Posted 1 декабря 2021,, 12:42

Published 1 декабря 2021,, 12:42

Modified 24 декабря 2022,, 22:37

Updated 24 декабря 2022,, 22:37

Question of the day: why are foreign vaccines banned in Russia and who can authorize them?

Question of the day: why are foreign vaccines banned in Russia and who can authorize them?

1 декабря 2021, 12:42
Фото: whatstrending.com
The vaccination program in Russia is going very badly. Today, slightly less than 40% of the population is vaccinated. The people do not believe in the Russian vaccine, which the authorities are already selling in 70 countries of the world. Neither persuasion nor prohibitions help.
Сюжет
Pandemic

Some of the unvaccinated want to be vaccinated with foreign vaccines. Why they are not there, Novye Izvestia figured out.

Yelena Ivanova, Natalia Seibil

Tragic mortality statistics from coronavirus

About 1,200 people die from the coronavirus every day in the country. Over 30 thousand are infected per day. But the number of vaccinated people has not yet exceeded 40% of the population. One in five says that he will not be vaccinated under any circumstances. 40% of refuseniks are afraid of the long-term consequences of vaccination, and a third are waiting and want to see how vaccination will affect the health of those already vaccinated.

In Russia, there are officially three vaccinations with varying degrees of effectiveness. In fact, Sputnik ousted all the others. According to doctors, scientists from the Gamaleya Center have created a good vaccine. They have no doubts about its effectiveness. Professor Anatoly Altstein believes:

- Our vaccine is not worse, but it is quite possible that many would want to be vaccinated with imported ones. Therefore, I think that if imported vaccines were on our market, it would increase the number of people who would take part in the vaccination. But in general, this is not a question of virology.

The people do not believe Sputnik and vote with their feet. It is not surprising when anti-axers are everywhere in Russia, from deep-seated people to the State Duma. Doctors in kovidny hospitals, wringing their hands, beg the elite opponents of vaccination to come to the red zone and see with their own eyes what the virus is doing to the unvaccinated. In response, the deputy chairman of the State Duma, United Russia Party member Pyotr Tolstoy, says in social networks that he has not gone and will not go anywhere, and will not be vaccinated for anything. Unlike Tolstoy and Shukshina, who do not need any vaccine, some of the unvaccinated could be vaccinated - but not with Sputnik. A month ago, news agencies mysteriously reported: tests are underway in Russia, and foreign drugs are about to be registered. People held their breath - is Pfizer allowed? Then everyone sighed in disappointment. It was about Chinese vaccines. Where are Pfizer and Modern?

How can a foreign vaccine be registered?

According to Russian law, a vaccine manufacturer must come to the Ministry of Health and register their drug. He must provide a complete dossier with information on the structural formula. In addition, it is necessary to disclose information about the pharmacological data of the drug, where it is produced, what are the results of preclinical and clinical trials. Larisa Popovich, Director of the Institute for Health Economics at the Higher School of Economics, says:

- In order for a drug to be registered in Russia, 61 laws, the main law on the circulation of medicines, require that clinical trials, if they are multicenter and made accordingly according to the existing standards of clinical trials, must be partially carried out in the Russian Federation. This is a requirement that is included in the legislation.

The first step is always taken by the manufacturer, experts say.

- Exclusively manufacturer! The manufacturer must declare to the Ministry of Health, - Larisa Popovich leaves no doubt.

In our country, everyone is registering drugs, and this does not cause any problems, the expert adds. No state can apply for registration of a drug because it cannot hold a patent.

So far, neither Pfizer, nor Moderna have submitted documents for vaccination preparations to the Russian Ministry of Health. But here's what is surprising: the same Pfizer is researching in Russia a drug for covid "Pakslovid". According to our sources, most likely it will be registered. Why does the manufacturer intend to sell the drug for covid, which is just passing the stage of clinical trials, in Russia, and the authorities want it, but the drug for vaccinations, which the concern has been selling in billions of doses for a whole year all over the world, and which has shown itself to be one of the most reliable , so you definitely don’t have to worry about him, he didn’t come under the scope of the Ministry of Health?

Politics is to blame

The political version, why Pfizer and Moderna did not even submit documents to the Ministry of Health, is that whatever they write in their beautiful presentations, whatever numbers they give, what successes they talk about, they will not receive permission for use in Russia until until Sputnik receives a mirror permit, at least in the EU.

"I think this is a political, commercial, not scientific question. We have our own vaccine, it is no worse. Perhaps that is why they limit the possibility of using imported drugs. Perhaps because they limit the use of our vaccines in Europe and America. They are trying to ensure that there is equality in this matter", - suggests Anatoly Altstein.

Sputnik may be a thousand times an excellent drug, but it is hard to deny that its entry into the international market was, to put it mildly, not the most successful one. Despite the publication of the results in The Lancet, the authorities' clumsy actions have greatly shaken the world's faith in the Russian vaccine. Larisa Popovich's words sound like a sentence:

- This is the result of a failed information policy at the beginning of the pandemic, the lack of an adequate response to fake stuffing, to the infodemia that existed from the very beginning, and a lack of understanding of how information about our vaccines should be presented. Nobody refuted the reasoning that it was impossible to make a normal vaccine in three months, without realizing that behind the same "Sputnik" there are twenty years of testing vector vaccines.

It remains a big mystery why, instead of first large-scale vaccination of its own population, Russia immediately rushed to sell "Sputnik" abroad. And those everywhere have their own rules. In bureaucratic Europe, it is difficult to obtain a permit for the use of medicines without following all procedures. When the certification process is also accompanied by marketing "Kremlin-style", with the denigration of competitors through bloggers and other arsenal of information wars from the times of Crimea and Donbass, it is not surprising that European medical officials look at the submitted documents with particular bias.

Yes, and there were mistakes with the filing. Usually, manufacturers hire special law firms that know exactly what documents and in what form need to be submitted to the EMA. As they wrote in the press, the Gamaleya Center decided to prepare the documents themselves, without the involvement of European lawyers. The desire to save money or natural suspicion played a cruel joke with scientists. The missing papers have not been collected so far. Officials of the European agency had to come to production to see with their own eyes how the safety measures and the technological process were being followed. At first, the visit was planned for the past summer, then it was postponed to autumn. Now there is information that the inspectors will arrive in December. Maybe they will come, but maybe not. In any case, there is no need to wait for permission for Sputnik until next spring.

Doctor of Medical Sciences Ayrat Farrakhov is not only a doctor, but also a statesman. The former Minister of Health of Tatarstan, the former Deputy Minister of Health of Russia, the deputy of the State Duma advocates the recognition of all vaccines by all countries, regardless of where they were produced.

- The fact that Pfizer is not recognized in Russia, I think, is an element of pressure to recognize the Russian vaccine. We are at least talking about this. This has led to the fact that in 70 countries our vaccine is used today, and it is quite effective. We must not speak, we must move in this direction. Non-recognition of our vaccine is an element of pressure on the Russian Federation, on our scientists, on our scientific achievements.

This means that the manufacturers of Pfizer and Moderna do not have to worry until that time and do not submit applications to the Ministry of Health. In addition, there is a danger that the Russian authorities will want to show the Americans the sky in diamonds and drag out the certification process. No one, even the most successful billion-dollar concern, needs such advertising. Money loves silence. Money made for health love her doubly. The success of any drug is built on trust, and no company wants to take risks. The Russian market is one of the largest in Europe, but it is not the only one. Billions of doses have been sold around the world, more than half of the world's population is not vaccinated. Why take risks with one offended state?

- Producers are really not interested in this market. They have where to sell the vaccine and incur additional costs due to the peculiarities of registration in Russia, why? And so there are colossal pieces that can be captured without letting the Russian vaccine go there. It is clear that there is politics, economics, and competition here. This is a normal fight for markets. Companies are using this situation to the fullest, - explains Larisa Popovich.

Compulsory licensing of foreign vaccines

If the mountain does not go to Magomed, then Magomed goes to the mountain, says the old Eastern wisdom. Western manufacturers are in no hurry to register their drugs for vaccination, vaccination with their own drug has stalled and has not crossed the mark of 50% of the population for several months. There is a part of the population that is ready to be vaccinated, but with foreign vaccines. What can the state do in this situation?

It turns out that any state can conduct compulsory licensing. This rule exists within the framework of the World Trade Organization. If there is a threat to national health, and some patent holder refuses to register a drug, the state pays some compensation, and the patent holder is obliged to transfer the technology for production in another territory. Larisa Popovich explains that such precedents have already happened:

“It was when a cure for HIV was required in Africa, it was not given to Western companies, and patents were forcibly obtained from them. This is often done by Indian manufacturers in India for drugs that Western companies do not want to give away.

There are drugs, for example, for the treatment of multiple sclerosis or oncology, which manufacturers do not register in Russia, because it is not commercially beneficial for them. Then, according to the indications of vital necessity, these drugs are imported for the treatment of specific patients. However, such purchases are legal for a small number of patients. The vaccine is a mass product, therefore registration in Russia requires clinical trials in Russians.

Obviously, there will never be compulsory certification in our country. For the Russian authorities, this has its own logic. First, we have our own vaccine, which is no worse than the Western ones. Secondly, even if someone wants to carry out compulsory licensing, the results will have to wait for years. This process is slow. Thirdly, for once a product appeared in the country that does not smell like oil or gas. If you enter the market right with it, it can be the first step away from the wells, forward to the technologies of the future.

All vaccines are for all Russians!

The Russian Constitution states that the state is obliged to take care of the health of citizens. From this perspective, the Russian authorities should make every effort to encourage the population to vaccinate. And if there are people who are ready to be vaccinated only by Pfizer or Modern, the state should make every effort and give them what they want.

There is only one way left - to negotiate.

- Chinese, Russian, American, European - we must do this. Later, the society should assess this. In a pandemic, it is wrong, when in the current situation, we, without asking any questions, do not recognize vaccines. Therefore, the UN, world leaders must do everything to implement the recognition of vaccines. Russia has openly stated this everywhere, - says Ayrat Farrakhov.

But even in one separate party, which is represented by Deputy Farrakhov, there is no common understanding of what to do in this situation. Some, like Ayrat Farrakhov, are in favor of vaccine parity. Others, like Tolstoy, carry the banner of anti-Axis high and expect "delayed results." And no one listens to doctors who wonder what "delayed results" vaccine opponents mean. With 7 billion doses of vaccines used in the world, what more proof of the usefulness and safety of vaccines is still needed?

In the meantime, the social scissors between rich and poor are diverging more and more. The richer citizens realized that they had to wait a long time for Pfizer in Russia. Therefore, vaccine tourism flourished. Montenegro, Romania, Serbia, Greece, Moldova - everywhere you can get yourself with RNA vaccines, if you had money. The rest of the Russians are asked not to worry. They don't even bother. 60% are not vaccinated and live their own lives, adding to the tragic statistics of deaths from the coronavirus and its consequences.

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