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Not authorized in the EU: Sputnik V vaccine vials
Photo: Eyepix Group / IMAGO
According to the EU medicines authority Ema, the test of the Russian corona vaccine Sputnik V for approval in the EU is on hold.
Nothing is happening there at the moment, said Fergus Sweeney, the head of the clinical trials department, on Thursday in Amsterdam.
"We are currently not in contact with the Russian authorities." He did not give any reasons.
It is unclear whether the disruption in communications is related to the war in Ukraine.
Sweeney said he doesn't expect the review process to resume any time soon.
Important data was missing
The vaccine is approved in Russia and some other non-EU countries.
Like the preparations from AstraZeneca and Johnson & Johnson, Sputnik V is a so-called vector vaccine.
Such vaccines are based on viruses that cannot be dangerous to humans, so-called vectors.
They serve as carriers for characteristic sections of the genome of the pathogen against which vaccination is to be carried out.
The body recognizes the genetic material as foreign and forms antibodies that prevent infection if it actually comes into contact with the virus.
About a year ago, Ema started the Sputnik V review process, based on the so-called rolling review principle.
Data from research and tests are continuously evaluated by experts, even if no official application for approval has yet been submitted.
This is intended to speed up the approval of vaccines against Covid-19.
The testing of Sputnik V had been delayed several times because the EMA experts were still missing important data.
mar/dpa
