Disinfo: EMA will try to postpone the authorisation of Sputnik V

Summary

The European Medicines Agency (EMA) is going to do everything it can to postpone the authorisation of the Russian vaccine Sputnik V.

Disproof

Pro-Kremlin disinformation about vaccines, including Sputnik V.

R-Pharm Germany GmbH applied for a rolling review of Sputnik V (Gam-COVID-Vac) by the EMA in March 2021. The EMA has initiated the rolling review of the vaccine on the 4 March, 2021.

Before that, the developer of Sputnik V received scientific advice from the EMA, providing them with the latest regulatory and scientific guidance for the development of the vaccine.

A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine during a public health emergency. EMA will evaluate data as they become available to decide if the benefits of the vaccine outweigh the risks. The rolling review will continue until enough evidence is available for formal marketing authorisation application.

Busy work is in progress and EMA will assess Sputnik V’s compliance with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.

See related disinformation cases alleging that EMA's delay in approving Sputnik V is political; and that Russian vaccine opponents are trying to eradicate trust in Sputnik V;

publication/media

  • Reported in: Issue 236
  • DATE OF PUBLICATION: 12/03/2021
  • Article language(s) Czech
  • Countries and/or Regions discussed in the disinformation: EU, Russia
  • Keywords: vaccination, Sputnik V, coronavirus
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Disproof

This is a recurring narrative by pro-Kremlin media claiming that the anti-Russian sanctions are groundless and illegal.

In reality, the sanctions were imposed on Russia for its aggressive policy and violation of international law. The first round of restrictive measures was imposed in March 2014 in the wake of Russia’s illegal annexation of the Ukrainian peninsula of Crimea. More action against Moscow was taken in the following months, the reason being its support of the pro-Kremlin separatists in the eastern Ukrainian region of Donbas. Some sanctions were only political, such as the suspension of Russia’s voting rights in the Council of Europe. However, its voting rights were restored in 2019. In addition, bans were also imposed on transactions with some Russian businessmen and officials.

The UK uses an anti-Russian rhetoric as a cover, it aims at weakening the EU

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Disproof

Disinformation aimed to discredit UK foreign policy and portray it as insidious and anti-EU as well as to question solidarity between the UK and EU member states.

Global Britain is a foreign policy concept used by UK officials. The September 2019 article, authored by UK Foreign Secretary Dominic Raab, reads:

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Disproof

A recurring disinformation narrative from pro-Kremlin media outlets aiming at deflecting attention away from Russia's direct engagement in the conflict in Ukraine.

The US provides Ukraine with military equipment and trains its soldiers, but does not issue military orders. Since the outbreak of Moscow’s aggression against Kyiv in 2014, the US has supported Ukraine, but there is no direct military US involvement in the Donbas war. The European Union also supports Ukraine, with no direct military assistance.