EMA announces study into Russian Sputnik V coronavirus (COVID-19) vaccine

EMA announces study into Russian Sputnik V coronavirus (COVID-19) vaccine

The European Medicines Agency (EMA) has announced that its human medicines committee (CHMP) has begun a rolling review into a Russian coronavirus (COVID-19) vaccine, Sputnik V. Studies of the vaccine so far have suggested it produces the desired immune response in adults to protect against COVID-19. EMA has therefore decided to assess whether the known benefits outweigh the known risks and whether the drug complies with EU standards on safety, quality and effectiveness.

A rolling review is a regulatory tool available during public health emergencies that can be used to quicken the study of a promising medicinal drug.

Source: EMA starts rolling review of the Sputnik V COVID-19 vaccine

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