The committee for human medicines (CHMP) of the EMA (European Medicines Agency) began in early March an ongoing review of Sputnik V (Gam-COVID-Vac), the vaccine against Covid-19 developed by the National Center for Epidemiology and Gamaleya Microbiology of Russia. However, the EU applicant for this medicine, R-Pharm Germany GmbH, has not yet submitted the marketing authorization application. Meanwhile, this medicine can already be administered in up to 57 countries.
Which countries have authorized the Russian Sputnik V vaccine
Antigua and Barbuda last month became the 57th country to authorize the Sputnik V coronavirus vaccine, the Russian Direct Investment Fund, which is in charge of marketing the vaccine, announced. In this way, the Russian drug has been approved for emergency use in a total population of more than 1.5 billion people.
Countries that have the Russian vaccine approved are Argentina, Bolivia, Mexico, Nicaragua, Paraguay and Venezuela, Iran, Pakistan, Turkey, Cameroon, Mauritius, the Philippines or Jordan.
How is the Russian Sputnik V vaccine (same type as AstraZeneca or Janssen)
Sputnik V, explains the Gamaleya National Research Center for Epidemiology and Microbiology, is the first registered vaccine in the world based on human adenoviral vectors. Thus, it works through a mechanism similar to the AstraZeneca and Janssen vaccine. Meanwhile, the alternatives from Pfizer and Moderna have a messenger RNA base.
Adenoviral vectors are genetically modified viruses that are introduced into human cells to cause the production of antibodies against another particular virus. The Sputnik V vaccine uses two types of adenoviral vectors (rAd26 and rAd5) created from two adenoviruses.
The use of human adenoviruses as vectors is safe because these viruses, which cause the common cold, are not new and have been around for thousands of years. In addition, these adenoviruses are considered among the easiest to genetically modify.
Thus, for the elaboration of this vaccine, the gene of the adenovirus, which is the cause of the infection, is subtracted and in its place a gene with the protein code of another virus is inserted, in this case that of Covid-19. . The inserted element is safe for the body and helps the immune system to react and produce antibodies that protect against infection.
How effective is the Russian Sputnik V vaccine?
‘Sputnik V’, explains the Gamaleya National Research Center for Epidemiology and Microbiology, offers an efficacy greater than 90%. “A vaccine efficacy of 91.6% has been determined based on data from 19,866 volunteers who received the first and second injection of the Sputnik V vaccine or a placebo; 78 confirmed cases of COVID-19 were recorded in the final control stage”, explains the laboratory.
The results of the study on the efficacy of the Sputnik V vaccine have been subjected to an international comparative evaluation; The data obtained have been published in The Lancet.
Another point in favor of this medicine is that the cost of a dose for foreign markets is less than 10 dollars and it can be stored between 2 and 8 degrees Celsius, which facilitates its distribution to the whole world, including the regions of Hard access.
What side effects does the Russian Sputnik V vaccine have?
To find information on the side effects caused by this vaccine, one must go to the data and studies that the countries that are administering it are reporting. This is the case of Argentina, which on January 20, 2021, published a report carried out by professionals from the DiCEI (Directorate for the Control of Immunopreventable Diseases), of the National Ministry of Health, in conjunction with the National Vaccine Safety Commission. This document states that a total of 8,841 post-vaccination side effects were reported, after having administered a total of 195,490 doses. In addition, 99.6% of the reported events were mild and moderate and only 0.4% of the cases had to be hospitalized.
The most frequent side effects described were:
1. Fever
2. Headaches
3. Muscle pain
4. Local reaction at the injection site
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