Post-approval, Russia vax trials share early data

Sept. 4, 2020

Almost a month after approving a coronavirus vaccine, Russia has published positive data from early, small-scale clinical trials of the shot.

Last month, the country’s health ministry reported that it has granted approval to a candidate being developed by a company called Sistema, even though it still hasn’t entered a large scale phase 3 trial.

The findings, published in the Lancet today, showed that the adenovirus vector vaccine was safe to use and generated immune response in all of its 76 test subjects. The results, based on a combined Phase 1 and 2 trial of two groups of 38 adults, showed that the level of virus-neutralizing antibodies of inoculated volunteers was 1.4 to 1.5 times higher than the level of antibodies of patients who had recovered from COVID-19.

Scientists and health experts in the West have continued to express concern over the hasty approval, with some calling it "reckless" and "unethical."
"Having a vaccine and proving a vaccine is safe and effective are two different things," said Dr. Fauci, when asked about Russia's vaccine claims during a National Geographic livestream event.

But Russian officials are pushing forward, expecting mass vaccinations to begin by end of this year.