MOSCOW. In Europe increasingly hungry for Covid-19 vaccines, due to vaccination campaigns that are struggling to take off and supply problems by Western companies, many are looking to Moscow. President Vladimir Putin’s announcement last August that Russia had authorized the use of the world‘s first vaccine against the Sars Cov-2 virus before the trial was even completed sparked skepticism in the international scientific community. But now the Russian Federation is reaping the rewards of what may be the biggest scientific breakthrough since the heyday of the Soviet era. Developed by the Gamaleja Center for Epidemiology and Microbiology and funded by the Russian Fund for Direct Investment (RFID), the Russian Sputnik V vaccine is 91.6% effective, economical, easy to store and transport. And apparently available.
The search for a vaccine like the space race
Since the first weeks of the pandemic, the Russian president had ordered scientific, political and military officials to get into combat gear so that Russia was the first to have a vaccine. Even if that meant taking shortcuts. In the spring of 2020, the director of the Gamaleja Center, Aleksandr Gintsburg, boasted that he had inoculated himself with an experimental version of what would become Sputnik V, a method that broke the usual protocols. On 11 August, Russian President Vladimir Putin announced the registration of the world‘s first vaccine against Covid-19, not surprisingly named as the first satellite with which the Soviets beat the US in the space race, plus the “V” of vaccine. Announcement accompanied by the launch of a social profile followed today by almost 200 thousand followers and a website now available in nine languages.
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On November 9, Pfizer announced that its interim Phase III data had shown that its vaccine was over 90% effective. Two days later the Gamaleja Institute issued a press release stating that Sputnik V was 92% effective, a figure updated two weeks later to 95% to respond to the 94.5% declared by Moderna, the other American rival.
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Finally, in December, when the United Kingdom announced the start of vaccination with Pfizer, not to be outdone Russia anticipated its campaign. The inoculation would have started in Moscow, initially reserved for health workers and other groups who had a high risk of exposure, including teachers and social workers.
An almost farcical run-up that aroused the fear of the international scientific community that the Russian authorities were putting national prestige before security. After all, the very decision to call the vaccine Sputnik underlined the geopolitical value that the country attributed to the goal: the fight against the pandemic as a modern space race to claim the role of world power as in the times of the Cold War and to conquer new spaces of ‘influence.
Experimentation
The announcement of the recording of Sputnik V aroused the suspicions of international experts also because Gamaleja had not shared the data of Phase 1 and 2 of his trial, based on a sample of only 38 cases, and had not even started Phase 3. which had to involve tens of thousands of volunteers. In return, the Institute’s researchers and the Russian elite had already benefited from the vaccine, including one of the Russian president’s two daughters.
“Understandable perplexities,” admits Svetlana Zavidova, head of the Russian Association of Clinical Trials Organizations (Acto). “The authorities put the cart before the horse: first the registration and vaccination, then the third phase of the trials. It is as if in the slalom, instead of passing between the poles, they had passed everyone by pulling a straight line to the finish line and then demanding a medal ”.
Gamaleja researchers only published the results of Phases 1 and 2 in The Lancet in early September. Three days later, about forty scientists, mostly Westerners, highlighted alleged “inconsistencies” in the data in an open letter asking for clarification. Most significant: The participants’ reported antibody levels looked eerily similar. However, doubts cleared as the result of the eternal “information war” against Russia or “russophobia”.
The doubts were dispelled only after a study by The Lancet set the effectiveness of Sputnik V against the symptomatic forms of Covid-19 at 91.6%, placing it on the podium together with Pfizer and Moderna. “Successful launch into orbit”, headlined the Russian newspaper Izvestija.
How does Sputnik V
Like the vaccine developed by the University of Oxford and AstraZeneca in the UK, CanSino Biologics in China and Johnson & Johnson in the US, Sputnik V is based on the “viral vector” technique used in vaccines for decades. It uses disabled viruses as “vectors” to inject genetic instruction into our cells and let them produce the antigen that triggers the immune response. The inoculated DNA is inserted into the genome of an adenovirus, which causes the common cold.
The U.S. drugs developed by Moderna and Pfizer and BioNTech instead rely on relatively recent technology that uses genetic instructions in a nucleic acid molecule called mRna (or messenger Rna) to program a person’s cells to produce the viral protein and trigger a immune response.
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Like the British, the Russians expect two-dose administration 21 days apart. But while the Oxford researchers use the same vector twice to carry the genetic code, those at the Gamaleja Institute use two different ones: Ad26 for the first injection, Ad5 – a more common strain – for the second.
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In addition to the high rate of effectiveness, Sputnik has at least two other strengths: it costs less than $ 20 (about 16 euros) for a single two-dose course, more than the Oxford-AstraZeneca vaccine, but less than Pfizer’s vaccines and Modern, and can be stored and transported in a standard refrigerator rather than a special cooler like US rivals that require very low temperatures.
The spread of the vaccine abroad
Russia immediately showed its willingness to distribute the vaccine around the world to show that it can do more than export arms and hydrocarbons. Overcoming foreign distrust, today over 50 countries have authorized the use of Sputnik V. Not only emerging or allied countries, but also nations traditionally close to the United States such as the Arab Emirates. Among its testimonials, the Russian vaccine boasts the president of Guinea Alpha Condé and the Bolivian leader Luis Arce.
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Sputnik V is even tempting to the EU. The European Medicines Agency (Ema) has started the so-called “rolling review” process. A continuous review of the studies, to be gradually integrated based on the requests of the institution, started at least 20 days late with respect to the RFID request also due to bureaucratic misunderstandings: according to some sources, the Russian Fund had initially forwarded the documentation to the Cesp, the portal of the Committee of the heads of the medical agencies of the various countries, and not the EMA.
Despite the clashes with Moscow over the Navalnyj case, Chancellor Angela Merkel has offered to speed up the process which should end with a green light in late April or, more likely, in May.
But Hungary to shorten the time has decided to go it alone by becoming the first country of the Twenty-seven to authorize it, followed by Slovakia, with Luxembourg and the Czech Republic preparing to do so. The president of the European Commission, Ursula von der Leyen, has opened up to the Russian vaccine as long as there is full transparency and it is approved by the EMA.
After months of defending the quality of its product, Russia may struggle to meet demand. The real Achilles heel of Sputnik V is production. The Gamaleja Center does research, not large-scale production. RFID has entered into “technology transfer” agreements with manufacturers at home and abroad.
The doses produced in Russia by six licensed producers are reserved for the Russian market. Those destined for export are produced abroad, in a dozen partner countries, including Kazakhstan, India, China, South Korea and Brazil. In Europe, RFID has signed an agreement with the Swiss biopharmaceutical company Adienne Pharma & Biotech, which has a laboratory in Monza, with factories in Spain and France and has contacted the Germans of Idt Biologika. But it is complex to guarantee product homogeneity which is one of the factors that regulatory agencies such as EMA are verifying.
Furthermore, so far, the lots delivered abroad have often been symbolic. Argentina reported the first delays. And at home, the regions often report supply difficulties. If for the moment the vaccine is widely available in big cities, it is only because of the distrust of the population.
The vaccination campaign in Russia
While mistrust has diminished abroad, at home 58% of Russians are wary of the national vaccine according to the latest survey by Levada Tsentr. A percentage which, according to the director of the socio-cultural research department of the independent institute Alexei Levinson, is closely correlated with the excess of propaganda. “People don’t trust power. He understands that the Kremlin is using the vaccine for political purposes ”. When the free and voluntary vaccination in Moscow started on 4 December, a center was even opened in the GUM luxury department store on Red Square. But the turnout was slow.
There are no official statistics. As of March 13, according to the media and authority-based website Gogov.ru, 8.3 million people had received at least one of two doses of the vaccine out of a population of 146 million. Figures inflated, according to some independent surveys, because they do not correspond to the statistics released by the individual regions.
The example did not come from above. 68-year-old Russian President Vladimir Putin has not yet been vaccinated. In December he said to await the green light for his age group and, now that it has arrived, to avoid overlapping with the calls against influenza and pneumococcus. Among the Russian officials, only the defense minister Serghej Shoigu and the ultra-nationalist deputy Vladimir Jirinovskij received the vaccine.
However, there is an urgent need. The authorities have decided not to impose new restrictions to preserve the already fragile economy, although Russia is the fourth most affected country in the world by the pandemic, with almost 4.5 million positives and around 94,000 deaths. But the Rosstat Institute of Statistics admitted that the dead could be three times the official tally, which would jump Russia to third place for deaths. However, these losses are not covered by the media or by the authorities. “Instead of ‘our vaccine is the best’ – complains Levinson – the message should be ‘the virus is dangerous'”.
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