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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has initiated an ongoing review of the Russian Covid-19 vaccine, Sputnik V.
Developed by the National Center for Epidemiology and Microbiology of Gamaleya, the vaccine is based on a platform of human adenoviral vectors.
The latest development is based on data obtained from laboratory studies and clinical studies carried out in adults.
According to studies, Sputnik V triggers the production of antibodies and immune cells to attack the SARS-CoV-2 virus and could provide protection against Covid-19.
In partnership with national regulatory authorities globally, the Gamaleya National Center and the Russian Direct Investment Fund (RDIF) will provide data on clinical trials related to Sputnik V.
RDIF CEO Kirill Dmitriev said: “We have provided EMA with comprehensive data on the Russian vaccine, which is now approved for use in more than 40 countries.
“Sputnik V can make a significant contribution to saving millions of lives in Europe and we look forward to a comprehensive review of the data by the CHMP.
“Following the approval of the EMA, we could provide vaccines to 50 million Europeans from June 2021.”
During ongoing review, EMA will analyze the data when available to verify whether the benefits outweigh the risks. The process will continue until sufficient evidence is obtained for a formal application for marketing authorization.
The EMA will also assess Sputnik V’s compliance with common European Union (EU) standards for efficacy, safety, and quality.
R-Pharm Germany is the applicant for the vaccine in the EU.
The agency will inform the time of submission of the marketing authorization request for the vaccine.
So far, 42 countries with a total population of more than 1.1 billion people have authorized the use of the vaccine.
Some of the EU member states have registered Sputnik V without EMA approval. Currently, Hungary and Slovakia have approved the use of the vaccine.
Last month, Mexican health regulator COFEPRIS authorized Sputnik V for emergency use after the country signed a contract to secure millions of doses of vaccines.
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