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EMA Clarifies Position on Sputnik V European Approval Process

February 11, 2021
BioPharm International Editors

EMA has clarified its position on the European approval process of the Sputnik V vaccine.

The European Medicines Agency (EMA) has issued a statement, clarifying its position on the European approval process of the Sputnik V vaccine, which is being developed by the Gamaleya National Centre of Epidemiology and Microbiology in Russia.

According to a Feb. 10, 2021 press release, the regulatory body has asserted that, despite reports stating the contrary, it has not received an application for the rolling review or a marketing authorization of Sputnik V. EMA has provided the vaccine’s developers with scientific advice and is in dialogue with the developers regarding next steps.

Sputnik V developers have expressed an interest in submitting the vaccine for rolling review consideration—a process that can only be employed during emergency situations. However, EMA’s Committee for Medicinal Products for Human Use needs to agree that the vaccine is suitable to progress via the accelerated review procedure prior to submission of the application.

Furthermore, EMA emphasized in the statement that any new assessments of COVID-19 vaccines or medicines being undertaken by the agency would be promptly announced so that the public are informed. Therefore, if there has been no communication from EMA regarding a vaccine or medicine, then the status of that specific therapy remains unchanged.

Source: EMA