EU to begin certifying Russian Sputnik V vaccine for use in Europe

EU to begin certifying Russian Sputnik V vaccine for use in Europe
Russia is applying for European certification for its Sputnik V coronavirus vaccine as scepticism begins to fade and demand rises / wiki
By Ben Aris in Berlin January 13, 2021

Russia will begin the process of certifying its Sputnik V vaccine for use in Europe on January 19, according to Kirill Dmitriev, director of the Russian Direct Investment Fund (RDIF) that funded the development of the medicine, reports Kommersant.

While the launch of Russia’s vaccine has been met with a great deal of scepticism as it was rushed through the domestic certification process in August last year and questions have been raised over the veracity of the trials data, the bottom line is no serious problems have come to light during the large-scale phase III trials so far.

And production is in full swing. Russia’s December industrial production results got a boost from the heavy investment and activity from the pharmaceutical sector – not a traditional Russian economic driver – thanks to the scaling up of Sputnik V’s production.

The Kremlin launched a mass inoculation roll out in December – the first country in the world to do so – offering the vaccine to all Russian citizens for free. It claims to have already inoculated 1.5mn people, although here too the Kremlin has been accused of inflating the numbers.

On the flip side Germany, where much of the scientific research was done to identify the virus, produce an effective test for it and develop of one of the working vaccines, has found itself short of supplies, thanks to a procurement screw-up: Germany had counted on several candidate vaccines being certified, whereas fewer actually were, so it didn't order enough doses from the available pool. The upshot is that despite being in the vanguard of the scientific effort to fight the virus, Germany will be in the baggage train in terms of actually rolling out a mass inoculation campaign.

Dmitriev claims that a scientific review of Sputnik V will begin in Germany on January 19 – the first step in certifying the vaccine for use in Germany, as the Bundestag scrambles to lay its hands on enough vaccine to inoculate its 80mn strong population, the largest in Europe after Russia’s.

An application for an emergency use authorisation (EUA) for the Sputnik V vaccine was submitted by RDIF to the German authorities on December 22.

The process of registration of the Russian vaccine with the European Medicines Agency (EMA) was also submitted at the end of October.

So far, EMA has registered only two vaccines: the joint production of Pfizer (USA) and BioNTech (Germany), as well as that from Moderna (USA). Other candidates from the UK and Asia have not yet been approved.

As time has passed, the international media have begun to warm to the Russian vaccine, which its producers, the Gamaleya Research Institute of Epidemiology and Microbiology, claim has an efficacy of over 90%.

“All over the world, except for a number of Western countries, the attitude towards the Russian vaccine is positive, and Russian medicine is recognised as one of the world leaders," Dmitriev told Kommersant. "This is confirmed by a survey conducted by YouGov in 11 largest developing countries, where one third of the world's population lives, which showed that more than 80% of respondents trust the platform on which Sputnik V is based and are well aware of the Russian vaccine." The survey was conducted in the countries of the Middle East and Southeast Asia.

Sputnik V has already generated the fourth most orders in the global coronavirus (COVID-19) vaccine market that is by some estimates worth up to $100bn. The Kremlin has also been using the vaccine as a political tool to promote its soft power relations with its allies, by offering discounted versions of the vaccine or joint production deals to its friends. Joint production of Sputnik V is due to be set up in Kazakhstan and Turkey, whereas Belarus is due to receive its first shipment in February. All-in-all Russia has done deals with some 50 countries, according to the RDIF.

Most recently, a small scandal was provoked in Ukraine where a pharmaceutical firm linked to Viktor Medvedchuk, the head of the pro-Russia Political Council of the Opposition Platform, the For Life Party, and a personal friend of Russian President Vladimir Putin, applied for a joint production licence for Sputnik V. Ukrainian President Volodymyr Zelenskiy has also hinted that Kyiv might be open to buying the vaccine from Russia, as his country is struggling to source dose from the West.

“In some Western countries there was initially a prejudice against our vaccine caused by unfair competition, but even in these countries they now understand the advantages of Sputnik V, such as more than 90% efficacy, a proven and safe platform for the human adenovirus vector, the absence of severe allergic reactions and ease of storage (at a temperature of two to eight degrees)," Dmitriev added. According to him, Sputnik V is already registered in seven countries, and will add another ten in the near future.

The fact that Sputnik V can be stored at room temperature is also a big plus, as the western vaccines based on RNA messenger technology have to be stored at -70C, making them difficult and costly to transport. Overall the Sputnik V vaccine is about a third of the price of its western counterparts, adding to its appeal to Russia’s traditional partners in the Commonwealth of Independent States (CIS) and other emerging markets.

“Now the vaccine is already being produced in Korea and India,” Dmitriev said. “Production in Brazil will begin on January 15 and production in China is planned. In addition to the Russian Federation, only eight countries will produce the Russian vaccine.”