The European Union’s drug regulator announced on Thursday that it was launching an ongoing review of the Russian – developed Sputnik V vaccine, after one of the members of the bloc moved unilaterally to use the shots and another on the spot. is to do the same.
The announcement by the regulator, the European Medicines Agency, comes amid a slow and frustrating explosion of vaccines in the European Union plagued by disappointments in supply as well as major logistical problems.
The review is the formal process used by the agency, in which scientists examine data on the effectiveness and side effects of the shots. This is the fastest way to investigate the vaccine as a whole, with the aim of eventually authorizing it for use in the European Union. Union.
The agency said in a news release that the Gamaleya research institute, which developed the vaccine, had applied for the ongoing investigation by a Germany-based entity called R-Pharm Germany.
Hungary broke the block and this year ordered its own share of Sputnik V vaccinations and the shooting authorization granted locally by its national regulator. When supply in the European Union began to bite, the Czech Republic announced this month that it would follow suit. An agreement for the acquisition of the Russian vaccine also caused a political crisis in Slovakia.
Several other European governments have considered a similar move, despite the fact that European Commission President Ursula von der Leyen, the bloc’s executive arm, recently questioned the Sputnik V vaccine.
“We still wonder why Russia theoretically offers millions upon millions of doses while not advancing enough to vaccinate their own people,” she said. Von der Leyen said during a news conference last month.
“This is also a question I have to answer,” she added. “They have to submit the complete collection of data and indeed go through the whole investigation process like any other vaccine.”
Although the announcement of the review is an important step in the formal scientific inquiry by the European regulator, it is not possible to say how long the process will take. The agency needs deep access to data underlying the vaccine’s performance, as well as visits to the production facilities, before it can be authorized.