Russia seeks facilities to manufacture Sputnik V vaccine in Spain

A medic holds a vial of the Russian vaccine Sputnik V. SHAMIL ZHUMATOV / Reuters

Spain is one of the candidate countries to manufacture the Russian vaccine Sputnik V. Kirill Dmitriev, director of the Russian sovereign wealth fund RDIF, which markets the vaccine in the world, assured on Tuesday on his country's state television that his fund has already reached agreements with production facilities in Italy, Spain, France and Germany to produce Sputnik, according to Reuters.

Sources from the Ministry of Health explain to EL PAÍS that although the Spanish Agency for Medicines and Health Products (AEMPS) is in talks with several companies with facilities that have the capacity to produce different vaccines in Spain, "there are no" agreements with Russia.

If suitable locations are found, in any case, AEMPS would have to issue permits so that they can manufacture biological products, something it has not done yet.

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The one that has signed an agreement with RDIF to manufacture the vaccine in Italy is the Swiss pharmaceutical company Adienne, as confirmed by the fund itself and the Italian-Russian chamber of commerce, although it still requires the approval of the country's regulators before it production can be launched.

This is an important step for the Russian drug, since one of the requirements that the European Union places to approve, buy and distribute vaccines among their countries is that they have manufacturing capacity on European soil.

Sputnik V has been licensed in 42 countries and is 92% effective.

However, it remains to be seen whether the production capacity is sufficient to cover the real needs of the EU.

Russian authorities announced in January that they were willing to deliver 100 million doses to Europe during the second quarter of the year, but in Russia itself only 6.7 million units have been injected so far, according to data from Our World in Data.

European Council President Charles Michel hinted on Tuesday that Russia's announcements are more propaganda than reality.

"We must not be fooled by China and Russia, both regimes with less desirable values ​​than ours, as they organize very limited but widely publicized operations to supply vaccines to others," he assured.

The Russian vaccine began the process of continuous evaluation to achieve authorization by the European Medicines Agency (EMA, for its acronym in English) on March 4.

But, as a Ministry of Health spokesperson explains, "for the moment, it is not possible to know the duration of this process and if it will finally be able to comply with all the guarantees of quality, safety and efficacy and, therefore, obtain an authorization.

"At this time, in addition to evaluating the information provided, the EMA will carry out inspections next April to check if the places of production comply with Good Manufacturing Practices, essential for the vaccine to be authorized in the European Union ”, Explains this spokesperson.

In Spain there are agreements to manufacture two vaccines that are already distributed: Moderna (in the plants of the Spanish company Rovi) and AstraZeneca (by Insud).

In addition, there are also plans for two others whose approval is imminently awaited: that of Janssen (at the Reig Jofre facilities) and that of Novavax (in Biofabri).