Russia’s First Vaccine with a 40,000-Scale Clinical Trial will Start Next Week, and the Second Vaccine is Expected to be Tested and Registered in September
Kirill Dmitriev, Head of the Russian Direct Investment Fund, and Daniel Logunov, deputy director of the 'Gamalea' National Research Center for Epidemiology and Microbiology, said on the 21st, the Russia’s large-scale clinical trial for the registered first new coronavirus vaccine 'Sputnik-V' will start next week, with 40,000 people participating.
It is understood that the 'Sputnik-V' vaccine was jointly developed by the Russian 'Gamalea' National Research Center for Epidemiology and Microbiology and the Russian Direct Investment Fund. Russian President Putin announced on August 11 that the vaccine was registered with the Russian Ministry of Health and became the first country in the world to register a new coronavirus vaccine.
Test Purpose : To Prove the Reliability of the Vaccine
According to RIA Novosti news, two phases of clinical trials have been carried out for 'Sputnik-V' before registration. In order to be safe and effective, vaccines should generally pass Phase III clinical trials.
Logunov said, 'The entire use of the vaccine will be under the strictest control. At present, we have agreed on a large-scale clinical trial agreement involving 40,000 people. The goal of the program is not only to study the immunogenicity of the vaccine, but also safety and effectiveness. We also need to evaluate the effectiveness of the vaccine to prove its reliability.'
Dmitriev said, 'Starting next week, we will conduct large-scale post-registration clinical trials of the new coronavirus vaccine. These trials will be conducted in full accordance with international standards. At the same time, vaccination of high-risk populations will be conducted simultaneously. "
Russian Health Minister Murashko previously stated that the 'Sputnik-V' vaccine is a conditional registration and clinical trials will continue. Logunov said that the vaccine will also be strictly monitored when it is used in private circulation. Once an adverse reaction is discovered, the registration status of the vaccine can be suspended at any time.
The 40,000-scale clinical trial will continue next week. Source : TASS
Test Site : Conducted in Russia and Other Countries
Dmitriev also mentioned, 'The test is mainly carried out in Russia, but will also be carried out in the UAE, Saudi Arabia, the Philippines, and India or Brazil.'
He said that he is currently in discussions with Indian and Brazilian regulators and will make a decision in early September. 'Maybe in both countries, but we hope there will be at least one.' In addition, Mexico will also receive at least 2,000 doses of the new coronavirus vaccine and conduct the third phase of clinical trials in the country according to the agreement.
The West is Constantly Questioning, but 'Putting People In' Behind the Scenes
Since Russia announced the registration of the new coronavirus vaccine, some Western countries have repeatedly questioned the safety and effectiveness of Russian vaccines.
According to the latest news from the TASS news agency, Western countries are currently trying to 'poach' researchers from the Gamalea Research Center.
In this regard, Alexander Gunzburg, head of the National Research Center for Epidemiology and Microbiology of 'Gamalea', said, 'The researchers of our team have been working at the Gamalia Research Center for ten years. Any American or European Research institutions will want to have such researchers; they are trying to 'poach' our scientists, but such attempts are futile and they will not succeed.'
Russian Health Minister : Criticism is Baseless
Gunzburg also said, 'It is foreseeable that Western countries will react like this to Russia’s registration of the first new coronavirus vaccine. I think they did not expect Russia to be the first to develop a new coronavirus vaccine, so this kind of negative remarks appeared. This is their opinion. The negative reaction to the first registration of Russian vaccines."
Earlier, Russian Health Minister Murashko emphasized that foreign colleagues’ worries and criticisms of Russia’s new coronavirus vaccine were unfounded and were caused by competition. He emphasized that the Russian-made new coronavirus vaccine has scientific basis and scientific data, and the vaccine can guarantee safety.
The Second Vaccine is Expected to Complete the Trial in September
The second Russian vaccine developed by the Russian National Science Center for Virology and Biotechnology is currently undergoing Phase II clinical trials.
In the second phase of the clinical trial, a total of 100 people participated. Currently, all volunteers feel good and have no side effects. According to a report on the 21st in magazine 'Russia', the clinical trial of the vaccine is expected to end in September, and national registration will be carried out thereafter.
It is understood that the 'Sputnik-V' vaccine was jointly developed by the Russian 'Gamalea' National Research Center for Epidemiology and Microbiology and the Russian Direct Investment Fund. Russian President Putin announced on August 11 that the vaccine was registered with the Russian Ministry of Health and became the first country in the world to register a new coronavirus vaccine.
Test Purpose : To Prove the Reliability of the Vaccine
According to RIA Novosti news, two phases of clinical trials have been carried out for 'Sputnik-V' before registration. In order to be safe and effective, vaccines should generally pass Phase III clinical trials.
Logunov said, 'The entire use of the vaccine will be under the strictest control. At present, we have agreed on a large-scale clinical trial agreement involving 40,000 people. The goal of the program is not only to study the immunogenicity of the vaccine, but also safety and effectiveness. We also need to evaluate the effectiveness of the vaccine to prove its reliability.'
Dmitriev said, 'Starting next week, we will conduct large-scale post-registration clinical trials of the new coronavirus vaccine. These trials will be conducted in full accordance with international standards. At the same time, vaccination of high-risk populations will be conducted simultaneously. "
Russian Health Minister Murashko previously stated that the 'Sputnik-V' vaccine is a conditional registration and clinical trials will continue. Logunov said that the vaccine will also be strictly monitored when it is used in private circulation. Once an adverse reaction is discovered, the registration status of the vaccine can be suspended at any time.
The 40,000-scale clinical trial will continue next week. Source : TASS
Test Site : Conducted in Russia and Other Countries
Dmitriev also mentioned, 'The test is mainly carried out in Russia, but will also be carried out in the UAE, Saudi Arabia, the Philippines, and India or Brazil.'
He said that he is currently in discussions with Indian and Brazilian regulators and will make a decision in early September. 'Maybe in both countries, but we hope there will be at least one.' In addition, Mexico will also receive at least 2,000 doses of the new coronavirus vaccine and conduct the third phase of clinical trials in the country according to the agreement.
The West is Constantly Questioning, but 'Putting People In' Behind the Scenes
Since Russia announced the registration of the new coronavirus vaccine, some Western countries have repeatedly questioned the safety and effectiveness of Russian vaccines.
According to the latest news from the TASS news agency, Western countries are currently trying to 'poach' researchers from the Gamalea Research Center.
In this regard, Alexander Gunzburg, head of the National Research Center for Epidemiology and Microbiology of 'Gamalea', said, 'The researchers of our team have been working at the Gamalia Research Center for ten years. Any American or European Research institutions will want to have such researchers; they are trying to 'poach' our scientists, but such attempts are futile and they will not succeed.'
Russian Health Minister : Criticism is Baseless
Gunzburg also said, 'It is foreseeable that Western countries will react like this to Russia’s registration of the first new coronavirus vaccine. I think they did not expect Russia to be the first to develop a new coronavirus vaccine, so this kind of negative remarks appeared. This is their opinion. The negative reaction to the first registration of Russian vaccines."
Earlier, Russian Health Minister Murashko emphasized that foreign colleagues’ worries and criticisms of Russia’s new coronavirus vaccine were unfounded and were caused by competition. He emphasized that the Russian-made new coronavirus vaccine has scientific basis and scientific data, and the vaccine can guarantee safety.
The Second Vaccine is Expected to Complete the Trial in September
The second Russian vaccine developed by the Russian National Science Center for Virology and Biotechnology is currently undergoing Phase II clinical trials.
In the second phase of the clinical trial, a total of 100 people participated. Currently, all volunteers feel good and have no side effects. According to a report on the 21st in magazine 'Russia', the clinical trial of the vaccine is expected to end in September, and national registration will be carried out thereafter.
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