DISINFO: Kremlin worries EMA’s review of Sputnik V is unusual and prejudiced
SUMMARY
It is unclear if the EMA’s announcement of an investigation into Sputnik V’s compliance with international scientific and ethical standards is part of regular procedure. It is unknown whether similar procedures have been carried out for other vaccines.
RESPONSE
This article implies that the EMA is biased against Sputnik V and is applying extraordinary measures to stifle its acceptance in the EU. The notion that Western states are discrediting Sputnik V due to their anti-Russian sentiments is a recurrent disinformation narrative used by the Kremlin in its politicization of COVID-19 vaccines.
In fact, EMA started a rolling review of the Sputnik V vaccine on 4 March 2021 by application of R-Pharm Germany GmbH. Concerns were initially expressed, including by Russian scientists, regarding Sputnik V’s fast approval in Russia before phase III clinical trials had begun and before publishing the results from phases I and II. There was also confusion in February 2021 regarding the start of the rolling review as the EMA and the developers of Sputnik V diverged on whether an application for approval had been filed. Nevertheless, there is no evidence to support the claim that EMA’s review is biased against the Russian vaccine.
The good manufacturing practice (GMP) and the Good Clinical Practice (GCP), which the article is referring to, are internationally accepted standards and all new medicinal products are checked for compliance by the EMA. Prior to travelling to Russian production facilities as part of the rolling review, the head of the EMA commented that it was her hope that Sputnik V would receive approval and that the agency is “committed to applying the same standards and scrutiny to this review as to any other scientific assessments”.
In April 2021, representatives of Russia’s sovereign wealth fund, which funded the development of Sputnik V, stated that they “are not aware of any concerns from the EMA regarding GCP” and that “Sputnik V team is going through a regular rolling review of EMA, in which good clinical practice is a part of the standard procedure for all vaccines”.
Similar disinformation cases claim that the EU is attacking Sputnik V just because it is Russian, that the head of the EMA stated she would seek to ban the Russian vaccine, that mass fatalities will be fabricated in Italy in order to discredit Sputnik V, that EMA’s delay in approving the Sputnik V is political and that Russia’s enemies are afraid of the advantage of Sputnik V and Russia’s leadership.