European Medicines Agency scheduled to to review Russian vaccine

Officials from the European Medicines Agency (EMA) will arrive in Russia today to assess the quality of manufacturing and clinical facilities for the Russian-produced Sputnik V COVID-19 vaccine.

The EMA, the EU’s independent medical regulator, began reviewing the vaccine in mid-March. Notably, the EMA’s assessment comes months after the Russian government controversially approved the vaccine for emergency use prior to clearing established regulatory hurdles.

The EU has remained hesitant to purchase Sputnik V doses, despite rising caseloads in countries such as Germany. Nevertheless, European states including Italy and Austria have expressed increasing interest in obtaining their own batches of the vaccine as the EU vaccination program has suffered from supply issues and a sluggish rollout.

In the near-term, expect European countries with closer ties to Russia to press the EU to consider purchasing Sputnik V. As the EU faces mounting demand for vaccines, expect the EMA to strongly consider authorizing Sputnik V for EU use in the months ahead. The EU’s prior purchase of the Johnson & Johnson vaccine and Sputnik V’s current inability to meet both domestic and international demand may relieve pressure on the EU to expedite a decision. Yet, expect the EU to ultimately determine that the benefits of a Sputnik V contract outweigh potential costs.