RDIF, the Moscow Government and the Gamaleya National Research Center of Epidemiology and Microbiology announce the start of a post-registration clinical trial of a vaccine against coronavirus

Press release, 26.08.2020

Moscow, August 26, 2020 – The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, the Government of Moscow and the Gamaleya National Research Center of Epidemiology and Microbiology announce the start of a post-registration clinical trial of a coronavirus vaccine in Moscow.

Forty thousand people will take part in the program - they will have an opportunity to be vaccinated against coronavirus with a vaccine developed by the Gamaleya National Research Center of the Ministry of Health.

Facilitated by RDIF, similar post-registration clinical trials of the coronavirus vaccine will also be carried out in five other countries.

The vaccine is reliable, because it is based on a ready-made technological platform with proven efficacy and safety created by Russian scientists. The use of adenoviral vectors began in the 1980s. Since then, scientists from the Gamaleya National Research Center have carried out successful experiments to create biotechnological drugs for the treatment of diseases associated with the dysfunction of various genes. Those developments made it possible to create a universal approach to the development of vaccines against various infectious diseases including especially dangerous ones. Six vaccines have already been developed on the basis of this platform. These vaccines are at various stages of circulation in Russia.

The vaccine has successfully passed two stages of clinical trials. Vaccinated people have developed antibodies and formed immunity, and, importantly, the vaccine is tolerated by the body in the same way as a regular vaccination.

The vaccine does not contain the coronavirus itself, which means that it is impossible to get sick or to infect others. A vaccinated person does not become a virus carrier. The vaccine is based on special structures created in the laboratory known as vaccine vectors that contain only the genetic material of the virus. The immune system produces protective antibodies and cells in response to the genetic material of the virus.

The post-registration clinical trial will allow for a permanent registration certificate and expansion of the circle of possible vaccine recipients, including the 60+ age group. This will help people protect their own health and the health of their loved ones, as well as completely returning to their usual way of life.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented:
“The human adenovirus vaccine platform is safe and has proven effective in the development of vaccines against other major diseases, including Ebola and Middle East respiratory syndrome (MERS).”

Alexander Gintsburg, Director of the Gamaleya National Research Center of Epidemiology and Microbiology, said:
“Employees of the Gamaleya National Research Center of Epidemiology and Microbiology have worked for years to develop safe vaccines based on human adenoviral vectors. Our Center’s technologies are currently the most effective in the world. The Center’s research team is ready to conduct a post-registration clinical study of the “Sputnik V” vaccine (Gam-COVID-Vac) in accordance with international best practices and expresses gratitude to the Ministry of Health of the Russian Federation, the Moscow Government and the Russian Direct Investment Fund for their help in organizing the trials”.

To enroll in the post-registration vaccination program an applicant should be a Russian citizen over 18 years old, with Moscow Compulsory Health Insurance, who has not had any acute respiratory infection for two weeks before and at the time of vaccination. A person can be vaccinated if he or she was not infected with COVID-19 and did not come into contact with coronavirus patients at least two weeks before the vaccination. All candidates will have to undergo health screening before participating in the program.

All participants of the post-registration clinical trial will stay under constant medical supervision. They will keep a diary of well-being accessible via a mobile app to register key parameters of the body's condition. Doctors, in turn, will constantly monitor the health of the vaccinated people with the help of telemedicine technology. In addition, some participants of the clinical trial will be given electronic bracelets to measure blood pressure and body temperature.

Volunteers willing to participate in the post-registration clinical trial of the coronavirus vaccine are invited to submit an application at: https://www.mos.ru/city/projects/covid-19/vaccine/

On August 11, the “Sputnik V” vaccine developed by the Gamaleya National Research Center of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19. Details on “Sputnik V” vaccine are available at www.sputnikvaccine.com

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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 RUB1.9 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

For additional information contact:
Arseniy Palagin
Russian Direct Investment Fund
Press Secretary
Tel: +7 495 644 34 14, ext. 2395
Mobile: +7 916 110 31 41
E-mail: arseniy.palagin@rdif.ru

Andrew Leach / Maria Shiryaevskaya
Hudson Sandler
Tel: +44 (0) 20 7796 4133