Wroclaw, Poland - 12 Jan 2021: Medic hold vaccine container with russian Sputnik V

European Medicines Agency Begins Evaluation of Sputnik V Vaccine

The European Medicines Agency has begun its evaluation of the Russian Sputnik V vaccine, as Russia promises to guarantee enough vaccines for 50 million people by June. Sharing a detailed summary of how the Sputnik V vaccine works, the EMA is soon also expected to approve vaccines from some other pharmaceutical companies. Photo Credit: Freepik / Illustrative Photo.

Czech Rep, March 5 (BD) – Yesterday, the European Medicines Agency (EMA) announced that the Committee for Medicinal Products for Human Use, which is responsible for preparing the Agency’s decisions on vaccines and other medicines, has started evaluating the Sputnik V vaccine, produced by the Russian Gamaleya National Centre of Epidemiology and Microbiology. The committee is conducting clinical trials of the vaccine in adults. The application was submitted by the German branch of the Russian pharmaceutical group R-Pharm. 

In light of the fast-growing number of COVID-19 cases across Europe, the EMA is trialling Sputnik V using a process known as ‘rolling review’, which allows the trial period to start before the end of the clinical study period, speeding up the evaluation compared to the standard approval process. The Slovak and Hungarian governments have already received shipments of the vaccine before it has been approved by the EMA. In the Czech Republic, Prime Minister Andrej Babiš and President Miloš Zeman support the use of the Russian vaccine, while the Minister of Health Jan Blatný insists that it should only be used with EMA approval. The Russian government has stated that 100 million doses of the vaccine, enough to vaccinate 50 million people, could be supplied to the EU by June in case of approval.

The Sputnik V vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, which may help protect against COVID-19. The EMA is evaluating Sputnik V according to three criteria: effectiveness, safety, and quality, and the Agency says that the evaluation will continue until satisfactory results are reached for formal market authorization. A final decision on the vaccine is expected to be announced soon. So far, the EU has approved vaccines from Pfizer / BioNTech, AstraZeneca, and Moderna, while the approval of the Johnson & Johnson vaccine is expected next week. 

How Does Sputnik V Work? 

The EMA’s website states that the advantage of the Sputnik V vaccine is the ability to equip the body with the necessary antibodies to defend itself against COVID-19. Sputnik V includes two viruses named Ad5 and Ad26, members of the adenovirus family. This virus type has been modified to contain the spike protein of SARS-CoV-2, yet without the ability to reproduce in the body. As Ad26 and Ad5 are introduced into the human body, they also deliver the SARS-CoV-2 gene into the body’s cells. If the vaccinated person is subsequently infected with COVID-19, the immune system will identify the spike protein on the virus and be prepared to tackle it, preventing it from entering the body’s cells, and therefore protecting against COVID-19.

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