and the vaccine’s developer, Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology, are now trying to get regulatory authorisation for a single-shot jab, Sputnik Light, which comprises of only the first dose of the Sputnik V. Dr Reddy’s is also in the process of seeking regulatory authorisation in India.
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