Icon: enlarge
Sputnik-V delivery in Budapest: The Russian vaccine is already being injected in Hungary
Photo: Zoltan Mathe / dpa
A representative of the EU drug authority Ema warns EU states against granting the Russian vaccine Sputnik V emergency approval as long as the agent has not yet been tested by Ema.
Too much is still unknown, decisive data from vaccinated persons are not available, said Christa Wirthumer-Hoche in the panel discussion "In the center" of the ORF.
"That is why I would strongly advise against issuing a national emergency license." Wirthumer-Hoche is Chair of the Management Board of Ema.
Usually the Ema makes a recommendation as to whether a vaccine should be approved in the EU.
However, individual EU countries can also issue emergency approvals.
Hungary, for example, has chosen this path.
Sputnik V is already in use there, and the Czech Republic is also examining national approval.
How Sputnik V triggered a state crisis in Slovakia
In Slovakia, Sputnik V even triggered a state crisis after Slovak Prime Minister Igor Matovič ordered doses of the vaccine on his own - after secret negotiations with Russia and against the express will of his coalition partners, reports, among others, the Deutsche Welle.
The first 200,000 doses of the vaccine have already arrived in Slovakia.
And there could be more doses of the Russian vaccine in Europe.
EU representatives announced that they would be able to start negotiations with vaccine manufacturers if at least four member countries request this, reports the Reuters news agency.
Wirthumer-Hoche spoke of Russian Roulette in connection with the emergency approval of Sputnik V in Hungary.
"We need records to check," she said.
In fact, Ema is currently examining a possible approval of Sputnik V in the EU.
Like four other vaccine candidates before, Spuntik V is in the so-called rolling review process, in which study data are continuously evaluated and not only when all the information relevant for approval is available.
Russia had already approved Sputnik V last summer, although important tests had not yet been carried out by then.
That had caused severe criticism internationally.
At the beginning of February, data were published in the medical journal »The Lancet«, according to which the vaccine is 91.6 percent effective.
Ema does not rule out the approval of Sputnik V.
This would put Sputnik V on a comparable level to the vaccines from Biontech and Moderna.
The AstraZeneca product, which is based on the same technology as Sputnik V, only achieved an effectiveness of 60 percent in the study, which was decisive for approval.
However, researchers expressed doubts about the study on the effectiveness of Sputnik V and criticized that the data were not publicly available.
Chancellor Angela Merkel and Health Minister Jens Spahn (both CDU) had shown themselves to be open to using Sputnik V in Europe if Ema recommends it.
(Read here how exactly Ema can test the vaccine.) According to Russian information, the vaccine has now been registered in more than 30 countries.
Wirthumer-Hoche also did not rule out that Ema would recommend the approval of Sputnik V.
The final decision is made by the EU Commission, but this is a matter of form.
Data packets from Russia came in continuously.
"We can have Sputnik V on the market," said Wirthumer-Hoche, "when we have checked the relevant data."
Icon: The mirror
koe
