The Russian sovereign fund RDIF on Monday said the early results from world’s first mix and match joint clinical trials of Sputnik Light and AstraZeneca COVID vaccine in Russia and Azerbaijan has shown full safety of the combination, with no serious adverse events reported.
AstraZeneca COVID vaccine is the same as Covishield which is used in India and several other countries.
According to the Phase-2 interim results of the trials, involving 100 volunteers in Russia and 100 volunteers in Azerbaijan, the vaccines combination demonstrated an acceptable safety profile, which is consistent with the results of previous AstraZeneca vaccine, Sputnik V and Sputnik Lite vaccines clinical trials.
The study conducted by RDIF, the Gamaleya Center, AstraZeneca, and Russian pharmaceutical company R-Pharm is the first study in the world to evaluate the combined use of components of different adenovirus vaccines to prevent coronavirus infection.
A joint phase II clinical trial to evaluate the safety and immunogenicity of a combination of AstraZeneca’s vaccine and the first component of the Sputnik V vaccine is being conducted under the memorandum signed in December 2020 by the Russian Direct Investment Fund, the Gamaleya Center, AstraZeneca and R-Pharm.
The study takes place in Azerbaijan, Russia and the United Arab Emirates.
Volunteers receive intramuscular injections of the AstraZeneca vaccine and the Ad26-S component of the Sputnik V vaccine in different sequences at 28-day intervals.
“Preliminary data from the trial to test Sputnik Light and AstraZeneca vaccines combination support the “mix and match” approach to revaccination,” said Kirill Dmitriev, CEO of RDIF.
“With new dangerous variants of concern emerging, this approach could provide safe, effective and long-term protection,” Dmitriev added.
The data from Russia and Azerbaijan may help Dr Reddy’s which has partnered with RDIF for Sputnik vaccine. The company has submitted a proposal to conduct clinical trials to test Sputnik Light as a booster to other vaccines. About 84% Indians took Covishield which is identical to AstraZeneca vaccine. India doesn’t allow the use of different COVID vaccine as a booster.