Phase II Trial Confirms Safety of AstraZeneca and Sputnik Light Vaccine Combination in Russia and Azerbaijan

Moscow, February 14, 2022 /PRNewswire/ -- The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund), AstraZeneca, and R-Pharm will announce interim results from the second phase of clinical trials on the safety of a combination of AstraZeneca's vaccine and the first component of the "Sputnik V" coronavirus vaccine (Sputnik Light, based on human adenovirus serotype 26).

In the study involving 100 volunteers in Russia and 100 volunteers in Azerbaijan, the combination demonstrated optimal safety and tolerability, consistent with earlier clinical research findings on the safety of AstraZeneca, "Sputnik V," and "Sputnik LIGHT" vaccines.

Volunteers were tested within 57 days after the first vaccination, showing a high safety record of the combined treatment. During the follow-up period, no serious adverse events related to vaccination were found.

The Russian Direct Investment Fund (RDIF), the Gamaleya Research Center, AstraZeneca, and R-Pharm are the world's first to launch a clinical research program to evaluate the combined use of different adenovirus vaccines for the prevention of coronavirus infection. In December 2021, the World Health Organization (WHO) recommended this approach, also known as heterologous booster vaccination, for use in real-world clinical practice. The WHO estimates that heterologous multivaccine regimens will provide greater flexibility to vaccination programs, making them more acceptable to people and improving the effectiveness of vaccinations.

According to the quadrilateral memorandum signed in December 2020 by the Russian Direct Investment Fund, Gamaleya Research Center, AstraZeneca, and R-Pharm, a joint Phase II clinical trial is underway to evaluate the safety and immunogenicity of a combination of AstraZeneca's vaccine and the first component of the "Sputnik V" vaccine. This study is being conducted in Azerbaijan, Russia, and the United Arab Emirates. Volunteers are receiving intramuscular injections of AstraZeneca's vaccine and the Ad26-S component of the "Sputnik V" vaccine at 28-day intervals in different sequences.

Russian Direct Investment Fund (RDIF) CEO Kirill·DmitrievIndicates:

"Preliminary data on the combined use of 'Sputnik V' and AstraZeneca vaccines confirm that using different vaccines during revaccination is appropriate. This approach can provide safe, effective, and long-lasting protection against the emergence of dangerous new strains of the coronavirus."

Irina, CEO of AstraZeneca Russia and Eurasia·PanalinaSay:

"The results obtained in the study indicate the safety of co-administration of vaccines. In response to the ongoing need for re-vaccination of the population by health systems around the world, the use of 'mixed vaccines' may be an option."

R-PharmVasiliy, CEO of the company·IgnatyevIndicates:

"The safety data adds to the previously reported high immunogenicity of this vaccine combination. We are one step closer to achieving the study's goals. Interpreting the data remains a work in progress."