This is how safe Sputnik Lite and AZ combo is!
MOSCOW, Feb. 14, 2022 — The Russian Direct Investment Fund, R-Pharm group and AstraZeneca says results of phase II clinical trials evaluating the safety and immunogenicity of the combined use of AstraZeneca’s vaccine and the first component of the Sputnik V coronavirus vaccine (Sputnik Lite) shows it is safe.
The interim results of the trials, involving 100 volunteers in Russia and 100 volunteers in Azerbaijan shows the combination of the vaccine demonstrate an acceptable safety profile. This is consistent with the results of previous AstraZeneca vaccine, Sputnik V and Sputnik Lite vaccines clinical trials.
Volunteers were being monitored for 57 days after the first dose. Monitoring results demonstrated a good safety profile of the combination. No serious adverse events related to vaccination were registered.
The research conducted by RDIF, the Gamaleya Center, AstraZeneca, and R-Pharm is the first study in the world to evaluate the combined use of components of different adenovirus vaccines to prevent coronavirus infection.
Sputnik Lite
In December 2021, the WHO recommended a similar approach, also known as heterologous prime booster vaccination.
The WHO estimates that interchangeability of different drugs will allow greater flexibility in vaccination programs, increase vaccine efficacy and affordability.
A joint phase II clinical trial to evaluate how it is to combine the two vaccines is being conducted under the Dec 2020 MoU signed 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.
Kirill Dmitriev, CEO of the RDIF says preliminary data from the trial to test Sputnik Light and AstraZeneca vaccines combination support the “mix and match” approach to revaccination.
With new dangerous variants of concern emerging, this approach could provide safe, effective and long-term protection.
Safety
Vasily Ignatiev, CEO of the R-Pharm Group JSC, believes the current safety data adds to the data on the high immunogenicity profile of the vaccine combination that has been announced earlier. We are one step closer to completing the studies. The results are being processed.”
Irina Panarina, GM, Russia & Eurasia says the results, obtained in the clinical trials, indicate the safety of vaccine combination.
“The use of «vaccine cocktails» may be an option in face of growing healthcare system needs to vaccinate population across the world”.