Sputnik approval in EU reportedly delayed

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In the EU, the approval of the Sputnik vaccine is reportedly still delayed. German government circles expect it to be approved in September, or even at the end of the year.

Approval of the Russian corona vaccine Sputnik V in the EU is “likely to be delayed until September, perhaps even the end of the year,” according to German government circles. The reason is that the Russian manufacturer has not yet submitted the necessary clinical trial data to the European Medicines Agency (EMA), the Reuters news agency learned. The clinical dossier was supposed to have been submitted by June 10.

The Russian state fund RDIF, which distributes Sputnik V, however, described the information as false. All necessary data on the clinical studies had been submitted and had received a positive comment. Initially, no comment could be obtained from the EMA.

RDIF already supplies the vaccine to numerous countries. In the EU, it is used by member states such as Hungary and Slovakia, despite the lack of approval by the EMA. Austria was negotiating with Russia, but the vaccine will not be used until it receives approval from the EMA.

RDIF assures no delays expected
RDIF stressed that clinical data review was ongoing and no delays were occurring. The EMA would have to decide, but approval was expected “within the next two months.”

  • sources: APA and vienna.at/picture: ptaheute.de
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