The Gamaleya National Research Center of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) today announced strong results of the study on neutralizing activity of sera from individuals vaccinated with Sputnik V vaccine against new variants of SARS-CoV-2. Vaccination with Sputnik V has produced protective neutralizing titers against new variants, including Alpha B.1.1.7 (first identified in UK), Beta B.1.351 (first identified in South Africa), Gamma P.1 (first identified in Brazil), Delta B.1.617.2 and B.1.617.3 (first identified in India) and Moscow endemic variants B.1.1.141 and B.1.1.317 with mutations in the receptor-binding domain (RBD).
The methodology was based on the assessment of virus neutralizing activity (VNA) using the live virus, which provides the most reliable data and is the gold standard. It compared neutralizing activity of Sputnik V induced sera to the internationally relevant variants with the neutralizing activity to the ancestral B.1.1.1 variant. The sera were obtained from individuals after vaccination with 2 doses of Sputnik V.
The study methodology was described in the research paper published in Vaccines leading international journal on July 12, 2021.
Virus neutralizing activity assay is not directly related to effectiveness of a vaccine.
The data confirms that Sputnik V remains protective against newly detected variants. Notably, Sputnik V demonstrated significantly less of a reduction in its virus neutralizing activity against a number of variants compared to data from other vaccine producers, which had earlier confirmed efficacy of their vaccines against new variants of coronavirus.
The Gamaleya Center is actively studying emerging variants of SARS-CoV-2 to access VNA and efficacy of Sputnik V against new strains as the virus is still evolving in various parts of the world. The Gamaleya Center and RDIF are also studying new opportunities to develop vaccine cocktails jointly with other leading COVID vaccine producers using the first component of Sputnik V.
To date, Sputnik V has been registered in 67 countries globally with a total population of over 3.5 billion people. The real world data obtained during the vaccination of the population in a number of countries, including Mexico, Argentina, Serbia, Bahrain, Hungary, San-Marino, UAE and others, demonstrates that Sputnik V is one of the safest and most effective vaccines against coronavirus.
Alexander Gintsburg, Director of the Gamaleya National Research Center of Epidemiology and Microbiology, said:
Our studies have demonstrated strong results of Sputnik V against new variants of SARS-CoV-2. We receive more evidence of the ability of coronavirus to transform and mutate across the globe. Today Sputnik V is one of the most effective vaccines against both original and new variants of coronavirus thanks to its unique approach of using two different adenoviral vectors as a delivery mechanism.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), commented:
Sputnik V pioneered the vaccine cocktail approach with two shots. The tests conducted by the Gamaleya Center have demonstrated validity of this approach as the virus neutralizing activity against new strains, which are more dangerous and infectious, remains higher than that of many other vaccines. RDIF will continue supporting further studies of efficacy of Sputnik V against new strains while also analyzing opportunities to partner with other leading vaccine producers for developing vaccine cocktails using the first shot of Sputnik V.
Sputnik V is based on a human adenoviral vector platform. The safety of vaccines based on human adenoviruses has been confirmed in more than 75 international publications and more than 250 clinical trials conducted during the past two decades – while the history of use of human adenoviruses in vaccine development started in 1953.
Adenoviral vectors are genetically modified viruses of the regular flu that cannot reproduce in a human body. When the Sputnik V vaccine is used, the coronavirus itself does not enter the body as the vaccine only contains genetic information about part of its outer protein coat, the so called “spikes” forming its crown. This completely eliminates the possibility of getting infected as a result of vaccination while also causing the body’s stable immune response.