The Russian Direct Investment Fund said on Wednesday that Russia will start a new phase of clinical trials of the "Sputnik-V" vaccine against the emerging corona virus, which will include more than 40,000 people in Moscow. What are the conditions for participation?
"We are starting with our colleagues at Gamalia National Research Center for Epidemiology and Microbiology, with the support of the Russian Direct Investment Fund, post-registration vaccine tests that will be conducted in Moscow," the Mayor of Moscow, Sergey Sobyanin, said in a statement. This is according to what was reported by Russia Today.
Sobyanin explained that "the tests will be conducted on the basis of the medical institutions in the city," noting that "this stage is the third for clinical tests, and it is important that it will take place in conjunction with the introduction of the vaccine for civilian use."
What conditions?
The mayor stated that participation in the exam will be on a voluntary basis, and with the following conditions:
1- The participant must be over 18 years old.
2- Does not exhibit symptoms of any acute respiratory viral infection.
3- The person should not have previously had COVID-19.
The Mayor of Moscow pointed out that the talk that the Russian vaccine was developed within a month or two is incorrect, stressing that the experts of the Gamalia Center have been carrying out scientific work since the eighties of the last century that allowed the design of an integrated approach in developing vaccines against various diseases, including serious infectious diseases, and confirmed in In this context, "the safety of the new vaccine is proven."
Meanwhile, the Russian Deputy Prime Minister, Tatiana Golikova, stated that there are 27 foreign countries that have expressed their interest in buying the Russian vaccine against the Coronavirus, indicating that this list includes Belarus, Azerbaijan, Brazil, Venezuela and Kazakhstan.
powder
The Russian Health Ministry, Gamalia Institute, has granted permission to produce the "Sputnik V" vaccine in powder form, according to Russia Today.
The Russian Health Information Office said in a statement issued Tuesday that the ministry issued a registration certificate for the "GAM-Covid-Fam-Liu" vaccine, which was developed by the Gamalia Center and "is produced in the form of a dry substance to prepare a solution that can be injected intramuscularly."
First country
Russia is the first country in the world to register a new anti-Coronavirus vaccine called "Sputnik V" and was designed by Gamalia Center for Epidemiology and Microbiology, and the launch of its serial production was on August 15, and it is expected that mass vaccination of Russian citizens with it will start in mid-September / September.
The vaccine, approved by Russia, has won praise from authorities and Russian scientists after two months of small-scale human trials, the results of which have not yet been announced.
The Russian Direct Investment Fund, which supports the vaccine, said that similar trials will be conducted in five other countries.
Questioning
The Russian announcement of developing the first Corona vaccine was met with caution and skepticism from some. For example, a virologist at the Bernhard Nocht Institute for Tropical Medicine, Jonas Schmidt-Chanasset, said in previous statements to the German news agency, "I am very conservative about the approval of launching this vaccine. So far there is no published data on it, and this is a matter of great difficulty."
According to experts, the biggest problem is the approval of launching the vaccine without completing the clinical testing phase, which violates the recognized medical protocol in developing vaccines. According to what Deutsche Welle quoted from the German news site "Tageschau", criticism rained down on Russia from the international medical community for "violating the established rules and risking the lives of its citizens."
The site quoted the head of the German Federal Medical Association, Klaus Reinhardt, as commenting on the vaccine, saying that allowing it to be presented is a "very dangerous experiment for humans," adding, "Getting entire groups of people with this vaccine at this early stage of its development is irresponsible."
Chanasset pointed out the importance of following the rules of the World Health Organization in developing vaccines, according to what was quoted by the German News Agency, adding that vaccines usually go through stages, and they are tested on humans in the third stage, which witnesses the experiment of the effectiveness of the vaccine on thousands of volunteers over a period of months to know how it works and to discover Its side effects.
Chanasset cited what happened in the Philippines when a vaccine against dengue fever was introduced in a similar way without making sure of its effectiveness, which made citizens feel as "guinea pigs" as he put it, which led to their reluctance to vaccinate in general because they lost confidence in the responsible authorities.