Tuesday, August 11, 2020. Vladimir Putin announced that Russia had just registered the vaccine against covid-19. It was the first vaccine registered against the new coronavirus in the world. The Russian President even added that one of his daughters had been vaccinated with a dose of the vaccine, revealing, despite the slight fever, that he was feeling well. The speed with which the drug appeared and its virtues were received with suspicion by the international scientific community, but the wind seems to be changing.
Thursday, March 4, 2021. After Hungary, Montenegro and Serbia have already started vaccinating populations with Sputnik V (which does not mean that it is exclusive), Europe is opening the door to that vaccine. This morning another encouraging sign came to the sides of the Kremlin: the European Medicines Agency (EMA) has announced that it is analyzing Sputnik V.
The agency “will assess Sputnik V’s compliance with the EU’s usual requirements in terms of effectiveness, safety and quality”, it explained in a statement, noting that it cannot predict deadlines for decisions and that an opinion on a possible marketing request “should take less time than usual “due to the work done during this continuous review. This so-called “continuous review” is a regulatory instrument that the EMA uses to speed up the evaluation of a promising drug during a public health emergency, since, by reviewing the data in real time, as they become available, more can arrive early to a final opinion on the marketing authorization, when it is received.
The Sputnik V vaccine was 91.6% effective against symptomatic forms of the disease, according to results published in early February in the medical journal “The Lancet” and validated by independent experts. “The development of Sputnik V has been criticized for its precipitation, for skipping stages and for the lack of transparency, but the results are clear and the scientific principle of this vaccination is demonstrated”, then estimated two British experts, Ian Jones and Polly Roy, in a comment attached to the study. This “means that an extra vaccine can be added to the fight against covid-19”, insisted the two researchers, who did not participate in the study.
Vaccine has the same technique as AstraZeneca
How can we define it? Sputnik V is a viral vector vaccine, that is, it uses other viruses that are rendered harmless to the human organism and adapted to fight covid-19. It is the same technique used by the AstraZeneca vaccine (Oxford), which is 60% effective, according to the EMA. While the AstraZeneca vaccine is based on a single chimpanzee adenovirus, Sputnik V uses two different human adenoviruses for each of the injections.
By Express, virologist Paulo Paixão explained why some reticence at the beginning of the process: “The Russian vaccine was presented very early: a political maneuver at a time when the results of phase 2 of the clinical trials had not yet been published. This undermines the credibility of a vaccine ”. The Minister of Health, Marta Temido, preferred caution in August: “It is very important to speed up the investigation process in relation to the discovery of an effective vaccine, but in this process, we cannot sacrifice either safety or therapeutic efficacy”. Feared then said, about Sputnik V, that there was information that phase 3, of testing in the community, “will eventually not have been fully accomplished”.
Paulo Paixão, heard in early February, admitted to being “pleasantly surprised” by the solution found by Moscow. And he continued: “This last trial was well done, with these data we can see that the vaccine works, there are no problems at all”. Virologist Pedro Simas, heard for the same article, followed the same path as the previous contribution: “The Russians did not follow the correct scientific procedures in clinical trials, but the scientific basis of the project was never criticized, not least because it had already proved its efficacy with the Ebola vaccine. The tests have now been completed, so there is no reason not to use it. ”
And he added: “Science is universal. Europe must open the door to Russia’s vaccine, of course it does: evaluate it, authorize it, and then buy it, in the same way that the Chinese vaccine should be used if it complies with all clinical trials [ainda em andamento] and it’s approved ”, he says. According to Simes, Portugal should be at the forefront of this process: “The law says that any country is sovereign to make its decisions, so it is possible to unilaterally approve the Russian vaccine. But I don’t recommend it. We are in the European space, so we must use these mechanisms. ”
Vaccine is already registered in 25 countries
The good indicators have led to a strong demand for this vaccine by several countries in the world. According to the official website of the vaccine, which belongs to the Russian Direct Investment Fund (RDIF, the sovereign wealth fund of the Russian Federation), Montenegro and the archipelago of Saint Vincent and the Grenadines were the last to register Sputnik V. This list is made up of 24 other countries: Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, Emirates United Arabs, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Bosnia and Herzegovina, Lebanon, Myanmar, Pakistan, Mongolia and Bahrain.
In early February, the Kremlin realized that it wanted to increase the production of its vaccine abroad. “In the near future, we want to start production in foreign countries to respond to the growing demand in more and more countries,” said then Dmitri Peskov, the spokesman for the Russian Executive, at the regular press conference.
THE Expresso had already written that Russia has limited capacity to produce its vaccine and that is why RDIF, the state fund that controls distribution, has sought to close deals with countries where the pharmaceutical industry is more developed, including in those deals clauses that allow Russia to receive millions of doses of its own vaccine and thus protect its population . In addition to Russia, there are four countries that produce Sputnik V: Kazakhstan, India, South Korea and Brazil.
In mid-February, the state fund told the Financial Times that it had signed production contracts with 15 companies in ten countries, which would translate into 1.4 billion doses, that is, enough to vaccinate 700 million people. Plus: some of these countries – like China, India or South Korea – will produce Sputnik V to export it to other locations, while others – like Brazil and Serbia – will only have to worry about their own intern market.
Another scenario that can be seen, due to the delay in receiving vaccines in the European Union (EU), which negotiated and ordered vaccines as a bloc, is that some Member States anticipate and solve their problem with peripheral solutions, even if they are drugs to be approved by the EMA, how did Hungary, the only EU nation in this register.
The Czech case and three more EU candidates
This eventuality was also observed in the statements by the President of the Czech Republic on 28 February, here cited by Al Jazeera, at a time when the country had the highest infection rate in the world. The new variants of the virus have punished that country in recent weeks, so Milos Zeman said the following on a television channel: “After consulting the Prime Minister, I sent a letter to Vladimir Putin, asking him for a supply of the Sputnik vaccine. Information from the Russian embassy suggests that vaccines may arrive in the next few days, ”he then admitted. Zeman did not stop there and also opened the door to the Sinopharm vaccine, produced by China, which was also not approved by the EMA.
Czech Prime Minister Andrej Babis reinforced the President’s words: “We cannot wait for the European Medicines Agency when Russia has not applied [para a aprovação]”, said. The prime minister also said that the approval of the cabinet equivalent to Infarmed will be sufficient for the process to proceed. President and Head of Government have already received the vaccine from Pfizer / BioNTech.
In addition to the Czech Republic, Slovakia, Croatia and Austria have also shown interest in Sputnik V, which could trigger a clash between eastern and western blocs. Slovakia has already acquired some doses of the vaccine and he is already managing them, after an operation secretly orchestrated by Igor Matovic, the prime minister of that country. Rather, this intention has generated discomfort in the right-wing coalition that governs Slovakia, leading to a veto, something that was overcome a few days ago.
A sign that this issue has crossed the borders of the health crisis was the intervention of Ursula von der Leyen, the President of the European Commission, in mid-February, who questioned the Russian Government for offering to sell millions of doses of its vaccine to other countries at a time when they were delaying the vaccination of their own people. “It is a question that we should see answered,” said von der Leyen, here cited by the “Politico”, adding that Russia would have to allow inspections of its factories and send all data for analysis as part of the regulatory approval process.
“After approval by the EMA, we will be able to supply vaccines to 50 million Europeans”
Russian authorities assured Thursday that they could supply vaccines against covid-19 to 50 million Europeans starting in June, after the European Medicines Agency announced the start of the analysis of the Russian vaccine Sputnik V.
“After approval by the EMA, we will be able to supply vaccines to 50 million Europeans starting in June 2021,” said the president of the Russian sovereign wealth fund, Kirill Dmitriev, who contributed to the development of this vaccine. “Sputnik V can make an important contribution to saving millions of lives in Europe,” he added.
“Vaccine partnerships must be disconnected from politics and cooperation with EMA is a perfect example that joining efforts is the only way to end the pandemic,” said Dmitriev, stressing that the drug has already been approved by about 40 countries around the world.
So far, EMA has given the green light to three vaccines for covid-19: that of Pfizer / BioNTech (also known as Comirnaty), on December 21, 2020, that of Moderna, on January 6, and of AstraZeneca, on January 29, and is expected to make a decision next week on the Johnson & Johnson vaccine, produced by the pharmaceutical company Janssen