Brussels to permit launch of Sputnik V? EU will consider recommending Russian Covid-19 vaccine, application for approval filed

The European Medicines Agency (EMA) announced on Wednesday that it has begun negotiations with the manufacturers of Russia’s pioneering Sputnik V coronavirus vaccine.

According to an official from the EU body, which licenses medicines and vaccines within the bloc, “the developer has contacted EMA and they are in early discussions now.” Regulators will assess data on Sputnik V before publishing a recommendation on whether it can be used by healthcare systems within EU member states. 

According to Kirill Dmitriev, the head of the Russian Direct Investment Fund, which bankrolled the development of the formula, an application for its approval was filed on 22 October. He suggested there was a possibility that it could even eventually be manufactured within Germany.

Earlier this week, the Gamaleya Center, which created Sputnik V, announced that the most recent analysis of clinical trial data suggested that it may be even more effective than previously thought. In a statement posted to the vaccine’s own Twitter account, the team indicated that more than 95 percent of those who received the jab developed immunity to Covid-19.

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Earlier this month, a row threatened to break out between leading European policymakers and health chiefs in Hungary over the Russian-made vaccine. Budapest has begun to import experimental quantities of the formula for research and testing, with a view to potentially ordering more in the future.

However, European Commission President Ursula von der Leyen warned national leaders that “all vaccines from our portfolio will be evaluated very carefully by our European Medicines Agency (EMA). They will only be authorised and placed on the market if they are safe and if they are effective."

A number of other countries have pushed forward with approval and uptake of Sputnik V, with Argentina announcing earlier this month that it would order 15 million doses for its citizens.

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