Sputnik V vaccine granted full approval in Russia
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Sputnik V vaccine granted full 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

  • By IPP Bureau | February 04, 2022

The Russian Direct Investment Fund (RDIF), that the Russian Sputnik V vaccine against Covid-19 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 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).

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