Russian COVID-19 vaccine is 92% effective, interim data suggest
Phase 3 clinical trial results indicate that Russia’s Sputnik V vaccine was 92% effective against COVID-19, according to a press release from the Russian Direct Investment Fund, or RDIF.
“The use of the vaccine and the results of clinical trials demonstrate that it is an efficient solution to stop the spread of coronavirus infection, preventive health care tool, and this is the most successful path to defeat the pandemic,” Mikhail Murashko, Minister of Health of the Russian Federation, said in the release.
Russian President Vladimir Putin announced his country’s approval of Sputnik V in August. However, little data on the vaccine were made available, making experts wary of the vaccine’s effectiveness. At that time, former FDA commissioner Scott Gottlieb, MD, noted that Russia’s vaccine approval process is not on par with that of the United States.
According to the RDIF, 40,000 Russian volunteers are currently enrolled in the double-blind, randomized, placebo-controlled phase 3 trials of Sputnik V, a “well-studied” human adenoviral vector vaccine. More than 20,000 have been vaccinated with the first dose, and 16,000 received both doses. The efficacy of the vaccine was based on an interim analysis obtained 21 days after the first injection.
The RDIF said “there were no unexpected adverse events during the trials,” and researchers are continuing to monitor participants.
Phase 3 trials of Sputnik V are also underway in Belarus, the United Arab Emirates and Venezuela, according to the release.
On Monday, Pfizer and BioNTech announced that their COVID-19 vaccine candidate named BNT162b2 was more than 90% effective in preventing the disease and showed no serious safety concerns in phase 3 trials. The companies said their mRNA-based vaccine likely will be submitted to the FDA for an emergency use authorization the third week of November.