EMA to begin certification for Russia's Sputnik vaccine

The European Medicines Agency (EMA) is set to begin reviewing Russia's Sputnik-V coronavirus vaccine, the firm accounted on Thursday.

The vaccine, which has been treated with a degree of skepticism from the international community, was technically the first Covid vaccine rolled out in the EU, with a government immunisation programme being launched days before the Pfizer vaccine was given approval in the UK, albeit only in Russia.

Read more: EU Chief Von der Leyen issues Covid vaccine export warning at virtual EU summit

A decision made by the EMA's human medicines committee (CHMP) is based on clinical trials conducted on both adults and children.

These studies indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against COVID-19,” the agency said in a statement.

It added: “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."

The jab has already been imported into a number of EU nations, such as Hungary and Slovakia, despite warnings from the Commissions about it standing to potentially undermine "trust" in the bloc's vaccine rollout and vaccines in general.


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