Interim Results Of A Pioneering Combination Study In Argentina With More Than 1,000 Participants Confirm The One-shot Sputnik Light Vaccine (The First Component Of The Sputnik V Vaccine) Is An Effecti

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the interim results of the study in Argentina on heterogeneous regimens combining Sputnik Light (the first component of the Russian Sputnik V vaccine against coronavirus) and vaccines produced by AstraZeneca, Sinopharm, Moderna and Cansino. The study is co-sponsored by the Ministry of Health of Argentina and RDIF.

The Sputnik Light vaccine is based on the human adenovirus serotype 26, the first component of Sputnik V. Interim results of the study in Argentina are based on data from 1,102 volunteers, and 12 various vaccine combinations. The overall design of the study will include 2,800 subjects – 560 in each of the 5 provinces of Argentina: City and Province of Buenos Aires, as well as Córdoba, La Rioja and San Luis.

The heterogeneous boosting approach (a "vaccine cocktail" using human adenovirus serotype 26 as the first component and human adenovirus serotype 5 as the second component) was pioneered by the world's first registered vaccine against coronavirus - Sputnik V. This approach was proven to be successful in creating a longer and more durable immunity against coronavirus. RDIF took the lead in initiating partnerships around the world to conduct joint studies on the combination of Sputnik Light with vaccines of other producers.

The first partnership of this kind was concluded in December 2020 with AstraZeneca aimed at cooperation in conducting joint clinical trial of safety and immunogenicity of a combination of AstraZeneca vaccine and the first component of Sputnik V.

Key interim findings from the study in Argentina:

• One-shot Sputnik Light is an effective universal booster for vaccines produced by AstraZeneca, Sinopharm, Moderna and Cansino. 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 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;

• The study provides the strongest scientific evidence to date supporting the mix&match approach with 5 vaccines involved.

One-shot Sputnik Light is a highly effective vaccine when used both on standalone basis and applied as a booster. The latest findings by the Gamaleya Center based on data from 28,000 subjects in Moscow have demonstrated 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 has been proven to be safe and highly effective by 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 also found Sputnik Light to be 93.5% effective during the country's ongoing vaccination campaign.

Combination studies between AstraZeneca and Sputnik Light vaccines in other countries.

Besides Argentina, joint clinical studies between Sputnik Light and AstraZeneca are successfully ongoing in a number of countries (Russia, Azerbaijan, UAE), demonstrating high safety and immunogenicity profile of the combination.

AstraZeneca/Sputnik Light combination showed higher immunogenicity levels than the original AstraZeneca vaccine.

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

"Positive interim results from Argentina confirm that the one-shot Sputnik Light vaccine is a universal booster for all the vaccines involved in the study. It is a safe and highly effective solution against COVID and its new variants, including the Delta variant. We keep receiving strong data from around the world on vaccination with Sputnik Light and mix&match studies, and RDIF reiterates its willingness to extend partnerships with other producers on vaccines' combinations."

Key advantages of Sputnik Light:

• Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of Sputnik V – the world's first registered vaccine against coronavirus.

• An efficacy level of almost 80% is higher than that of many two-dose vaccines.

• Sputnik Light has proven effective against all new strains of coronavirus, as demonstrated by the Gamaleya Center during laboratory tests.

• The Sputnik Light vaccine is based on a well-studied human adenoviral vector platform that has proven to be safe and effective, with no long-term side effects, as confirmed in over 250 clinical trials conducted globally over the past two decades (while the history of use of human adenoviruses in vaccine development started in 1953).

Source: The Russian Direct Invest Fund (RDIF)