DISINFO: Europe is delaying registration of Sputnik V
SUMMARY
The registration of the Russian vaccine in Europe is being delayed so that competitors have time to sign long-term contracts.
The delays in the registration of the Russian vaccine in Europe are related to the commercial interests of those who do it. When the European agency [EMA] gives permission to use the Russian vaccine in Europe, it turns out that the market is busy, long-term contracts have been signed, the train has left for Russian companies.
RESPONSE
Recurrent disinformation message around Sputnik V targeting the European Medicines Agency (EMA).
There is no evidence of the EU or its regulatory bodies' bias against the Russian vaccine. EMA and EU leaders have publicly stated they would welcome Sputnik V if it meets the applied standards for vaccines. 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 the Lancet article published on 12 May 2021, critical questions about the Sputnik V data for the phase III clinical trial were raised.
According to reporting by Reuters, the developer of Sputnik V missed a recent deadline of June 10, 2021 to submit required data, which may postpone the approval process.
There is no Russophobia or commercial aspect 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.
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; The West criticises the Russian vaccine because their companies will lose billions of dollars