In recent days both the Russian officials – including President Vladimir Putin himself – and the Russian state media have been conducting a campaign to accuse the European Medicines Agency of blocking the approval of the Sputnik V coronavirus vaccine in the EU. But this is not the case at all, and the vaccine is being checked in accordance with the EU procedures.
Russian authorities and state media accuse the European Medicines Agency (EMA) of deliberately delaying the approval procedure for the Russian coronavirus vaccine Sputnik V. President Vladimir Putin mentioned this in his recent (April 21) state of the state address.
Accusations of this kind have been formulated several times by the Russian Ministry of the Interior, as well as by the state-owned Russian Direct Investment Fund (RDIF) responsible for the sale of Sputnik V in the world.
Such theories were also put forward in journalistic programs, including on the state television „Pervy Kanał”. The argument is that the EMA is blocking the positive certification of the Russian vaccine to „discredit” it.
This was stated by the spokeswoman for the Russian Ministry of Foreign Affairs, Maria Zakharova, in an interview with the press agency „RIA Novosti”. In turn, the Foreign Intelligence Service (SWR) in its March report put forward that the „European bureaucrats” are responsible for the situation. Examples of such disinformation were compiled by the European External Action Service (EEAS) in its report.
Russian officials and state media often point out that vaccines created by American or European pharmaceutical companies were allowed on the EU market much faster. This is supposed to testify to an alleged EU plot to block wide sales of Sputnik V to European countries.
But all this is not true, because the EMA examines research documents on Sputnik V in accordance with its procedures, and even uses – as in the case of the already approved preparations against coronavirus – the so-called accelerated evaluation.
However, everything takes longer – and so far only a little longer – than with the Pfizer-BioNTech, Moderna, or AstraZeneca vaccines, because research on the Russian vaccine was conducted in a different way and the EMA had no insight into them. The reason for the delays is therefore not some „Euro-conspiracy”, and the responsibility is almost entirely on the Russian side.
At the beginning of the pandemic, there was a loud talk about the so-called mask diplomacy. China, which at the time produced most of the professional mouth and nose protectors on the market, was exporting scarce goods as a priority to countries with which Beijing wanted to make other deals.
Now there is a lot of talk about the „vaccine diplomacy”. Preparations that provide immunity to the coronavirus are currently lacking for everyone, even in the richest Western countries, and much poorer or simply poor countries are still waiting for their supplies.
Most of them so far rely mainly on small batches of vaccines distributed by the World Health Organization (WHO) as part of the COVAX program. However, this usually allows only for the immunization of medical personnel.
That is why some of the richer countries – such as the US, Russia, China, or the EU Member States – share some resources with their allies. At the same time, medical companies, constantly increasing their production capacity, are competing for contracts for the supply of vaccines to African, South American, and Asian countries.
Russia is very active in promoting its Sputnik V vaccine, although the country has developed two other, less advertised preparations – EpiVacCorona and CoviVac.
RDIF, which financed the work of scientists from the Moscow Institute of Gamalei, has already signed contracts for the supply of this vaccine, among others to Argentina, Mexico, Bolivia, Venezuela, Egypt, Iran, and Kazakhstan.
Brazil did not authorize Sputnik V
The big image blow for Sputnik V, however, was the refusal from the 27th April to have it registered by the Brazilian Agency for the Safety of Drugs and Medical Products, Anvis, despite the fact that Brazil has already contracted 10 million doses of the Russian vaccine.
Anvisy’s five-member management committee unanimously decided that „the manufacturer is unable to provide adequate guarantees for the safety, quality and efficacy of the product.” The agency pointed to doubts about the correct attenuation (and thus neutralization by preventing reproduction) used for this vaccine as vectors for the so-called coronavirus spike proteins which cause harmless colds.
Anisa’s announcement is important because Brazil was one of the countries where the third phase of clinical trials of Sputnik V was conducted. The vaccine was approved by the Russian Ministry of Health on August 11 last year, so it was the world’s first coronavirus preparation that was approved officially in any country.
The problem is that the Russians – probably very much wanting to be the first – certified Sputnik V only on the basis of the first and second clinical phase of tests, and not waiting for the results of phase III, which is equally important because it is conducted on the largest group of volunteers (usually consisting of several thousand people), with the goal of representing age or ethnic groups as broadly as possible.
Moreover, in the third clinical phase, the study participants are observed for a long time. This allows not only to confirm the effectiveness of maintaining the developed immunity, but also to accurately measure the appropriate interval between doses.
The WHO was therefore skeptical and loudly urged Russia to wait for the results of phase III clinical trials before starting to administer the preparation to its citizens. Such research was also requested by countries potentially interested in Sputnik V, including Brazil, where parts of the research eventually took place.
In February, a periodic analysis of further research on Sputnik V was published by the prestigious British medical magazine Lancet. It showed that the effectiveness of the preparation was determined by the manufacturer at 91.6%, which is a result similar to other vaccines used around the world. However, the article based solely on documents sent by the Russian side.
Disputes over Sputnik V in Slovakia
The refusal to register the Sputnik V vaccine in Brazil is not the only image problem of this preparation abroad. There is still no opinion issued by the EU regulator, i.e. the European Medicines Agency (EMA), although it has already been approved by Hungary, which administers it to its citizens.
The vaccine was also ordered by the Slovak authorities, although the dispute over the purchase of a preparation not approved by the EMA led there to a reconstruction of the government and a change in the position of prime minister. This is because the then head of the government, Igor Matovič, decided to negotiate with the Russians without the consent of all parties making up his cabinet.
In addition, the Slovak regulatory agency – the State Drug Control Institute (SUKL) – refused to register Sputnik V because the documents provided by RDIF were deficient. Therefore, SUKL was not able to properly verify, among other things, the course of pre-clinical tests (i.e. carried out on e.g. animals), as well as subsequent human clinical trials.
Therefore, the Slovak regulator ordered additional research on this preparation. At that time, the Hungarian authorities, whose government is the most enthusiastic about the Russian vaccine in the EU, offered their help.
But another, more prosaic thing turned out to be a problem for SUKL. 200,000 doses of Sputnik V have already reached Slovakia. But the bottles with the preparation had a different volume than expected from the documents that RDIF sent to the EMA and from research published by the Lancet.
It also turned out that this implies the administration of a different amount of the vaccine intramuscularly than previously declared by the manufacturer. Therefore, the vaccine approval procedure in Slovakia could not even begin. Furious RDIF representatives demanded the immediate return of the vaccine bottles and accused SUKL of „spreading fake news” about Sputnik V.
EMA is considering the Sputnik V application
In such circumstances, it is not surprising that the EMA, which received the application for the registration of Sputnik V on March 4, has not yet reached a decision. The EU regulator has also repeatedly informed about gaps and inaccuracies in the documentation submitted to Amsterdam (where the EMA is located). The Russian side was asked to complete them.
Regarding Sputnik V, as well as other vaccines already approved in the EU, the EMA has applied the so-called accelerated fall-back approval procedure. It does not, however, mean less in-depth verification, only its prioritization.
In this sense, the assessment of documents by the EMA is simply ahead of the assessment of other drugs or medical products which are less relevant to the public health at present. Every year, the EU agency receives hundreds of applications for new preparations or their modernized versions.
But this accelerated mode also assumes close cooperation with manufacturers still at the stage of clinical trials. In the case of vaccines, which are found in the so-called common portfolio of EU purchases coordinated by the European Commission, their producers forwarded their research documentation to EMA on an ongoing basis so the EU agency could verify them immediately.
This was an extremely important factor for the rapid approval in the EU of Pfizer-BioNTech, Moderna, AstraZeneca, and Johnson & Johnson vaccines. It is on these preparations – as well as the CureVac and Valneva vaccines still in development – that the EU vaccination program is based on.
This is why the European Commission negotiated that the EMA would have access to the results and some reports already during the research. And thanks to this, these preparations could be approved for use shortly after the manufacturers announced the end of the tests. Sometimes even less than a month was enough for the entire process.
Gaps in documentation
This type of procedure could not be carried out in the case of Sputnik V. Not only because this vaccine is not in the common EU purchase portfolio, but also because the third phase of clinical trials of this preparation still continued when the first doses of Pfizer / BioNTech or Moderna vaccines have already been reaching the EU.
And even now there are still gaps in the documents, so although the EMA has adopted an accelerated evaluation procedure for the Russian preparation, there is no way that Sputnik V will be certified as quickly as the American vaccines or the British-Swedish AstraZeneca.
In addition, these vaccines are largely manufactured in factories in the EU (e.g. in Belgium, Germany or Italy) or in the UK, which remains close to the EU despite Brexit. Thus, the EMA also has much easier insight into the manufacturing procedures.
Meanwhile, the RDIF, instead of full clinical trial reports, offers data from the observations of 3.8 million people who have already received Sputnik V in Russia. But these are not equivalent documents. Research conducted thoroughly on each volunteer and in accordance with clearly defined procedures offers different data than information collected post-factum based on interviews with patients.
In addition, the Russian media are trying to convince the public that the checks conducted by the EMA on Sputnik V take much longer than in cases of other vaccines. Information about submitting the application to the EU regulatory body appeared in Russia on February 9 for the first time, and according to them, the documents were to be submitted on January 29.
On the other hand, on the official Twitter account of Sputnik V, there was a claim that the documents were sent to the EMA even as early as on January 22. The EU agency denied this information on February 10 and instead confirmed the submission of the application – as we wrote above – only in March.
The positive opinion of the EMA very important
For Russia, the positive assessment of the EMA is very important, because the opinion of an internationally respected EU regulatory body can be useful in convincing its potential contractors – not only in the EU – to buy the vaccine.
RDIF informs that Sputnik V has already been contracted by over 65 countries, and the total number of orders has already exceeded 1 billion doses. But the vaccine has so far only been approved by just over 20 national regulators and is being administered in a dozen countries.
In addition, the positive recommendation of the EMA has one more important meaning. The so-called Green Digital Certificate – commonly known as the „covid passport” – is to grant the right to travel within the EU without quarantine from the 25th of June.
There are many indications that it will only include vaccines approved by the EMA. Therefore, the lack of this recommendation will probably reduce the interest in accepting Sputnik V among the citizens themselves.
Meanwhile, RDIF hopes to sell its preparation widely in the EU. Initial interest in it was already expressed, among others, by Germany, Austria, Bulgaria, and Italy. But it is almost certain that none of these countries will decide to buy the vaccine unless it is approved by the EMA.
Hence, it is convenient for the Russian authorities or state media to suggest that there is some kind of conspiracy in the EU to block the admission of Sputnik V to the EU market, despite the fact that the EU officials avoid even speaking about this vaccine.
Meanwhile, some absurd accusations about American or European preparations are being spread in Russia, in particular about the AstraZeneca vaccine developed with the participation of researchers from the University of Oxford.
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