Russia offers vaccine data to India, Phase 3 proceedings are one alternative here

Sputnik V Covid vaccine was developed by Gamaleya Research Institute of Epidemiology and Microbiology under the Russian Health Ministry. The vaccine went under Phase 1 and Phase 2 in Russia.

The vaccine candidate triggered a “strong” immune response in Phases 1 & 2 of the clinical trials on 76 people.Russian research institute has now submitted “comprehensive data” on the vaccine’s safety and efficacy to Indian authorities.

The engagement for vaccine from India is being coordinated here by Renu Swarup, Secretary, Department of Biotechnology, and, in Russia, by Indian Ambassador D B Venkatesh Varma.

Experts in India evaluated the “comprehensive data” and they found that India can have separate Phase 3 clinical trial here only after necessary approvals from regulators. Russia plans to conduct Phase 3 clinical trials in many countries like Saudi Arabia, UAE, Brazil, and the Philippines, according to official Sputnik V website, run by sovereign wealth fund Russian Direct Investment Fund.

“In conclusion, these data collectively show that the heterologous vaccine based on rAd26-S and rAd5-S is safe, well tolerated, and does not cause serious adverse events in healthy adult volunteers. The vaccine is highly immunogenic and induces strong humoral and cellular immune responses in 100% of healthy adult volunteers,” the study said.  Russian researchers published their preliminary findings of Phase 1 and 2 of their vaccine on September 4.