RDIF: Single dose vaccine, Sputnik Light, authorized for use in Russia

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MOSCOW, May 6, 2021 /PRNewswire/ --

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

The single dose Sputnik Light vaccine demonstrated 79.4% efficacy according to analyzed data taken from 28 days after the injection was administered as part of Russia's mass vaccination program between 5 December 2020 and 15 April 2021.

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.

Phase I/II of the Safety and Immunogenicity Study of the Sputnik Light vaccine has demonstrated that:

• Sputnik Light can elicit the development of antigen specific IgG antibodies in 96.9% of individuals on the 28th day after vaccination;
• The Sputnik Light vaccine elicits the development of virus neutralizing antibodies in 91.67% of individuals on the 28th day post immunization;
• Cellular immune response against the S Protein of SARS-CoV-2 develops in 100% of volunteers on the 10th day;
• The immunization of individuals with pre-existing immunity against SARS-CoV-2 with Sputnik Light can elicit the increase of the level of antigen specific IgG antibodies by more than 40x in 100% of subjects 10 days after immunization;
• No serious adverse events were registered after vaccination with Sputnik Light.

As of May 5, 2021, more than 20 million people globally have received their first shot of Sputnik V.

Sputnik Light is compatible with standard vaccine storage and logistics requirements, while also being affordable with a price of less than $10. The single dose regiment allows for immunization of a larger number of people in a shorter time frame, furthering the fight against the pandemic during the acute phase.

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).

The two dose Sputnik V vaccine remains the main vaccination tool. 

The Russian Ministry of Health, the Gamaleya National Research Center of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announce that Sputnik Light, a single dose COVID-19 vaccine, has received authorization for use in Russia.

Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of the Sputnik V coronavirus vaccine.

The single dose Sputnik Light vaccine demonstrated 79.4% efficacy according to analyzed data taken from 28 days after the injection was administered. An efficacy level of near 80% is higher than that of many two-dose vaccines.

The efficacy rate was calculated based on data obtained from Russians vaccinated with a single injection, having not received the second one for any reason during the mass vaccination program between December 5, 2020 and April 15, 2021.

The infection rate among vaccinated subjects from the 28th day from the date of the injection was only 0.277%. Over the same period, the infection rate among the unvaccinated adult population was 1.349%.

The following formula was used to calculate the vaccine's efficacy:

Phase I/II Safety and Immunogenicity Study of the single dose Sputnik Light vaccine was initiated in January 2021, and the interim results were received on March 10, 2021:

• The results demonstrated that the vaccine can elicit the development of antigen specific IgG antibodies in 96.9% of volunteers on the 28th day after immunization;
• Virus-neutralizing antibodies developed in 91.67% of volunteers on the 28th day post immunization.
• Cellular immune response against the S Protein of SARS-CoV-2 developed in 100% of volunteers;
• No serious adverse events were registered after vaccination with Sputnik Light;
• The immunization of individuals with pre-existing immunity against SARS-CoV-2 with Sputnik Light can elicit an increase of the level of IgG antibodies by more than 40x in 100% of volunteers on the 10th day after immunization;
• Sputnik Light demonstrated safety for all subjects, including those with pre-existing immunity to SARS-CoV-2.

On February 21, 2021 the Gamaleya Center and RDIF launched a global efficacy study of Sputnik Light. The Phase III clinical study involving 7,000 people is conducted in multiple countries including Russia, the UAE, Ghana and others. The interim results are expected in May 2021.

As of May 5, 2021, more than 20 million people globally have received the first injection of the Sputnik V vaccine, containing the first component. There have been no cases of Cerebral Venous Sinus Thrombosis (CVST) reported. The production of the vaccine meets the strictest standards, with four stages of purification (two chromatographic stages and two stages of tangential filtration).

The Sputnik Light vaccine is based on a well-studied human adenoviral vector platform that has proven to be safe and effective. The cost of the Sputnik Light vaccine globally will be less than $10, while it has simple storage requirements, at +2 +8, which provide for easy logistics. The one shot regimen allows for the vaccination of large groups of the population in a short time, helping to speed up the fight against the pandemic during the acute phase.

Alexander Gintsburg, Director of the Gamaleya National Research Center of Epidemiology and Microbiology, said:
"Sputnik Light will help to prevent the spread of coronavirus through the faster immunization of larger population groups, as well as supporting high immunity levels in those who have already been infected previously. Sputnik Light offers strong value in initial vaccination and re-vaccination, as well as boosting efficacy when taken in combination with other vaccines."

Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), commented:
"The Sputnik Light vaccine significantly reduces the possibility of severe cases leading to hospitalization, with only one injection needed. The single dose regimen solves the challenge of immunizing large groups in a shorter time, which is especially important during the acute phase of the spread of coronavirus, achieving herd immunity faster. The characteristics of the vaccine provide for simple storage and logistics, while Sputnik Light has an affordable price of less than $10. The two dose Sputnik V vaccine remains the main source of vaccination in Russia, while the Sputnik Light vaccine will be exported to our international partners to help increase the rate of vaccinations in a number of countries in the face of the ongoing fight with the pandemic and new strains of coronavirus."

The safety of vaccines based on human adenoviruses has been confirmed in more than 75 international publications and more than 250 clinical trials conducted during the past two decades - while the history of use of human adenoviruses in vaccine development started in 1953. Adenoviral vectors are genetically modified viruses of the regular flu that cannot reproduce in a human body. When the Sputnik Light vaccine is used, the coronavirus itself does not enter the body as the vaccine only contains genetic information about part of its outer protein coat, the so called "spikes" forming its crown. This completely eliminates the possibility of getting infected as a result of vaccination while also causing the body's stable immune response.

The Gamaleya National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation is one of the oldest research centers in Russia, which celebrated its 100th anniversary in 1991. The main focus of the center's research is the fundamental problems in epidemiology, medical and molecular microbiology, and infectious immunology. More information can be found at www.gamaleya.org

Russian Direct Investment Fund (RDIF) is Russia's sovereign wealth fund established in 2011 to make equity co-investments, 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 more than RUB2 tn and covering 95% of the regions of the Russian Federation. RDIF portfolio companies employ more than 800,000 people and generate revenues which equate to more than 6% of Russia's GDP. RDIF has established joint strategic partnerships with leading international co-investors from more than 18 countries that total more than $40 bn. Further information can be found at www.rdif.ru

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