EU Approval of Sputnik V Vaccine Delayed

On Jun 16, 2021

European Union approval of Russia’s Sputnik V COVID-19 vaccine will be delayed as deadline to submit data was missed.

According to a German government official, he said the failure to provide the necessary clinical trial data to the EU medicines watchdog would postpone any go-ahead in the bloc until at least September.

“Approval of Sputnik will be delayed probably until September, maybe until the end of the year.”

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.

The Russian Direct Investment Fund (RDIF), which markets the vaccine, said the EMA review was on track.

“All of the information on the Sputnik V vaccine clinical trials has been provided and General Clinical Practice review has been completed with positive feedback from the European Medicines Agency.

“While it is up to EMA to decide on the timing of the approval procedure, the Sputnik V team expects the vaccine approval with the next two months,” RDIF said.

Despite lack of EU approval, the EU’s second country after Hungary to start inoculating people with Sputnik V was Slovakia.

Kamila/Reuters