Even as Lancet published the results of Phase-1 and Phase-2 clinical trial data of the Sputnik V vaccine — cleared by Moscow regulators for public use — the Russian research institute has now submitted “comprehensive data” on the vaccine’s safety and efficacy to Indian authorities, The Indian Express has learnt.
Senior officials said India had sought this from the Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology. The vaccine candidate triggered a “strong” immune response in Phases 1 & 2 of the clinical trials on 76 people.
“We are now deeply engaged with Russia on the vaccine front,” a source said. This engagement is being coordinated here by Renu Swarup, Secretary, Department of Biotechnology, and, in Russia, by Indian Ambassador D B Venkatesh Varma.
As this “comprehensive data” is evaluated by experts in India, one option, sources said, is to have a separate Phase 3 clinical trial after necessary approvals from regulators here. In fact, according to the official Sputnik V website, run by sovereign wealth fund Russian Direct Investment Fund, Russia plans to conduct Phase 3 clinical trials in many countries, including Saudi Arabia, UAE, Brazil, and the Philippines.
The production of the vaccine is expected to start in September 2020. Significantly, it states that at least 20 countries, including India, “had expressed interest in obtaining the Sputnik V”; these countries include the UAE, Saudi Arabia, Indonesia, the Philippines, Brazil, and Mexico.
Western experts have been sceptical about the Russian claim given the speed and secrecy with which the Gamaleya candidate got regulatory approval. The Lancet study states that Sputnik’s Phase 3 trial will involve 40,000 volunteers from different age and risk groups. And will include “constant monitoring” of volunteers through an online application, with each dose of vaccine having its own QR code assigned to the volunteer.
On September 4, the Russian researchers published their preliminary findings of Phase 1 and 2 of their vaccine candidate in the Lancet based on two open and non-randomised trials of two formulations at two hospitals in Russia. “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.