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Sputnik V is 91.4% effective in trial

A view shows boxes containing vials with Gam-COVID-Vac, also known as Sputnik-V, vaccine against the coronavirus disease (COVID-19) at a production facility of BIOCAD biotechnology company in Saint Petersburg, Russia. (REUTERS)Premium
A view shows boxes containing vials with Gam-COVID-Vac, also known as Sputnik-V, vaccine against the coronavirus disease (COVID-19) at a production facility of BIOCAD biotechnology company in Saint Petersburg, Russia. (REUTERS)

  • The efficacy rate of the vaccine was determined when 78 covid-19 cases were reported across the vaccine and placebo arms of the trial, and was the same as the rate calculated in the second interim analysis after 39 cases were reported

The third interim data on Sputnik V vaccine’s phase 3 trial in Russia has shown that the adenovirus vector jabs were 91.4% effective at preventing covid-19, its co-developer Russian Direct Investment Fund (RDIF) said on Monday.

The interim analysis of the phase 3 trial was the last one before the trial is completed in May, when the vaccine developer would conduct a final analysis to determine the safety and efficacy of the vaccine, a company spokesperson said.

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The efficacy rate of the vaccine, co-developed by Gamaleya National Research Center for Epidemiology and Microbiology and RDIF, was determined when 78 covid-19 cases were reported across the vaccine and placebo arms of the trial, and was the same as the rate calculated in the second interim analysis after 39 cases were reported.

“The Sputnik V vaccine efficacy against severe cases of coronavirus was 100%. Among the confirmed cases of coronavirus infection, 20 severe cases were recorded in the placebo group, while no severe cases were recorded in the vaccine group," RDIF said.

The evaluation of efficacy in the third interim analysis was carried out among 22,714 volunteers, with three-fourths of them receiving the vaccine and the rest getting the placebo.

While there were 62 cases in the placebo arm, 16 were reported in the vaccine arm.

“We will share the results with the scientific community and will be happy to discuss them with all interested colleagues. Monitoring of the condition of participants will continue," Gamaleya deputy director Denis Logunov said.

As of 14 December, more than 26,000 volunteers were vaccinated at 29 medical centres in Russia as part of the ongoing clinical trials. Phase 3 clinical trials are also going on in Belarus, the United Arab Emirates, Venezuela and other countries, while in India Dr Reddy’s Laboratories is conducting phase 2 and 3 studies.

Dr Reddy’s is in a pact with RDIF to conduct clinical trials of the vaccine in India as well as sell up to 100 million doses of it, when the shots get approval from the Indian regulator.

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