DISINFO: EMA is still biased against Sputnik V while there are no concerns about side effects
SUMMARY
The European Medicines Agency (EMA) insists on a preferential stance on Western vaccines against COVID-19. However, according to the newest analysis appearing in the "Nature" journal, there are no side effects and, particularly, thrombosis caused by the Russian vaccine, compared to the vaccines made by Western pharmaceutical companies.
RESPONSE
A recurring disinformation narrative about the Sputnik V targeting the European Medicines Agency (EMA).
First of all, the article in the "Nature" journal on Sputnik V offers a more nuanced view than the one presented in this report. It does not actually say that there is a correlation between Western vaccines and thrombosis while mentioning that phase III study of Sputnik V concerns a small number of cases to reach safe conclusions.
The relevant abstract from the "Nature" journal article reads as follows:
Virologist Alyson Kelvin at Dalhousie University in Halifax, Canada, says there is a theory that the clotting disorder is associated with viral-vector vaccines, but adds, “I don’t think we have exact causation of what component of those vaccines are causing it”, or whether Sputnik might also be affected. She notes that although the phase III study of Sputnik V enrolled only 21,977 people, and thus was too small to pick up rare adverse events, the vaccine is now in use globally, which means that reports should appear “if a safety signal comes up”. It is not clear whether Russia is in a position to detect such rare events, however.
Additionally, claims that the EU or its regulatory bodies are biased against the Russian vaccine or that EU officials are blocking its certification are not supported by evidence. 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. The EMA applies the same regulatory approach to all vaccine applications to check them for safety and efficacy. According to reporting by Reuters, the developer of Sputnik V missed a recent deadline of 10 June 2021, to submit required data, which may postpone the approval process.
See related earlier disinformation claims, alleging that EMA deliberately delays registration of Sputnik V; that high-level EU officials delay Sputnik V authorisation by EMA; that non-recognition of Sputnik V by EMA has a political background.