Rolling Review of Sputnik V COVID-19 Vaccine Begins in Europe

BioPharm International Editors

The European Medicines Agency has begun a rolling review based on laboratory and clinical studies of the Sputnik V (Gam-COVID-Vac).

The European Medicines Agency (EMA) announced on March 4, 2021 that its human medicines committee (CHMP) has begun a rolling review of the Sputnik V (Gam-COVID-Vac) COVID-19 vaccine. The review is based on results from laboratory and clinical trial studies that indicate the vaccine triggers the production of antibodies and immune cells. The rolling review will look at data as they become available and will continue until there is enough evidence to support a formal marketing authorization application. The usual standards for effectiveness, safety, and quality will be assessed by the agency for the vaccine, according to EMA.

Sputnik V (Gam-COVID-Vac) was developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. EMA states that the vaccine is made up of Ad26 and Ad5 adenoviruses that “have been modified to contain the gene for making the SARS-CoV-2 spike protein; they cannot reproduce in the body and do not cause disease. The two adenoviruses are given separately: Ad26 is used in the first dose and Ad5 is used in the second to boost the vaccine’s effect.”

Source: EMA