DISINFO: Ursula von der Leyen shouldn’t decide on the safety of Sputnik V; EU's approval process is politicised
SUMMARY
Moscow denounces the politicisation of the approval process for the COVID-19 Sputnik V vaccine in the European Union. Russian authorities point that pharmaceutical lobbies may be delaying this approval. The anti-Russian rhetoric in this area has no justification. The president of the European Commission Ursula Von der Leyen said that there is not enough information for the approval of the Sputnik V because its developers haven’t provided all data about its safety. But this is not her role, she should adopt political decisions but not decide on the quality of a vaccine, which is the task of the European regulatory body.
RESPONSE
Contrary to the claim, European Commission President Ursula von der Leyen doesn’t decide on the safety or quality of the vaccine, which is the exclusive competence of the European Medicines Agency (EMA). As a political representative, von der Leyen merely conveyed the information available to the European Union, which is that the developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that European regulators deem to be standard requirements of the drug approval process. This misleading affirmation aims to back the long-term pro-Kremlin disinformation narrative about the Sputnik V being blocked in the EU for political reasons.
There is no evidence of any bias against the Russian vaccine by the EU or its regulatory bodies. EMA and EU leaders have publicly stated they would welcome Sputnik V if it meets the applied standards for vaccines. EMA Executive Director Emer Cooke said she hoped the Sputnik V vaccine would be approved. For that, EMA is conducting a rolling review including visits to Russian facilities. The EMA is committed to applying the same regulatory approach and scientific rigour to all vaccine applications that meet European requirements for safety, efficacy, and quality and is in dialogue with more than 50 vaccine developers from across the globe.
See other examples of similar disinformation narratives in our database, such as claims that this vaccine is still not recognised in the EU due to a political component, that it faced huge disinformation in Slovakia, that the West is waging a targeted campaign against it, or that Western politicians attitude towards Sputnik V feeds vaccine hesitancy in Russia.