this morning was the world’s first vaccine against the new coronavirus infection, – said Vladimir Putin at a meeting with government members on Tuesday. It works quite effectively, form a stable immunity and passed all the necessary tests.
the Drug has developed a national research centre of epidemiology and Microbiology named Gamalei, Russian Ministry of health. “One of my daughters made themselves such a vaccine, – said the head of state. – I think in that sense it participated in the experiment.” Putin said that the vaccination was two, and the reaction to them was a small rise in temperature. Now the daughter of the President, he said, “feels good, and titers (antibodies) high.”
– I Know that many people have no external symptoms and no fever after vaccination, – said Putin. All passes as if nothing did.
He called the main, in the future was ensured absolute safety of use of the vaccine and its effectiveness. The head of state expects that in the near future will begin mass production of the drug. For citizens, he emphasized, the decision about vaccination will be voluntary.
– We must be grateful to those who made this first step very important for our country and for the entire world, – said Putin. – I hope that we will be able to soon begin mass production of this drug, so anyone who wants is, of course, should be done only voluntarily – could take advantage of the developments and achievements of our specialists and scientists.
the President noted that the vaccine in question, is not the only – work on preparations of this kind in Russia continues to other institutions. “I wish all the experts of the success”, – Putin said.
the Minister of health of the Russian Federation Mikhail Murashko told the details of the first vaccine. Its development began immediately after was declared a pandemic of the novel coronavirus. The base for this has already been experiments that started in the 90 years allowed to create a universal platform for the development of vaccines against different infections, including threat. Thus, for a pandemic COVID-19 specialists of the center Gamalei came up with a technology with proven efficacy and safety. This, according to the Minister, and became a guarantee that a vaccine against coronavirus managed to create in the shortest possible time.
According to studies, the vaccine demonstrated high efficacy and safety, confirmed Murashko President. “All the volunteers developed high titers of antibodies COVID-19. While none of them noted serious complications of immunization,” said he. However, this research does not end, they will continue with the participationment of several thousand people. For operational monitoring of the health status of the vaccinated, the Ministry of health of Russia creates a single digital circuit.
the Vaccine, continued Murashko, will be made at two sites – the very Center of Gamaliel and the company Binnopharm. But after the development of technical regulations of production will be engaged in other pharmaceutical companies. Meanwhile, the drug is already interested and in other countries.
In Russia, the first drug to get doctors and teachers. It is important to start with them, because first work directly with patients and the second with the children, explained the Minister. As later clarified by Deputy Prime Minister Tatiana Golikova, vaccination of doctors and teachers will begin in late August.
meanwhile, the President drew attention to the statement of Mikhail Murashko on that Russian vaccine – “one of the first registered vaccine in the world.” He said, what about other vaccines it is. The Minister said that “there is the development of the Chinese colleagues”, who are at the stage of registration. “There are a number of other countries, but there is still undergoing clinical trials, he added. – In fact, registration card in full issued in Russia first.”
“so we have a first registration has happened,” confirmed Vladimir Putin. He expressed the hope that scientists abroad “work too will move.” Because then in the global pharmaceuticals market will be a lot of vaccines that can be used, said the Russian leader.
during the meeting were discussed and other topics in healthcare. The President recalled that the end of the period payments to physicians who work with patients with COVID-19. “Payments ends and the infection-that went nowhere, he recalled. – Yes, we have decline, there are positive trends… But still the virus is present.”
In this regard, Putin proposed the government to devise new financial incentives for physicians. In addition, he drew attention to the problem: some of them are not underpaid due to the fact that the number of beds repurposed for patients with coronavirus, was unclaimed. “It turned out that we COVID someone paid, and in the core of their activities are not underpaid,” said Putin. This is unfair because doctors “here at anything”, he said and asked the government to consider the solution of the question.
Deputy Prime Minister Tatiana Golikova said that is to be allocated 47.5 billion roubles for the health facilities. These funds, according to her, needed to avoid problems and that the doctors were not losing their incentive payments. If the President will support this approach, the Cabinet is ready to consider the draft decree of the government at the next meeting, Golikova said. “Well,” Putin responded.
the President’s focus��roVal attention of the Cabinet at another financial question. Due to the fact that “the economy a bit to shorten” because of the pandemic and the fall in energy prices, the Ministry of Finance offered in some areas to reduce costs, he said. Putin recommended “not to cut”. “But if something already proposed to recover costs associated with purchase of medicines for preferential categories of citizens and cancer”, – he stressed. Tatyana Golikova, the head of state instructed to calculate the costs of support in the fight against cancer, including spending on drugs and high-tech medical care.
the meeting discussed the preparation of schools and universities by the beginning of the school year. The President focused on the theme of providing free hot meals for pupils of primary school. With such initiative Vladimir Putin addressed the Federal Assembly, and then a law was passed, which reads as follows: juniors in all schools of the country should be fed hot food at least once a day.
To comply with the ready schools in 58 regions, said Prime Minister Mikhail Mishustin. “The reasons why the program start is delayed, all different, he said. – Somewhere there are some schools that have no canteen, somewhere in there the technical readiness of the kitchens, where local authorities have time to prepare”. In unprepared regions, he added, 75% of schools still have meet the requirements.
the Cabinet, according to him, considers it unjust “to punish some schools for what others in their region were not ready”. “In this regard, we came to the conclusion that it is necessary to change the rules for the provision of Federal funds to regions that previously could not qualify for it received a subsidy this year – said Mishustin. – Its size will be calculated based on the number of schools that are ready to provide hot meals, and the number of primary school pupils”. For this purpose, according to the calculations of the Cabinet, will have to allocate about 39 billion rubles for three years.
the remaining schools that are not ready yet, funding for the organization of hot meals will go at the expense of the regions, said the Prime Minister. Federal funds for these schools, the regional guide will begin to obtain only after will bring them into compliance with the established requirements.
“Good. Let’s do it” – supported the President. He also drew attention to the proportion of ready to providing hot meals for schools. “It seems like 75% is a lot, but I want to say that 25% of unready schools – that’s a lot, – said Putin. – I want to know when all Russian schools will be ready to complete this work.” He instructed the government of the Russian Federation together with regional governments, envoys and Kremlin administration to analyze the situation. N��necessary to find out “what, where, how and when this problem will be finally closed”. Report of the President’s waiting in the near future.
This also applies to small schools, said Putin. According to him, there are opinions that there to feed the children according to the General rules is not necessary. But it is not. “Families who send their children to these schools should not be put in a position worse than other Russian families”, – said the head of state.
they Discussed preparations for the 1st of September and in other areas . The Ministry of education keeps under special control the issue, reported to the head of Department Sergey Kravtsov. He stressed that educational institutions September 1, will start operating in the normal full-time mode in compliance with the requirements of the CPS. By the way, on this day all schools will have a lesson dedicated to the 75-th anniversary of Victory in the great Patriotic war, said the Minister.
he is also told that by the end of the year, schools will receive more than 55 thousand new places, and by 2025 it is planned to introduce 1,750 schools on the 1.5 million places.
the Universities will also begin work on 1 September, while the wearing of masks is mandatory education classes will be held outdoors. This was reported to the Minister of education and science Valeriy Falkov. For foreign students, he said, introduced a special requirement – they will be allowed to study in Russian universities according to the results of a two-week quarantine after arrival.
“First of September in our country is always the occasion. I ask you to do everything to ensure that this holiday was secured”, – Putin addressed members of the Cabinet.
Sergey Glagolev, Advisor to the Minister of health of Russia, Chairman of the Committee of the Parties of the Convention, Meditrim, Vice-President of the Mechanism who falsified and substandard medicines
Registration of the vaccine is based on two components of an expert assessment. First, in order to assess the balance of benefits and risks when applying new preparetextures study data of animal experiments and clinical studies involving humans.
during clinical studies of the vaccine Center Gamalei was confirmed by the ability to form a strong immunity to COVID-19. Serious complications of the vaccine have been identified. It should be emphasized that during the examination were evaluated and the statistical reliability of the data about vaccine efficacy.
a Second pillar of expertise is the establishment of quality parameters and confirm compliance with these requirements of the registered drugs. This is particularly important for vaccines, biologics, the slightest deviation in quality parameters which can greatly affect the profile of efficacy and safety. Moreover, vaccine applicationsprivate bathrooms with showers feature millions of people in a short time. Registration of the drug is possible only if benefits of its use outweigh the potential risks, and quality parameters ensure safe use.
In the case of vaccine COVID-19 we were in a unique situation: current level of development of biotechnology has allowed deciphering the genome of the virus in a matter of weeks to design a vaccine, and a little more than six months to carry out all necessary stages of testing, first in animals and then in healthy volunteers. To protect the health of patients during a pandemic, Russia, the EU and the USA, have developed mechanisms to fast-track the registration of drugs for the prevention and treatment of new infections. In Russia and abroad, registration of such drugs, including vaccines, is on particular conditions.
In particular, the developer of the drug shall conduct a further clinical study of the efficacy and safety of and after registration.
In the case of vaccine Center Gamalei provides for the conduct of clinical research involving two thousand patients of different sex and age, with different health features, etc.
will this Last phase of research for a long time – within six months, all indicators of the health of the volunteers will be closely monitored by physicians. In addition, each participant of the third phase of the research will be included in a special digital register vaccinated, which also will gather data about the effectiveness and potential complications of vaccination.
Another innovation: for rapid communication with physicians, all participants of the third stage will receive the mobile application, they will be able to quickly transmit the slightest changes in their health status.
Thus, the safety profile and efficacy of a new drug will be monitored in real time.
the Uncontrolled use of vaccines no permit.
make no mistake, and now, when recruiting participants for the third phase of the research, and in the future vaccination will be strictly voluntary.
it is Important to stress that in contrast to “synthetic” drugs and for vaccines in Russia and in the EU, provides for a special procedure of issuance of each series of the drug is required to be monitored kolaborator regulatory authority. And it additionally guarantees quality.
the Global vaccines market COVID-19 is in the focus of attention of many pharmaceutical companies. A significant number of foreign countries want to get access to the vaccine. Therefore the recent statements by non-core structures. backed by a foreign company for postponement of registration must be taken, mindful of the competition.
