Posted 21 августа 2020, 12:08

Published 21 августа 2020, 12:08

Modified 24 декабря 2022, 22:37

Updated 24 декабря 2022, 22:37

Head towards a breakthrough: everything you wanted to know about the Sputnik-V coronavirus vaccine

21 августа 2020, 12:08
Сюжет
Pandemic
The last month of summer 2020 was marked by an important event: on August 11, the Russian Ministry of Health registered the domestic vaccine Sputnik-V, which became the first registered vaccine against the novel SARS-COV-2 coronavirus in the world.

Thanks to this breakthrough, a term immediately appeared in the world medical community - the so-called "Sputnik moment". This "moment" opened a new page in the story of the struggle of mankind against an insidious infection.

In 1957, the successful launch of the first space satellite by the USSR intensified space research in different parts of the planet, and the Sputnik V vaccine owes its name to this outstanding event.

Currently, there are about 165 different coronavirus vaccines in development worldwide. The following main types of vaccines can be distinguished: viral vector vaccines, vaccines based on viruses, nucleic acids and proteins.

The Russian Sputnik V vaccine was created on the basis of an adenoviral vector.

“Human adenoviral vectors are used in the development of vaccines against coronavirus by the world's leading pharmaceutical companies. At the same time, their vaccines are single-vector: CanSino (PRC) uses the Ad5 vector, which has already been approved for use in the PRC army, Johnson & Johnson (USA) uses the Ad26 vector. Johnson & Johnson has received orders for more than 140 million doses of the drug based on the vector Ad26 from the United States and Europe, ”the Direct Investment Fund said in a press release.

Our developers clarify: the use of two vectors is a unique technology of the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya distinguishes the domestic vaccine from other vaccines based on adenovirus vectors being developed in the world, having a clear advantage over the single-vector approach.

“The results of recent studies show that double vaccinations are needed to create long-term immunity. Since 2015, Russian scientists have been working on a two-vector approach, the essence of which is to use two types of adenoviral vectors, Ad5 and Ad26, in the COVID-19 vaccine. Thus, they “trick” the body that has developed immunity against the first type of vector, and enhance the effect of the vaccine by administering a second dose containing a different vector. It is like two trains trying to deliver an important cargo to the human body's fortress, which needs this cargo to start producing antibodies. The second train is necessary in order to ensure the arrival of the cargo at its destination, and must be different from the first one, which has already been attacked by the body's immune system and is familiar to it. Other vaccine manufacturers send only one train to the fortress, while we have two”, - said Kirill Dmitriyev, CEO of the Russian Direct Investment Fund, in his publication.

“The first thing to say to Russian scientists and Russian doctors is 'bravo!' There is a lot of respect for the vaccine. Both as a doctor and as a scientist, I think that they have created a truly remarkable thing and made a great breakthrough in science”, - said Professor Polina Stepenskaya, an immunologist, the head of the department of bone marrow transplantation and immunotherapy at the Hadassah University Hospital, in an interview for RIA Novosti. The scientist is confident in the quality of the Russian vaccine, because it was created on the basis of a well-known and proven technology, the agency writes.

The news of the "launch" of Sputnik V spread throughout the international media, giving hope, but also raising many questions. Moreover, a whole campaign of misinformation about our vaccine has begun in a number of foreign media outlets.

To provide clear answers and disseminate accurate and up-to-date information about Sputnik V, the Russian Direct Investment Fund (RDIF, the sovereign wealth fund of the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya specially opened a separate website https://sputnikvaccine.com. All interesting details about the unique Russian vaccine can be found here, as they say, first-hand, in eight languages: Russian, English, French, Spanish, Arabic, Chinese, Indonesian, Portuguese.

The site contains links to scientific publications on the history of vaccines based on human adenoviruses and human adenovirus vectors, their clinical trials, the technological platform, the proven safety of this approach, as well as their application in the fight against various diseases.

“Unfortunately, instead of understanding the scientific evidence behind Russia's proven and proven adenoviral vector vaccine platform, some international politicians and media have opted to focus on politics and attempts to undermine confidence in the Russian vaccine. We consider this approach counterproductive and call for a political ceasefire on vaccine-related issues amid the COVID-19 pandemic”. - this is told in the article titled “Sputnik Vaccine - An International Life-Saving Partnership”, which was rejected by all leading Western media.

“The Russian vaccine is already ready and registered. The first two phases of clinical trials have passed and the results will be published this month in accordance with international requirements. These documents will provide detailed information about the vaccine, including the exact antibody levels according to several independent tests and a test invented at the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya, which detects the most effective antibodies. They will also show that all participants in clinical trials have developed 100 percent immunity to the COVID-19 virus.

Studies in Syrian hamsters, which tend to die from COVID-19, have shown 100 percent protection and no lung damage after a lethal infectious dose. After registration, international clinical trials will be conducted in three other countries. The mass production of the vaccine is expected to begin in September, but there is already a high interest in it abroad. Skepticism from international media and politicians arose when Russia announced plans to begin mass production of the COVID-19 vaccine.

When I spoke to Western media representatives, many of them refused to include key facts about Russian research on the COVID-19 vaccine in their articles. We view this skepticism as an attempt to undermine our efforts to develop an effective vaccine that will stop the pandemic and help restore the global economy.

… It is not the first time that Russia has faced international doubts about its leadership in science, when politics gets in the way of important scientific discoveries and endangers public health. During the polio outbreak in Japan in the 1950s, mothers whose children were dying of polio marched against their government, which banned the import of Soviet polio vaccine for political reasons. The protesters achieved their goal and the ban was lifted, saving the lives of more than 20 million Japanese children. Today, politics is once again hampering the development of Russian technologies that could save the lives of many people around the world. Russia is open to international cooperation in the fight against the current pandemic and pandemics that may arise in the future”, - writes Kirill Dmitriyev, the General Director of the Russian Direct Investment Fund, in his article.

How do adenoviral vector vaccines work?

The site sputnikvaccine.com has a detailed explanation. "Vectors" are carriers that can deliver genetic material from another virus into a cell. In this case, the genetic material of the adenovirus that causes the infection is removed and material with a protein code from another virus, in this case from the thorn of the coronavirus, is inserted. This new element is safe for the body, but it helps the immune system respond and produce antibodies that protect against infection.

The adenovirus-based vector technology platform simplifies and accelerates the development of new vaccines by modifying the original carrier vector with genetic material from newly emerging viruses, allowing new vaccines to be produced on a tight schedule. Such vaccines elicit a strong response from the human immune system.

By the way, human adenoviruses are considered to be among the easiest to modify, which is why they have become very popular as vectors.

About the safety and effectiveness of the Sputnik V vaccine.

After the outbreak of the pandemic, Russian researchers extracted a fragment of the genetic material of the new coronavirus SARS-COV-2, which encodes information about the structure of the S spike protein of the virus (a protein that forms the "crown" of the virus and is responsible for its binding to human cells), and inserted it into the already familiar adenovirus vector for delivery into a human cell, thus creating the world's first vaccine against the SARS-COV-2 coronavirus.

To ensure long-term immunity, Russian scientists have proposed using two different types of adenoviral vectors for the first and second vaccinations, enhancing the effect of the vaccine.

It is also noted that the use of human adenoviruses as vectors is safe, since these viruses that cause SARS are not new and have existed for thousands of years.

“We are getting a lot of questions about the Sputnik V vaccine, including the ones about the platform on which it was developed. RDIF and the Institute named after Honorary Academician N.F. Gamaleya strive for maximum transparency about the details of vaccine development, which is why we post all information about adenovirus vaccines on sputnikvaccine.com. We would like to thank everyone for their interest in Sputnik V both in Russia and abroad - the site about the vaccine has already been visited by representatives of more than 200 countries. We plan to expand the website's content with new details about the vaccine in the future”, - says Kirill Dmitriyev.

RDIF representatives report that next week in Russia, simultaneously with the vaccination of volunteers from risk groups, a previously planned post-registration randomized, double-blind, placebo-controlled multicenter clinical study of the efficacy, immunogenicity and safety of the Sputnik V vaccine will begin.

This study will involve over 40 thousand people in more than 45 medical centers.

By the end of 2020, it is planned to bring the production of the Sputnik V vaccine to 200 million doses, including 30 million doses in Russia.

More than 20 countries have expressed interest in acquiring Sputnik V , including the UAE, Saudi Arabia, Indonesia, the Philippines, Brazil, Mexico and India.

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