the first test of a Russian vaccine against the coronavirus began today, the national research centre of epidemiology and Microbiology named Gamalei. Started with the troops of volunteers who, according to the chief virologist of the armed forces Sergey Borisevich, gave their consent for participation in clinical trials. The Ministry of health was allowed to conduct a clinical vaccine research COVID-19, despite the fact, many virologists consider them to be too hasty.
Recall that the industrial production of vaccines at the Institute Gamalei Deputy Prime Minister Tatiana Golikova promised to start in September.
Scientists led by the Chairman of the Ethical Council of the Ministry of health, academician Alexander by Chuchalina to the last took a principled stance and “good” for clinical trials is not allowed. In an interview with “Nauka I zhizn” academician referred to the need for completing all the formal resolution procedures, which are possible only in the case that the members of the Commission will know: is it safe for a day or two after the introduction.
“against this backdrop, – said Chuchalin, – I regret the position of some of our scientists who make irresponsible statements about vaccines ready. Put before them the question: have you registered your vaccine? No. You went all the way approved by the legislation of the Russian Federation and the international scientific community? No! This work is not done. Thus, grossly violated one of the ethical principles of medicine – do no harm.”
I Appeal to the creators of the vaccines in the Institute. Gamalei. The scientist spoke with us on condition of anonymity.
– can you Tell us what kind of vaccine your school now for clinical trials?
a vaccine vector based on the adenovirus. For this type we have produced a vaccine against Ebola haemorrhagic fever. It was created and widely used. The work was successful, the path is displayed, so went for it. Does the vector -the carrier of the adenovirus which is another “filling” — s protein of the coronavirus. This is an antigen which when injected into the human body will produce antibodies to an infectious disease.
Where and who will be the first test?
– the Tests begin at the Institute in Sergiev Posad.
For the military?
– Yes. But be sure to emphasize that these are volunteers and that we now have to cling to every word.
What guarantees do you give to volunteer?
– explain to Him, what are the possible complications after the introduction of the new vaccine. Insure it for a certain amount, – what do you think, what does this mean? Plus pay money for the trial itself.
Can call the amount Strahovand and reward.
– This is a commercial secret.
– As tested on monkeys-the rhesus monkey? As far as I know, they were delivered to the school on April 22. How many people are involved in the experiment?
– Usually 50-60 people. Get a dose, then, according to the research plan, it would be watched usually, this happens within a few months. Some may have in the early days, depending on their health, for a few days to be hospitalized.
– What result will allow us to move to the next phase of testing in a larger group of volunteers?
– Proof of vaccine safety for human health, that God forbid not to hurt him, and of course – efficiency. And what is efficiency? Is the development of his body has antibodies to the coronavirus.
When can these results be obtained?
– the autumn will end the first phase of clinical trials and will begin the transition to the second.
As you can see, there are significant differences between what scientists say and what say the members of the government. Is Tatyana Golikova, who promised by the fall of industrial production of the vaccine from Institute Gamalei, not aware of real time?
I had to explain to a third, independent specialist, expert in public health, immunology, candidate of medical Sciences Nikolay Kryuchkov.
– In this case, it is not clear how the vaccine Institute Gamalei safe, – says Nikolay Kryuchkov. – Any immunobiological drug requires a mandatory preclinical studies (cultures and animals of different species) and clinical studies in humans.
it is Clear that now in view of the emergency, a number of procedures have been accelerated. The volume of preclinical and clinical studies has been reduced.
How?
In the United States, for example, reduced pre-clinical studies of the new RNA vaccines up to 1.5 -2 months. This type was never used for immunization of the population, however, scientists go at it in connection with the coronavirus.
Now it is obvious that people will hold only the first and second phase clinical trials and then immediately goes to industrial production. On the third phase to complete the registration says today no one although it is in principle wrong. In order to produce truly safe vaccines, it is necessary to know the average and long-term criteria of security, that is, to track its action in six months to two years after the introduction.
Now the world has developed more than 100 products candidates. Among them, 7 types of vaccines, among them such that are already on the market, such as, for example, RNA, DNA vaccine and hell��novorussia vaccines, which in the market.
the Leader in terms while China, which promises to complete the study vaccine by the end of December this year or by early spring of 2021. The United States intends to create a vaccine for longer – the early results promise there only in the summer-autumn of next year. Why? Because attach importance to security and don’t want to risk it. Accordingly, Europe is somewhere in between.
What do we have in Russia? If the vaccine we have will be in September, as they say in official statements, it will be a world record.
– What are the risks?
– is Not in vain in the creation of vaccines there are certain terms that have to withstand. Need to make sure that the drug that will be administered to millions, appears to be not very harmful, in a portable, high immunogenic.
the Institute Gamalei take a live, weakened adenovirus and put it “stuffing” – fragments of the genetic code of the SARS-COV-2, the result is something like a Trojan horse. They have the experience with adenoviruses (but, alas, no vaccine for civilian purposes, not present, report it, we have not seen). That is the question and is likely to be very much.
it is Theoretically possible to accelerate a clinical trial?
– it is Clear that there is now a fast-track system approved. But, first, we can greatly speed up the recruitment of patients, and can reduce the time of their participation in the experiment. We can’t wave a magic wand to tell the immune system not be formed in a month and a week. We must also make sure that people are not affected after the drug administration not only after 1-2 days, but after 3-6 months.
What is the procedure for testing?
– these Are performed in several stages. After receiving permission from the Ministry of health first selects a small group, for example, of 10 people in the case, the victims were not too much. Imagine if we take at once 100 people and 50% of side effects we get from 50 patients in hospital beds.
So it happens in stages: first 10 people, then 100-200. Everyone need to observe. Now summarize: to test the vaccine needs three phase (1.5 months, 2 months and 3-4 months, respectively). It is the minimum! Fold and it turns out that the most optimistic predictions, we are completing clinical trials only to December (!) this year.
And then – data analysis – report –a very expedited procedure for the approval of the Ministry of health – industrial production. Get the vaccine sometime in March 2021.
That’s the most realistic terms instead of September.
