The Serum Institute of India (SII), the world’s largest vaccine manufacturer, is set to begin producing Russia’s Sputnik V COVID-19 vaccine in September, paving the way to scale up globally available COVID vaccines. 

The Sputnik V vaccine, produced by Moscow’s Gamaleya Institute and marketed abroad by the Russian Direct Investment Fund (RDIF), is a two-dose adenovirus vaccine that has boasted an efficacy of 91.6% in clinical trials. 

The new agreement with SII will produce over 300 million doses of the vaccine in India every year. 

“RDIF is delighted to cooperate with Serum Institute of India, the world’s largest vaccine manufacturer,” said Kirill Dmitriev, CEO of the Russian Direct Investment Fund, in a press release.

“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,” Dmitriev added.

BREAKING: RDIF and Serum Institute of India @SerumInstIndia, the world’s largest vaccine producer, to start production of Sputnik vaccine in September. Serum received cell and vector samples from Gamaleya Center, will make over 300 mln doses in India/yr.https://t.co/yHhetKRhoc

— Sputnik V (@sputnikvaccine) July 13, 2021

The cell and vector samples for the vaccine have been sent from the Gamaleya Center as part of the technology transfer process. 

“With technology transfer underway, we expect the first batches of the vaccine to be produced jointly with SII in coming months,” said Dmitriev.

RDIF currently has agreements with six pharmaceutical companies in India to produce Sputnik V, making India the hub of production for the vaccine.

Sputnik V is priced at only $10 per dose, which is only a third of the cost of its mRNA counterparts – Moderna and Pfizer/BioNTech – and it can be stored in conventional refrigerators for months.

“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,” said Adar Poonawalla, CEO of the Serum Institute of India.

Study Shows Sputnik Produces Weaker Antibody Response Against Some Variants

A new study, conducted by Russian researchers and published in Vaccines journal on Monday, found that the Sputnik V vaccine was less effective against agressive new SARS-CoV2 variants.

Researchers of the study, who were involved in the development of the vaccine, used blood samples from people who had been fully vaccinated to test the vaccine-induced neutralizing antibody response against seven prominent variants.

Significant reductions in the neutralizing effect was observed against three variants of concern identified by WHO: Delta, first identified in India, Beta, identified in South Africa, and Gamma, identified in Brazil.

A 3.1 fold reduction in virus-neutralizing activity was found against Delta, 2.8 fold decrease against Beta, and 2.5 fold reduction agsinst Gamma.

Although there was a “statistically significant…reduction…Notably, this decrease is lower than reported in publications for other vaccines,” said the study.

The Gamaleya Center and RDIF are reportedly studying opportunities to develop vaccine cocktails jointly with other leading COVID vaccine producers using the first component of Sputnik V.

Sputnik Awaits Authorization from WHO and EMA

Sputnik V has been authorised for use in 67 countries, but it is still awaiting emergency use listing from WHO and authorization from the European Medicines Agency (EMA).

WHO has required additional data from the Gamaleya Center and plans to follow up on inspections of Sputnik V’s domestic production facilities, with no date set to make the final decision on authorization. 

The EMA has delayed Sputnik V’s approval following the RDIF’s failure to submit additional clinical trial data by a deadline that was initially set for early June.

Image Credits: Ministry of Defence of the Russian Federation, RDIF.