Why hasn’t the Russian COVID-19 vaccine been approved by the EU yet?

Russia launched its “Sputnik V” vaccine for COVID-19 in August 2020. But, despite it being the first to be registered globally, the European Medicines Agency (EMA) still hasn’t approved the vaccine, which is required before it’s deployed to EU countries.

So far, the only country in the union to give the green light to the Russian vaccine is Hungary. It has also been rolled out in a number of non-EU European nations, including Bosnia-Herzegovina and Serbia. 

The developers claim it’s the “best vaccine” available, and it’s already been taken up in 31 countries globally. Both the Russian authorities and Hungarian prime minister Viktor Orban have criticized the EU for delaying its approval and potentially saving lives. 

Why is the EU taking so long to approve the vaccine? 

According to a study carried out by The Lancet, Sputnik V is estimated to be 91.6% effective in protecting against symptomatic COVID-19. So, with the current vaccine policies costing lives and damaging economies, why is the EU so slow to approve it? 

The EMA claims that Sputnik V will not be approved for use in the EU until it’s been through the same detailed process as other vaccines. This could be a lengthy process, and the issue at the moment, according to the EU, is that it hasn’t had the full data sets.

This involves, firstly, a “continuous review” of data and clinical trials. Following this, the vaccine will need to be put through a formal application process and one-year conditional authorization. 

At the moment, the Pfizer-BioNTEch, AstraZeneca, and Moderna vaccines have all been authorized, and the Johnson & Johnson, Novavax, and CureVac have all started the review process which must be completed in the coming year. 

Although the EMA says it hasn’t received the information it needs, the developers of Sputnik say they have submitted the requests and  “filed an application for registration” on January 19.

In a Twitter thread, the vaccine’s developers posted: “The world needs Russian, Chinese, Western vaccines. COVAX, run by UK and US, should be more inclusive and include Russian and Chinese vaccines. Political biases and narrow minds make us weaker. Together we are stronger!”