SPUTNIK V: One of the world's most sought-after vaccines

Photo by Mufid MajnunThe official Twitter account of "Sputnik V" reports new successes every day. Last week alone, the Russian Corona vaccine was approved in Egypt, Kyrgyzstan, Honduras, Guatemala and the Republic of Moldova; deliveries have arrived in Mexico and Serbia, and the first doses have been administered in Paraguay.

8 countries have now registered "Sputnik V"; Hungary is also among them, an EU country that did not want to wait for the EU medicines agency EMA's review and is now bearing the risks itself. The Czech government also announced on Saturday that it had approached President Vladimir Putin about supplying the Russian vaccine. The vaccine, meanwhile, is particularly coveted in poorer countries because, at just under $20 for the two doses, it is rather cheap and can be stored in a refrigerator. A study in the scientific journal "The Lancet" also confirmed that "Sputnik V" is highly effective and safe.

It is still unclear whether Russia will be able to fulfill its delivery promises, as it relies on factories abroad, for example in India and Brazil, some of which, according to media reports, are not even producing yet. So far, Russian supply volumes are nowhere near those of Western producers. This is probably one of the reasons why Russia has announced that it will offer a "light version" of its vaccine from March onwards, providing only one vaccine dose instead of two.

Doubts branded as "politicization"
This could also solve the problem that "Sputnik V" is apparently not so much cheaper than the competition after all, as claimed by Kirill Dmitriyev, for example, the head of the state investment fund RDIF, which helped finance the development of "Sputnik V" and is now marketing the vaccine abroad. According to the Financial Times, the African Union has negotiated significantly better prices for the Russian vaccine than with Biontech and Astra-Zeneca, for example.

Nevertheless, "Sputnik V" is already a success: In terms of orders, it is currently one of the most sought-after vaccines in the world. So was the skepticism, especially in the West, misplaced for a long time? Officials in Moscow put it this way. Doubts or criticism are branded as "politicization" of the vaccine search. When EU Commission chief Ursula von der Leyen recently expressed surprise at why Moscow was offering millions of doses of its vaccine to other countries while the vaccination campaign at home was making slow progress, Russia's permanent representation to the EU tweeted in response, "No to politicization of Covid vaccine issue."

So far, the skepticism was mainly due to scientific concerns. Until its publication in "The Lancet" in early February, the safety and efficacy of "Sputnik V" could not be independently assessed, because the developers hardly released any data. When Russia approved the vaccine last summer, fewer than 100 people had participated in clinical trials, and the crucial third phase of studies was still pending and has not been completed to date. This rush to judgment and disregard for international standards fueled mistrust.

Comparisons to World War II
The study in "The Lancet" has answered not all, but many questions. The Kremlin is also using the publication to promote the vaccine in its own country; President Vladimir Putin praised the scientific journal for its "objectivity." When "The Lancet" published a study in December on the poisoning of opposition activist Alexei Navalnyi with the agent Novichok, Putin's spokesman had said: "We do not read medical journals. Now the success of "Sputnik V" offers Russia the opportunity to improve its tarnished image in the world. For this purpose, major comparisons are being made. For example, the RDIF drew a connection to World War II: "Sputnik V" wants to work with the United States and other countries to meet this challenge to humanity, "just as we did in World War II."

Moscow also says it is seeking EU approval. However, contradictory information on this came from Russia, which sows new doubts about the seriousness of those responsible: Already at the end of January, the RDIF had announced that it had applied for EU approval. This was rejected by the EMA, the drug agency, which said that only a "scientific consultation" had taken place and that the developers had expressed an interest in starting a "rolling review" process.

In Russia, confidence in Sputnik V is low
In this review process, used in the pandemic to save time, vaccine developers send data to the EMA on an ongoing basis while clinical trials are still underway. Before that, however, the EU agency checks whether the vaccine is promising and whether sufficient data are available. Only when the EMA gives its approval can developers submit a request for "rolling review." The RDIF tweeted in mid-February that this request had been made. However, the EU Medicines Agency confirmed to the F.A.Z. that this was not the case. Next steps are being defined "in dialogue with the company."

It is clear that the EMA's requirements are very high; for example, all patient data from the studies must be submitted and the production sites inspected. In addition, the EMA now also requires reliable data on the effectiveness of the vaccine against the new virus mutations. According to the state-run Gamaleja Institute in Moscow, which developed "Sputnik V," booster vaccinations should also help against the British and South African variants. However, data on this have not yet been published.

In Russia, the mutations have played almost no role so far. Infection figures are falling, although there are hardly any restrictions, spacing and masking rules are only half-heartedly followed, and so far only 2.7 percent of the population has received at least one vaccine dose. Although all adults can now be vaccinated in many regions, confidence is low.



Photo by Mufid Majnun

 


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