Berlin, Düsseldorf, Paris, Athens, Madrid, Brussels, Stockholm, Rome The EU Commission sees the joint European vaccine procurement as a success despite fierce criticism. Brussels points out that more than two billion cans have been ordered from six different manufacturers. The majority of these cans currently only exist on paper. Only three of the six vaccines that Europe has counted on have been approved so far.
In the midst of the vaccine chaos, Europe received an offer from Russia that wants to help the EU out with its Sputnik V vaccine. A few months ago there were still great doubts about the effectiveness of Sputnik V, but the latest data are considered to be very promising. The EU Commission and Germany are now open to the possible use of the Russian vaccine, but some questions remain.
What did Russia offer the EU?
A spokesman for the Russian state fund RDIF, which finances the development and production of Sputnik, promised the EU 100 million vaccine doses for the second quarter – if the EU drug authority Ema approves the vaccine. The topic came up at the highest political level, during phone calls between President Vladimir Putin and Chancellor Angela Merkel and French President Emmanuel Macron.
Top jobs of the day
Find the best jobs now and
be notified by email.
European-Russian relations have been strained for years, and the condemnation of the opposition politician Alexej Navalny has currently exacerbated tensions. Moscow is likely to have an interest in presenting itself as a partner of the EU by cooperating on vaccines.
The RDIF wants to deliver to the EU “after the main part of the mass vaccination in Russia” has been completed. But that can take a while: According to the Russian Ministry of Health, two million Russians have been vaccinated against Covid-19 so far. Putin promised to have 70 million Russians by June. But that wouldn’t even be half of the population.
The production figures are also only slowly picking up speed: the industry is already producing “significantly more cans than planned,” said Putin. The plan so far calls for production of eleven million cans in February and an increase in March to 15 million cans. If necessary, production could even be increased, underlined Industry Minister Denis Manturov.
How this is to be done is unclear. Putin had also admitted that there had been insufficient production capacities so far. During the telephone calls between the Russian President and Merkel and Macron, it was also about European countries getting into Sputnik production. The bottlenecks in domestic production could also be a reason why Moscow approached the EU with its range of vaccines.
According to media reports, the Russians have contacted the Dessau company IDT Biologika, which emerged from the former VEB Kombinat Veterinary Vaccines of the GDR. The company had initially worked on its own corona vaccine, but it failed after initial tests. The company is now being discussed as a possible production partner for Sputnik V. IDT Biologika did not respond to a request from the Handelsblatt. Even the RDIF spokesman did not want to comment on a possible cooperation with the company from Saxony-Anhalt.
In which countries is Sputnik already being used?
The vaccine is already being used far beyond Russia’s borders. It is currently approved in more than 15 countries, including Russia, Argentina, Tunisia, Egypt and Pakistan. According to the Russian state investment fund RDIF, the drug has already been administered to more than two million people worldwide – mostly through emergency approvals. There is also no official approval in Russia as the studies have not yet been finalized. But the country already started Sputnik vaccinations in high-risk groups in December. Mexico, severely affected by the pandemic, ordered 24 million doses at the end of January through emergency approval.
Sputnik has also already been ordered in the EU: Hungary granted the product an emergency license at the end of January and is to receive two million cans. However, the management of the Hungarian Medical Association announced that “they cannot recommend the use of these products to their colleagues with a clear conscience”.
What is the European position on the Russian vaccine?
Both Chancellor Merkel and Health Minister Jens Spahn recently made it clear that they can imagine using Sputnik V. Openness towards the vaccine can be felt across the EU.
In response to a question about the Russian vaccine Sputnik V, the new Spanish health minister Carolina Darias said in parliament that the government would accept any vaccine approved by Ema “openly and enthusiastically”. Italy’s Minister of Health Roberto Speranza emphasized hopes for “Sputnik”: One should “not be afraid of it”.
The Czech pro-Russian President Milos Zeman has also announced that he will ask Putin to send Sputnik V to his country. French President Macron referred to the pending approval by the Ema: “This is a scientific decision, not a political one,” he said. The exchange between French experts and Russian scientists about Sputnik V was “very positive”.
The Commission in Brussels said that any vaccine is in principle welcome. “But the security of the citizens has absolute priority,” said a senior EU official. It is seen in a similar way in the European Parliament. “If there is a vaccine that is worth anything, we should use it in Europe,” said the internal market spokesman for the EPP group and MEP Andreas Schwab.
In EU circles, however, there is a warning against the impression that Sputnik V is available in larger quantities for the international market. The vaccine doses delivered to Hungary and the EU candidate country Serbia are classified in Brussels as a “PR trick” by the Russian government.
It is questionable how big the Sputnik effect would actually be for the European vaccination program. The agent should be approved by the Ema in the second quarter at the earliest. At this point in time, the supply situation in the EU could have eased significantly. The manufacturers of Biontech products that have already been approved, Modern and Astra-Zeneca are currently ramping up their productions. By the second quarter at the latest, it is expected that the RNA vaccine from Curevac and the vaccine from Johnson & Johnson is allowed.
What is the current status of approval in the EU?
In Moscow it is said that the RDIF applied for the registration of the vaccine and submitted all the information about it to the Ema. It is now up to the EU authority to determine the speed of the inspection process. A formal application for approval for the Russian vaccine has apparently not yet been submitted.
Also to a rolling approval process, as is the case for the vaccines from Astra-Zeneca, Biontech, Moderna, Johnson & Johnson and, most recently, for the vaccine from Novavax was initiated, nothing is known in the Sputnik case. It can therefore be assumed that it will take at least three months before EU approval is possible.
Marco Cavaleri, head of the Ema Department of Vaccines and Biological Health Hazards, said on the issue of approval for the Russian vaccine recently that it was in discussions with the Russian institute and was providing scientific advice on many aspects related to clinical development . The Paul Ehrlich Institute (PEI) is also involved, according to its own information: As part of “regulatory consultations”, the Russian colleagues are supported in providing the data and evidence necessary for approval and in meeting the requirements for an EU approval application .
How does the vaccine work?
Sputnik-V is a so-called vector vaccine in which a genetically modified virus is used to transport the genetic code for the spike protein of the Sars-CoV-2 virus into the body cells. These are then prompted to produce the protein, whereupon the immune system reacts with the formation of antibodies and defense cells. The mRNA vaccines work in a similar way. However, they transport the code for the protein in the form of messenger nucleic acids (messenger RNA).
The developers of Sputnik V claim that their vaccine “is really more effective than the competition” by using two different adenoviruses as vectors (Ad26 and Ad5) for the first and second dose. The concept could help to avoid one of the main weaknesses of vector vaccines: With this technology there is a risk that people already have a certain immunity to the adenoviruses or develop it after the first vaccination.
In this case, the viruses are intercepted by the immune system and can then no longer fulfill their actual task as a transport vehicle for the actual vaccine substance, which can reduce the effectiveness of the vaccines, especially with the second dose.
How effective is Sputnik?
In the scientific community, the early statements of the Gamaleya Institute and the early emergency approval for the vaccine in Russia were in part sharply criticized. An interim analysis of a larger phase 3 study with almost 20,000 participants recently published in the renowned specialist journal “The Lancet” shows the vaccine from the Russian state Gamaleya Institute to be one of the most effective vaccines against Covid-19.
According to these data, the vaccine reduces the risk of symptomatic Covid infections by 91.5 percent. The effectiveness is almost at the level of the mRNA vaccines from Biontech and Moderna already approved in Europe and promises a better protective effect than the vaccines from Astra-Zeneca and Johnson & Johnson, which like the Gamaleya product are based on genetically modified adenoviruses.
For the recently approved Astra-Zeneca vaccine, the European drug agency Ema is assuming an effectiveness of just under 60 percent in its approval dossier. Johnson & Johnson recently reported an overall effectiveness of 66 percent for its product.
Peter Kremsner, the director of the Institute for Tropical Medicine at the University of Tübingen, rates the results as very solid – provided that the data were all correctly determined. “The data are very comparable to the two already approved mRNA vaccines from Biontech and Moderna,” he said of the Lancet analysis. “This would give us a very good third vaccine that works in a similar way in older people.”
More: The journal “The Lancet” has published encouraging study results on the vaccine approved in Russia. That is also interesting for the EU.