AstraZeneca, Sputnik V vaccine joint trials show high safety profile

Announcing the initial safety results of the world's first study of a combination of the AstraZeneca and Sputnik V COVID-19 vaccines, the Russian Direct Investment Fund (RDIF), on Friday said that interim analysis of the data demonstrates a high safety profile for the combined use of the vaccines with no serious adverse events or cases of coronavirus after vaccination.

Russia's sovereign wealth fund on Friday announced initial safety results of the world's first study of a combination between the COVID-19 vaccine developed jointly with the University of Oxford and the first component of the Russian COVID-19 vaccine (Sputnik Light vaccine based on human adenovirus serotype 26) in the Republic of Azerbaijan. "The heterogeneous boosting approach ("vaccine cocktail") using human adenovirus serotype 26 as the first component and human adenovirus serotype 5 as the second component) was at the core of Sputnik V, the world's first registered vaccine against coronavirus," read a statement issued by the RDIF.

The RDIF initiated the study in December 2020. The first partnership of this kind was concluded in December 2020 in the presence of Russian President Vladimir Putin. RDIF, The Gamaleya Center, AstraZeneca and R-Pharm signed a Memorandum of Intent aimed at cooperation in vaccine development.

The RDIF was the first in the World to initiate such a study in December 2020. "The first partnership of this kind was concluded in December 2020 in the presence of the President of Russia Vladimir Putin. RDIF, The Gamaleya Center, AstraZeneca and R-Pharm signed a Memorandum of Intent aimed at cooperation in vaccine development," said RDIF's statement.

Studies on the safety and immunogenicity of the combination of the AstraZeneca vaccine and the first component of the Sputnik V vaccine in Azerbaijan began in February 2021.

"To date, 50 volunteers have been vaccinated and new participants are invited to join the trial. Interim analysis of the data demonstrates a high safety profile for the combined use of the vaccines with no serious adverse events or cases of coronavirus after vaccination."

According to the statement, the initial data on the immunogenicity of the combined use of AstraZeneca will be in August 2021.

"In August 2021, RDIF and partners will publish initial data on the immunogenicity of the combined use of the AstraZeneca vaccine and the first component of the Sputnik V vaccine in Azerbaijan. Clinical trials of a combination of vaccines are being carried out in several countries as part of a global program. Volunteers are being vaccinated in UAE, and regulatory approval to conduct trials has been granted in Russia and Belarus," it said.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF) said, "As new strains of Coronavirus emerge, partnerships between vaccine manufacturers and combining different vaccines are key to successfully fighting the pandemic. Based on the high efficacy of the heterogeneous boosting ("vaccine cocktail") approach, RDIF was the first in the world to initiate partnerships with other coronavirus vaccine manufacturers." "The first partnership of this kind was a joint clinical trial with AstraZeneca. We look forward to its success in Azerbaijan and other countries, which will allow more effective implementation of vaccination programs and protect people around the world. We consider it important to conduct joint research on combining the first component of Sputnik V with vaccines from other manufacturers for a more effective fight against emerging new strains of coronavirus," added Dmitriev.

Irina Panarina, General Manager, AstraZeneca Russia and Eurasia said, "A heterogeneous prime-boosting involving administering components of different vaccines to a patient is one of the most promising vaccination regimens to study."

"It is becoming especially relevant now when the issue of preventing the spread of new strains of coronavirus infection is acute, and the need for revaccination of the population is also coming to a head. That is why the results of the study can be of great importance for those countries where both the vaccine by AstraZeneca and the University of Oxford and the Sputnik V vaccine are registered," stated Panarina.

Vasily Ignatiev, CEO of R-Pharm Group, said, "The initial results obtained at times when the delta strain is spreading are very important for assessing the safety and early efficacy of the vaccine combination. We will continue researching and analyzing the data with the prospect of a publication in an international journal."