Why has Sputnik V Not Been Approved by EU Authorities Despite Positive Reviews?

The Russian vaccine, Sputnik V, has garnered attention for its positive reviews, affordability, and favorable storage temperature requirements. However, despite these merits, Sputnik V has not yet been approved by the European Union (EU) sanitary authorities. This article explores the reasons behind this delay and the geopolitical implications.

The Lack of Trust and Political Influences

Although Sputnik V has received commendable reviews and is relatively inexpensive, its approval process has faced significant challenges. Many Russians themselves do not trust the vaccine, a fact that has influenced the vaccine's reputation and acceptance. Even though it has been approved in some countries that were part of the Iron Curtain, such as Hungary, the EU stands firm in its requirement for thorough examination of the production standards and safety data submitted by the Russian manufacturer.

EU Scrutiny of Safety Data

The EU's approval process is rigorous and requires extensive scrutiny of all provided safety data. Phase III testing has not been fully completed, and the final papers submitted by the Russians have been criticized for containing gaps and errors. The EU authorities have also insisted on an on-site inspection of Sputnik V's manufacturing facilities to ensure they meet stringent EU standards. This scrutiny comes with a delay, as information to prove the vaccine's efficacy and safety is still being gathered and presented.

Geopolitical and Regulatory Factors

The reluctance of the EU to approve Sputnik V is not solely due to a lack of trust or inadequate paperwork. Geopolitical and regulatory factors have played a significant role. There is skepticism among EU members due to the vaccine's origin. Critics argue that the Russian vaccine could be used as a tool for geopolitical leverage, especially as Russia has yet to fulfill its promise to supply vaccines to developing nations. Additionally, there is a great reluctance among the Russian population to use Sputnik V, which has affected the appetite for wider distribution.

Rolling Review and Progress

Despite the challenges, the rolling review process by the European Medicines Agency (EMA) continues. On January 19, 2021, the Russian authorities applied for the registration of Sputnik V in the European Union. On February 10, the EMA acknowledged receiving this application. On March 4, 2021, the Committee for Medicinal Products for Human Use (CHMP) began a rolling review of the vaccine. However, in June 2021, Reuters reported that approval was to be delayed until September due to insufficient clinical data.

Emergency Use and Global Impact

Emergency use of Sputnik V has been authorized in several countries, including Algeria, Bolivia, Serbia, the Palestinian territories, and Mexico. An interim analysis published in The Lancet on February 2, 2021, indicated a 91.6% efficacy, with no unusual side effects. This positive data has sparked interest globally, but the EU's regulatory processes have remained cautious. The rolling review by the EMA continues, and with time, there may be a resolution to the pending approval status of Sputnik V.

FURTHER READING: If you want to know more about the Sputnik V vaccine, its global impact, and the challenges faced during its approval process, you can explore the following resources:

European Medicines Agency (EMA)LylaBio: A Research Network in virologyInterim Analysis of Sputnik V Efficacy Data Report from The Lancet