Updated: September 7, 2020 6:56:29 am
The candidate vaccine elicited a “strong” immune response in Phases 1 and 2 of clinical trials in 76 people. (AP Photo)
Even when the Lancet published the data from the phase 1 and phase 2 clinical trials of the Sputnik V vaccine – approved by Moscow regulators for public use – the Russian research institute has now submitted “comprehensive data” on the safety and efficacy of the vaccine to Indian authorities, The Indian Express has learned.
Senior officials said India had requested this from the Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology. The candidate vaccine elicited a “strong” immune response in Phases 1 and 2 of clinical trials in 76 people.
“We are now deeply committed to Russia on the vaccine front,” said a source. This engagement is being coordinated here by Renu Swarup, Secretary of the Department of Biotechnology and, in Russia, by Indian Ambassador DB Venkatesh Varma.
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As this “full data” is evaluated by experts in India, one option, the sources said, is to have a separate Phase 3 clinical trial after the necessary regulatory approvals here. In fact, according to the official website Sputnik V, run by sovereign wealth fund Russian Direct Investment Fund, Russia plans to conduct phase 3 clinical trials in many countries, including Saudi Arabia, the United Arab Emirates, Brazil, and the Philippines.
Production of the vaccine is expected to begin in September 2020. Significantly, it states that at least 20 countries, including India, “had expressed interest in obtaining Sputnik V”; These countries include the United Arab Emirates, Saudi Arabia, Indonesia, the Philippines, Brazil, and Mexico.
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Western experts have been skeptical of the Russian claim given the speed and secrecy with which Gamaleya’s candidate obtained regulatory approval. The Lancet study states that Sputnik’s phase 3 trial will involve 40,000 volunteers of different ages and risk groups. And it will include a “constant monitoring” of the volunteers through an online application, with each dose of vaccine having its own QR code assigned to the volunteer.
On September 4, Russian researchers published their preliminary findings from Phase 1 and 2 of their candidate vaccine in The Lancet based on two open-label, non-randomized trials of two formulations at two hospitals in Russia. “In conclusion, these data collectively show that the rAd26-S and rAd5-S-based heterologous vaccine 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.
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