Russia’s Sputnik V vaccine is 91.6% effective: Lancet study

Sputnik V, the coronavirus vaccine developed by Russia’s Gamaleya Institute, has an efficacy rate of 91.6% in preventing Covid-19, according to an interim analysis of the Phase 3 clinical trials published in the medical journal The Lancet on Tuesday.

The study paves the way for the vaccine candidate to seek approvals for emergency roll-out across the world, and adds to the world’s arsenal of tools to fight the pandemic. At present, doses by Pfizer-BioNTech, Moderna and Oxford-AstraZeneca have been approved for use by several countries and, in addition to Sputnik V, shots by Novavax, Johnson&Johnson-Janssen, Sinovac and Sinopharm have shown to be effective in preventing Covid-19. India has also rolled out an indigenous vaccine, Covaxin, created by Bharat Biotech.

Sputnik V is also being manufactured in India, which is also expected to help the country have access to another dose. “Most of our vaccine will be produced in India. India trials are going exceedingly well with Dr Reddy’s. India and Korea are already producing the vaccine. The production in China will start later this month, and Brazil is producing trial doses. The production will soon also start in Kazakhstan,” said Kirill Dmitriev, CEO, Russian Direct Investment Fund (RDIF), in a media briefing.

Sputnik V is based on an adenovirus platform, similar to the Oxford-AstraZeneca dose, but it uses different adenoviruses that the developers say will help boost its efficacy.

In the interim efficacy analysis of the randomised, double-blind, placebo-controlled clinical trial, data from 19,866 volunteers were included in the efficacy analysis (14,964 of whom received the vaccine and 4,902 the placebo).

“The publication of internationally peer reviewed data on Sputnik V’s clinical trial results is a great success in the global battle against the Covid-19 pandemic. The Russian vaccine’s safety and high efficacy are shown by the hard scientific data presented… Several vaccines have already been created based on human adenoviruses and this tool is one of the most promising for development of new vaccines in the future,” said Alexander Gintsburg, director, the Gamaleya Research Institute of Epidemiology and Microbiology.

The Russian vaccine was looked at with suspicion initially for having been developed in haste.

“The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency. But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of Covid-19,” said Ian Jones, University of Reading, and Polly Roy, the London School of Hygiene & Tropical Medicine, in a comment document shared by The Lancet.

The vaccine generated both, a robust humoral as well cell-mediated immune response. The makers also claimed that the vaccine was showing same level of immunity against the new variants

“The publication of trial results that show high efficacy (91.6%) in the respected medical journal like The Lancet dispels all concerns. This is great news not just for Russia but the entire scientific community as Lancet did a very unbiased work despite all the political pressure that might have been out there. Russia was right all along that we have a vaccine that is safe and efficacious,” Dmitriev said.

“Only three Covid-19 vaccines have shown more than 90% efficacy so far in the world: Pfizer, Moderna and Sputnik V. And just four vaccines have published their phase 3 trial results in a peer reviewed journal. Oxford-AstraZeneca vaccine is the other vaccine,” he added.

The vaccine has been co-developed by the Gamaleya National Research Center of Epidemiology and Microbiology of the ministry of health of the Russian Federation, and the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund).

“Because of its high efficacy, safety, and low cost, Sputnik V truly becomes the vaccine for the mankind. It costs one-third of the other Covid-19 vaccines with more than 90% efficacy. The vaccine has also shown no major side-effects such as allergies or anaphylactic shock. About 94% of all the adverse conditions were very mild and short-lasting. It showed 100% protection in severe cases and 100% cellular immune response that provides stronger and long-lasting immunity, and more than 90% efficacy in elderly above 60 years of age” said Dmitriev.

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 vaccine is already registered in 16 countries, and by the end of next week is likely to be registered in 25 countries.

“The vaccine is 100% effective in preventing serious disease or death, which in the end is the most crucial parameter; we can all deal with the sniffles as long as we stay out of the hospital or the graveyard. Even after a single dose of this prime-boost regimen protection against disease was at 87.6%,” said Hildegund CJ Ertl, professor, vaccine and immunotherapy center, The Wistar Institute, USA.