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A preliminary study published in the medical journal The Lancet on Friday showed that the Sputnik-V vaccine, which is being developed in Russia against the new coronavirus, triggered an immune reaction among all volunteers who participated in early-stage clinical trials and did not cause Serious side effects, a fact stated a month ago by the Russian government, which had not published the data related to these investigations, informs AFP and Reuters assumed by agerpres.
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These results do not yet prove that the Russian vaccine provides effective protection against infection by the new coronavirus, an aspect that will have to be demonstrated by larger studies, medical experts said.
On August 11, the Russian authorities announced the entry of their potential vaccine into phase 3 -which is also the last- of the clinical trials and their intention to homologate it as of September, without waiting for the results provided by the final phase of these tests. they are done “in several thousand people”.
Following the August announcement, several researchers and some countries, such as Germany, have expressed doubts about the effectiveness and safety of the Russian vaccine, mainly due to the lack of public data on the tests carried out. Western experts have warned against using the vaccine in Russia until all international testing and certification steps have been completed.
However, after the results of the first tests were published for the first time in a prestigious scientific journal on Friday and after the phase 3 study began last week in Russia on a sample of 40,000 people, a senior official from The Russian administration said that in this way his country had managed to dismantle criticism from abroad.
The Sputnik-V vaccine, named after the first artificial satellite in the world, launched by the former USSR, is based on two different compounds, administered through two successive injections, in an interval of three weeks, details the article published this Friday in the British magazine. The lancet.
These are “viral vector” vaccines: they use as support two human adenoviruses (a family of common viruses), transformed and adapted to combat the COVID-19 disease.
Two small-scale tests, performed with two different formulations of the Sputnik-V vaccine, were conducted on a total sample of 76 healthy adult volunteers.
The authors of the tests concluded that each of the two components of the vaccine did not cause “serious side effects” and that the successive administration of the two compounds “determines the synthesis of antibodies” for 100% of the participants.
Photo source: The lancet / Twitter
The two studies were conducted between June 18 and August 3 by researchers from the Russian Ministry of Health and the Ministry of Defense and were funded by the Russian Ministry of Health.
Photo source: The lancet / Twitter
Kirill Dmitriev, director of the Russian Direct Investment Fund (RDIF), said that at least 3,000 people had already been recruited for Phase 3 of the Sputniv-V vaccine, which began last week, and that the first results are expected in October. or November.
The race to develop a vaccine
The world’s governments and major pharmaceutical companies are competing for a truly international race to develop a vaccine to end the COVID-19 pandemic, a disease that has already infected some 26 million people and caused more than 850,000 deaths. Worldwide. .
According to the WHO, a total of 176 potential vaccines are being developed around the world, of which 34 have entered clinical trials, meaning that they have begun to be tested in humans. Of these, eight have reached phase 3, which is the most advanced.
Tens of thousands of participants are conducting phase 3 clinical trials and several pharmaceutical companies, including the British group AstraZeneca and the American groups Moderna and Pfizer, are expected to find out before the end of this year whether their potential COVID-19 vaccines they are efficient and safe.
The Lancet reports that phase 1 and 2 clinical trials in Russia suggest that the Sputnik-V vaccine has produced a positive reaction in some structures of the immune system called T cells.
Scientists are carefully examining the role of T cells in fighting new coronavirus infections during this period, and several recent findings have shown that these cells provide longer-lasting protection compared to antibodies.
The Russian vaccine, developed by the Gamaleya Institute in Moscow, is administered in two doses, each based on different vectors, which often cause common colds: human adenoviruses Ad5 and Ad26.
However, some experts believe that the use of this delivery mechanism could make the Russian COVID19 vaccine less effective, as many people have already been exposed to Adenovirus Ad5 and have developed immunity to it.
In China and the United States, about 40% of people have high levels of antibodies from previous exposure to Ad5. In Africa, this percentage could reach 80%, according to experts.
Denis Logunov, one of the developers of the Russian vaccine at the Gamaleya Institute, told Reuters that Sputnik-V uses a strong enough dose of Ad5 to overcome any previously acquired immunity without compromising the safety of the vaccine.
The booster dose, based on a rarer adenovirus, Ad26, provides further support for the Russian vaccine, as the likelihood of broad immunity to both types of viruses among the world’s population is minimal.
Russia has announced plans to produce between 1.5 million and 2 million doses every month for its possible COVID-19 vaccine by the end of 2020 and then gradually increase production to 6 million doses per month.
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