The EU agency said the decision of its human medicines committee (CHMP) to start the rolling review is based on results from laboratory studies and clinical studies in adults.
“These studies indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against COVID-19.”
The EMA says it will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for formal marketing authorization application.
The EMA’s rolling reviews are aimed to speed up the process of approving a successful vaccine by allowing researchers to submit findings in real-time, even before final trial data is ready.
Sputnik V vaccine
A study published in The Lancet last month showed Sputnik V to be 91.6% efficacious.
Also known as Gam-COVID-Vac, the vaccine uses a heterologous recombinant adenovirus approach using adenovirus 26 (Ad26) and adenovirus 5 (Ad5) as vectors for the expression of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein. The use of two varying serotypes, which are given 21 days apart, is intended to overcome any pre-existing adenovirus immunity in the population.
The recombinant adenovirus route to protection is shared with the Oxford–AstraZeneca vaccine, which uses a chimpanzee adenovirus (ChAdOx), the Johnson & Johnson vaccine that uses only Ad26, and the CanSinoBIO and Beijing Institute of Biotechnology developed Ad5-based vaccine whose phase 3 trial began in September last year.
EU approvals to date
Europe has, to date, approved COVID-19 vaccines from Pfizer-BioNTech, Moderna and Oxford-AstraZeneca, while the EMA is expected to give its assessment of J&J’s single-shot vaccine on March 11. EMA rolling reviews of CureVac and Novavax’s candidates are in progress.