EMA Postpones Decision on Sputnik V Vaccine Approval Until September
Key Insights
The European Medicines Agency (EMA) has delayed its decision on approving the Russian Sputnik V vaccine, with a decision expected no earlier than September due to missing data.
Bavaria's Prime Minister Markus Söder has urged the EMA for a swift approval of Sputnik V, emphasizing the need to avoid delays and ensure the vaccination process continues without interruption.
Despite not having EMA approval, Hungary and Slovakia are currently using the Sputnik V vaccine, while nearly 70 countries have authorized its use.
The European Medicines Agency (EMA) will not decide on the possible authorization of the Russian "Sputnik V" vaccine for use in the European Union until at least September, according to a report in the German newspaper "Bild am Sonntag," citing government sources. The delay is attributed to the lack of sufficient data required for approval.
Bavarian Prime Minister Markus Söder has advocated for a faster decision by the EMA, emphasizing the importance of maintaining momentum in vaccination efforts. "The vaccination engine must not stall," Söder stated, urging against delays based on ideological reasons. Bavaria has anticipated the purchase of 2.5 million doses of "Sputnik V."
Russia approved the "Sputnik V" vaccine in August of last year, preceding the completion of standard scientific studies, a decision that drew criticism from scientific circles. Nevertheless, approximately 70 countries have since authorized the vaccine's use.
The EMA initiated a supervision procedure in early March within the framework of a "Rolling Review." This process involves the verification of test results, even in the absence of complete data submission and a formal request for a use permit.
Currently, two EU countries, Hungary and Slovakia, are administering the Russian vaccine despite the absence of EMA approval. To date, the EMA has licensed vaccines from BioNTech/Pfizer (search), Moderna, AstraZeneca, and Johnson & Johnson, all of which are manufactured by Western companies.