The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), investor in the Russian Sputnik V vaccine against coronavirus, announces the results of its joint work with Ministries of Health and regulators of the leading countries to collect and analyze real world vaccination data on the first anniversary of the vaccine’s registration confirming its high safety and efficacy profile.
Real-world data obtained during mass vaccinations in Argentina, Bahrain, Hungary, Mexico, Russia, Serbia, the Philippines and UAE demonstrate lack of serious adverse events (such as CVTs or myocarditis). In several countries where multiple vaccines are used, the Russian vaccine has demonstrated one of the best safety and efficacy parameters.
Sputnik V has also pioneered the unique heterogeneous boosting (“vaccine cocktail”) approach based on use of two different human adenoviral vectors for two injections in the course of vaccination to achieve stronger and more durable immunity. This has become the core of the partnership of Sputnik V with other producers and this approach is now being followed by other producers as they try their own vaccine combinations.
To date Sputnik V has been approved in 69 countries with total population exceeding 3.7 billion people – nearly half of the global population.
RDIF has concluded production partnerships with more than 20 companies in 14 countries, including the leading manufacturers in India, China, South Korea, Argentina, Mexico and other countries.
Russia: Sputnik V demonstrated 97.6% efficacy based on the analysis of data from 3.8 million vaccinated individuals in Russia. The results obtained over the course of mass vaccination were even better than those seen during clinical trials (91.6% efficacy).
The Gamaleya Center has conducted a study on neutralizing activity of sera from individuals vaccinated with Sputnik V vaccine against new variants of coronavirus with strong results published in Vaccines leading medical journal. 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 data confirms that Sputnik V remains protective against newly detected variants and retains one of the best safety and efficacy parameters.
The Russian Ministry of Health has also published data on Sputnik V’s efficacy against the Delta variant. The vaccine is 83.1% effective and shows 6x reduction of infection risk. Sputnik V is also 94.4% effective against hospitalisations with 18x reduction in hospitalisation risk.
UAE: according to data from UAE’s Ministry of Health, Sputnik V’s efficacy during mass vaccination in the country was 97.8%, while efficacy against severe cases of COVID-19 stood at 100%. There’s been no serious vaccination-related adverse events, no cases of hospitalization, CVTs or myocarditis.
Bahrain: according to data from Bahrain’s Ministry of Health, Sputnik V demonstrated overall efficacy of 94.3% (14 days after the second shot) with 98.6% of all COVID cases 2 weeks after the second shot being mild. There have been no serious adverse events, cerebral venous thrombosis (CVT) cases or deaths related to vaccination.
Argentina: data from the Ministry of Health of the province of Buenos Aires showed that Sputnik V helped to elicit antibodies in 94% of those vaccinated with the first component and in 100% of persons who have received both doses.
A study carried out by Argentina’s Institute of Virology of the National University of Cordoba and the Government of Cordoba has confirmed neutralization effectiveness of the Russian two-dose Sputnik V coronavirus vaccine against the Manaus (Brazilian) variant and overall strong immune response after vaccination with Sputnik V.
In addition to two-dose Sputnik V vaccine, the single dose Sputnik Light vaccine is also demonstrating high safety and efficacy results in Argentina. Sputnik Light is the first component of Sputnik V (recombinant human adenovirus serotype number 26 (rAd26)). In particular, data from the Ministry of Health of the province of Buenos Aires showed that Sputnik Light had helped to elicit antibodies in 94% of those vaccinated and provided for a strong immune response.
The data collected by the Ministry of Health of the province of Buenos Aires also showed Sputnik Light (the first component of Sputnik V) is 78,6-83,7% effective among the elderly.
Hungary: official government research showed that of the five vaccines used against COVID-19 in the country, Sputnik V had the best safety and efficacy parameters, infection rate per 100,000 vaccinated is less compared to other vaccines (95 – Sputnik V, 177 – Moderna, 356 – Sinopharm, 555 – Pfizer, 700 – AstraZeneca).
Mexico: analysis of results of the mass vaccination campaign conducted by Mexico’s Ministry of Health, confirmed that Sputnik V was the safest of all the vaccines used in the country with incidence of serious adverse events per 100,000 doses lower than that of other vaccines (Sputnik V – 0.79; Sinovac – 1.07; Cansino – 1.14; AstraZeneca – 1.22; Pfizer – 1.34). No link between vaccination and serious adverse events was found.
Serbia and the Philippines: official data from Serbia’s Ministry of Health and the Philippines’ Department of Health demonstrate Sputnik V has the best safety rates during the vaccination campaign: no vaccine-related serious adverse events were reported, there have been no cases of death or CVTs attributed to vaccination.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), said:
“During the year following initial authorization Sputnik V vaccine has proven its highest safety and efficacy as confirmed by the real world vaccination data from leading countries.”