The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has started a rolling review of Sputnik V, the COVID-19 vaccine developed by Russia’s National Centre of Epidemiology and Microbiology. The EU applicant is R-Pharm Germany GmbH.
The CHMP’s decision to start the rolling review is based on results from laboratory studies (non-clinical data) and early clinical trials in adults. These studies indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus.
The EMA will evaluate the data from these and other clinical trials as they become available. The rolling review will continue until enough evidence is available for formal marketing authorisation application.
EMA will assess the vaccine’s compliance with the usual standards for effectiveness, safety and pharmaceutical quality. While EMA cannot predict the overall timeline, it should take less time than usual to evaluate a possible application because of the work done during the rolling review.
How is the vaccine expected to work?
Sputnik V is expected to prepare the body to defend itself against a COVID-19 infection. The SARS-CoV-2 virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause COVID-19.
Sputnik V is a viral vector vaccine, which uses a virus that is already known but does not cause a disease in humans. This may be a harmless virus or a live attenuated virus used in another vaccine. Sputnik V has two different adenoviruses (Ad26 and Ad5). Ad26 is used in the first dose and Ad5 in the second dose. An antigen (spike protein) or the genetic code of an antigen is added to this viral vector.
They cannot reproduce in the body and cannot cause the disease. The cells then produce a spike protein. The person’s immune system will treat this spike protein as foreign and produce natural defences − antibodies and T cells − against this protein.