The European Medicines Agency’s (EMA) human medicines committee (CHMP) has launched a rolling review of Russia’s Sputnik V COVID-19 vaccine.
Sputnik V was developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology, with the EU applicant for the vaccine being R-Pharm Germany.
The CHMP decided to begin the rolling review based on results from laboratory studies and clinical studies of the vaccine in adults.
In a statement, the EMA said that these studies suggest that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 virus, which causes COVID-19.
All the data will be evaluated as it becomes available and the rolling review will continue until there is enough evidence for a formal marketing authorisation application.
In December 2020, the Russian Direct Investment Fund (RDIF) confirmed efficacy of over 90% for the Sputnik V vaccine.
Evaluation of efficacy was carried out among volunteers (22,714) 21 days after receiving the first dose of the vaccine or placebo upon reaching the third and final statistically significant representative control point of the trial.
The data analysis at the final control point of the trials demonstrated a 91.4% efficacy rate.
The analysis was carried out on the basis of 78 confirmed cases identified in the placebo group (62 cases) and in the vaccine group (16 cases).
The vaccine showed 100% efficacy against severe coronavirus cases, the group said, noting that there were 20 severe cases of coronavirus infection among confirmed cases in the placebo group and no severe cases in the vaccine group.