DISINFO: Non-recognition of Sputnik V by EMA has a political background
SUMMARY
Regarding the recognition of vaccines, the EU regulatory authorities (represented by the European Medicines Agency) have not yet registered Sputnik V. But I hope that all of us together will be able to overcome this contradiction, which has a political background that is not so grounded in sanitary and epidemic well-being.
RESPONSE
Recurrent disinformation message around Sputnik V targeting the European Medicines Agency (EMA).
There is no evidence of 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 a visit to 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 a Lancet article published on 12 May 2021, critical questions about the Sputnik V data for phase III clinical trial were raised.
There is no Russophobia in the way in which 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 its 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 voluntary delayed for political or economic reasons.