The European Medicines Agency (EMA) has launched an accelerated evaluation of the Russian Sputnik V vaccine, which is already being used in many parts of the world to vaccinate the population against Covid-19. This decision comes at a time of growing dissatisfaction with the Covid-19 vaccine shortage and the slow pace of vaccination in the European Union.
- The ESA will assess whether the Russian vaccine meets all safety and quality standards.
- Some countries have already started vaccination with Sputnik V without waiting for an ESA decision.
- In one study, Sputnik V showed an efficiency of 91.6%.
- Some worry that Russia will use the vaccine as a geopolitical tool.
- In Russia, only 30% of the population wants to be vaccinated with Sputnik V.
ESA experts will assess whether the Sputnik V vaccine meets all the standards of efficacy, safety and quality in force in the European Union.
If the assessment is positive, it will be approved for use in EU countries. However, two EU Member States, Hungary and Slovakia, have already started using Sputnik V without waiting for an ESA decision.
Russia promises vaccine to 50 million Europeans
“We expect several more EU countries to register Sputnik before the ESA’s decision,” said Kirill Dmitryev, head of the Russian Direct Investment Fund. This fund funded the development of the vaccine. Dmitrijev promises that after EZA’s decision to approve Sputnik V, Russia would be ready to supply the vaccine to 50 million Europeans starting in June.
The Sputnik V vaccine has already been approved in more than 40 countries, including some European countries: Belarus, Serbia, Armenia, Montenegro, San Marino, Hungary, Moldova and Slovakia.
A positive assessment by the ESA would allow the vaccine to be used in all EU Member States. The European Union has very strict quality standards for medicines, so the effectiveness of the vaccine and whether the benefits outweigh the risks will be assessed.
Studies show high efficiency
Accelerated assessment is one of the tools of the ESA that is used to speed up the assessment of promising medicines in the event of a public health emergency. As a general rule, in the case of a formal application for registration, all data on the efficacy, safety and quality of the medicinal product, as well as all the necessary documents, must be submitted at the beginning of the evaluation. In the case of accelerated assessment, the Committee for Medicinal Products for Human Use (CHMP) of the EMEA will evaluate the data as soon as they become available from clinical trials.
The decision to initiate an accelerated assessment is based on the results of laboratory and clinical studies in adults. These studies show that Sputnik V causes the formation of antibodies and immune cells against the SARS-CoV-2 virus and may help protect the body against Covid-19.
Although the ESA cannot predict the total duration of the evaluation, it should take less time than the normal evaluation of the application due to the work done in the accelerated evaluation.
A recent study published in the British medical journal The Lancet confirmed that Sputnik V provides more than 90% effectiveness against severe Covid-19.
Hungary started using Sputnik V to vaccinate its population several weeks ago, but Slovakia has also started doing so this week. It is expected that in the face of vaccine shortages, such a decision could be taken by several more countries.
Russians are reluctant to get vaccinated
There are currently three authorized Covid-19 vaccines in the European Union: Pfizer / BioNTech, Moderna and AstraZeneca. The Johnson & Johnson vaccine is expected to be added to the range on March 11, as the EZA will decide on its approval on that day.
Meanwhile, vaccination against Covid-19 in Russia itself is not going so smoothly, so there are concerns that Sputnik V’s exports abroad are being used as a tool of geopolitical influence to brighten Russia’s image in the world.
A public opinion poll conducted by the Levada Center shows that only 30% of the population in Russia would be ready to be vaccinated with Sputnik V, but 62% do not want to do so. 4% of respondents admitted to having already received the vaccine.
Sputnik V is expected to prepare the body for protection against SARS-CoV-2 virus infection. This virus uses proteins on its outer surface called peak proteins to enter the body’s cells and cause Covid-19.
Sputnik V consists of two different viruses belonging to the adenovirus family – Ad26 and Ad5. These adenoviruses have been modified to contain the SARS-CoV-2 peak protein gene. These viruses cannot multiply in the body or cause disease. Each of the adenoviruses is given separately – Ad26 is given with the first dose and Ad5 is given with the second dose to increase the effect of the vaccine.
After the vaccine is given, it delivers the SARS-CoV-2 gene to the body’s cells. Cells use this gene to make peak proteins. The vaccinated person’s immune system perceives this peak protein as outside the body and makes natural defenses against it – antibodies and T cells.
If a vaccinated person is later exposed to SARS-CoV-2, the immune system will recognize the peak protein on the surface of the virus and be prepared to fight it: antibodies and T cells can work together to kill the virus, prevent it from entering the body’s cells and kill the infected cells. helping to protect against Covid-19.
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