Peer-reviewed data on Russia’s Covid-19 vaccine, Sputnik V’s advanced trials has been published in The Lancet, said the Russian Direct Investment Fund (RDIF), adding that the data confirmed the vaccine’s safety and efficacy.

The interim analysis of the Phase III trials confirmed over 91 per cent efficacy, including in those over 60 years, said a note from Russia’s Gamaleya National Research Center (that developed the vaccine) and RDIF (Russia’s sovereign wealth fund).

Independently compiled and reviewed by peers, the published data showed that Sputnik V protected against severe Covid-19, said Kirill Dmitriev, RDIF Chief Executive Officer. “This makes Sputnik V one of only three vaccines in the world with the efficacy of over 90 per cent but outperforms them in terms of safety, ease of transportation due to storage requirements of +2 to +8 degrees and a more affordable price. Sputnik V is a vaccine for all mankind,” he added.

The development comes in the wake of scepticism in parts of the scientific world on the Sputnik V’s approvals and registration being too rushed. However, some European countries are presently evaluating the vaccine for its population. And this comes against the backdrop of supply shortages of vaccines from AstraZeneca and Pfizer, a sore-point between the authorities in Europe and these companies.

India has a couple of alliances involving the clinical trials of Sputnik V (with Dr Reddy’s Laboratories) and production (Hetero Biopharma). “Most of our vaccines will be made out of India,” Dmitriev told a select media briefing, adding that they expected an emergency use authorization in India on the vaccine around February-March.

The vaccine has been approved in 16 countries and the CEO expected it to touch 25 by late next week. “Vaccines should be beyond politics,” he said, adding that they were open to partner and improve vaccines that had efficacy below 90 per cent. RDIF has an alliance with the AstraZeneca-OxfordUniversity vaccine in this regard. Explaining the significance, he said, months down the line when there are multiple vaccines in the market, problems would arise in terms of who is chosen to get a vaccine with higher efficacy, while another is given a vaccine with a lower efficacy.

Giving details on the randomised, double-blind, placebo-controlled clinical trial, the note said, data on 19,866 volunteers were included in the efficacy analysis (14,964 of whom received the vaccine and 4,902 the placebo). The two-dose treatment of Sputnik V administered 21 days apart demonstrated efficacy of 91.6 per cent against Covid-19. The calculation is based on the analysis of 78 confirmed cases of Covid-19 identified, with 62 being in the placebo group and 16 in the vaccine group. Importantly, the study included 2,144 volunteers over 60 years old with the maximum ages of 87 years (vaccine group) and 84 years (placebo group), showing great safety results for the elder age strata., the note said.

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