EU Regulator to Make Decisions on Sputnik V Vaccine Based Only On Scientific Data

BRUSSELS (Sputnik) – The European Medicines Agency (EMA) will review the compliance of Sputnik V, a Russian vaccine against COVID-19, with standards of the European Union and make recommendations based solely on the scientific data, a spokesperson from the EMA told Sputnik on Tuesday.

According to the spokesperson, the EMA is currently evaluating Sputnik V via a rolling review procedure. The representative added that the EU drug regulator will make its recommendations on Sputnik V based solely on scientific data on the effectiveness and safety of the Russian vaccine and nothing else.

The EMA spokesperson also said that the regulator will review data on Sputnik V as it becomes available to decide if the benefits of the vaccine outweigh its risks.

A healthcare worker prepares a dose of Russia's coronavirus vaccine Gam-COVID-Vac, trade-named Sputnik V, at a coronavirus vaccination center at a shopping mall, in Moscow, Russia.

In August 2020, Russia became the first country in the world to register a vaccine against the coronavirus, dubbed Sputnik V, and developed by the Gamaleya research institute.

According to analysis of phase 3 clinical trials of Sputnik V, published by The Lancet medical journal, Sputnik V has 91.6 percent efficacy against symptomatic COVID-19.

On Thursday, EMA announced that it had started a rolling review to test the Russian vaccine for compliance with EU standards for effectiveness, safety and quality.

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