DISINFO: EMA will try to postpone the authorisation of Sputnik V
SUMMARY
The European Medicines Agency (EMA) is going to do everything it can to postpone the authorisation of the Russian vaccine Sputnik V.
RESPONSE
Pro-Kremlin disinformation about vaccines, including Sputnik V.
R-Pharm Germany GmbH applied for a rolling review of Sputnik V (Gam-COVID-Vac) by the EMA in March 2021. The EMA has initiated the rolling review of the vaccine on the 4 March, 2021.
Before that, the developer of Sputnik V received scientific advice from the EMA, providing them with the latest regulatory and scientific guidance for the development of the vaccine.
A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine during a public health emergency. EMA will evaluate data as they become available to decide if the benefits of the vaccine outweigh the risks. The rolling review will continue until enough evidence is available for formal marketing authorisation application.
Busy work is in progress and EMA will assess Sputnik V’s compliance with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.
See related disinformation cases alleging that EMA's delay in approving Sputnik V is political; and that Russian vaccine opponents are trying to eradicate trust in Sputnik V;