DISINFO: EMA deliberately delays registration of Sputnik V
SUMMARY
Although Sputnik V is officially recognised in 46 countries of the world, there are only two European states among them - Hungary and Slovakia. The European Medicines Agency (EMA) launched a procedure for the consistent examination of the registration dossier of the Russian vaccine on March 4. But the matter did not get off the ground. In Moscow, they are sure: they are deliberately delaying. The EMA received in this regard signals from the high offices of the European Union.
The countries of the EU are ready to purchase a reliable and safe vaccine. However, Brussels does not allow this.
RESPONSE
Recurrent disinformation message around the Sputnik V targeting the European Medicines Agency (EMA).
There is no evidence of the EU or its regulatory bodies' bias against the Russian vaccine or that EU officials are blocking its certification. EMA Executive Director Emer Cooke said she hoped the Sputnik V vaccine would be approved. For that EMA is conducting a rolling review including visiting Russian facilities.
The EMA has certified four vaccines so far. The rolling review of Sputnik V was launched on 4 March 2021. Pro-Kremlin media often quote an article in The Lancet magazine, which showed 91.6 per cent effectiveness of Sputnik V without considerable side effects. However, there have been some doubts as to its efficacy, especially where the trial procedures are concerned (see here and here.) Recently, in the Lancet article published 12 May 2021 critical questions about the Sputnik V data for phase III clinical trial were raised.
There is no Russophobia in the way the EMA is dealing with the Sputnik V vaccine.
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 and EU leaders have publicly stated they would welcome Sputnik V if it meets the same standards for vaccines.
Read also related stories: EU prepares new smear campaign against Russia, accuses it of anti-vax activities, The head of the EMA stated that she would seek to ban Russian vaccine, EMA's delay in approving Sputnik V is political; Registration of Sputnik V in the EU is voluntarily delayed for political or economic reasons.