The world’s first new coronal vaccine registered in Russia: who will evaluate its safety

Global times Liu Yupeng, Li Sikun, Russian President Vladimir Putin announced on the 11th that Russia’s first new coronavirus vaccine has been registered, thus becoming the world’s first officially registered new coronavirus vaccine. Russian medical experts have analyzed the reasons why Russia can take the lead in developing new crown vaccine. A who spokesman said the safety of the Russian vaccine would be evaluated. “As far as I know, the new coronavirus vaccine has been registered this morning, which is the first time in the world,” Putin said at a meeting of government members on the same day, according to the 11 daily news of Russian news agency. I hope our foreign friends can also push forward the relevant work. There are enough products available in the world drug and vaccine market. ” “I know this vaccine is quite effective and can form a stable immunity,” Putin said at the same time. I repeat that the vaccine has passed all necessary tests. One of my daughters has tried out a new crown vaccine. She feels good now. We need large-scale production of new coronavirus vaccine in Russia in the near future. I thank all those who participated in the first batch of vaccine development, because this is a very important step for the whole world. ” < / P > < p > Mikhail murashko, Russian health minister, said the new coronavirus vaccine showed high efficiency and safety. At present, vaccines are produced in two places: one is the National Research Center for epidemiology and microbiology in gamaliya of the Russian Ministry of health, and the other is binnopharm company. At the same time, Russia is formulating technical regulations needed to expand production scale. The Russian direct investment fund is responsible for investment in vaccine production and overseas promotion. He said clinical trials involving thousands of people would continue on the vaccine. The first new coronavirus vaccine registered in the world was named “satellite-v”. Russia’s Ministry of health information office said that the two dose vaccination program can form long-term immunity. Based on experience with such vaccines, immunity can last up to two years. It is a human adenovirus based vaccine, which has passed the safety and effectiveness tests on a variety of animals, and also carried out clinical trials on two groups of volunteers. < / P > < p > why Russia can develop a new vaccine so quickly is a topic of great concern to the outside world. Russian health minister murashko said that the Russian Research Center began to develop vaccines immediately after the who announced a new coronavirus pandemic, the Communist Youth League Daily said. Russian scientists use their own experience and mature technology to produce adenovirus vector vaccine. Regarding whether there are similar vaccines registered in other countries in the world, murashko said that China and some other countries have similar studies, but they are still in clinical trials. In Russia, the new vaccine showed high efficiency and safety according to the results of clinical trials. All volunteers produced antibodies, and there were no serious side effects. < / P > < p > as for the meaning of national registration, Chinese vaccine experts explained that it can be considered that after registration, the new crown vaccine can be produced and inoculated legally and normally. In fact, it may be inoculated for high-risk groups first, but it may not be sold directly on the market. < / P > < p > according to the Russian media, the Russian government plans to start the vaccination from occupations at risk of infection with the new coronavirus, which is expected to start at the end of August or early September. The vaccine will be launched on January 1 next year. In other words, the elderly and other groups are likely to start mass vaccination next year. The Russian Association of clinical research organizations called on the Russian Ministry of health to put forward a proposal to postpone the national registration of the first batch of vaccines developed in Russia to the successful completion of the third phase of clinical trials, according to the Russian opinion newspaper on the 11th. At the same time, some pharmaceutical companies called on the Russian Ministry of health to delay the registration of the vaccine. In response, Nikolay buriko, chief non staff epidemiologist of the Russian Ministry of health, said that the technology used in the vaccine had been used in the development of other vaccines before, so there was no need to delay the registration of this vaccine. The vaccine of gamaliya center doesn’t come out of thin air. The center has been working in this direction for more than ten years and has developed vaccines against Ebola and other viruses. Adenovirus vector technology has been used in the development of new coronavirus vaccine, and related technologies have existed. Especially important, the vaccine has passed the relevant research stage. These stages are very strict, more stringent than when drugs were developed. In view of the emergency caused by the new crown epidemic, registration can be accelerated, because the supervision after registration helps to evaluate the long-term safety and effectiveness of the vaccine. < / P > < p > however, there are also doubts about the safety of Russia’s new vaccine. U.S. media said that U.S. presidential assistant kailian Conway said that there are too few clinical human trials on Russia’s new coronavirus vaccine, which lags behind the progress of the United States. She said she understood from the Russian announcement that this is far from the current situation of the US side. Kailian Conway said trump will listen to a briefing on the work of the new vaccine in the United States later on the 11th local time, and may keep the outside world informed of the latest progress. < p > < p > Russian opinion 11 reported that Matty Selberg, director of the Department of laboratory medicine at Karolinska Medical College in Stockholm, said Swedish scientists are not sure whether Russia’s new coronavirus vaccine is successful. It’s hard to talk about the effectiveness of vaccines. Because the standard procedure for testing drugs before registration requires 10000 people to test them. There is no data on such tests for vaccines in Russia. < / P > < p > Yang zhanqiu, Professor of the Institute of Virology, School of basic medicine, Department of medicine, Wuhan University, told the global times on the 11th that in March this year, China and the United States simultaneously announced the start of clinical trials of the new coronal vaccine, but Russia did not announce it at that time, but it can not be said that Russia is lagging behind. After the outbreak of the new crown disease, many countries have rapidly started the research and development of vaccines. In this regard, many countries around the world are synchronous. From the general law of vaccine development, one and a half years of research and development cycle is relatively fast. It has been about eight months since January this year. The safety and effectiveness of the vaccine can be initially solved in more than half a year. If this problem has not been solved, Russia should not dare to release this news. It can only be said that Russia has accelerated the transition process from laboratory research to commercialization. < / P > < p > who spokesman Tariq yasarevich said at the meeting on the 11th that who and the Russian government maintain contact on the safety and efficacy evaluation of the first new coronavirus registered vaccine. < / P > < p > regarding the prospect of cooperation with foreign countries, Russia’s TASS 11 Daily reported that kiril Dmitriyev, President of Russia’s direct investment fund, said that the third phase of the trial will start 12 days after registration. Phase III clinical trials of the vaccine will be launched in the United Arab Emirates, Saudi Arabia and the Philippines in the near future. The data of each phase will be published as soon as they are available. “We have received initial applications from more than 20 countries for more than 1 billion doses of Russian vaccine,” he said. We have signed vaccine production agreements with five countries, and now we have the capacity to produce 500 million doses of vaccine in the next 12 months. It is possible to take the lead in launching vaccine production in Cuba in November. Cuba could be one of the main centres of vaccine production. ” < / P > < p > Philippine President duterte said in a televised speech to the citizens on 11 November that he would voluntarily become the first person to test Russia’s new coronavirus vaccine in person. According to reports, President vuccic of Serbia said that his country is ready to become the first country to receive the Russian vaccine. < p > < p > Yang zhanqiu believes that this progress in Russia will promote vaccine development in China, the United States and even the world. Russia’s preemptive announcement of this news has something to do with Russia itself and the epidemic situation in Europe. Russia’s preemptive announcement of major progress in vaccine development will help to seize the European market. < / P > < p > according to the latest report released by who on July 31, there are 165 vaccine candidates in the world, of which 139 are still in the stage of preclinical evaluation, and the other 26 are in different stages of human trials, of which 6 vaccines are ahead of schedule and enter the phase 3 clinical trials.