‘The Sputnik creators were framed and snatched the deserved recognition’

“They simply don’t have some elements to obtain authorisation”

The key Russian vaccine Sputnik V hasn’t yet received the permission of the European Medicines Agency to be used in the European Union. What do you think impedes the process of recognition?

I am convinced that everything is in the hands of the Sputnik’s creators. If they work with regulatory agencies in Europe correctly, provide the information they are requested, there won’t be any problem. At the moment, they simply don’t have some elements to obtain authorisation.

What data can be missing?

The medication authorisation system, particularly when it comes to vaccines, is a very complicated case. This system has been created for decades. It is important to correctly plan clinical trials, know how to organise them, how to monitor, how to set up production, what control to implement, what forms need to be filled in for the regulatory agency.

Some special firms, contract-based clinical organisations that do trials. Even a small company that has been making vaccines for years anyway uses services of such consultancies that are well-versed in this. People who have worked in the FDA, European Medicines Agency and know inner workings very well work there. Such firms usually help vaccine manufacturers to make a dossier, which consists of volumes of documentation. And if something is missing, the regulators — FDA, European Medicines Agency — don’t have the right to issue a licence by law.

It can be detailed information about the production, its stability. Or clinical trials were done with violations: in the case of Sputnik, this is certainly a case in point. It had been authorised before its efficacy trials began, while the trials themselves weren’t done in a way they are carried out around the world. And now it is hard to get accurate data with hindsight.

This is the problem: European medical regulators demand them, while there is nothing to offer. It seems to me that the delay in obtaining the permit is a hundred per cent the fault of the creators of the vaccine, and it isn’t the result of bureaucrats or politicians’ intrigues who want to stop, who impede it. It is rubbish! When vaccine creators start to say such things instead of providing documentation, this doesn’t create the right setting for dialogue. They came for a permit but try to push their rights. Though they should simply provide what they are asked for.

It seems to me that the delay in obtaining the permit is a hundred per cent the fault of the creators of the vaccine, and it isn’t the result of bureaucrats or politicians’ intrigues who want to stop, who impede it

“Moreover, the vaccine turned out to be quite good”

Perhaps, this is one of the factors of the failed vaccination campaign in Russia.

Yes, this is the reason. People think there is a double game. They see that the vaccine started to be pushed on all the channels, they started to say they are the first before reliable safety and efficacy evidence was obtained. Because it started to be used before clinical trials kicked off. This immediately had an impression that somebody was in a hurry and cut corners.

Secondly, this spoiled the clinical trials. If everybody can go and receive a vaccine, how to meet the condition so that people in the placebo group remain unvaccinated? The authenticity of results of clinical trials was questioned. Therefore the trials had to stop before they ended: it turned out this data didn’t work.

Of course, people understand they are touted something. And this obviously smells of political propaganda. Even the name Sputnik immediately demonstrates it. The satellite itself was a political project in 1957, the Sputnik V is now: it was necessary to tick the box of Russia, that it is the first. So was it, we were the first to make the vaccine.

Moreover, the vaccine turned out to be quite good. Perhaps, the Sputnik V isn’t worse than the AstraZeneca or J&J vaccines. It uses the same technology and somehow turned out to be even better. But the creators of the Sputnik were framed and divested of the deserved recognition. If they worked calmly and did everything correctly, everybody would applaud and say: “Bravo! Well done! You worked great.” While here everything was turned into a political issue. And people see it. Therefore the public doesn’t trust this vaccine. In the end, they make a queue for the CoviVac.

Perhaps, the Sputnik V isn’t worse than the AstraZeneca or J&J vaccines. It uses the same technology and somehow turned out to be even better. But the creators of the Sputnik were framed and divested of the deserved recognition

“The production is not big enough to pump the whole country with the CoviVac”

Yes, but the regions have not lately had the CoviVac at all...

It is necessary to understand that the production of the CoviVac is quite a tricky issue. It is necessary to breed this dangerous virus in huge bioreactors containing 2 tonnes of very infectious liquid. It is a very dangerous issue. Everything must be done very carefully, complying with technologies and requirements. The Chumakov Centre has this experience. It has experimental production that has already been used to make other vaccines. But their production is not big enough to pump the whole country with the CoviVac.

Now they are creating additional production capacities: they need to be equipped, arranged, tested. In normal conditions, this takes years. As I understand, the Chumakov Centre doesn’t yet have capacities. And the results of the CoviVac’s trials that have been published aren’t enough.

People tend to believe the CoviVac because the institute has a good reputation: the centre has been creating and making vaccines for nearly 70 years, it is worldwide known. Its products are exported around the globe. The Gamaleya Institute doesn’t have such a reputation at the moment because it is a research institute, it did not develop any vaccine earlier.

Some experts say that the CoviVac might be not a good vaccine, especially regarding new variants. Do you agree with this opinion?

I don’t know, I don’t have such data. Theoretically, the CoviVac can be a good vaccine. But as people say, the devil is in the detail. The idea of the vaccine isn’t bad and time-tested: take a virus, inactivate and use it. This will immediately create immunity against all proteins, not only one spike. Potentially and theoretically, it has a wider range of immune response.

Practically, much turns on how the virus is inactivated: there is a very fine line here. It can be inactivated in a way that everything is killed. Or the other way round, if it isn’t killed sufficiently, it must be much worse because in this case the vaccine will infect people. It is a tricky process. Virus inactivation is an old tested technology that can undoubtedly help to fight the pandemic. But it isn’t as simple process as it might seem for a layman.

This is why nobody in Europe and America created a coronavirus vaccine of this kind because the future lies with more modern approaches based on the latest biotechnological accomplishments. The adenovirus vaccine isn’t bad, but is already obsolete, it isn’t as flexible and universal technology as mRNA vaccines.

The production of the CoviVac is quite a tricky issue. It is necessary to breed this dangerous virus in huge bioreactors containing 2 tonnes of very infectious liquid. It is a very dangerous issue. Everything must be done very carefully, complying with technologies and requirements. The Chumakov Centre has this experience

What do you think of the nasal vaccination that the creators of the same Sputnik presented?

In theory, it is a very good idea, and many are working in this direction. Such intranasal immunisation is expected to created immunity of the lining, local immunity. In other words, antibodies will circulate not only in the blood, but immunity will also be created on the lining, that’s to say, in the place the virus gets first. And it is good. Yet, there can be a big difference between what you expect and what you get in the end.

The nose is too close to the brain. What if the virus can get into it through olfactory nerves? Here there are a lot of questions related to safety. Everything needs to be done carefully: this cannot be done thoughtlessly, everything needs to be checked carefully, on animals first, then gradually on people.

“All sensations should be evaluated without panic”

Aren’t you scared of the news about constantly appearing new mutations of coronavirus, particularly A.30? The first five cases of the new coronavirus variant AY.4.2 were recently registered in Russia, two of them are in Tatarstan...

As for the A.30, it is rather a horror story they try to offer us: allegedly, the new mutation passes antibodies by. Not exactly. I read this article: the authors sell their data at a higher price that it really costs. The difference isn’t significant there. We already knew that some variants need more antibodies to be killed. Okay, more antibodies are needed, what’s next? This doesn’t mean that they stopped to react to immunity at all. This is not true. The same article illustrates that people vaccinated with two different vaccines have almost no difference. Now a lot of scientists are trying to show off: “I have discovered this and that.” They yell like children in the kindergarten. So you often see a big headline, then you start to read, and it turns out to be nothing.

Can the delta be the most dangerous variant for humankind?

In fact, the new variant AY.4.2 is delta+. In other words, it is the same delta but it has another mutation. In Great Britain, this variant already accounts for about 15% of all cases, and the tendency is growing.

The AY.4.2 can likely spread much faster than the classic delta. Perhaps, it isn’t so important, but it better. It means it will be the delta+. But the measures will be the same.

For instance, South Africa had the beta variant that had reduced sensitivity to antibodies. Indeed, the AstraZeneca vaccine worked badly with it. When the Pfizer vaccine was checked, it turned out to work well. In the end, the beta simply disappeared because the delta drove it out. So all these sensations should be evaluated realistically. Perhaps, some new variants do appear. But it is yet unclear if they can turn into dominating.

Now a lot of scientists are trying to show off: “I have discovered this and that.” They yell like children in the kindergarten. So you often see a big headline, then you start to read, and it turns out to be nothing

“There is a chance that even a fully vaccinated person can fall ill”

In Russia, according to the data provided by the Ministry of Health Care, only 2% of people vaccinated against coronavirus get COVID-19. How is it in the US given the bigger share of immunisation of the population?

Vaccinated people also end up in the hospital: the vaccine isn’t a hundred per cent efficient, nobody promised that. There is a chance that even a fully vaccinated person can fall ill, especially if it is an old person with aggravating diseases. But it is absolutely clear that mostly unvaccinated people fall ill and go to hospital.

Is revaccination on in the USA? Do people want to be revaccinated six months after the full immunisation?

Those who want are vaccinated. It is available. Pfizer and Moderna vaccines were permitted for revaccination. In general it is recommended for people over 65 years. While there isn’t such a recommendation for younger ages. Though if they think they should be revaccinated, they can go and do it.

On 29 October, FDA issued an urgent permit to use a lower dose of PfizerBioNTech’s vaccine for children from 5 to 11.

Vaccination for schoolchildren will likely start in the USA. The Pfizer vaccine was recommended for children over 12 a long time ago — more than a month ago. While now the results of trials on younger children were presented. It turned out there is no reason for concern, so the vaccine was recommended for five-year-olds and above.

According to Russian Minister of Health Care Mikhail Murashko, the COVID-19 incidence among minors in Russia rose many times, half of patients have clinical symptoms. What’s it like in the USA?

The incidence among children in the USA has increased. It is unknown why at the moment. Perhaps, the variant somehow changed. Statistically, the number of children with the disease has increased notably...

Did the virus switch to a more accessible target?

If children aren’t vaccinated, while two-thirds of adults are vaccinated, of course, the virus has people to infect. If adults weren’t vaccinated, the proportions of infected adults and children would stay at the previous level. Since adults were protected unlike children, there appeared imbalance, and children started to be infected. Perhaps, the new variants besides being more contagious provide a more severe and faster course of the disease. And this wouldn’t be a surprise: if the virus knows how to bind with the organism’s cells, the disease will likely be more intense. We don’t so far know this, but it is a fact that children started to fall ill more often.

Moreover, schools opened, children stay in the classroom almost the whole day. Of course, they infect each other easily. Hopefully, this will end with the approval of the vaccine. Schools can introduce stimuli for children’s vaccination. For instance, children who have not been vaccinated against measles, whooping cough and other infectious diseases aren’t allowed to go to school anymore. Perhaps, schools can require a vaccine against COVID-19 too. I don’t know if this will be done. Of course, in any case, every state will make such a decision. The federal government has no right to this decision.

If adults weren’t vaccinated, the proportions of infected adults and children would stay at the previous level. Since adults were protected unlike children, there appeared imbalance, and children started to be infected

“I think rational and responsible people will have their children vaccinated”

Do you think Americans will have their children vaccinated? Because on the Net in Russia, the following comments are spread: “We will not let our children be given this unexamined liquid.”

There are completely frenzied anti-vaxxers in America too. Some people are under their influence, but the majority is conscious of vaccination. It seems to me that people who received a vaccine against COVID-19 don’t have paranoia about chipping. And they will likely have their children vaccinated.

Many ask me when children can be vaccinated, they are waiting for the green light. My children will certainly have their children vaccinated as soon as this is available. And their friends will be immunised too. I think rational and responsible people will have their children vaccinated. Unfortunately, there are people who have issues everywhere. And America isn’t an exception here.