Sputnik V developer partners with SII for 300mn jabs a year

The developers of Russia’s Sputnik V Covid-19 vaccine and Serum Institute of India (SII) announced a partnership agreement on Tuesday to manufacture more than 300 million doses in India, with production set to start in September.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), told a virtual news briefing that the developers of Sputnik V are looking at using the vaccine along with the AstraZeneca dose (marketed as Covishield in India) in a “mix and match” format. Results of the first trials using a mix of the two vaccines in Azerbaijan are set to be released in the next two weeks.

September will be a “key month” for scaling up the production of Sputnik V in India as SII and several other companies are expected to launch production by then, and RDIF is in talks with the Indian government to allow the export of “some portion” of the vaccines after the immediate needs of the Indian population are met, he said.

Though the RDIF-SII partnership agreement was announced on Tuesday, Dmitriev said the two firms had been working jointly for the past three months. As part of the technology transfer process, SII has received cell and vector samples from Russia’s Gamaleya Center.

“We have all the ingredients approved by the Drugs Controller General of India and we have started the cultivation process,” he said.

“We are quite advanced in the technology transfer process with Serum Institute,” he said, adding the work done over the past few months will facilitate the ramping up of production in the country.

On July 4, the drugs controller general of India (DCGI) granted a test license to SII for manufacturing small batches meant for examination, test, and analysis at SII’s licensed Hadapsar facility in Pune.

SII CEO Adar Poonawalla said: “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.”

SII is the world’s largest company in terms of Covid-19 vaccines production. In addition to developing its own vaccine, it currently manufactures Covishield and Covovax (developed by Novavax) and is conducting trials of Codagenix in the UK.

Talking about the “mix and match” approach of vaccines – which is now being considered by a growing number of countries due to shortage of doses – Dmitriev said Sputnik V was a “leader in this field” and was the first to start trials along with AstraZeneca vaccines in Azerbaijan and some other countries.

“We expect to release the results of the trials in the next two weeks. We are open to the mix and match approach with Covishield vaccine in India. We believe that it can produce a great result,” he said.

“We believe the trials in Azerbaijan will show the high efficacy of this approach and Serum Institute of India will be able to produce Sputnik V for a mix and match and booster approaches,” he added.

Dmitriev said RDIF perceives India as a major production hub for Sputnik V as agreements were earlier reached with pharmaceutical companies such as Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and Morepen.

Sputnik V has so far been registered in 67 countries with a total population of more than 3.5 billion. Data obtained by regulators of several countries during vaccination, including Argentina, Bahrain, Mexico and the UAE, has demonstrated Sputnik V is safe and effective, Dmitriev said.

Sputnik V has an efficacy of 97.6% based on the analysis of data on Coronavirus infection rate among people in Russia vaccinated with both components of the vaccine from December 5, 2020 to March 31, 2021.

Dr Reddy’s laboratories has a partnership with RDIF to market the first 250 million doses of Sputnik V in India and it announced on Tuesday that commercial launch will begin in the coming week.