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A study published in The Lancet confirms the one-shot Sputnik Light vaccine has a high safety profile and induces a strong humoral and cellular immune response both in the seronegative and seropositive groups


News provided by

The Russian Direct Invest Fund (RDIF)

03 Nov, 2021, 08:45 GMT

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MOSCOW, Nov. 3, 2021 /PRNewswire/ -- The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces a new publication by the Gamaleya Center in The Lancet, one of the world's most respected medical journals, showing the one-shot Sputnik Light vaccine against coronavirus demonstrates a high safety profile and induces a strong humoral and cellular immune response. RDIF has sponsored the study.

The article in The Lancet is available at:

https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(21)00227-1/fulltext

The study on safety, tolerability and immunogenicity of the Sputnik Light vaccine has confirmed that the vaccine induces strong humoral and cellular immune response both in the seronegative and seropositive groups.

Most of the solicited adverse reactions observed during the study were mild or moderate. No serious adverse events were detected.

One-shot Sputnik Light is a highly effective vaccine when used both on standalone basis and applied as a booster. Sputnik Light has been authorized in more than 15 countries with the registration process ongoing in a further 30 countries.

The earlier findings by the Gamaleya Center based on data from 28,000 subjects in Moscow have demonstrated the Sputnik Light vaccine administered standalone has 70% efficacy against infection from the Delta variant of coronavirus during the first three months after vaccination. The vaccine is 75% effective among subjects under the age of 60.

Efficacy of one-shot Sputnik Light as a booster against Delta variant for other vaccines will be close to the efficacy against the Delta variant of the Sputnik V vaccine: over 83% against infection and over 94% against hospitalization.

Sputnik Light has demonstrated a superior efficacy compared with some two-shot vaccines, which have shown a major decline in efficacy against the Delta variant to less than 50% five months after injection. Standalone use of Sputnik Light also provides much higher efficacy against severe disease and hospitalizations.

Sputnik Light is a safe and highly effective vaccine against COVID as confirmed by the real-world vaccination data:

  • In particular, the vaccine has demonstrated efficacy of between 78.6-83.7% among the elderly as confirmed by the Ministry of Health of Buenos Aires, Argentina.
  • Paraguay's Ministry of Health found Sputnik Light to be 93.5% effective during the country's ongoing vaccination campaign.

The vaccine is tested as a booster shot in a number of clinical trials around the world. In particular, a combination of AstraZeneca/Sputnik Light show higher immunogenicity levels than the original AstraZeneca vaccine.

RDIF and the Ministry of Health of Argentina are co-sponsoring the first multivaccine combination trial targeting 2,800 subjects (560 in each of the 5 provinces: City and Province of Buenos Aires, as well as Córdoba, La Rioja and San Luis).

Interim results of the study in Argentina on heterologous regimens combining Sputnik Light and vaccines produced by AstraZeneca, Sinopharm, Moderna and Cansino from over 1,000 volunteers show Sputnik Light is an effective universal booster for these vaccines. 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.

The data from Argentina also demonstrated high safety profile of using Sputnik Light in combinations with all other vaccines with no serious adverse events following the vaccination in any combinations.

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