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11 августа

Transcript of the President's meeting with government members on COVID-19 vaccine and other issues

President of Russia Vladimir Putin: Good afternoon, colleagues.

We will discuss current issues, just as we have been doing for some time now.

Perhaps, it would be inaccurate to describe some of them as current issues, considering their importance for the country and the entire world. I have been told that the world’s first coronavirus vaccine was approved this morning. I am asking Healthcare Minister Mikhail Murashko to share some details on this subject, even though I know that it is quite effective, helps develop immunity and has gone through all the necessary trials.

We will hear Mr Murashko, who will share his professional perspective. Mr Murashko, go ahead please.

Healthcare Minister Mikhail Murashko: Mr President,

Allow me to report on the state registration of the first vaccine against the novel coronavirus. Immediately after the World Health Organisation announced that the novel coronavirus SARS-CoV-2 was officially a pandemic, the Gamaleya National Research Centre of Epidemiology and Microbiology of the Russian Healthcare Ministry began to work on a vaccine to prevent the novel coronavirus spread relying on the experience and well-established technology for the manufacture of adenovirus vectors.

I would like to note that the scientists at the Gamaleya Centre conducted the first successful experiments to develop gene therapy drugs back in the 1990s. Due to the further development of this project, they created a universal platform for the development of vaccines against various infectious diseases, including especially dangerous ones. On this platform, microbiologists from the Gamaleya Centre have already developed, on instructions from the Healthcare Ministry, as many as six vaccines that are now at various stages of the process in the Russian Federation. Some of them are going through the registration and regulatory approval procedure.

One of the most striking examples of the use of the Gamaleya Centre platform was the creation of a vaccine against Ebola fever, and another type of coronavirus, MERS. This means that the Gamaleya Centre approached the COVID-19 pandemic with a well-developed technological platform with proven effectiveness and safety. As a result, a group of developers led by Dr Alexander Gintsburg created a coronavirus vaccine in the shortest possible time. The group has received a Russian Federation patent for the invention.

The pharmacovigilance experts involved in the drug quality and clinical research discussion have helped develop trial programmes and address regulatory issues of drug safety.

The preclinical trials of the vaccine were carried out at the Gamaleya Centre and the 48th Central Scientific Research Institute of the Defence Ministry. The clinical trials took place at two locations: the Sechenov University of the Healthcare Ministry and a branch of the Burdenko Military Hospital. According to the results, the vaccine has shown high effectiveness and safety. All volunteers developed high titres of COVID-19 antibodies, while none of them had any serious complications or side effects.

Based on the analysis of clinical trials data, experts from the Healthcare Ministry issued a conclusion, and today a decision was made on granting state registration for the vaccine to prevent the novel coronavirus, developed by the Gamaleya Centre of the Russian Healthcare Ministry. It is one of the first registered vaccines in the world that has proven its effectiveness and safety.

The vaccine is registered in accordance with the procedure for market access for medicines to prevent COVID-19, adopted by the Russian Government. We have already reported that a number of medicines were previously released for treatment and are now effectively used by medical institutions.

The vaccine developers have prepared documents for further clinical trials involving several thousand people. For emergency monitoring of the health status of those vaccinated and to control effectiveness and safety, the Healthcare Ministry is developing a single digital system that makes it possible to monitor the safety and quality of the medication at all stages of the life cycle. This includes a registry of the vaccinated patients, and on July 1, Russia launched a system for monitoring the circulation of medicines, including an individual code on each package.

Vaccine production will now begin at two sites: the Gamaleya Centre of the Russian Healthcare Ministry and the company Binnopharm. At the same time, with the assistance of the Ministry of Industry and Trade and the Sberbank project office, technical regulations are prepared to increase production at the sites of a number of domestic manufacturers, which exist in our country.

Following your instruction, the RDIF is investing in the production and promotion of the vaccine abroad. A number of countries are already showing interest in it. At the same time, the vaccine will be gradually introduced among civilians, and, first of all, we consider it necessary to offer vaccination to those whose work involves dealing with infected people – medical workers – as well as our teachers, whom the health of children depends on.

Mr President,

I want to thank you for your help and support of scientists and medical workers at all stages of the fight against the novel coronavirus, including the creation of the new medication – the first domestic vaccine against the novel coronavirus.

Of course, I would like to thank the researchers and the volunteers who took part in its trials, as well as medical workers. I would like to thank Prime Minister Mikhail Mishustin, supervising Deputy Prime Minister Tatyana Golikova and my colleagues from the Cabinet of Ministers for their well-coordinated work during this period and the creation of the vaccine. In my opinion, a huge contribution has been made to the victory of humankind over the novel coronavirus.

Thank you very much. My report on this issue is finished.

Vladimir Putin: Thank you. You said this is one of the first registered vaccines. Are there similar vaccines registered anywhere around the world?

Mikhail Murashko: There is our Chinese colleagues’ research that is undergoing the registration process now. There are similar developments in other countries as well, but clinical tests are still underway. In fact, Russia has the first full registration certificate.

Vladimir Putin: Which means we have the first registration. I hope the work of our foreign colleagues will also make progress, and there will be a lot of medicines and vaccines on the global market that can be used.

I know this vaccine, as you have said, is based on adenoviral vectors, but I think its advantage is that it is based on human adenoviral vectors. It works more precisely and forms stable antibody and cellular immunity. I know this very well, too, because one of my daughters has got this vaccination. I think that in this sense she has taken part in the experiment. After the first shot, she had a fever of 38 degrees, but the next day it went down to just over 37, and that was it. After the second shot, her temperature went up a little, but then came down again. She feels well, and the titres are high. I know that many people have no symptoms or fever after the shot. In fact, they feel as if nothing happened. The main thing is to ensure unconditional safety and effectiveness of this vaccine in the future. I hope this will happen.

I would like to congratulate Academician Gintsburg and all his colleagues who worked on this vaccine and succeeded. I know that work on similar vaccines continues in Russia at other institutions. I wish success to all experts. We have to be grateful to those who have taken this first, very important step, very important for Russia and for the entire world. I hope that soon we will be able to launch mass production – this is very important – of this preparation, so that everyone who wants (of course, this must be voluntary, as I have said many times) can benefit from our scientists’ innovations and achievements.

Thank you very much to you and to Mr Prime Minister. I know that everyone worked on this most actively. Deputy Prime Minister Golikova focused on the matter as its curator. This is success, and once again, I congratulate you.