DISINFO: EMA's delay in approving Sputnik V is political
DISINFORMATION CASE DETAILS
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Sputnik V coronavirus

DISINFO: EMA's delay in approving Sputnik V is political

SUMMARY

It appears that the delay in approval by the European Medicines Agency is related to political or geopolitical reasons, not medical, and this is a mistake, especially at a time when there is a need to vaccinate citizens to get out of a social and economic emergency as well as health emergencies.

RESPONSE

Recurring pro-Kremlin disinformation narrative aiming to promote the Russian Sputnik V vaccine. The claim was neither counterbalanced nor critically challenged in the article.

All vaccines, authorised by the European Medicines Agency (EMA), are welcome in the EU. As of the 17 February 2021, the producer of the Sputnik V vaccine has not submitted a market authorisation to the European Medicines Agency.

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.

EMA is offering scientific advice free of charge. The EMA is currently in dialogue and collaborating with Sputnik V developers to define the next steps in compliance with due procedure. The developers have expressed their interest that the vaccine be considered for a rolling review. This ad-hoc procedure can only be used during emergencies such as the current pandemic. It allows the EMA to assess data on a vaccine or a medicine as they become available, while the development is still ongoing. The formal marketing authorisation procedure can then take place in a very short timeframe.

On February 2 2021, interim results from a phase 3 trial of the Sputnik V COVID-19 vaccine were finally published in The Lancet. The trial results show a consistent strong protective effect across all participant age groups, meaning that the Sputnik V vaccine candidate appears safe and effective.

The same disinformation campaign includes statements such as "Western attacks on the Russian coronavirus vaccine are a corporate cold war against humanity" or "Russian progress in COVID-19 vaccine has become for the West an outrageous challenge", that Sputnik V is a target of the corporate cold war; that the West wants to discredit the Sputnik V; that the WHO and Microsoft sabotaged the Russian vaccine, that the West criticises the Sputnik V because it can’t accept Russia’s primacy and because its pharmaceutical companies will lose billions of dollars.

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Disclaimer

Cases in the EUvsDisinfo database focus on messages in the international information space that are identified as providing a partial, distorted, or false depiction of reality and spread key pro-Kremlin messages. This does not necessarily imply, however, that a given outlet is linked to the Kremlin or editorially pro-Kremlin, or that it has intentionally sought to disinform. EUvsDisinfo publications do not represent an official EU position, as the information and opinions expressed are based on media reporting and analysis of the East Stratcom Task Force.

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