The Brazilian Citizens' Health Surveillance Agency (ANVISA) said it had found a live virus in the Sputnik-V vaccine. What does it mean, and why haven't the more established Western players identified similar reasons for concern? There are other concerns as well. Both massive Western Covid-19 adenovirus vaccines cause unusual blood clots that have already been fatal. Are those who expect the same side effects from Sputnik right, and why have they never been able to find them in this case?
Sensation! The Brazilians managed to surpass both The Lancet and the entire scientific world
It all started on April 28, when the Brazilian government agency ANVISA posted on its website a decision that it would not allow the import of the Sputnik-V vaccine into the country. In support of the statement, absolutely strange things were stated. For example, that “deficiencies were identified during product development at all stages of clinical trials (phases 1, 2 and 3)”. This is a truly impressive statement: The Lancet, the most authoritative medical peer-reviewed journal in the world, took and published the results of all three phases of clinical trials without comment, and ANVISA (a much less authoritative voice in the world of medicine, really) took and found flaws in three phases at once.
For the successes of the Brazilians, one could only rejoice if they in the refusal and limited themselves to general words like "shortcomings were identified", but did not indicate them specifically. Unfortunately for ANVISA employees, they did not feel the moment and for some reason tried to point out specific problems. A literal quote from the main one makes an amazing impression:
“That the [human] cells where the adenoviruses that power the vaccine are produced allow their replication” (original: “que as células onde os adenovírus são produzidos… permitem sua replicação”).
The question arises: replication of whom? Who are these "them"? Adenovirus? As it became clear from additional statements by Brazilian officials, they meant exactly this: that adenoviruses from Sputnik can multiply.
Pulls for a sensation, and on a large scale. The fact is that vector vaccines such as "Sputnik" use non-replicating ("non-multiplying" in a vaccinated person) viruses as a "workhorse". If the viruses are "multiplying", from such a vaccination, you can get sick with adenoviral colds. Of course, dying from a cold is difficult, but there is nothing pleasant either.
Therefore, the sensational statement of the Brazilians was immediately disseminated in the Western press. Sputnik's doses contain a virus that causes the common cold and can multiply in human cells. The unintentional presence of such viruses in a vaccine can cause injury and death.”
So that's it. Death. Agree, an information bomb.
One thing remains to be clarified: how did the Brazilians manage to find replicating adenoviruses in Sputnik and how many of them are there specifically in each dose?
At this time in the real world …
Of course, the Sputnik developers also wanted to ask this question.However, in the subsequent comments of the Brazilian regulators, it suddenly became clear: they themselves did not try to find a replicating virus in any dose of Sputnik. Generally. And neither did they try, nor did they intend to. But what is there: ANVISA, in principle, does not have a laboratory where it would be possible to do something like that.
At a press conference on April 29, 2021, ANVISA representatives said they meant something completely different. In the documents describing the vaccine, there is a mention that in one dose of Sputnik, according to technical tolerances, there should not be more than a thousand adenoviruses that can multiply - out of 100 billion that are contained there. The Brazilians believed that this supposedly means the following: in each dose there are a thousand reproducing adenoviruses. It was in this way that they managed to "find" them where no one had succeeded before.
However, in order to make such an outstanding "paper" discovery, Brazilian regulators had to close their eyes to the letter they received on March 26, 2021 from the developer - SIC named after Gamaleya. Where it was directly stated: there are no adenoviruses capable of multiplying in humans in this vaccine. It is well known that the quality of all batches of Sputnik vaccine produced in Russia is controlled by this center (and not by commercial manufacturers). In other words, no one else has a more powerful opinion on the issue.
The creators of Sputnik want to sue ANVISA because of this story. They can be understood: the whole world thought that the Brazilians allegedly found a “wild” “multiplying” virus in Sputnik, but in reality none of this happened. But we have a pretty good idea of how justice works in Latin America, so we would not bet much on the success of the Russian side in court.
What was it?
Let's try to add two and two. It is known that Brazil has lost 400 thousand people from the coronavirus, almost as many as Russia. However, the Pfizer vaccine was not enough for her, so at first the local Ministry of Health wanted to inject everyone with the drug from AstraZeneca. When it became clear that it was not enough, the Ministry of Health urgently approved the Chinese CoronaVac. These, frankly, are not the best vaccines: the Chinese have an efficiency of 50-62% (depending on the time gap between injections), and the British AstraZeneca has 76% (if we take only cases when there are symptoms).
Against this background, Sputnik looks like a good alternative. Its effectiveness is estimated at 91.6% (if we count the protection from 21 days after the first injection) to 97.6% (if from the 35th day, however, NS already wrote that the second figure is somewhat overestimated). The difference is obvious, and it is important: the higher the efficiency, the lower the likelihood that the vaccinated person will catch the mild form of Covid-19 and begin to spread the coronavirus further, infecting other members of society with it.
Why did the Brazilian regulators close their eyes to the letter from the developers of the Russian vaccine and instead began looking for artificial reasons to reject it, although no one (including ANVISA) was ever able to find a multiplying adenovirus in Sputnik doses?
The answer to this question is extremely simple. Let's flip through the U.S. Department of Health's 2020 report. On page 48, we find an amazing subsection: "Confronting Pernicious Influences in the Americas." Quoting from it:
“The [Ministry of Health]’s Office of Foreign Affairs has used diplomatic relations with the Americas to stop the efforts of countries such as Cuba, Venezuela and Russia. Examples include the use of the Office's Health Attaché department to persuade Brazil to reject the Russian coronavirus vaccine.”
And don't think that only the Ministry of Health is working on this. We can say with a high degree of certainty that the State Department and a number of other American government agencies are working in the same direction.
The 2021 report has yet to be published. But we can be sure: in the new year, the American Ministry of Health is not sleeping, but is working intensively. And he is completely indifferent to how many Brazilians die: the main thing is that they reject the "Russian vaccine".After all, it is a "harmful influence", you understand.
The states have nothing to blame. This is their normal foreign policy: it has always been and always will be. It is pointless and even immoral to criticize a lion for sometimes eating other animals. This is his function: in this way he keeps the weaker in shape. It makes no sense to criticize the United States for efforts to slow down vaccinations in some third world country. After all, is it the Americans who need it more than anyone to get Brazil to defeat the epidemic faster? No, the Brazilians need it. And if they really wanted it, Washington would hardly have stopped them with one "persuasion."
Brazilian regulators also have nothing to blame. In Latin American countries, it is often difficult to make important decisions if Washington does not want them to be made. And with those who persist too much, there may be, let's say, incidents.
Well, then. Let's take a closer look at the personality of the head of ANVISA, António Barr Torres (for some reason they write him as Torres, apparently due to the low prevalence of Portuguese in Russia). How did this learned man come to his post? How did you stand out in the field of medical regulation before? The biography of this man is unusual and extremely instructive. To begin with, he never worked for regulatory agencies, since he spent his entire life (albeit on a medical and administrative line) in the Brazilian navy, where he rose to the rank of Rear Admiral.
How did the admiral become the head of ANVISA, the country's most important medical agency? Everything is simple: he was a friend of Brazilian President Bolsonaro, a wonderful man nicknamed "Captain Chainsaw". As it is easy to guess by his nickname, Bolsonaro is also a former military man. In addition, he is a supporter of the military dictatorship that ruled in Brazil in 1964-1985. His claims are widely known that the regime's torture was a legitimate measure ("I support torture, and you know that"), that the military dictatorship's mistake was that it tortured but did not kill. And we will not even list a lot of the like.
We are not interested in these cute pranks of his, but in how the president and the civil servants appointed by him showed themselves earlier in the sense of admitting other vaccines to the Brazilian market. And their achievements are really non-trivial. In particular, Captain Chainsaw constantly argued that the coronavirus is not scary, this is another flu. Even after having had it, Balsonaru noted that neither he nor his family would be vaccinated. António Barra Torres was not inferior to his friend the president in unusual steps during the pandemic. A couple of weeks after fasting, he abruptly stopped trials of the Chinese vaccine CoronaVac in the country, which slowed down the start of its use.
When Torrish did so, the Brazilian press writes, “it challenged the independence of ANVISA, to the point where members of the Federal Supreme Court, Congress and the Federal Court of Audit suspect that the Rear Admiral has put the political game ahead of the interests of millions of Brazilians who are waiting for funds. against disease ". As we can see, there is nothing new in Torrish's position on the Russian vaccine: he demonstrated the same in the past, albeit not so vigorously, with regard to the Chinese vaccine.
You can understand his position: since the time when the United States supported the Brazilian military dictatorship, the Brazilian military, including the former ones, have a good attitude towards everything that comes from Washington and bad attitude towards everything that comes from its opponents. In addition, China and Russia have traditionally supported left-wing parties in Latin America, and the Brazilian military has always fought (and still fights) the Brazilian left. Naturally, anything that comes from the friends of your enemies will cause suspicion.
At first glance, the story of how a supporter of torture and massacre bets on the admiral's vaccine control agency, and he claims something incompatible with reality, it may seem funny. In fact, there is nothing funny here.The really funny thing is that the position of the department, which could not even correctly read the Russian documentation, caused a huge flurry of publications in the Western and even Russian media. Dozens of publications comment on the words of the admiral and his subordinates, although they are not based on anything at all. Despite the fact that in the documentation, contrary to ANVISA, nowhere is it stated that at least one replicating virus was found in at least one sample of the Russian vaccine, and the vaccine developer directly and unequivocally denies this, which the same ANVISA knew back in March.
In search of a replicating adenovirus that does not exist in Sputnik, some publications even interviewed major scientists, such as Konstantin Severinov, about how adenovirus could get into a domestic vaccine. And he immediately offered a number of options. What could be more absurd than a search for an explanation for a phenomenon, the very existence of which no one has ever registered?
So, we have established that Sputnik's main problem in Brazil is that it is Russian, and the sovereignty of Latin American countries (as well as the intellectual independence of their authorities) should not be overestimated. But does this vaccine have some other, non-ethnic flaws?
Adenovirus vaccines and blood clots: why are they only combined by Western manufacturers so far?
Back in the first half of April, EU medical authorities determined that the two-dose adenovirus vaccine AstraZeneca had a rare but unpleasant side effect. Namely: among the 25 million injected by her at that time, there were 86 cases of atypical thrombosis, 18 of their victims died. Most of the deceased were women under the age of 60.
We emphasize right away: this is less than one death per million vaccinated, and if they were not vaccinated, sooner or later about ten thousand people per million would die from the coronavirus. Although AstraZeneca does not protect against the disease in about a third of cases, it still weakens it to the point that a person will not get severe Covid-19 and die. That is, if you live in a place like Brazil, it is better to get vaccinated with AstraZeneca than to wait: all the more specifically in Brazil you can not wait. Finally, if you do not live in Brazil, in case of thrombosis after the injection of AstraZeneca, now that this side effect is known, you will be provided with medication.
But even this rare side effect was surprisingly interesting. The fact is that with ordinary thrombosis, the number of platelets in the blood increases - and it is they that cause the formation of a thrombus. It blocks blood flow, which increases the risk of heart attack and stroke.
But with thrombosis from AstraZeneca, the picture is the opposite: thrombi are formed with a reduced concentration of platelets in the blood. This rare phenomenon was previously observed in only one case: after taking a drug called heparin. The mechanism of "heparin" thrombosis is frankly unclear to science, and this condition occurs extremely rarely.
More recently, a more disturbing thing has come to light: Johnson & Johnson's adenovirus vaccine also causes strange blood clots. At first, the probability was estimated as very low: one case of thrombosis in one and a half million, several times less often than after the AstraZeneca vaccine. As information accumulated, it turned out that there is one case in about half a million injected. Given that AstraZeneca requires two shots and Johnson & Johnson requires one, the risk of thrombosis is approximately the same for both Western adenovirus vaccines.
It goes without saying that this is somehow related to the adenoviral nature of both drugs. If so, Sputnik should have similar cases. But is there?
Unfortunately, in Russia this issue is dealt with by the Ministry of Health, which communicates pathologically poorly with the press. For example, Naked Science has been waiting for an answer from him on one of the questions since August 2020 - and, we suppose, will never wait. In addition, the department is known for supporting attempts to underestimate the number of victims of the coronavirus epidemic in Russia, which excludes it as an effective source of information on blood clots.
However, fortunately, Sputnik is exported to countries with a normal Ministry of Health, for example, to Argentina. The local Ministry of Health carefully collects all data on the effects of all vaccines used in the country. The main one is "Sputnik", and no unusual thrombosis (and fatal thrombosis) has yet been noted there.
The scientific world cannot yet answer the question of why Western adenovirus vaccines have heparin-type thrombosis, while the Russian does not. The problem arose too suddenly, and in the West it will hardly ever be seriously investigated at all: from a PR point of view, any comparison of Western adenovirus vaccines and Sputnik is unprofitable, since it will be favorable for the latter. And the American Ministry of Health has already substantively explained that it has a "detrimental effect."
But some theoretical considerations can be expressed. It is extremely doubtful that the cause of blood clots after AstraZeneca and Johnson & Johnson was precisely the adenovirus that is part of them. After all, adenovirus infects at least tens (rather hundreds) of millions of people every year. If he could cause atypical thrombosis, they would have long been typical, simply because of the high frequency of such phenomena.
It is more likely that the matter is in some substances that come along with adenovirus vaccines from Western manufacturers. Substances with an effect similar to heparin. Judging by the absence of such cases after the injection by "Sputnik", it does not contain such substances. A natural question arises: why? Aren't all adenovirus vaccines produced the same way?
Oddly enough, no. Even the environments differ - human cells, in whose cultures their adenoviruses are grown. AstraZeneca uses its own version of HEK 293, the creators of Sputnik use their own, and Johnson & Johnson uses a fundamentally different nutrient medium, PERC6® TetR.
The first environment is noticeably older and more worked out, all of its pitfalls were revealed in operation. However, it is unlikely that this is only a matter of nutrient media: they are quite close for AstraZeneca and Sputnik. However, the differences in the specific composition of the vaccines do not end there. And not all of them are really well understood today. In such conditions, one must be guided by empirical data: and according to them, neither in Hungary, nor in Argentina, nor in other countries, strange thrombosis from the Russian vaccine has not been recorded.
Let's summarize. Brazil found something in Sputnik that is not there - and this is a big problem. But not for the Russian vaccine, but for those Brazilian citizens who will die, because the queue for vaccination will never reach one of them. It is also a problem for the media, which are forced to seriously deal with the admiral's claims as if there were at least some facts behind them - although there are no facts. However, this episode is a good indication of the main problem of vaccination in Brazil and the world as a whole. It is not enough to have a good vaccine - you also need people who read well enough and a lot to be willing to use it.
But there is good news as well. Due to some still unclear factors, the most massive of Russian vaccines is unlikely to lead to the formation of life-threatening blood clots. But will it help if outright nonsense like the potential danger of "Sputnik" due to no one and never detected replicating virus will be broadcast by the media, even when it was sucked out of the finger by a department led by an ignorant Brazilian admiral?