the Situation is unique: scientists first managed to make a vaccine quickly, before the end of the epidemic. So we have a chance to defend themselves “here and now”, because the coronavirus continues to attack and kill. It is for these extraordinary circumstances, provides for a special procedure and conduct of clinical trials of vaccines and drugs, and registration for the widespread of their use, said the Ministry, stressing that speeding up the process in any case does not mean reducing the quality requirements.
“Now the bulk of the accumulated vaccine will go to post-licensure study. Then, after two or three weeks, maybe a month, the vaccine will start to arrive into the public market,” explained Gunzburg. Earlier that widespread vaccination will begin in October, said the Russian Minister of health Michael Murashko. He himself, incidentally, is going to be vaccinated now, in August, along with fellow doctors taking part in the final phase of the research.
around the world continue to ask the question: how the Russian managed to make a vaccine so quickly? And while the who welcomed the creation of a “Satellite V” (the so called vaccine), giving estimates to the new drug, from the United States, Britain, Germany, our design met with hostility. By the way, in all these countries output its own vaccine from COVID-19.
The nits of Gamaliel explained: about how to beat the competition, it’s not thought to quickly create a reliable protection from the evil of infection. Gamaleeva to some degree lucky, although this kind of luck – the whole merit of the scientists themselves, they had accumulated database, which helped to speed up the vaccine COVID-19. Four years ago, in early 2016, SIC name Gamalei registered a new vaccine from the threat of Ebola. It was also a vector vaccine, when the genetic material of the virus that causes a dangerous disease, “delivered” in the body of another, harmless virus vector. The vaccine, as this was also a two-component – vaccine was conducted in two stages. The drug turned effective and safe, it was approved by the who, and over the years, as said also, it used more than 3.5 thousand people.
Now the same technology or, as scientists say, the platform used for vaccine COVID-19. “Of course, all that great experience that was used to create the vaccine, not just useful, it was largely just the same moved, like the matrix, when creating a vaccine against coronavirus,” – said the academician.
He said that now as vectors, we used two strains of adenoviruses, easily penetrating the human body, but not causing him any harm. By the way, the same scheme is designed not only Russian vaccine, but also vaccine COVID-19 in China, B��itanyi and the United States.
Gunzburg explained that due to previous experience, the scientists at the beginning of the research already had an idea about the required doses of immunization for animals and humans, and it also seriously saved search time – after all, the selection of effective doses always takes a long time.
“Although it’s certainly been tested, but we have checked in a targeted manner. There were no particularly search moments. We already know the concentration of virus that must be entered, starting from mouse, monkey and man”, – said Alexander Ginzburg.
Now is the preparatory work for the final, post-marketing studies, in which it planned to vaccinate two thousand volunteers. As has been said, to recruit them will be doctors and teachers – those professional groups protection from COVID-19 needed primarily because of the high risk of contact with infected patients and children. Thus, as emphasized by Mikhail Murashko, vaccination, of course, will be strictly voluntary, and will teach not all in a row. Participants will check for the presence of antibodies to the crown – about 20 percent of physicians, according to the Minister, already have passive immunity, and to instill in them is not necessary. And only after this phase the vaccine will be tested in the most vulnerable groups – pensioners and children.
Interestingly, simultaneous to the post-marketing study on the efficacy of “Satellite V” from SIC name Gamalei, Russia will launch the final phase of testing another vaccine COVID-19. The Russian Ministry of health gave permission to conduct the third phase clinical trials of the candidate vaccine, developed by Chinese specialists in Russia, testing is organised by the Russian company “Petrovax”, well known in particular for its effective vaccines against influenza. As told “RG” in the company, clinical studies of the vaccine on humans of its developed by a large biotech company CanSinoBIO – early in March, in the hospitals of Wuhan, the results of the first two phases of the test published in the prestigious Lancet. One of the advantages of the vaccine – it is sufficient to enter only once. “The demand for vaccination COVID-19 in the world are so great that they cannot be closed by only one manufacturer, – have explained “RG” in the company. – The third phase of clinical trials in Russia is carried out within the framework of international studies. “Petromax” is a partner in this international project. Our task at this stage is to provide incoming inspection and release of the drug, the logistics, choose the vaccination centers, recruit volunteers and organize medical supervision. In addition, we organize laboratory diagnosis and statistical analysis of the data”.
In SLthe case of successful completion of testing, the company said, “we will ensure the production of the vaccine in full cycle on our Suburban enterprise. Our production facility has Russian and international certificates of GMP and has all the necessary resource for large-scale vaccine production”.
most Likely, the Russians will be available and the vaccine, developed at Oxford University and the British-Swedish company “АstraZeneka”. Recently Russian company “R-Pharm” announced the collaboration in an international project for the production of the vaccine at its facilities in Yaroslavl. “In Russia, the transfer of the cell line and the adenoviral vector, it is planned to produce the antigen and produce a finished dosage form. At the same time Russia will be one of the hubs for the production and supply vaccines to international markets”, – reported in “R-Pharm”.