BERLIN, June 16 (Reuters) – European Union approval of Russia’s Sputnik V coronavirus vaccine will be delayed because the June 10 deadline for submitting data has not been met, two people told Reuters close to the case, diminishing the prospect of firing in the EU pandemic response.
One of the sources, a German government official, said failure to provide the necessary clinical trial data for the EU drug watchdog would postpone any green light in the bloc until September. less.
“Sputnik’s approval will probably be delayed until September, possibly until the end of the year,” the official said, speaking on condition of anonymity.
The European Medicines Agency (EMA) was previously scheduled to conclude its review of the Russian vaccine and issue a decision in May or June.
A second source said the June 10 deadline was missed and the EMA gave the vaccine developer, the Russian Gamaleya Institute, another week to file the required data.
The Russian Direct Investment Fund (RDIF), which markets the vaccine, said the EMA review is on track.
“All information on the clinical trials of the Sputnik V vaccine has been provided and the GCP (General Clinical Practice) review has been completed with positive feedback from the European Medicines Agency,” said RDIF.
“Although it is up to the EMA to decide the timing of the approval process, the Sputnik V team expects the vaccine to be approved within the next two months,” he added. The EMA was not immediately available for comment.
The government of German Chancellor Angela Merkel has had talks to buy Sputnik V, but made any purchase conditional on EMA approval.
Frustrated by a slow vaccination campaign, some regional German states, including Bavaria, earlier this year expressed interest in placing orders for Sputnik V, but vaccination has since accelerated.
Slovakia became the second EU country after Hungary to start vaccinating people with Sputnik V this month, despite the lack of EU approval.
Report by Andrease Rinke in Berlin, Emilio Parodi in Milan; Additional reporting by Polina Ivanova in Moscow Writing by Ludwig Burger and Joseph Nasr; Editing by Hans Seidenstuecker, Mark Heinrich and Giles Elgood
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