Russia’s vaccine proves effective in early trial data, company says.

The New York Times, November 11, 2020 (with Andrew Kramer)

Russia’s coronavirus vaccine has shown strong effectiveness in early data from a clinical trial, according to a statement on Wednesday from the Russian financial company promoting the shot.

The Russian Direct Investment Fund said that the vaccine, called Sputnik V, demonstrated 92 percent efficacy, based on results from 20 people in the trial who developed Covid-19 after getting either the experimental vaccine or a placebo shot. Because few scientific details were given, independent vaccine experts could not fully assess its veracity.

“It’s very hard to say much with 20 cases and no other details,” said Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University.

The scientists behind the Russian vaccine have not released the trial blueprints, known as protocols, which are needed for a thorough review of the data. The Russian developer, the Gamaleya Research Institute of Epidemiology and Microbiology, plans to publish details of the interim results in a peer-reviewed article, the Russian Direct Investment Fund said in its statement.

The results are not implausible, especially considering the news from earlier in the week that Pfizer and BioNTech’s vaccine was “more than 90 percent effective” in preventing the illness. Like all vaccines now in clinical trials, the Pfizer and Sputnik V vaccines present a coronavirus protein called “spike” to the immune system.

Because Pfizer’s data was so strong, “it boosts my confidence in other vaccines as well,” said Natalie Dean, a biostatistician at the University of Florida who specializes in infectious disease outbreaks.

There are now 11 vaccines in late-stage clinical trials worldwide, including three in Russia.

Since August, Russia has sought to get ahead in the global race to market vaccines by announcing its product was effective before clinical trials showed that to be the case, and by approving it for emergency use at home. China has also approved a vaccine for emergency use before its trials are completed. The World Health Organization rebuked Russia for skipping steps in the approval process.

Trial results are based on a statistical analysis of study subjects who come down with Covid-19. If more people receiving the placebo than the vaccine become ill, then the vaccine is effective.

The Pfizer and BioNTech results were based on 94 confirmed cases, making them more statistically compelling than the 20 cases in the Russian data. In the vaccine trial by Pfizer and BioNTech, half of the participants received two doses of the vaccine three weeks apart, and half received a placebo. The first analysis was based on 94 volunteers who had developed Covid-19. To calculate the efficacy rate, an independent board of experts compared how many of those 94 cases were in the placebo group, and how many were in the vaccinated group. (If all 94 had been in the placebo group, for example, the vaccine would be considered 100 percent effective.)

Gamaleya Research Institute plans to test the two-shot vaccine on 40,000 people. So far, about 16,000 people have received both doses. Separately, the Russian Ministry of Health has vaccinated about 10,000 volunteers under the emergency use approval, according to the statement released on Wednesday.