Prior to the results of laboratory and clinical studies, the European agency responsible for drug approval has begun a “continuous review” of the “Sputnik V” vaccine, which was developed by the Russian National Epidemiology and Microbiology Center Gamaleya against COVID- 19 vaccines.
European Medicines Agency (EMA) Has announced the start of Artificial satellite, Russia’s vaccine against covid-19.The process includes real-time analysis of the safety, validity and quality of the data, and may lead to Authorized use This drug is used in the European Union (EU).
This is a statementThe European regulatory agency explained that the decision to take this step is “based on adult laboratory and clinical research results,” the drug’s developer has published and shared with EMA’s European scientists.
The technical requirement for the agency to start research on this drug is called Gam-COVID-Vac, Part of the German laboratory R-Pharm GmbH, Germany.The vaccine is made by Gamaleya National Center for Epidemiology and Microbiology Russia.
According to the EMA, Sputnik V “triggered against SARS-CoV-2 and They can help protect people who have been vaccinated against covid-19.”
The agency will evaluate whether the vaccine meets the EU’s conventional standards for efficacy, safety and quality, and will determine whether its benefits outweigh the risks.
The announced review will continue until there is enough information to submit a formal marketing authorization application in the EU, and EMA has not yet set a timetable for this.They estimate “It takes less time than usual“ Evaluate this request thanks to the work that has already been done during the ongoing review process.
Therefore, Sputnik V has also been added to the list of vaccines that are still in the ongoing evaluation process and still do not have a date for the required use authorization date, such as a vaccine developed by a German laboratory CureVac And American Novavax.
The person who has made a formal request to EMA to authorize conditional use of the license is Jensen, Is the Belgian subsidiary of Johnson & Johnson. It is expected to be authorized on March 11.If it succeeds, it will become The fourth vaccine is available Products of Pfizer/BioNtech, Moderna and AstraZeneca in the EU.
How the vaccine works
As they explained from EMA, Sputnik V is Composed of two different viruses It belongs to the adenovirus family Ad26 and Ad5. These adenoviruses cannot multiply in the body, nor can they cause disease.The two are in Two doses: The first one uses Ad26 and the second one uses Ad5 to enhance the effectiveness of the vaccine.
Thereafter, the vaccine carried the SARS-CoV-2 gene into human cells. Cells will use this gene to produce Spike or S protein. The human immune system recognizes the S protein as a foreign substance and produces natural defenses (Antibodies and T cells) To her.
If the vaccinated person comes into contact with SARS-CoV-2 later, the immune system will recognize the S protein in the virus and Ready to attack him. Antibodies and T cells can work together to kill the virus, prevent it from entering human cells, and destroy the infected cells, thereby preventing COVID-19.