Sputnik V vaccine demonstrates strong safety profile during vaccination campaign in San Marino

Sputnik V vaccine demonstrates strong safety profile during vaccination campaign in San Marino

·        High tolerability profile in ≥60 age group;

·        Nearly all reported AEFIs were mild or moderate and/or lasted less than 2 days;

·        The rate of local symptoms for ≥60 age group is substantially lower than for other approved COVID-19 vaccines, at the same time systemic symptoms are on the same level;

·        No hospitalizations or deaths reported.

Moscow, July 11, 2021 – The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), investor in the Russian Sputnik V vaccine against coronavirus, today announced positive safety data of the vaccine in San-Marino obtained during the vaccination campaign in the country and published in EClinicalMedicine (an open access clinical journal published by The Lancet, one of the world's most respected medical journals). Link for the article:

https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00307-2/fulltext

Beginning from 4 March to 8 April 2021, a nationwide study was conducted among individuals in San Marino who received one or two doses of Sputnik V. A descriptive analysis was conducted to quantify incidence of adverse events following immunization (AEFI) on both occasions.

Authors (Marco Montalti, Giorgia Soldà, Zeno Di Valerio, Aurelia Salussolia, Jacopo Lenzi, Marcello Forcellini, Edoardo Barvas, Susanna Guttmann, Rossella Messina, Elisabetta Poluzzi, Emanuel Raschi, Rossano Riccardi, Maria Pia Fantini, Giusy La Fauci, Davide Gori), note the following in the article:

“Our results, albeit preliminary, suggest that Sputnik V has a high tolerability profile in the population aged ≥60 years in terms of short-term AEFIs.

This preliminary analysis suggests a higher or equal tolerability profile of the Sputnik V vaccine in the 60+ age group, after both doses, as compared with other widely adopted COVID-19 vaccines. Our results also align with the findings of phase 1 and 2 previously conducted studies, then confirmed by phase 3 of the vaccine trial, in terms of overall safety and tolerability. No hospitalizations or deaths were reported. Nearly all reported AEFIs were mild or moderate and/or lasted less than 2 days.”

Findings of phase 3 trial of Sputnik V were also published in The Lancet journal on February 2, 2021.

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 besides San Marino, including Mexico, Argentina, Serbia, Bahrain, Hungary, UAE and others, demonstrates that Sputnik V is one of the safest and most effective vaccines against coronavirus.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), commented:

“San Marino was the first country in Europe to defeat COVID and lift restrictions thanks to inclusion of Sputnik V vaccine in the national portfolio. The data published recently demonstrates strong safety profile of the Russian vaccine with no hospitalization cases and tolerability among the elderly. Lack of political bias in decision making helped San Marino choose the Russian vaccine which has proven itself as one of the best in the world in terms of both safety and efficacy.”