Why did we get the vaccine before everyone else?
According to the Minister of Health Dmitry Murashko,
Scientists used experience and debugged technologyproduction of adenoviral vectors, explained the head of the Ministry of Health. According to him, back in the 1990s, researchers at the Gamaleya Center conducted the first successful experiments to create gene therapy drugs.
And the further development of this area made it possible to create a universal platform for the development of vaccines against various, including especially dangerous infectious diseases.
Dmitry Murashko, Minister of Health
How does the developed vaccine work?
The vaccine of the Gamaleya Center is inactivated.To put it simply, you have grown a weed, and therefore you have inactivated it, in other words, you have killed it.
Vector vaccines, such as the developed one, also cause a cytotoxic reaction of immunity - immune cells appear, which are targeted to destroycells infected with the virus told Meduza in an interview with Denis Logunov, deputy director for research at the Gamaleya Center.
It is not entirely correct to transfer the talk about the ADE effect to a vector vaccine – studies have shown that it is notno ADE effect for vector vaccines.You don't need to investigate it further and you don't need to look at it, but the Oxford and Chinese [vector] vaccines [against SARS-CoV-2] studied in primates do not show any ADE effect.
We also tested our vaccine for this effect in primates.And, although we cannot say for sure whether humans will have the same picture as primates, now we should be wary of the possibility of the ADE effect, but nothing more. A vaccine made on this principle canCause only antibody protection.
Also, at a government meeting, the presidentasked the Minister of Health if such vaccines were registered anywhere else in the world. The head of the Ministry of Health replied that there are similar developments in China and some other countries, but there are still clinical trials.
In Russia, according to Murashko, a new vaccine"Has shown high efficacy and safety in clinical trials." All volunteers had high titers of antibodies to COVID-19, and at the same time, "none of them had serious complications of immunization," the minister said.
Putin said that his daughter tested the new vaccination on herself.After the first injection, her temperature rose to 38 degrees, the next day it was just above 37.
After the second injection, the temperature also rose a little, and then everything came to naught, he feelsyourself well and the credits are high.
Vladimir Putin, President of Russia
What vaccine should be?
Doctors and virologists note that the effectiveness of the COVID-19 vaccine is made up of two key parameters.
The first is immunogenicity, that is, the abilitythe drug to induce an immune response in the human body. In other words, the drug should trigger a reaction and force the body to produce antibodies to the coronavirus. In many respects, the success of this or that vaccine depends on this, and it is for the most rapid search for a vaccine that the Russian Ministry of Defense and various research institutes are testing several ways to trigger an immune response at once.
It is impossible to make a completely harmless drug in a few weeks.
The second parameter had questions: Yesterday, on August 10, the Association of Clinical Research Organizations suggested that the Ministry of Health of the Russian Federation postpone the registration of the vaccine, since the Gamaleya Center has not completed its trials involving “even hundreds of people,” and the drug has not yet been mass produced.
In addition, it is based on another vaccine from MERS, the trials of which are still ongoing, so "there is still no reason to conclude on its effectiveness."
Accelerated registration will no longer make Russia a leader in this race; it will only expose the final consumers of the vaccine, citizens of the Russian Federation, to unnecessary danger.
Letter to the Ministry of Health
As stated in the letter, participation in the trialsdeveloped by the National Gamaleya Center, fewer than 100 people have taken in, and during the third phase of testing, drugs are usually tested on several thousand. Thus, at the moment, nothing is known about what the quality of the drug will be: there is no data on the safety of the vaccine for the elderly, whom they want to vaccinate in the first place, and there is also no information on what the mass production of the vaccine will be, according to AOKI.
In response to the accusation, the chief freelancethe epidemiologist of the Ministry of Health of the Russian Federation Nikolai Briko told RIA Novosti that he sees no reason to "put obstacles" for the registration of the coronavirus vaccine developed at the Gamaleya Center.
Nikolai Briko said that the vaccine of the Gamaleya center “did not appear out of nowhere,” since the center has been working in this direction for over 10 years, developing vaccines against Ebola and MERS.
When creating a vaccine for COVID-19The same technology is used, based on an adenovirus, so in this case it is not subject to any revision or delay, because the technology has already been developed.
Nikolay Briko, chief freelance epidemiologist of the Ministry of Health of the Russian Federation
What are the risks associated with using the vaccine?
The coronavirus vaccine may cause side effectseffects in the first two days after its use, and they will disappear over the next three days, according to the instructions for the vaccine, published in the State Register of Medicines.
Adverse events typical for usevaccines are predominantly mild or moderate in severity, can develop in the first or second day after vaccination and are resolved within the next 3 days. More often than others, short-term general (short flu-like syndrome characterized by chills, fever, arthralgia, myalgia, asthenia, general malaise, headache) and local (pain at the injection site, hyperemia, swelling) reactions may develop.
Instruction manual
According to experts, writes L’Express.There are concerns about the speed of development of Russian vaccines - experts believe that some stages may have been skipped to speed up development. They compare the race for a vaccine to the USSR's launch of the first Sputnik in 1957.
WHO shares such concerns and sent Russiaa caveat calling for adherence to current protocols when developing a vaccine. The organization's spokesman Christian Lindmeier noted that this is necessary to make sure what the vaccine works against, who it can help, whether it has side effects and does not outweigh the positive qualities.
When will coronavirus vaccination start in Russia?
First, it is planned to vaccinate people from groupsoccupational risk of coronavirus infection - health workers and teachers. They are expected to be vaccinated from the end of August or the beginning of September. At the same time, according to Roszdravnadzor, post-registration clinical trials “on thousands of people” will continue, and the effects of vaccination will be strictly monitored.
According to official data, the drug will go into circulationfrom January 1, 2021. That is, both the elderly and the rest of the population, most likely, will begin to be vaccinated en masse as early as next year. As Putin stressed, vaccination will be exclusively voluntary.
How will the new vaccine be administered?
The Ministry of Health registered the vaccine in the form of a solution for intramuscular administration.
As stated in the instructions, the vaccine is administered indeltoid muscle (the upper third of the outer surface of the shoulder). Vaccination is carried out in two stages: the first injection and three weeks later the second (with different components). "After the administration of the vaccine, the patient must be under the supervision of health workers for 30 minutes," emphasizes the accompanying documentation for the drug.
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