Sputnik V vaccine granted full permanent approval in Russia

Highest safety and efficacy of Sputnik V confirmed during clinical trials and in real-world use in more than 60 countries around the world

Sputnik V has been authorized in 71 countries with total population of over 4 billion people.

MOSCOW, Feb. 4, 2022 /PRNewswire/ -- The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces that the Russian Sputnik V vaccine against coronavirus has been granted full permanent approval by Russia's Health Ministry. It had previously held temporary emergency use authorization (EUA) from the Russian regulator.

Sputnik V was authorized on August 11, 2020, becoming the world's first vaccine against COVID-19 to be granted emergency use authorization. Sputnik V has been authorized in 71 countries with a total population of over 4 billion people. Its one-component version, Sputnik Light, is authorized in over 30 countries, both as a standalone vaccine and a universal booster to other vaccines.

Sputnik V and Sputnik Light are based on a safe and effective human adenoviral vector platform and have not been associated with rare serious adverse events following vaccination, such as myocarditis or pericarditis. The highest safety and efficacy of Sputnik V and Sputnik Light was demonstrated in more than 30 studies and real-world data from more than 60 countries.

A unique comparative study[1] conducted at Lazzaro Spallanzani National Institute for Infectious Diseases in Italy by a team of 12 Italian and 9 Russian scientists led by Francesco Vaia, Director of the Spallanzani Institute and Alexander Gintsburg, Director of the Gamaleya Center has shown that Sputnik V vaccine demonstrates more than 2 times higher titers of virus neutralizing antibodies to Omicron (B.1.1.529) variant than 2 doses of Pfizer vaccine (2.1 times higher in total and 2.6 times higher 3 months after vaccination).

The study was conducted in the equal laboratory conditions on comparable sera samples from individuals vaccinated with Sputnik V and Pfizer with a similar level of IgG antibodies and virus neutralizing activity against Wuhan variant. Sputnik V showed significantly smaller (2.6 times) reduction of virus neutralizing activity against Omicron as compared to reference Wuhan variant than Pfizer vaccine (8.1-fold reduction for Sputnik V in contrast to 21.4-fold reduction for Pfizer vaccine).

Based on the data collected by the Spallanzani Institute and results of previous studies, heterologous ("mix & match") boosting with Sputnik Light is the best solution to increase other vaccines' efficacy and extend the booster protection period as optimal adenoviral platform configuration provides better protection against Omicron and other mutations.

A preliminary study of the Gamaleya Center has found that Sputnik Light as a booster significantly increases virus-neutralizing activity against Omicron, which is comparable to titers observed after Sputnik V against wild-type virus, associated with high levels of protection.

Sputnik Light is based on recombinant human adenovirus serotype number 26 (the first component of Sputnik V). A one-shot vaccination regimen of Sputnik Light provides for ease of administration and helps to increase efficacy and duration of other vaccines when used as a booster shot.

Clinical studies and the real-world data in many countries have demonstrated Sputnik Light is a safe and effective vaccine when used both on a standalone basis and as a booster.

A study in Argentina on heterogeneous regimens combining Sputnik Light and vaccines produced by AstraZeneca, Sinopharm, Moderna and Cansino has demonstrated that each "vaccine cocktail" combination with Sputnik Light provided higher antibody titer on 14th day after administering the second dose as compared to original homogenous (same vaccine as first and second dose) regimens of each of the vaccines.

[1] https://www.medrxiv.org/content/10.1101/2022.01.15.22269335v1

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