The European Union drug regulator announced on Thursday that it was starting a continuous review of the Sputnik V vaccine developed in Russia, after one member of the bloc acted unilaterally to use the injections and another is about to do the same.
The regulator’s announcement, the European Medicines Agency, comes amid a slow and frustrating launch of vaccines in the European Union, which has been hampered by disappointments in supply as well as major logistical problems.
The review is the formal process the agency uses, in which scientists examine data on vaccine efficacy and side effects – it is the fastest way to examine the vaccine as a whole, with a view to eventually granting it authorization for use in Europe. .
The agency said in a press release that the Gamaleya Research Institute, which developed the vaccine, requested continuous review through a German-based entity called R-Pharm Germany.
Hungary broke with the bloc and ordered its own quota of vaccines against Sputnik V this year, granting local vaccination authorization through its national regulator. As supply problems in the European Union began to ease, the Czech Republic announced this month that it would do the same. An agreement to acquire the Russian vaccine also sparked a political crisis in Slovakia.
Several other European governments were considering a similar move, despite the fact that Ursula von der Leyen, president of the European Commission, the bloc’s executive arm, recently cast doubt on the Sputnik V vaccine.
“We still wonder why Russia is theoretically offering billions of doses until it has made enough progress in vaccinating its own people,” said Ms Von der Leyen during a news conference last month.
“This is also a question that I think needs to be answered,” she added. “They have to send the entire data set, in fact, go through the entire scrutiny process like any other vaccine.”
Although the announcement of the review is an important step in formal scientific scrutiny by the European regulator, there is no telling how long the process will take. The agency will require deep access to data underlying the vaccine’s performance, as well as visits to production facilities, before granting authorization.