EMA delays Sputnik vaccine approval after missed deadline

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European Union approval of Russia's Sputnik V coronavirus vaccine will be delayed because a 10 June deadline to submit data was missed, two people familiar with the matter told Reuters, diminishing the shot's prospects in the EU's pandemic response. "Approval of Sputnik will be delayed probably until September, maybe until the end of the year," an unnamed German government official told Reuters.
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The European Medicines Agency (EMA) had previously been expected to conclude its review of the Russian vaccine and issue a decision in May or June, which would have made it easier for Hungarians to travel abroad.

A second source said the 10 June cut-off date not been met and that the vaccine's developer, Russia's Gamaleya Institute, said it will file the requested data next week or at the latest at the end of the month. In this case, the September date mentioned by the first source appears realistic.

Hungary was the first EU member to order the Sputnik V vaccine, and most of the 2 million doses have been administered as shown below, which means the current development directly affects about 1 million Hungarians. Without EMA approval, it will be up to individual member states whether they allow those vaccinated with Sputnik to enter the country without limitations.

Germany has held talks to buy Sputnik V but has made any purchase contingent on EMA approval. Frustrated by a sluggish immunisation campaign, some regional German states including Bavaria earlier this year flagged interest in placing orders for Sputnik V, but vaccination has since picked up speed.

Slovakia became the EU's second country after Hungary to start inoculating people with Sputnik V this month, despite lack of EU approval.

Cover photo: Péter Szijjártó’s Facebook

 

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