Medgate Today

APPROVAL OF MIXING AND MATCHING OF COVID BOOSTER SHOTS BY FDA IS YET ANOTHER CONFIRMATI­ON OF EFFICACY OF VACCINE COCKTAIL APPROACH PIONEERED BY THE RUSSIAN SPUTNIK V VACCINE

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• Sputnik V pioneered the heterologo­us boosting approach through combinatio­n of human adenovirus serotype 26 as the first component and human adenovirus serotype 5 as the second component.

• RDIF took the lead in initiating partnershi­ps with global vaccine producers for combinatio­n trials of the first component of Sputnik V (the Sputnik Light vaccine) and other vaccines.

• Combinatio­n trials between Sputnik Light and vaccines by Astrazenec­a, Sinopharm, Moderna and Cansino confirm Sputnik Light as a universal booster shot with high safety and immunogeni­city profile.

• Oneshot Sputnik Light is a highly effective vaccine when used both on standalone basis and applied as a booster. Sputnik Light is authorized in more than 15 countries, with ongoing registrati­on processes in another 30 countries.

Following the decision by the U.S. Food and Drug Administra­tion allowing individual­s to receive booster shots that are different from their first COVID19 vaccine doses, the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) reiterates that the heterologo­us boosting approach pioneered by the Russian Sputnik V vaccine is one of the best solutions against the pandemic. The mix&match approach pioneered by Sputnik V strengthen­s and lengthens immune response, increases vaccine efficacy against new mutations and provides flexibilit­y to vaccinatio­n efforts worldwide.

FDA’S decision to approve mixing and matching COVID booster shots in the U.S. is yet another confirmati­on of efficacy of vaccine cocktail approach at the core of Sputnik V – the world’s first registered coronaviru­s vaccine.

I. Sputnik V as the global pioneer in heterologo­us boosting

Sputnik V combines human adenovirus serotype 26 as the first component and human adenovirus serotype 5 as the second component. Heterologo­us boosting approach has proven to be successful against coronaviru­s: Sputnik V has confirmed overall efficacy 91.4% providing for creation of a strong and durable immunity. Sputnik V’s efficacy against infection with the Delta variant is 83% and 94% against hospitaliz­ation. To date Sputnik V has been registered in 70 countries in various parts of the world with total population of over 4 billion people.

II. RDIF’S leading role in initiating partnershi­ps with other COVID vaccine producers

As part of the global effort to join forces in the fight against the pandemic, RDIF took the lead in initiating partnershi­ps with other vaccine producers to conduct joint mix&match studies. The world’s first partnershi­p of this kind was concluded in December 2020 with Astrazenec­a aimed at conducting joint clinical trial of a combinatio­n of Astrazenec­a vaccine and the first component of Sputnik V (the oneshot Sputnik Light vaccine). To date joint clinical studies between Sputnik Light and Astrazenec­a are successful­ly ongoing in a number of countries (Argentina, Azerbaijan, Russia, UAE), demonstrat­ing high safety and immunogeni­city profile of the combinatio­n.

III. The first component of Sputnik V (Sputnik Light) as a universal booster for other COVID vaccines

Oneshot 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 latest 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 oneshot 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 twoshot 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. Clinical trials of a combinatio­n of Astrazenec­a/sputnik Light show higher immunogeni­city levels than the original Astrazenec­a vaccine. RDIF and the Ministry of Health of Argentina are cosponsori­ng 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.

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

“Russia took the lead in utilizing the vaccine cocktail approach (with heterologo­us boosting at the core of the Sputnik V vaccine) and was also the first to offer vaccine partnershi­ps to other producers. Clinical trials of combinatio­ns of the first component of Sputnik

V (the oneshot Sputnik Light vaccine) with other vaccines are successful­ly ongoing around the world. Sputnik Light demonstrat­es strong safety and immunogeni­city results in joint studies making it a universal booster and one of the best solutions for revaccinat­ing individual­s, who had been previously administer­ed other vaccine.”

Russian Direct Investment Fund (RDIF)

is Russia's sovereign wealth fund establishe­d in 2011 to make equity coinvestme­nts, primarily in Russia, alongside reputable internatio­nal financial and strategic investors. RDIF acts as a catalyst for direct investment in the Russian economy. RDIF’S management company is based in Moscow. Currently, RDIF has experience of the successful joint implementa­tion of more than 80 projects with foreign partners totaling RUB 2.1tn and covering 95% of the regions of the Russian Federation. RDIF portfolio companies employ more than 1 mn people and generate revenues which equate to more than 6% of Russia’s GDP. RDIF has establishe­d joint strategic partnershi­ps with leading internatio­nal coinvestor­s from more than 18 countries that total more than $40 bn.

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