Sputnik V: Did Western arrogance ruin a good opportunity?
Suspicion and derision were the West's answer to Russia's announcement that it had developed the first corona vaccine. Now it's being left behind.
Berlin-The West's reaction was not exactly objective in August 2020 when Russia presented the world's first corona vaccine. Words like "vaccine muck from Moscow", "nasty vaccine propaganda", and accusations of "clumsy manipulations" of a "high-risk experiment on humans". Distrust, malice and suspicion were easier to find. One newspaper quipped that Sputnik V was effective not only against the virus, but also against "homosexuality as well as epilspsy and hives."
Now, six months later, the tide has turned. Half the world seems to be turning to Sputnik V and even Chancellor Angela Merkel spoke of "good data" - it has a reported efficacy of 91.6 per cent. Health minister Jens Spahn is already considering having the vaccine produced in Germany, possibly by IDT Biologika in Dessau. Amidst the EU's recent vaccine failure, maybe the Russian vaccine would be just the thing. Each dose costs about $10. By comparison, AstraZeneca's vaccine costs just under €2 per dose in the EU, while Biontech/Pfizer's costs €12. And Sputnik V has another advantage over RNA vaccines like Biontech: You don't need a monster freezer for it. Sputnik V can be stored in a refrigerator at 2 to 8 degrees.
But Europe is apparently too late to the party. Other countries in the world are already in line. On Twitter, for example, a Latin American wrote in response to a tweet by health politician Karl Lauterbach: "You said yesterday on 'Lanz' that Sputnik V is the 'Lada' among vaccines. I would actually call it more a 'Volkswagen' in the best sense. Easier to produce and logistically easier to trade and affordable. That's what Latin America needs, where I live myself."
Apparently, the Russian proclamation that Sputnik V is a "vaccine for the world" has come true, at least for large parts of the world. While Europe argued over the failure to order vaccines, some 20 countries by early February had already approved the Russian vaccine, including Argentina, Bolivia, Uruguay, Venezuela, Mexico, Algeria, Guinea, Iran, Hungary, Serbia, and Palestine. The other vaccines prevalent in emerging and developing countries are from AstraZeneca and China.
Researchers themselves show little prejudice
Maybe the West, in its arrogance, missed an opportunity to embrace Sputnik V and combat the pandemic more quickly and broadly. Should the EU have pre-ordered large quantities of the Russian vaccine early on – on spec, as it were, as others did? And was this prevented by the prejudices of certain circles who still believe that Russia is an underdeveloped "Upper Volta with nuclear missiles," as German Chancellor Helmut Schmidt, deep in the throes of the Cold War, once called it.
Plenty know modern Russia is different – especially in research, where close cooperation is often part of success. Asked whether there are fundamental reservations among the researchers he knows about a vaccine from Russia, Emanuel Wyler, a systems biologist from Berlin, answered quite clearly: "No. In the end, it's the same technology as that used by AstraZeneca/Oxford and Johnson & Johnson." It's a technology that's been used many times before, he said, although not yet applied in such large numbers as it is now.
Sputnik V is a vector vaccine that relies on harmless cold viruses – in this case, an adenovirus – to introduce some of the genetic information from the coronavirus into the body's cells. Antibodies and T cells are then produced to fight it. One would only have to trick the partly already existing immunity against these transport viruses because most people have already been infected with some adenovirus subtype at some point. "That's where the Oxford idea of using a chimpanzee virus had more charm at first, but two different subtypes for the first and second vaccination, as with Sputnik V, seem to possibly work better," Wyler said.
Translation: the Russians know their stuff. Just a reminder: Anatoly Smorodintsev, a Russian, produced the world's first live flu vaccine in 1936. Vaccines against Ebola and Mers have already been developed at the Gamaleya Institute in Moscow. The problem for many German scientists was not that they doubted this. But rather that concrete information for evaluating the efficacy and safety of the vaccine was available only sparsely and late. This explains the reluctance even among serious researchers.
Russia chose a course of action that seems inexplicable to many today. It announced the approval of Sputnik V in August 2020, before sufficient tests had even taken place. Basically, by then, there was only some unpublished data from Phase II trials with 76 subjects. The requisite Phase III trials with tens of thousands of test subjects were just starting. These are the only way to determine on a larger scale how well a vaccine protects and what its rarer side effects are.
The World Health Organization (WHO) warned that potential vaccines would have to go through all the testing phases before they were put on the market. But by then, President Putin had already gone public: "The Russian coronavirus vaccine is effective and builds durable immunity." One of his daughters, he said, had already been vaccinated. Likewise, the mayor of Moscow and the Russian defense minister had asked to be immunised to promote the vaccine. Mass vaccinations have already been announced for the end of the year.
Such an approach would not have been possible in Germany. For example, Biontech/Pfizer were only able to submit the official application for approval of their vaccine to the European Medicines Agency (EMA) after the results of the Phase III tests with 43,500 subjects had been published in the New England Journal of Medicine in December. And even then, a number of unanswered scientific questions about the vaccine's efficacy and safety remained. By comparison, Sputnik V would have then only become viable on 2 February 2021 when the interim results from its Phase III trial with around 22,000 subjects were published in medical journal Lancet. Only then could its developers submit an application for approval in the EU.
It must have been clear to Russia that it had no chance of early approval on the European market with its approach. But apparently that wasn't even part of the plan. Or, as one German researcher puts it, "I think that from the Russian point of view, it didn't matter what people in the West thought about their vaccine, even though there are certainly different views."
Klaus Cichutek is president of the Paul Ehrlich Institute (PEI), which oversees the scientific testing of vaccines in Germany. Cichutek complained in August that although his institute cooperates with Russian authorities, it hadn't heard anything about the complex vaccine development beforehand. Vaccine developers usually disclose early data through the media or through scientific publications, he said. "That didn't happen here."
But the Russians probably weren't interested in sharing data with the world early about a development they wanted to be a surprise. Especially since data is a rather thorny issue in the first place. Western vaccine developers are also very careful that their research data doesn't fall into the wrong hands. And in this case, Russia apparently saw a particularly pronounced competitive situation, in addition to a unique opportunity.
To understand this, you have to look back at the spring of 2020. The pandemic was spreading. Not much was heard from Russia at first. But statistics showed that the number of infections increased in April/May. By September, there were more than 1 million officially registered infected people. The number of dead was officially reported at 14,000 at the end of July. And Moscow was particularly hard hit. Strict curfews had been in place since April. "Due to the rapid global spread of SARS-CoV-2 infection and the high mortality rate, the development of a vaccine is an urgent task," Russian researchers wrote in their first publication in Lancet in September. It was an emergency situation using a very unconventional approach.
Corona sparked about 170 vaccine projects worldwide. And it was clear: whoever had a vaccine first would be able to quickly protect its population, gain international prestige, expand its influence and cash in on a billion-dollar business. The West doesn't think any differently. "We will be able to vaccinate in the Western Balkans and in Africa as well," EU Commission president Ursula von der Leyen said in a video conference as recently as November.
Russia, however, didn't talk much, it just acted. Vaccine development was a top state priority. The money flowed through the Russian Direct Investment Fund (RDIF), a $10 billion sovereign wealth fund. Driving it all was RDIF Director General Kirill Dmitriyev. Born in Kiev in 1975, the financial manager had already promoted the production of the corona drug Avifavir, which is exported to more than 15 countries around the world. And he was an early backer of a vaccine based on proven vector technology. The vaccine was developed at Gamaleya based on experience gained in developing vaccines against Ebola and Mers, researchers said in the Lancet.
"We will be the first," RDIF head Kirill Dmitriev told CNN. And the name Sputnik was apparently chosen quite deliberately. The announcement was meant to be a "Sputnik moment" for the world, as Dmitriev put it - just as it was in 1957 when the Soviet Union launched the namesake satellite high above the earth.
Russia leads with developing nations
In a way, it was such a moment. The announcement of the first government approval of a corona vaccine in August 2020 was quickly met with an international response, to say the least. And often an interested, receptive one. Apparently, there is no fundamental distrust of Russian research in a large number of the world's countries. Advance orders had been received from more than 20 countries, RDIF head Kirill Dmitriyev said at the time - for more than 1 billion doses of the vaccine. Interest came mainly from Latin America, the Middle East and Asia. Vietnam, for example, pre-ordered up to 150 million doses. Israel also showed interest and made contact. "If we come to the conclusion that this is a serious product, we will also try to start negotiations," Israeli health minister Juli Edelstein said. And he was thinking strategically: "The vaccine will not come tomorrow."
In the competition for developing countries, Russia now had its nose to the grindstone. After all, these countries cannot afford to be arrogantly sceptical of vaccine offers. Especially since the vaccine also has to be relatively inexpensive and easy to transport, and Russia had also developed a light version of Sputnik V, in which just one vaccination should provide good protection. Certainly, the aim is to gain as large a share as possible of the world market for vaccines. A market worth tens of billions.
Of course Russia's approach didn't meet international standards for vaccine approval. In Russia, too, there were those who criticised the fact that the vaccination of the Russian population had already begun in December in clinics, department stores and even the opera house before the Phase III trials had been completed. And there is apparently also seemingly widespread vaccination skepticism among the population. Basically, it could even be said that - for the sake of acceleration - testing and vaccination ran side by side. Apparently, given the proven technology, those responsible were sure they had a good vaccine with few side effects.
Precisely this was confirmed when the interim Phase III results were published on 2 February. Nobody hid their opinions. "The development of the Sputnik V vaccine has been criticised for its outrageous haste, shortcuts and lack of transparency," British virologist Ian Jones and a colleague agreed. "However, the result reported here is unequivocal." Now, he said, another vaccine can join the fight against Covid-19.
Still, some researchers are still looking for the "vaccine hoax" and the "clumsy manipulations." The magazine Der Spiegel recently ran the headline, "Criticism of Russian vaccine." It reported on the search for errors being carried out by a group led by Italian molecular biologist Enrico Bucci. These include numerical errors, inconsistencies in the number of subjects, missing raw data. The researchers say there's "cause for concern." There is also speculation about possible data falsification.
A researcher from Berlin says: "The reports from the Phase III studies of Moderna and Biontech were perhaps a little better, but also no highlight in terms of quality. Many details were missing, but that's the way it is when things have to be done quickly. That's why it's all the more important to look closely at what happens in Phase IV – that is, in the actual application." And this has been underway in the case of Sputnik V for quite a while. One key question that is still open is how the vaccine works against new virus variants.
Cooperation is vital during an emergency
Where do we go from here? For Europe, the ship has sailed on vaccinating early with Sputnik V. Russia has said it wouldn't be possible to deliver to the EU before May – possibly 100 million doses. Hungary is the only EU country that has already given approval. The Czech Republic also expressed interest. However, at the moment, emergency approvals from individual countries provide the only possible loophole. Throughout Europe, Sputnik V has yet to receive traditional approval. The EMA, which would have to give a recommendation, said no official application has even been submitted yet. And only then would the procedure begin.
Of course, vaccines must be safe. Germany is taking an especially hard look even though experience shows that serious side effects are very rare. Nevertheless, one wonders what can be learned from all this. After all, this may not be humanity's final emergency – be it pandemics, climate catastrophes or something else. It could be important to reach out to each other and break down barriers, to see each other as partners, not as opponents. It is important to accept each other as equals and not to take a moral high ground over others.
Despite political differences, cooperating on the pandemic at a humanitarian level is possible, Chancellor Merkel said recently. The collaboration announced in December between the Russian Gamaleya Institute and the Swedish-British pharmaceutical company AstraZeneca is just one such example. The aim is to test whether a combination of the two vaccines leads to better long-term immunity. The Russian researchers tweeted in late November: "Sputnik V is happy to share one of its two human adenoviral vectors with AstraZeneca to increase the efficacy of the AstraZeneca vaccine."